Clean Needle TechniqueManual

Best Practices for AcupunctureNeedle Safety

and Related Procedures

7th Edition

Published by the Council of Colleges of Acupuncture and Oriental Medicine©2015

CCAOMCleanNeedleTechniqueManual

7thEdition

BestPracticesforAcupunctureNeedleSafetyandRelatedProcedures

SeventhEdition

Revised May 2017

CouncilofCollegesofAcupunctureandOrientalMedicine

www.ccaom.org

©2015bytheCouncilofCollegesofAcupunctureandOrientalMedicine.

ReviewedandupdatedMay 19, 2017.

Allrightsreserved,includingtherighttoreproducethisworkinanyformwhatsoever,withoutpermissioninwritingfromthepublisher,exceptforbriefpassagesinconnectionwithareview.

PrintedintheUnitedStatesofAmerica

ISBN978-0-9963651-0-9

Editor:JenniferBrett,N.D.,L.Ac.

CoverDesign:RobertaMcGrew

CoverPhotos:Leaf©123RF.com,NanetteGrebe©123RF.com

TheCleanNeedleTechnique(CNT)Manualisintendedforuseprimarilybystate-licensedacupuncturistsandstudentsenrolledinaformalcourseofinstructionataschoolapprovedbytheAccreditationCommissionforAcupunctureandOrientalMedicine.Asastatementofbestpracticesconcerningacupunctureneedlingandrelatedtechniques,themanualmayalsobebeneficiallyusedbystate-licensedhealthcareprofessionalsinotherdisciplineswhohaveacupunctureandrelatedmodalitieswithintheirlawfulscopeofpracticeandbyacupuncturistsoutsidetheUnitedStateswhoareappropriatelyauthorizedtopracticeacupuncturewithintheirrespectivenationaljurisdictions.Themanualisnotintendedforusebypersonswithoutformaltrainingandregulatoryauthorizationtopracticeacupuncture.Themanualfocusesonsafetyandisnotaguidetoappropriatetreatmentforparticularhealthconditions.Whilethemanualisintendedtoreflectbestpracticesasofthedateofpublication,opinionsastobestpracticesmaydifferandchangeovertime.Ongoingstudyanddebateconcerningbestpracticeswithintheacademicandpractitionercommunitiesisencouraged.TheCouncilassumesnoliabilityforanyinjurythatmayoccurasaresultofapractitioner'suseof,orrelianceupon,anysafetyprotocolcontainedinthismanual.

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TableofContentsPreface..............................................................................................................................................xiv

Acknowledgements...........................................................................................................................xvi

Introduction......................................................................................................................................xvii

References.........................................................................................................................................xix

PartI:AOMClinicalProcedures,Safety,AdverseEvents(AEs)andRecommendationstoReduceAEs..1

References...........................................................................................................................................2

1.Acupuncture........................................................................................................................................3

Safety/AdverseEvents–AReviewoftheLiterature...........................................................................3

PreventingAcupunctureNeedlingAdverseEvents.............................................................................4

BruisingandBleeding......................................................................................................................4

SafetyGuidelinestoPreventBruising,Bleeding,andVascularInjury..........................................5

NeedleSitePain/Sensation..............................................................................................................5

SafetyGuidelinestoPreventNeedleSitePain.............................................................................6

Fainting............................................................................................................................................7

SafetyGuidelinestoPreventFainting..........................................................................................7

StuckNeedle....................................................................................................................................7

SafetyGuidelinestoAvoidand/orRespondtoStuckNeedle.......................................................8

FailuretoRemoveNeedles..............................................................................................................8

SafetyGuidelinesforNeedleRemoval.........................................................................................9

AggravationofSymptoms................................................................................................................9

SafetyGuidelinesforAggravationofSymptoms........................................................................10

PreventingRarebutSeriousAdverseEvents(SAEs)AssociatedwithAcupunctureNeedling...........10

Pneumothorax...............................................................................................................................10

SafetyGuidelinestoAvoidPneumothorax.................................................................................12

InjurytoOtherOrgans...................................................................................................................13

CentralNervousSystemInjury......................................................................................................15

SafetyGuidelinestoAvoidOrganandCentralNervousSystemInjury......................................15

TraumaticTissueInjury..................................................................................................................15

PeripheralNerves......................................................................................................................15

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BloodVessels.............................................................................................................................16

SafetyGuidelinestoAvoidTraumaticTissueInjury...................................................................16

Infections.......................................................................................................................................16

SafetyGuidelinestoPreventInfection.......................................................................................17

BrokenNeedle...............................................................................................................................18

SafetyGuidelinestoPreventBrokenNeedles............................................................................19

References.........................................................................................................................................19

2.Moxibustion.......................................................................................................................................24

Safety/AdverseEvents–AReviewoftheLiterature.........................................................................24

PreventingMoxibustionAdverseEvents...........................................................................................25

Burns..............................................................................................................................................25

SafetyGuidelinestoPreventMoxaBurns..................................................................................26

SecondaryInfectionfromMoxaBurns..........................................................................................26

SafetyGuidelinestoPreventSecondaryInfectionfromMoxaBurns.........................................27

NauseaorOtherAdverseReactionstoMoxaSmoke....................................................................27

SafetyGuidelinestoPreventAdverseReactionstoMoxaSmoke..............................................27

OtherHeatTherapies.....................................................................................................................27

SafetyGuidelinesforHeatTherapiesOtherthanMoxa............................................................28

References.........................................................................................................................................29

3.Cupping..............................................................................................................................................31

Safety/AdverseEvents–AReviewoftheLiterature.........................................................................31

FireCupping...................................................................................................................................31

SuctionCupping.............................................................................................................................32

WetCupping..................................................................................................................................32

OtherCuppingProcedures.............................................................................................................32

CuppingAdverseEvents....................................................................................................................32

SkinReactions................................................................................................................................32

Cardiovascular................................................................................................................................33

Infections.......................................................................................................................................34

PreventingCuppingAdverseEvents..................................................................................................35

Burns..............................................................................................................................................35

SafetyGuidelinestoAvoidFireCuppingBurns..........................................................................35

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Infections.......................................................................................................................................35

SafetyGuidelinestoPreventCupping-RelatedInfections..........................................................36

StandardsforReuseofCuppingDevices.......................................................................................36

CleaningandDisinfectingCups......................................................................................................37

SafetyGuidelinesforCupDisinfection.......................................................................................38

ExtensiveBruising&OtherSkinLesions........................................................................................39

SafetyGuidelinesforPreventingCuppingSkinLesions..............................................................39

UnintendedDeepPenetrationoftheNeedle................................................................................39

SafetyGuidelinesforNeedleCupping........................................................................................40

SafetyGuidelinestoPreventCuppingAdverseEvents...............................................................40

References.........................................................................................................................................40

4.Electroacupuncture(EA)....................................................................................................................43

Safety/AdverseEvents–AReviewoftheLiterature.........................................................................43

ExcessiveCurrent...........................................................................................................................44

AnatomicalConsiderations............................................................................................................44

PreventingEAAdverseEvents...........................................................................................................45

SafetyGuidelinesforPreventingEAAdverseEvents..................................................................45

InjuriesDuetoMuscleContraction...............................................................................................45

SafetyGuidelinesforPreventingExcessiveMuscleContractionDuringEA...............................45

ElectricalInjury..............................................................................................................................46

SafetyGuidelinesforPreventingElectricalInjuryDuringEA......................................................46

InterferencewithaCardiacPacemaker.........................................................................................46

SafetyGuidelinesforPreventingInterferencewithaCardiacPacemakerDuringEA................46

References.........................................................................................................................................46

5.TherapeuticBloodWithdrawal..........................................................................................................48

Safety/AdverseEvents–AReviewoftheLiterature.........................................................................48

PreventingAcupunctureBleedingTherapyAdverseEffects..............................................................49

SafetyGuidelinesforAcupunctureBleedingTherapy................................................................50

References.........................................................................................................................................50

6.GuaSha..............................................................................................................................................52

Safety/AdverseEvents–AReviewoftheLiterature.........................................................................52

PreventingGuaShaAdverseEvents..................................................................................................53

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SafetyGuidelinesforGuaSha....................................................................................................53

DisinfectionofGuaShaDevices.....................................................................................................54

SafetyGuidelinesforDisinfectionofGuaShaTools...................................................................55

References.........................................................................................................................................55

7.PlumBlossomNeedling.....................................................................................................................57

Safety/AdverseEvents–AReviewoftheLiterature.........................................................................57

PreventingPlumBlossomNeedlingAdverseEvents.........................................................................57

SafetyGuidelinesforPlumBlossom(SevenStar)Therapy.........................................................57

References.........................................................................................................................................58

8.PressTacksandIntradermalNeedles................................................................................................59

Safety/AdverseEvents–AReviewoftheLiterature.........................................................................59

AuricularTherapy/PressTacks.......................................................................................................59

IntradermalNeedling.....................................................................................................................59

SafetyGuidelinesfortheUseofPressTacksorIntradermalNeedling......................................60

References.........................................................................................................................................61

9.EarSeeds............................................................................................................................................63

Safety/AdverseEvents–AReviewoftheLiterature.........................................................................63

PreventingEarSeedAdverseEvents.................................................................................................63

SafetyGuidelinesfortheUseofEarSeeds.................................................................................63

References.........................................................................................................................................63

10.TuiNa...............................................................................................................................................64

Safety/AdverseEvents–AReviewoftheLiterature.........................................................................64

PreventingTuiNaAdverseEvents.....................................................................................................65

SafetyGuidelinesforTuiNa.......................................................................................................65

References.........................................................................................................................................65

11.OtherAcupuncture-RelatedTools...................................................................................................67

Manaka/JapaneseAcupunctureTools...............................................................................................67

AReviewoftheLiterature.............................................................................................................67

PreventingAdverseEvents............................................................................................................67

ShonishinPediatricJapaneseAcupunctureTools..............................................................................67

AReviewoftheLiterature.............................................................................................................67

PreventingCommonAdverseEvents.............................................................................................67

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PartII:BestPracticesforAcupuncture-CNT......................................................................................68

1.CNTProtocol......................................................................................................................................68

HandSanitation.................................................................................................................................69

SafetyGuidelinesforHandSanitation...........................................................................................69

PreparingandMaintainingaCleanField...........................................................................................70

SafetyGuidelinesforPreparingandMaintainingaCleanField.....................................................70

SkinPreparation.................................................................................................................................71

AlcoholSwabMethod....................................................................................................................72

SafetyGuidelinesforSkinPreparation...........................................................................................73

IsolationofUsedSharps....................................................................................................................73

StandardPrecautions.........................................................................................................................74

BasicStepsoftheCleanNeedleTechniqueforAcupuncture............................................................74

2.CNTBasicPrinciples...........................................................................................................................76

SettingUptheCleanField..................................................................................................................77

InspectingNeedlePackagingPriortoUse.........................................................................................78

SkinPreparation.................................................................................................................................78

PalpatingthePoint............................................................................................................................78

InsertingNeedletoCorrectDepth.....................................................................................................79

NeedleRemoval.................................................................................................................................80

DealingwithBloodtoBloodContact.................................................................................................80

ManagingUsedNeedles................................................................................................................80

CountingNeedles...........................................................................................................................81

3.CNTinanOfficeSetting.....................................................................................................................82

TreatmentProtocolinanOfficeSetting............................................................................................82

4.CNTforHouseCalls/TravelSetting....................................................................................................84

TravelKit/TravelKitCarrier...............................................................................................................84

CleanItems....................................................................................................................................84

Non-CleanItems............................................................................................................................85

TravelKitItemsNotinBags...........................................................................................................85

HandCleanser................................................................................................................................86

TravelSharpsContainer.................................................................................................................86

PreparingtheKit................................................................................................................................86

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TreatmentProtocolinaTravelSetting..............................................................................................86

5.CNTinaCommunityAcupunctureClinicorNADASetting................................................................89

TreatmentProtocolinaCommunityClinicorNADASetting.............................................................89

6.CNTinaPublicHealthSetting............................................................................................................91

Handwashing.....................................................................................................................................91

AcupunctureEquipment....................................................................................................................92

PositioningthePatient.......................................................................................................................92

RemovingNeedles.............................................................................................................................92

PotentialComplications.....................................................................................................................93

7.ToyohariAcupuncture.......................................................................................................................94

ModificationstoStandardCleanNeedleTechniqueforContactNeedling.......................................94

8.SummaryofSafetyRecommendationsforCleanNeedleTechnique................................................95

References.........................................................................................................................................98

PartIII:BestPracticesforRelatedAOMOfficeProcedures...............................................................101

1.Moxibustion.....................................................................................................................................102

MoxibustionOverview.....................................................................................................................102

GeneralMoxibustionPrecautions...................................................................................................103

MoxaBestPracticeGuidelines.........................................................................................................104

DirectMoxibustion-TechniqueforNon-ScarringMoxibustionwithMoxaCones.....................104

Method....................................................................................................................................104

SafetyConsiderations..............................................................................................................105

DirectMoxibustion-TechniqueforScarringMoxibustionwithMoxaCones.............................105

Method....................................................................................................................................105

SafetyConsiderations..............................................................................................................106

IndirectMoxibustion–TechniquewithInterposedMoxibustion................................................107

Method....................................................................................................................................107

SafetyConsiderations..............................................................................................................108

IndirectMoxibustion-WarmingNeedleMoxibustion................................................................108

Method....................................................................................................................................108

SafetyConsiderations..............................................................................................................109

IndirectMoxa–TechniquewithMoxaStick................................................................................110

Method....................................................................................................................................110

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SafetyConsiderations..............................................................................................................110

MoxaDisposal..............................................................................................................................111

2.HeatLamps......................................................................................................................................112

BestPracticeProtocolsforHeatLamps...........................................................................................112

Method........................................................................................................................................112

SafetyConsiderations..................................................................................................................112

3.Cupping............................................................................................................................................114

CuppingOverview............................................................................................................................114

GeneralRecommendationsforCupping..........................................................................................114

SampleBestPracticeProtocolsforCupping....................................................................................115

FireCuppingMethod...................................................................................................................116

SafetyConsiderations..................................................................................................................116

SuctionCupping...............................................................................................................................117

Method........................................................................................................................................117

WetCupping....................................................................................................................................117

Method........................................................................................................................................118

4.TherapeuticBloodWithdrawal........................................................................................................119

BleedingOverview...........................................................................................................................119

GeneralRecommendationsforBleedingTechniques......................................................................119

SampleBestPracticeProtocolforBleedingAcupuncturePoints....................................................119

Method........................................................................................................................................120

5.PlumBlossom/SevenStarNeedle....................................................................................................122

PlumBlossomOverview..................................................................................................................122

GeneralRecommendationsforPlumBlossom................................................................................122

BestPracticeProtocolsforPlumBlossom.......................................................................................122

Method........................................................................................................................................123

6.GuaSha............................................................................................................................................124

GuaShaOverview............................................................................................................................124

SummaryofGuaShaRecommendations........................................................................................124

GuaShaBestPracticeProtocols......................................................................................................125

Method........................................................................................................................................125

7.AcupointInjectionTherapies...........................................................................................................126

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AcupointInjectionTherapyBestPracticeProtocols........................................................................127

SafetyConsiderations..................................................................................................................128

SummaryofSafetyRecommendationsforCleanInjectionTechnique............................................129

References.......................................................................................................................................129

PartIV–InfectionsAssociatedwithAcupunctureandRelatedHealthcarePractices........................131

1.Pathogens........................................................................................................................................131

2.MechanismsofDiseaseTransmission..............................................................................................131

AutogenousInfections.....................................................................................................................132

Cross-Infections...............................................................................................................................132

3.BloodbornePathogens....................................................................................................................133

Hepatitis...........................................................................................................................................133

HepatitisA(HAV).............................................................................................................................134

HepatitisASurvivalintheEnvironment......................................................................................134

HepatitisB(HBV).............................................................................................................................135

TransmissionofHBV....................................................................................................................135

HBVSurvivalintheEnvironment.................................................................................................136

IndividualsatRiskofHBVInfection.............................................................................................136

ExposuretoHBV..........................................................................................................................137

HBVVaccination...........................................................................................................................137

TheHBVInfectionProcess...........................................................................................................138

TreatmentofHBV........................................................................................................................139

HepatitisC(HCV)..............................................................................................................................139

AcuteSymptomsofHepatitisC...................................................................................................140

RiskFactorsforHCVInfection......................................................................................................140

HCVSurvivalintheEnvironment.................................................................................................141

ConsequencesofHCVInfection...................................................................................................141

HepatitisD(HDV).............................................................................................................................141

HDVSurvivalintheEnvironment.................................................................................................142

HepatitisE(HEV)..............................................................................................................................142

ChronicCarriersofHepatitis............................................................................................................142

PreventionofHepatitis....................................................................................................................143

Table1:SummaryofHepatitisCharacteristics............................................................................143

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HumanImmunodeficiencyDisease(HIV)........................................................................................143

HIVTransmission.........................................................................................................................144

HIVSurvivalintheEnvironment..................................................................................................145

RiskofTransmissionthroughInvasiveProcedures......................................................................145

IndividualsatRiskofHIVInfection..............................................................................................145

Testing..........................................................................................................................................146

Reporting.....................................................................................................................................147

TheHIVInfectionProcess............................................................................................................147

TreatmentofHIV.........................................................................................................................148

AdditionalRiskstoHealthcareWorkers(HCWs).........................................................................148

4.OtherHealthcareAssociatedInfections..........................................................................................149

Tuberculosis.....................................................................................................................................149

TBSurvivalOutsideHost..............................................................................................................151

AcupunctureTBSafety.................................................................................................................151

SkinInfections..................................................................................................................................151

Staphylococcus............................................................................................................................151

Methicillin-ResistantStaphylococcusAureus(MRSA).................................................................152

Prevention................................................................................................................................152

MRSASurvivalintheEnvironment..........................................................................................153

Streptococcus..............................................................................................................................153

MycobacteriaOtherthanTuberculosis(MOT)............................................................................153

HerpesSimplex............................................................................................................................154

Influenza..........................................................................................................................................155

InfluenzaSurvivalintheEnvironment.........................................................................................155

CDCFundamentalElementstoPreventInfluenzaTransmission.................................................156

Norovirus.........................................................................................................................................156

PreventionofNorovirus...............................................................................................................156

Clostridiumdifficile..........................................................................................................................157

PreventionofSpreadofClostridiumdifficile...............................................................................158

5.SummaryofPreventionofDiseaseTransmissioninAcupuncturePractice.....................................159

BasicCriticalPrinciples.....................................................................................................................159

PreventingPatienttoPatientCrossInfections–CriticalRecommendations..................................159

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PreventingPatienttoPractitionerCrossInfections.........................................................................159

PreventingPractitionertoPatientCrossInfections.........................................................................159

Review..............................................................................................................................................160

References.......................................................................................................................................160

PartV:PersonnelHealth,CleanlinessandSafetyPractices...............................................................168

1.Handwashing...................................................................................................................................168

EffectiveHandwashingTechnique...................................................................................................169

HandHygieneTechnique:SoapandWater.....................................................................................169

HandDrying.....................................................................................................................................170

HandHygieneTechnique-Alcohol-BasedSanitizers.......................................................................170

Handwashing-AntisepticTowelettes.............................................................................................170

HandFlora........................................................................................................................................171

Rings/Jewelry...................................................................................................................................171

HealthcareworkersandActualHandwashingPractices..................................................................171

NecessityofHandwashing...............................................................................................................171

Whatistherightwaytowashyourhands?.....................................................................................172

Recommendations...........................................................................................................................173

2.PatientSkinPreparation..................................................................................................................173

AlcoholSwabMethod......................................................................................................................175

OptionsforSkinPreparation...........................................................................................................175

Recommendations...........................................................................................................................176

3.RecommendationsforPractitionerHealthandHygiene.................................................................176

YearlyPhysical.................................................................................................................................177

Clothing............................................................................................................................................177

HandCare........................................................................................................................................177

PersonalHealth................................................................................................................................177

TestingforTB,HBV,HCVandHIV....................................................................................................178

TBtesting.....................................................................................................................................178

HBVtesting..................................................................................................................................178

HCVtesting..................................................................................................................................178

HIVtesting....................................................................................................................................179

4.PersonalProtectiveEquipment(PPE)..............................................................................................179

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Areglovesneededforacupunctureneedleinsertion?....................................................................181

Areglovesneededforacupunctureneedleremoval?.....................................................................182

5.NeedlestickInformation..................................................................................................................183

References.......................................................................................................................................183

PartVI:CleaningandPathogenReductionTechniquesinHealthcareandAOMPracticeLocations...189

1.Disinfectants....................................................................................................................................189

ClassificationsofDisinfectants.........................................................................................................190

TypesofDisinfectants......................................................................................................................190

ChlorineandChlorineCompounds..............................................................................................190

MicrobiocidalActivity..............................................................................................................191

Glutaraldehyde............................................................................................................................191

Hydrogenperoxide......................................................................................................................192

Iodophors.....................................................................................................................................192

Phenol..........................................................................................................................................192

EPAandFDAApprovalofDisinfectants...........................................................................................192

MonitoringandLabelingofDisinfectants........................................................................................192

2.IndicationsforSterilization,High-LevelDisinfection,andLow-LevelDisinfection..........................193

3.CleaningEquipment.........................................................................................................................193

ReuseofSingle-UseMedicalDevices...............................................................................................193

Pre-cleaningofReusableMedicalEquipment.................................................................................193

InstrumentCleaning........................................................................................................................194

SafetyGuidelinesforDisinfectingReusableMedicalEquipment................................................194

4.CleanUseofLubricants....................................................................................................................196

5.CleaningandDisinfectingEnvironmentalSurfacesinHealthcareFacilities....................................196

UseofDisinfectantsforSurfaceCleaning........................................................................................197

6.BloodorBodyFluidSpills.................................................................................................................197

7.LaunderingSheets,TowelsorOtherLinens.....................................................................................198

8.SharpsandNon-SharpsBiohazardEquipmentandDisposal...........................................................198

9.RegulatedWaste..............................................................................................................................199

Disposal............................................................................................................................................200

ContaminatedLaundry....................................................................................................................200

SummaryofRecommendations–PartVI............................................................................................201

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References.......................................................................................................................................202

PartVII:OfficeProceduresforRiskReduction..................................................................................204

1.FederalStandardsandGuidelines...................................................................................................205

OSHA:BloodbornePathogensStandard..........................................................................................205

StandardPrecautions.......................................................................................................................206

NSPA................................................................................................................................................206

OSHA:ExposureControlPlan..........................................................................................................207

OSHA:HazardousCommunication..................................................................................................210

OSHA:OtherHazards.......................................................................................................................211

OSHA:DisposingofBiohazardousWaste........................................................................................211

Discardinggloves,cottonballsandothermaterialcontaminatedwithblood............................213

Whatshouldpatientsdowithpresstacksorotherimbeddeddevicesthattheyneedtoremoveathome?......................................................................................................................................213

2.SafetyConsiderationsRegardingthePracticeEnvironment...........................................................214

3.Recordkeeping.................................................................................................................................215

Charting...........................................................................................................................................215

GeneralChartingConsiderations.................................................................................................215

StandardRequirementsforAOMcharting..................................................................................217

DailyAppointmentSchedules..........................................................................................................219

4.PatientConfidentiality.....................................................................................................................219

HIPAAHealthInformation...............................................................................................................219

ReportingofCommunicableDiseaseandAbuse.............................................................................221

5.InformedConsent............................................................................................................................221

6.High-RiskPatients............................................................................................................................222

7.OtherImportantSafetyPractices....................................................................................................222

PreventingTripsandFalls................................................................................................................222

HowtoPreventFallsDuetoSlipsandTrips................................................................................223

ResponsetoaBodilyFluidSpill........................................................................................................223

FirstAid............................................................................................................................................223

MentalHealthIssues/Suicide..........................................................................................................224

8.SummaryofRecommendations–PartVII.......................................................................................224

References.......................................................................................................................................225

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PartVIII–Appendices......................................................................................................................227

AppendixA:Glossary/Abbreviations...................................................................................................227

AppendixB:WheretoFindMoreInformation....................................................................................233

HealthcareAssociatedInfections.....................................................................................................233

CDC/SpecificPathogens...................................................................................................................233

Hepatitis.......................................................................................................................................233

HIV...............................................................................................................................................234

TB.................................................................................................................................................234

OtherDiseases.............................................................................................................................234

Handwashinginformationanddetails.........................................................................................235

StandardPrecautions...................................................................................................................235

OSHADocumentsandTrainingRequirements................................................................................235

OSHABloodbornePathogenStandards.......................................................................................235

ExposureControlPlan(ECP)Samples..........................................................................................235

OSHADocumentsRelatingtoECPs..............................................................................................235

HazardousCommunication..........................................................................................................235

HIPAA...............................................................................................................................................236

AppendixC:AcupuncturePointsthatRequireSpecialSkill.................................................................237

References.......................................................................................................................................239

CleanNeedleTechnique7thEditionFAQ.........................................................................................240

Index...............................................................................................................................................246

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Preface

TheprofessionofacupunctureandOrientalmedicine(AOM)intheUnitedStatescontinuestogrowandevolve.Aspartofthisevolution,practitionersareprovidingacupunctureservicesinhospitals,integratedmedicalcenters,andteachingclinics.Asmoreacupuncturistsprovidecareinthiscomplexarrayofintegratedsettings,theneedforevidenced-basedbestpracticesinsafetyisessential.AcupunctureeducationintheU.S.hasevolvedtomeetthischallenge.Accordingly,AOMinstitutionsthathaveachievedaccreditationoraccreditationcandidacystatuswiththeAccreditationCommissionforAcupunctureandOrientalMedicine(ACAOM)continuetoexpandtheircurriculumtomeetthechangingneedsoftheprofession,includingcourseworkinbioscience,evidence-basedpractice,riskmanagement,andsafeclinicalpractices.

TheinformationavailablefromtheCentersforDiseaseControlandPrevention(CDC),theOccupationalSafetyandHealthAdministration(OSHA),aswellasstateandlocalhealthdepartments,hasalsoevolvedsincethereleaseofpreviouseditionsoftheCleanNeedleTechniqueManual.Changingepidemiologicalpatterns,changesinwhatisconsideredbestpracticesincleanandaseptictechnique,andchangesintechnologyhaveallcontributedtoimprovingclinicalsafety.WhathasnotchangedistheneedforacupuncturiststoapplyCleanNeedleTechniquescrupulouslyassafetyremainsacriticalaspectofclinicalpractice.

ThepurposeoftheCleanNeedleTechniqueManualhasalsoevolved.ThefirsteditionofthemanualwasoneofthefewEnglishlanguagesourcescoveringsafepracticestandardsforacupuncturists.AOMeducationalinstitutionsnowhavearangeofresourcesandanaccreditationmandatetocoverbloodbornepathogens,safepractice,emergencyprocedures,riskmanagement,andsafetyprotocolsintheircurricula.InformationprovidedintheCleanNeedleTechniqueManualhasalsospreadglobally,promotingbettersafetystandardsworldwide.

Needlingandotherrelatedacupunctureproceduresarecarriedoutinauniquemannerwhereneedlesmaybeplacedintotissueandremoved,ormaybeplacedintotissueandresideforaperiodoftimebeforetheirremoval.Othermodalitiesmayalsobeappliedontothesurfaceoftheskinandlikewisebeimmediatelyremovedorretainedforaperiodoftime.Assuch,theapplicationofevidenced-basedbestsafetypracticestakesintoaccountthemannerandtimingoftreatment.IndevelopingtheCleanNeedleTechniqueManual,expertsfromOSHAandtheCDCwereconsultedtoensurethattherecommendationsinthemanualmeetcurrentOSHAandCDCstandards.

TheCleanNeedleTechniqueManualplaysanimportantroleinpreparingacupuncturestudentsforsafepracticeandprovidingbasicinformationrequiredfornationalcertificationin

xv

acupuncturebytheNationalCertificationCommissionforAcupunctureandOrientalMedicine(NCCAOM)andforstatelicensure.ThismanualsummarizesimportantprinciplesthatgovernsafepracticesuitedtosupporttheworkdoneinintroductoryacupuncturetechniquecoursesinacupuncturecollegesandtheCleanNeedleTechniquecourseofferedbytheCouncilofCollegesofAcupunctureandOrientalMedicine(CCAOM).TheinformationinthismanualsupportsandcontributestotheeducationalcurriculaintheareasofAOMofficeproceduresafety,bloodbornepathogens,andriskreductionconcerningacupunctureandotheradjunctivetherapiesaspracticedinprivatepractice,conventionalandCAMintegratedclinicalsettings,andintheteachingclinicsinaccreditedAOMprograms.

ThislatesteditionoftheCleanNeedleTechniqueManualhasbeenexpanded,updated,andexhaustivelyreviewed.Whileeveryefforthasbeenmadetoensurethatup-to-datestatisticswereincludedwithrespecttoadverseeventsarisinginAOMofficepractices,includingthesmallriskofspreadinginfectiousdiseases,itisimportanttorememberthatthesestatisticsareconstantlychanging.AcupuncturepractitionerscanfindupdatedinformationregardinghealthcareassociatedillnessesonU.S.governmentwebsites,anumberofwhicharelistedinAppendixB.

xvi

Acknowledgements

TheseveneditionsoftheCleanNeedleTechnique(CNT)ManualrepresentthecollectivethinkingandenergyofNationalAcupunctureFoundationBoardMembers,NCCAOMCommissioners,CouncilofCollegesofAcupunctureandOrientalMedicineCleanNeedleTechniqueCommitteeMembers,andCNTInstructorsandcolleaguesacrosstheUnitedStates.

TheNationalAcupunctureFoundationBoardMembersinvolvedincludeMalvinFinkelstein,L.Ac.;BarbaraMitchell,J.D.,L.Ac.,(Editor,fourthandfifthedition);WilliamSkelton,L.Ac.;andJamesTurner,J.D.

TherollcalloftheCommissionersoftheNationalCertificationCommissionforAcupunctureandOrientalMedicine(NCCAOM)involvedintheprocessincludesJuneBrazil,L.Ac.;EdithDavis(Editor);GlennEarl,L.Ac.;StevenFinando,Ph.D.,L.Ac.;AlanFrancis;DanielJiao,L.Ac.;StuartKutchins,L.Ac.;JimMcCormick,L.Ac.(Editor);MarkSeem,Ph.D.,L.Ac.;AngelaTu,L.Ac.;andGraceWong,L.Ac.

OtherprofessionalswhomadevaluablecontributionsincludeRezanAkpinar,D.D.S.(Europe),M.S.,L.Ac.,L.M.T.;AnnBailey,L.Ac.;MatthewBauer,L.Ac.;JennyBelluomini,N.D.;MaryC.Bolster,M.S.,R.N.;EdnaM.Brandt,M.Ac.,L.Ac.,Dipl.Ac.;RalphCoan,M.D.;GaryDolowitz,M.D.;RobertDuggan,L.Ac.;KevinErgil,L.Ac.;SteveGiven,D.A.O.M.,L.Ac.;MarthaHoward,M.D.(Editor);HaigIgnatius,M.D.;JosephKay,L.Ac.;DekeKendall,L.Ac.;PatriciaKlucas,R.N.;SuLiangKu,C.A.;ShenPingLiang,L.Ac.;WilliamMueller,L.Ac.;TomRiihimaki;FlorencePatriciaRoth,M.S.,L.Ac.;RonSokolsky,M.S.O.M.,L.Ac.,Dipl.Ac./C.H.;TierneyTully,M.S.O.M.,L.Ac.;BrookeWinter,L.Ac.;JulieZinkus,L.Ac.;andWalterBondoftheCentersforDiseaseControlandPrevention.

JenniferBrett,N.D.,L.Ac.istheprincipaleditorforthepresent7theditionofthemanual.SubstantivecommentsconcerningthemanualwerereceivedbyMichaelJabbour,C.S.P.,M.S.,L.Ac.;LixingLao,Ph.D.,C.M.D.(China),L.Ac.;ZoeBrenner,L.Ac;andtheCouncil’sCNTinstructorsDarleneEaston,M.S.,Dipl.OM,L.Ac.;DanielJiao,D.A.O.M,L.Ac.;XiaotianShen,L.Ac.,M.P.H.;andJamie(Qianzhi)Wu,L.Ac.,M.S.,M.D.(China).CCAOMCNTCo-chairsValerieHobbs,Dipl.OM,L.Ac.;BarbaraEllrich,M.A.;CNTProgramManagerPaulaDiamond,B.A.;CCAOMExecutiveDirectorDavidSale,J.D.,LL.M.,andCCAOMAdminstrativeAssistantMaryValle,B.A.,alsomadesignificanteditorialcontributionstothemanual.AppreciationisexpressedtoJeffreyHageman,M.H.S.,DeputyChief,PreventionandResponseBranch,DivisionofHealthcareQualityPromotion,CentersforDiseaseControlandPrevention;andhiscolleaguesattheCDCfortheircommentsconcerningseveralaspectsofCNTprotocolthatareaddressedinthismanual.AdditionalappreciationisexpressedtoDouglasJ.Kalinowski,Director,DirectorateofCooperativeandStatePrograms,federalOccupationalSafetyandHealthAdministration,forOSHA’scommentsconcerningaCNTprotocolissue.

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Introduction

In1984,attherequestoftheacupunctureprofession,theNationalCertificationCommissionforAcupunctureandOrientalMedicine(NCCAOM)developedguidelinesandrecommendationsforthesafeandcleanpracticeofacupuncture.Theguidelineswerebasedonthetheoryandpracticeofsafetycommonlyusedinhealthcare.Conscientioususeoftheproceduresrecommendedanddescribedinthismanualwillreducetheriskofspreadinginfectionandaccidentsinthepracticeofacupuncture.

Increasingknowledge,alongwiththeapplicationofStandardPrecautions,safeclinicalpractices,andriskmanagementtechniques,reducestheriskofanumberofpotentialadverseeventsrelatedtoacupuncturepractice,reducesthespreadofinfection,andhelpensurepublicsafety.Furthermore,fromthemedical,legal,andethicalperspectives,itisthepractitioner’sresponsibilitytoensurethatCleanNeedleTechniquehasbeenfollowedcorrectly.

Inadditiontogeneralpublichealthsources,suchastheCDC,OSHA’sBloodbornePathogensStandards,andtheU.S.PublicHealthService,theinformationinthismanualhasbeendrawnfromacupunctureresearchthroughouttheworldandadaptedtotheuniquerequirementsandthepracticeofacupuncture.Thus,manyoftherecommendationsinthismanualaremodificationsoftechniquescurrentlyinusethroughouttheUnitedStatesinmanyhealthcareprofessions.TheguidelinesandstandardsthathavebeendevelopedaretheresultofthesynthesisofEastAsianandWesternresourcesfromacademic,research,andclinicalarenas.

Thismanualreflectsthecurrentunderstandingofbestpracticesinthefieldofacupunctureclinicaltechniques.Bestpracticesaredefinedas“activities,disciplinesandmethodsthatareavailabletoidentify,implementandmonitortheavailableevidenceinhealthcare…Theseactivitiesgaininputmainlythroughfourdisciplines:clinicalresearch,clinicalepidemiology,healtheconomicsandhealthservicesresearch.”(1)Inthisapplication,bestpracticeprinciplesarebeingusedtolimitrisksassociatedwithacupunctureclinicalpractices.

ThesepracticesarethebasisofboththewrittenandpracticaltrainingandexamportionsoftheCNTcourseandexamofferedbytheCouncilofCollegesofAcupunctureandOrientalMedicine.Acupunctureschoolsandpractitionersneedtomaintainanawarenessofinformationalupdatesconcerningsafetyinmanyareasofpractice(includinghealthcareassociatedinfectionsandOSHAbloodbornepathogensstandards),andcontinuallyupdatetheirunderstandingofthebestclinicalpracticesinthefield.

Thismanualisnotmeanttodefinestandardpracticesorstandardofcareinacupuncturetechniques.Thetermstandardofcareisoftenusedsynonymouslywithcustomarypractice.Itis

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alegaltermthatiscommonlydefinedas“whataminimallycompetentphysicianinthesamefieldwoulddointhesamesituation,withthesameresources.”(2)

Standardsofcareinmedicinemayalsobedefinedasthecustomarypracticeofaparticularareaorlocality.Acupunctureclinicalpracticesvarybyschool,region,andtraining.Giventhehistoricallywidevarietyofvalid,documentedacupunctureclinicalpractices,thismanualcannotbeutilizedtodefineacupuncturestandardpractices.

Forthepurposesofthismanual,thefollowingtermswillbeutilizedtohelpacupuncturepractitionersapplybestpracticestotheirpersonalpractices:

Critical:Thisaddressestheareaofhighestclinicalrisk.Theprotocolisconsideredessentialforthesafetyofthepatientandpractitioner,andscientificdatademonstratesthatomissioncouldconstituteaseriouspublichealthrisk.

StronglyRecommended:Thesemeasuresarestronglysupportedbyclinicalstudiesthatshoweffectivenessofthemeasuresinreducingriskorareviewedasimportantbyhealthcarepractitioners.Theyareconsideredessentialmeasuresandfrequentlyaddressareasofhighclinicalrisk.

Recommended:Thesemeasuresincludetwotypesofrecommendations:(1)thosethataresupportedbyhighlysuggestive,butperhapslesseasilygeneralized,clinicalstudiesinarelatedfield,and(2)thosethathavenotbeenadequatelyresearched,buthaveastrongtheoreticalrationaleindicatingthattheyareeffectiveforcleanandsafepractice.Bothtypesofrecommendationsarejudgedtobepracticaltoimplement,butarenotconsideredessentialpracticeforeverypractitionerineverysituation.Practitionersshould,however,considertheserecommendationsforimplementationintotheirpractices.

Acupunctureproceduresareperformedaspartoftheauthorizedscopeofpracticeofsomeotherhealthcareprofessions.Moreover,somehealthcarepractitionersuseterminologyfromtheirownprofessionfortherapeuticneedlingtechniquesthatisindistinguishablefromtherapeuticneedlingtechniqueinthepracticeofacupuncture.Triggerpointdryneedling,dryneedling,functionaldryneedling,andintramuscularmanualtherapyfallintothiscategory.Otherhealthcareproviderswhomayuseneedlingtechniquesintheirpractice,whetherornottheprovidersdescribethesetechniquesasacupuncture,aresubjecttothesamesafetyguidelinessincethesafetyguidelinesapplyaccordingtowhattoolthepractitionerisusingandhowthattoolisappliedinthecourseoftreatment.Accordingly,throughoutthismanualthegeneralterm“practitioner”isusedinasmuchasthesafetystandardscontainedinthemanualrepresentbestpracticesapplicabletoanyhealthcarepractitionerwhousesafiliformneedleorrelatedtechniquesasdescribedherein.

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Practitioners,instructors,patients,andothersoftencontacttheCCAOMnationalofficeforclarificationconcerningthebestsafetytechniquesforacupunctureprocedures.OverviewoftheSections:

• InPartIofthemanual,theliteratureidentifyingthepotentialforinfectionsandotheradverseeventsandthereforetheneedforspecifictechniquesandskillsisreviewedasarationaleforbestpractices.

• InPartII,safetyconsiderationsforneedlingaredescribedindetailandtheprecautionsfromPartIarerepeated.Therepetitionisintentionalasbothateachingtoolandtoreinforcethefactthatbestpractices,includingCleanNeedleTechniquebasics,applyinallsituations.

• InPartIII,samplebestpracticesforotherAOMofficeproceduresarediscussedandtheprecautionsfromPartIrepeatedspecificallyforthesepractices.Theprocedurestolimitburnsassociatedwithmoxibustionapplyevenwhendifferentformsofmoxaareutilized.Room,tableandpractitionerpreparationarethesamenomatterwhattypesoftreatmentsarebeingrendered.Ifusedasateachingtool,thismanualmakessuchrepetitionnecessaryandbeneficial.

• PartIVdetailsthehealthcareassociatedinfectionsconcerningwhichacupuncturepractitionersneedtobeaware,bothbloodborneandcontactassociatedinfections.

• PartVdiscussespersonnelsafetypractices.• PartVIdiscussescleaningoftheoffice,equipmentandlaundry.• PartVIIreviewssomeoftheimportantfederalregulationsandnationwidestandardsfor

riskreductionthatapplytoacupuncturepractitioners.• PartVIIIcontainsappendicesforpractitionerinformation.

References 1.PerlethM.,JakubowskiE.,BusseR.Whatis'bestpractice'inhealthcare?Stateoftheartand

perspectivesinimprovingtheeffectivenessandefficiencyoftheEuropeanhealthcaresystems.HealthPolicy.2001Jun;56(3):235-50.

2.MoffettP,MooreG.TheStandardofCare:LegalHistoryandDefinitions:theBadandGoodNews.WestJEmergMed.2011February;12(1):109–112.

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Part I: AOM Clinical Procedures, Safety, Adverse Events (AEs) and Recommendations to Reduce AEs

Safetyremainsthemostimportantconsiderationforallclinicians,includingacupuncturists.Anyclinicalefficacyispotentiallyendangeredwhenaclinicianisnotcognizantofthepotentialrisksofaclinicalproceduretothepatient,patient’sfamily,ortheclinicianandclinicalstaff.ThefieldofacupuncturehasflourishedintheUnitedStatesinpartbecauseacupuncturistsareperceivedbymembersofthepublic,stateregulators,andotherproviderstobewelltrainedandthepracticeofacupuncturetoberelativelysafe.Inthissection,commonlyusedacupunctureandrelatedclinicaltechniqueswillbereviewedfortheirsafetyhistoryalongwithanoverviewofthebestpracticesforlimitingadverseevents(AEs).DetailsofsafetyprotocolsforacupunctureandAOM-associatedclinicalprocedureswillbegiveninPartIIandPartIII.

AccordingtotheWorldHealthOrganization(WHO):(1)

Incompetenthands,acupunctureisgenerallyasafeprocedurewithfewcontraindicationsorcomplications.Itsmostcommonlyusedforminvolvesneedlepenetrationoftheskinandmaybecomparedtoasubcutaneousorintramuscularinjection.Nevertheless,thereisalwaysapotentialrisk,howeverslight,oftransmittinginfectionfromonepatienttoanother(e.g.,HIVorhepatitis)orofintroducingpathogenicorganisms.Safetyinacupuncturethereforerequiresconstantvigilanceinmaintaininghighstandardsofcleanliness,sterilizationandaseptictechnique.

Thereare,inaddition,otherriskswhichmaynotbeforeseenorpreventedbutforwhichtheacupuncturistmustbeprepared.Theseinclude:brokenneedles,untowardreactions,painordiscomfort,inadvertentinjurytoimportantorgansand,ofcourse,certainrisksassociatedwiththeotherformsoftherapy classifiedundertheheadingof“acupuncture.”Acupuncturetreatmentisnotlimitedtoneedling,butmayalsoinclude:acupressure,electroacupuncture,laseracupuncture,moxibustion,cupping,scrapingandmagnetotherapy.

Finally,therearetherisksduetoinadequatetrainingoftheacupuncturist.Theseincludeinappropriateselectionofpatients,errorsoftechnique,andfailuretorecognizecontraindicationsandcomplications,ortodealwithemergencieswhentheyarise.

[LicensedacupuncturistsintheU.S.arewell-trained.Asnotedintheintroductiontothismanual,thereareanumberofhealthcarepractitioners,however,whoutilizeacupuncturewithminimalandinadequatetraining.—Ed.]

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ThisfirstpartofthemanualisareviewofthemedicalliteraturedetailingthesafetyofvariousacupunctureandrelatedAOMpracticesalongwiththeuncommonrisksorcomplicationsthatmayarisefromthesepractices.Pleasenotethatthispublicationdoesnotcoverthesafetyissuesthatmayarisewhenutilizingmateriamedica,whichisbeyondthescopeofthismanual.

Thereareanumberofacupunctureproceduresforwhichthereareveryfewornostudiesofadverseevents(AEs).SomeofthestudiesthatincludeAEsintheirreportingarelimitedintheirapplication.Usingtheprinciplesofevidence-informedpractices,theinformationpresentedhereisthebestinformationavailableatthetimeofpublication.WhilethereareanumberofwelldevisedandreportedstudiesoftheminimalAEsassociatedwithacupunctureneedling,better,largerstudiesofAEsassociatedwithmoxibustion,guasha,tuinaandotherproceduresareneeded.Whenthesebecomeavailablerecommendationsforbestpracticesintheseproceduresmaychange.

References 1.GuidelinesonBasicTrainingandSafetyinAcupuncture.WorldHealth

Organization.http://apps.who.int/medicinedocs/en/d/Jwhozip56e/Published1996.AccessedDecember2012.

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1. Acupuncture

Safety/Adverse Events – A Review of the Literature Acupunctureistheinsertionofneedlesintotheskinwherethetherapeuticeffectisexpectedtocomeprimarilyfromtheactofinserting,manipulatingand/orretainingtheneedlesinspecificlocations.Whileacupuncturepointsmaybestimulatedbyavarietyofmethodsbyacupuncturepractitioners(needling,moxibustion,cupping,manualpressure,electricalstimulation,laserstimulation,magnets,plumblossom,bleeding,andinjectiontherapiesamongothers),whentheprimaryeffectisexpectedfromtheactofinsertingtheneedleitself,thisisacupuncture.

EarlyreviewsoftheliteratureincludethosebyErnstandWhite,andLaowhoconclude:“Theriskofseriouseventsoccurringinassociationwithacupunctureisverylow,belowthatofmanycommonmedicaltreatments.”(1)“AcupunctureperformedbytrainedpractitionersusingCleanNeedleTechniqueisagenerallysafeprocedure.”(2)

Laoetal.reviewedliteraturecoveringtheyears1965-1999.“Overthe35years,202incidentswereidentifiedin98relevantpapersreportedfrom22countries…Typesofcomplicationsincludedinfections(primarilyhepatitisfromafewpractitioners),andorgan,tissue,andnerveinjury.Adverseeffectsincludedcutaneousdisorders,hypotension,fainting,andvomiting.Thereisatrendtowardfewerreportedseriouscomplicationsafter1988.”(2)

Itshouldbenotedthatsingle-usedisposablesterileneedleswerebecomingmorefrequentinuseinthelatterhalfofthe1980s.

WhitereviewedasignificantbodyofpublishedevidenceregardingAEsassociatedwithacupunctureofferinganumericalvalueofAEsassociatedwithacupuncturetreatments.“Accordingtotheevidencefrom12prospectivestudieswhichsurveyedmorethanamilliontreatments,theriskofaseriousadverseeventwithacupunctureisestimatedtobe0.05per10,000treatments,and0.55per10,000individualpatients....Theriskofseriouseventsoccurringinassociationwithacupunctureisverylow,belowthatofmanycommonmedicaltreatments.”(3)

Laterprospectivestudiesconcludesimilarlythatthevastmajorityofadverseeventsareminorandrequirelittleornotreatment.Parketal.(4)studied2226patientsover5weeksofacupuncturetreatmentsandfoundonly99adverseeventsduringthattime(4.5%).Themostcommonwerebleeding/bruising(2.7%)andneedlesitepain(2.7%).Themostlikelymoderatelyseveresideeffectwasnerveinjury(0.31%)describedastemporaryparesthesiawhichdisappearedwithin1week.Noseriousadverseeventswereexperiencedbyanypatientsduringthisstudy.

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Wittetal.(5)observed229,230patientsreceiving,onaverage,tentreatmentsforcommoncomplaintssuchaspainandallergies.Ofthese,19,726reportedadverseevents(8.6%).Commoneventsagainincludedbleeding/bruising(6.14%),fatigue(1.15%),headache(0.52%),painincludingpainatthesiteofneedleinsertion(1.7%),andaggravationofsymptoms(0.31%).Seriousadverseeventsincluded2casesofpneumothoraxand31casesofnerveinjury(0.014%).31instancesoflocalinfectionsattheacupunctureinsertionpointswerereported(0.014%)and5systemicinfectionswerereported.[IntheWittstudy,85%oftheacupuncturepractitionersreceivedonly140hoursofacupuncture-specifictrainingandonly15%hadmorethan350hoursofacupuncturetraining.—Ed.]

Inthemostrecentcomprehensivereviewofadverseeventsassociatedwithacupuncture,moxibustionandcupping,Xuetal.foundthatbetween2000and2011(12years),“117reportsof308AEsfrom25countriesandregionswereassociatedwithacupuncture(294cases),moxibustion(4cases),orcupping(10cases).”(6)Seriousorganandtissueinjurycontinuetobereportedbutthemajorityoftheacupuncture-associatedAEsareinfections.Clustersofhepatitishadbeenreportedinthepastbutnotasinglecaseisreportedinthisperiod(2000-2011).Notably,theinfectionshadchangedfromthepastassociationofacupuncturewithhepatitistoskinandsofttissueinfectionssuchasMycobacteriumincludingM.abcessusandStaphylococcusspp.Thisisasignificantreductioninthenumberofinfectionscomparedtoearlierreports.TheauthorssuggestedthisreductioninAEsintheU.S.islikelyduetotheintroductionofCNTcourse.(Seepage11ofthepaper.)(6)

Preventing Acupuncture Needling Adverse Events Althoughrareintermsoffrequency,themostcommonadverseeventsassociatedwithacupunctureareneedlesitebleeding,superficialhematomaandneedlesitepain.Lessfrequently,faintingduetoacupuncture,tiredness,aggravationofsymptomsandbrokenneedlearereported.Otherpracticeissuesdiscussedherearestuckneedleandforgottenneedle.

Bruising and Bleeding Giventhenatureofacupunctureneedling,itisdifficulttopreventallbleedingandbruising.Insomecases,someminimalbleedingmaybeexpectedandevenbeneficial.Itispossibletopreventseverebleedingandhematomas.Acupuncturepractitionersmustbeawareofthevascularanatomyoftheirpatients.Needlingshouldbeperformedsuchthatarteriesandthelargerveinsareavoided.Mildpressureappliedafterneedleremovalwilllimitmostminorbleeding.

Specialconsiderationmustbegiventoneedlingofthescalpandthepinna/auricleoftheear.Duetothevascularanatomyofthesestructures,bleedingismorecommon.Acupuncturistsshouldapplycleancottonorgauzetopreventbleedingwhenremovingtheneedlesinthese

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areasandholdthatcottonagainstthescalporpinnaafewsecondslongerthanwhenremovingneedlesfromotherbodyparts.Additionally,thescalpand/orpinnashouldbecheckedasecondtimeafterallneedleshavebeenremovedasbleedingcanbecomeapparentafteradelayduetothemicrocirculationinthesestructures.

Anticoagulantmedicationsmayincreasethetendencyforbruisingandbleeding.Somesupplementsmayalsohavethiseffect.Obtainingacompletemedicationandsupplementhistory,andanynotedsideeffectsfromtheiruseisimportantinformationtoassessthepotentialsforbruisingorbleeding.

Safety Guidelines to Prevent Bruising, Bleeding, and Vascular Injury Critical • Avoidneedlingdirectlyintoarteriesandmajorveinsthrough

anatomicalknowledge.• Identifythoseacupuncturepointswhichlieoverornextto

majorvessels:o LU9Taiyuan(radialartery)o HT7Shenmen(ulnarartery)o ST9Renying(carotidartery)o ST12Quepen(supraclaviculararteryandvein)o ST13Qihu(subclavianartery)o ST42Chongyang(dorsalispedisartery)o SP11Jimen(femoralartery)o HT1Jiquan(axillaryartery)o LR12Jimai(femoralarteryandvein)o BL40Weizhong(poplitealartery)

StronglyRecommended • Palpatesubcutaneousstructures,includingmajorvessels,beforepreparingthesiteforinsertion.

• Applycautioninpatientsonmedicationsorsupplementsthatthintheblood,especiallyelderlypatients.

• Toavoidsuperficialbleedingorhematoma,applypressuretopointsafterremovingneedles.Reexamineneedledsitesasecondtimeforsignsofbleedingorhematomaandifnecessary,applypressure.

Recommended • Visualizesurfacevesselsandpalpatethosevesselsimmediatelyadjacenttoacupuncturepointsbeingneedledduringneedleinsertion.

Needle Site Pain/Sensation Needlepainmayoccurasaresultofanumberoffactors.Practitioner-relatedissuesthatmayincreaseneedlingsensationincludepoortechnique,needlingsiteswherealcoholremainsontheskin,needlingintodenseconnectivetissuesuchastendons,periosteumandperimysium,

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excessiveneedlemanipulation,orneedlingintoanerve.Patient-relatedconditionsthatmayincreaseneedlingsensationincludeanxiety,nervousness,andmovingbodypartsduringneedleinsertion.Someneedlesitesensation,including“heavy,”“tight,”“tingling,”orotherdiscomfort,maybeexpectedordesired(deqiresponse).Acupuncturepractitionersshouldlearnwhichsensationsareexpectedinadeqiresponsesotheycandifferentiatethatfromnervepain.Studentpractitionersneedtohonetheirskillspriortoworkingonpatientsinordertolimitthepainassociatedwithpoortechnique.Adequateanatomicalknowledgeandattentiontothesensationsofthetissuesthroughwhichaneedleisproceedingisneededtoavoidneedlingintostructuresthatstimulatenervepain.Practitionersshouldlimittheamountofneedlemanipulationperformedwithasingle-directiontwirlingmotionsoastopreventsubcutaneoustissuefibersandfasciafrombeingtwistedaroundaneedleshaftbeyondthatneededfordesiredtherapeuticresults.

Itisalsocommonthatapatientwithchronicpainmaydevelopallodynia(apainfulresponsetoanormallyinnocuousstimulus)orhyperalgesia(anincreasedresponsetoapainfulstimulus).Whenapatientpresentswithachronicpainconditionsuchasfibromyalgia,thatpatientmayhaveanincreasedsenseofpainfromeitherhyperalgesiaorallodynia.(7,8)

Caffeineconsumptionmayalsoaffectpatients’painperceptions.Studieshavefoundthatcaffeinemayattenuatetheindividual'sperceptionofpainduringexercise(9,10)andenhancemuscularstrengthperformance.(9)Caffeineconsumptionmayalsoheightenanxietyandheightenedanxietyisassociatedwithincreasedperceptionofpain.(11)Anearlystudyfoundthatcaffeinecouldblocktheelectroacupuncture-inducedelevationofthenociceptivethresholds.(12)Somepractitionershavealsoreportedthatwhenpatientsconsumecaffeinebeforeacupuncture,theymayreportanincreaseinthesensationofneedleinsertion,particularlyinanxiouspatients.

Safety Guidelines to Prevent Needle Site Pain StronglyRecommended

• Ifalcoholisusedtocleantheacupuncturesites,allowalcoholtodrybeforeneedling.

Recommended • Visualizeanatomicalstructureswhileinsertingtheneedleandduringallneedlemanipulation.

• Palpatesubcutaneousstructures,includingtendons,musclesandbones,beforepreparingthesiteforinsertion.

• Manipulateneedletodeqiresponseexpectedofaspecificpoint,ifdesired;avoidnon-therapeuticpainresponse.

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Fainting WhilefeelingfaintorlightheadedisapossibleAEofacupuncture,moststudiesreportthatmorepeoplereportasensationoffaintnessorlightheadednessthanactuallyfaintafterneedleinsertion.ThestudybyWittetal.foundthatwhile0.72%ofpatientshavesomesortofvegetativesymptomsonly0.027%actuallyfaint.(5)Whiteetal.intheSurveyofAdverseEventsFollowingAcupuncture(SAFA)studyreportedpresyncopein93patientsbutfaintingofonly6patients.(13)InthereportbyMcPhersonetal.8patientshadsymptomsoffaintnessbutonly4actuallyfainted.(14)

Manysourcesreportthatpatientsmayexperiencelightheadednessorfaintnessmorecommonlyduringthefirsttimetheyreceiveacupuncture,iftheyarenervous,ifthereisexcessiveneedlemanipulation,orifthepatientisparticularlyhungryortiredpriortoneedleinsertion.(15)

FaintingasaresultofacupunctureisreportedmorefrequentlyinareviewoftheChineseliterature(16)whencomparedtooutcomesfromstudiesofothercountriesoforigin.Thismightbeassociatedwithstrongneedlingstimulationofpatientsinasittingposition,whichcancauseamarkedvasodilatationleadingtoadecreaseofbloodpressure.(2)Feelingfaintcanalsobeassociatedwithmoreintenseneedlemanipulation.(17)

Safety Guidelines to Prevent Fainting StronglyRecommended

• Placeafirst-timepatientinthesupinepositionwiththekneesslightlyelevatedforthefirstacupuncturetreatment.

Recommended • Explainacupunctureprocedureindetailandanswerallquestionsbeforeacupunctureneedleinsertiontoallayconcernsandnervousness.

• Informpatientsthattheyshouldeat1-2hoursbeforeacupuncturetreatments.

• Limitneedlemanipulationduringthefirstacupuncturetreatmentoruntilclinicalassessmentofthepatient’sresponsetoacupuncturehasbeenestablished.

Stuck Needle Afteraneedlehasbeeninserted,practitionersmayfinditdifficulttorotate,liftorwithdrawtheneedle.Thisismorecommonifapatientmovesaftertheneedleinsertion,ifthepractitionerusesexcessivemanipulationortwirlingoftheneedleinasingledirection,oriftheneedleisinsertedtothedepththatitentersintothemusclelayer.Tomanageasituationwheretheneedleisstuck,reassurethepatientifheorsheisnervousandaskhimorhertorelaxhisorhermuscles;thenmassageorlightlytaptheskinaroundthepointafterwhichtheneedleshould

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moreeasilyberemoved.Iftheneedleisstilldifficulttowithdraw,askthepatienttoliecalmlyforafewminutesorperformanotherneedleinsertionnearbysoastorelaxthemusclesintheareaofthestuckneedle.Iftheneedleisentangledinfibroustissue,turnitintheoppositedirectionfromtheinitialneedlestimulation,twirlinguntilitbecomesloosened,thenwithdrawtheneedle.

Safety Guidelines to Avoid and/or Respond to Stuck Needle StronglyRecommended

• Identifytherecommendeddepthoftheneedleinsertionforaparticularpointandutilizeproperstimulationtechniquesforneedlesinsertedbelowthesubcutaneouslevel.

Recommended • Situatepatientsinaninitialpositionwheretheyarerelaxedandnotlikelytoneedtomove.Remindpatientstoremainstillduringacupuncturetreatment.

• Ifaneedlethatwasrotatedinonedirectionbecomesstuck,rotatetheneedlebackintheoppositedirection.

• Stimulatetheareanearastuckneedlewithsimplefingermanipulation,tappingoranotherneedleinsertion;thentryagaintoremoveastuckneedle.

• Leaveastuckneedleinplaceforafewminutes;thentryagaintoremovetheneedle.

Failure to Remove Needles Since1999,prospectivestudiesidentifyasmallbutpersistentnumberofpatientsinwhichneedlesarenotremovedfromthepatientbeforetheyleavethetreatmentroomorclinic.(5,18)

Thiserrorbypractitionersmayberelatedtodistractionsfrompatientcare.Someverybasicstepscandramaticallydecreasetheoccurrenceofthispractitionermistake.Retainedneedlesmaybemorecommonwithinthehairline,onthechestorbackifthereissignificanthairpresent,onthedorsumofthescalporneckinapatientlyingsupine,orintheearduetothedecreasedvisibilityofthesmallneedlehandlewhenpartiallyorfullycoveredbyhair.Palpatingareaslookingforforgottenneedlesmayincreasetheriskofneedlestickinjuries.DocumentingthenumberofneedlesinsertedatthetimeofinsertionandthencountinganddocumentingthenumberofneedlesremovedattheendofatreatmentwillhelppreventthisAE.Usecountingandproperdocumentationtocheckformissingneedles.However,ifneedlecountsdonotmatch,palpationmaybenecessarybutshouldbedonewithextremecaution.

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Safety Guidelines for Needle Removal StronglyRecommended

• Countandwritedownthenumberofneedlesused,includingthosediscardedduetoimproperneedleplacement.Countthenumberofneedleswithdrawnfromthepatient.Confirmthatthesamenumberofneedlesinsertedhasbeenwithdrawnanddiscarded.

Recommended • Documentneedlecountsinthepatientchart.• Keepused/emptyneedlepacketsinthetreatmentroomuntilthe

endofthepatient’streatment;confirmallneedlesremovedfrompackagingareaccountedforeitherbyremovalfromthepatient,discardedunusedordiscardedaftercontamination.

Aggravation of Symptoms Aggravationofsymptomsoccursasaresultofacupunctureonaninfrequentbutconsistentbasis.(6,13,14,18)Aggravationofsymptomsisreportedbothasapotentialadverseeventandasanintendedresponsetotreatment,knownas“MenkenorMengenphenomenon,”or“healingcrisis.”(19)Manytraditionalmedicinetechniquesincludedeliberateaggravationofsymptoms(usingahotbathtobringaboutdiaphoresisinthecaseoffever,purgingasatreatmentforgastricdistress,etc.).Practitionersneedtobeclearaboutexpectedoutcomeswhenspeakingwithpatientspriortotreatments.Whenaggravationofsymptomsincludesimmediatefatigueanddrowsiness,patientsshouldbewarnedaboutdrivingimmediatelyaftertreatment.(19)

Inflammationmaybeanexpectedresponsetoatreatment.Inflammation,includingcellularresponsestostimuli,mayincreasetheinflammatoryresponsethatthenbringsaboutimprovementofhealth.(20-23)

Theroleoftransientinflammatoryresponseasahealing,restorativeprocessiswidelyrecognized.Withinthetissues,inflammatoryproteinstransduceintracellularsignalstodefinecellularresponsesessentialtocarryingoutthehealingprocesses.Bymanipulatingtheinflammatoryphasesofthehealingprocess,itmaybepossibletoacceleratetissuerepairfunctions.(22-26)Aggravationofsymptomsfromacupuncturemaybesignalingthishealingresponse.

Ifanaggravationofsymptomsisnottheexpectedoutcomeofanacupuncturetreatment,theacupuncturistshouldevaluatethediagnosisandtreatmentplanforthepatientandassesswhetherconsultationwithorreferraltoanotherpractitionerwouldbebeneficial.

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Safety Guidelines for Aggravation of Symptoms Recommended • Informthepatientofthelikelyeffectsofacupuncture

treatment.• Adviseapatientthataggravationofsymptomsmaybea

transientoutcomeoftreatment.• Ifunexpectedaggravationofsymptomsoccursasaresultof

acupuncturetreatment,considerconsultationwithorreferraltoanotherpractitionerforfurtherevaluationpriortoperformingadditionalacupuncturetreatments.

• Providepatientswithinformationonacupuncturetherapiesincludingpractitionercontactinformationintheeventtheyhavequestionsorconcernsfollowingtreatment.

Preventing Rare but Serious Adverse Events (SAEs) Associated with Acupuncture Needling

Pneumothorax Pneumothoraxisdefinedastheabnormalpresenceofairinthespacebetweenthelungandthewallofthechest(pleuralcavity),whichpreventslungexpansion.Primaryspontaneouspneumothorax(PSP)occursinhealthypeoplewithoutaprecipitatingeventsuchaslungillnessorpuncture.Asmallareaonthesurfaceofthelungthatisfilledwithair(“bleb”)rupturesallowingairtopassintothethoraciccavity.Youngmenwhoaretallbutotherwisehealthyareclassicpresentersofprimaryspontaneouspneumothorax.IngeneraltherateofPSPis7.4/100,000menperyearintheU.S.andlessforwomenat1.2/100,000peryear.(27)

Secondaryspontaneouspneumothorax(SPS)isdefinedaspneumothoraxthatoccursasacomplicationofunderlyinglungdiseaselikechronicobstructivepulmonarydisease(COPD),cysticfibrosis,sarcoidosisorlungcancerandsoon.(28)50to70%ofSSPisassociatedwithCOPDintheliteraturecaseseries.(29)

Traumaticpneumothoraxiscausedbypenetratingorblunttraumatothechestsuchasastabbing,gunshotwoundorsevereblow.Iatrogenicpneumothoraxresultsfromacomplicationofadiagnosticortherapeuticintervention.(30)Pneumothoraxfromacupunctureisanexampleofiatrogenicpneumothorax.

PneumothoraxisariskofacupunctureneedlingoccurringonlytwiceinnearlyaquarterofamilliontreatmentsaccordingtoErnst&White:“Thoseresponsibleforestablishingcompetenceinacupunctureshouldconsiderhowtoreducetheserisks.”(30)Yamashitaetal.found25casesofpneumothoraxinJapaneseliteratureasof2001.(18)ReviewingtheChineseliterature,Zhangetal.found201casesofthoracicorganandtissueAEswithpneumothoraxbeingthemost

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frequent.(31)MostrecentlyaXuetal.reviewofpneumothoraxesreportedatotalof13acupuncture-relatedpneumothoraxespublishedfrom2000to2010infromChina,Japan,UK,NewZealand,SingaporeandtheU.S.(6)However,additionalcaseswerereportedinthistimeperiod(32-37)andreportsofcasessincetheXuetal.review(38-43)indicatepneumothoraxcontinuestobeariskofAEinacupuncturepractice.

Symptomsofacupuncture-relatedpneumothoraxcanpresentimmediatelyuponpenetratingthelungorhourslater.Symptomsmayincludedyspnea(shortnessofbreath)onexertion,tachypnea(increasedrespiratoryrate),chestpain,drycough,cyanosis,anddiaphoresis/sweating.(44)Acupuncturepractitionerscanbeunawareofhavingcreatedapneumothoraxorwhatpointorpointswereimplicatedbecausepatients,bynecessity,reporttoanemergencydepartment,andtheinformationregardingpractitionerorpointsusedisnotrecorded.

Patientsatincreasedriskforpneumothoraxfromacupunctureincludecigarettesmokersandmarijuanasmokersandthosesufferingfromlungdiseasesuchaschronicasthma,emphysemaandCOPDaswellaspatientswithlungcancerorwhoareoncorticosteroids.(35)PatientswithMarfansyndrome,homocystinuria,andthoracicendometriosisarealsomorepredisposedtoPSPthanothers.(30)

Patientswithchroniclungdiseasewillhavelossofmusclemass;theirmusculaturethinsand“barrels”becauseventilatorymusclesarechronicallyoverloadedandoverworkedfromairflowobstructionandhyperinflation.

Pneumothoraxisalsoacomplicationofdryneedling.Thiscanbeseenwiththepatientwhosuffersapneumothoraxduringademonstrationofdeepdryneedling(DDN)totreattheiliocostalismuscle.(45)

Theprimaryareasassociatedwithacupunctureordryneedling-inducedpneumothoraxaretheregionsofthethoraxincludingtheuppertrapezius,thoracicparaspinal,medialscapular,andsubclavicularareas.(44)

Itiscriticalthatamedicalhistoryestablishesorrulesoutincreasedacupuncture-pneumothoraxriskfactorssuchassmoking,includingmarijuanasmoking,and/orhistoryorpresenceoflungdiseasesuchaschronicasthma,emphysema,COPD,lungcancerand/ortakingcorticosteroids.Itisalsocriticaltoassessthephysiqueofapatient.Averytall,thinpatientoronewithatrophyormusclemasslossfromhyperinflationwillhaveashallowsurfacetolungdepth,increasingtheriskofpenetratingthelungresultinginpneumothorax.Needlingshouldbelimitedtosuperficialpenetrationoverthechest,back,shoulderandlateralthoracicregion,nodeeperthanthesubcutaneoustissue.Itisalsostronglyrecommendedtouseneedlesthatarenot

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longerthansafeneedlingdepthatanythoracicregionareaincludingtheHuatuojiajipoints,bladderchannel,andanyintercostalspace.

Safeneedlingdepthisrecommendedat10-20mm;lessthanthefacewidthofaU.S.nickel,20-centEurocoin,Canadian25-centpieceorEnglish20pence.Ratherthanneedlingataperpendicularangle,itisstronglyrecommendedtoneedleatanobliqueangle.Thisalsoensuresthatneedleswillnottraveldeeperintothebody.Placingablanketoverneedlesinthethoracicareacausedneedlestobeinserteddeepenoughtocauseapneumothoraxinonereportedcase.(46)Obliqueneedleplacementwouldpreventthiscomplication.

CareshouldbetakenwhenneedlingtheGB21(Jianjing)andtheuppertrapeziusmusclesincetheapexofthelungextends2–3cmabovetheclavicularline.(44)Incorrectneedlingofthisareahasbeenassociatedwithpneumothorax.

PointsmostfrequentlyassociatedwithpneumothoraxeventsintheChineseliterature(31)are:Jianjing(GB21;30%),Feishu(BL13;15%),Quepen(ST12;10%),andTiantu(Ren22;10%);infrequenteventsoccurredatGanshu(BL18),Jiuwei(Ren15),Juque(Ren14),Jianzhen(SI9),Quyuan(SI13),andDingchuan(EX-B1).

Peuker&GrönemeyeridentifyriskpointsST11(Qishe)andST12(Quepen),LU2(Yunmen),ST13(Qihu),KI27(KI22-27),andST12-18.(47)However,anypointsneedledinthethoracicbodyregionriskpenetratingthelung,includingthefront,back,orlateralbody,thelowerneck,shoulderandscapularregionaswellasthechest,ribsandjustbelowtheribsdependingonthepositionofthepatient.

Safety Guidelines to Avoid Pneumothorax Critical • Obtainamedicalhistoryfromapatientregardinglungfunction,lung

diseasesandsmokinghistorybeforeneedlingonthechestorback.• Assessphysiqueofapatient.Averytall,thinpatientoronewith

atrophyormusclemasslossfromhyperinflationwillhaveashorterdepthofsurfacetolung,increasingtheriskofpenetratingthelungresultinginpneumothorax.

• Safeneedlingdepthtoavoidpneumothoraxonmostpatientscanbeaslittleas10-20mm.

• Limitthedepthofacupunctureneedleinsertiontothesubcutaneouslayerandinitialperimysiumoftheintercostalmuscles.

StronglyRecommended

• Needleatanobliqueangleratherthanataperpendicularangleinthethoracicbody(fromthetopoftheshoulderstotheT-10areaontheback,orfromthetopoftheshoulderstothexiphoidlevelonthechest).Thisalsoensuresthatneedleswillnottraveldeeperintothebodyfromtheweightofasheetorgownusedtocoverthepatient.

• Limitverticalmanipulationofneedlesonthechestorback.

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• Donotcupoverneedlesonthethoraxintheareaofthelungstoavoidtissuecompressionthatcancauseneedlepenetrationtointernalorgans.

• Ifthereareindicationsorsuspicionsthatanorganmayhavebeenpunctured,emergencytransportshouldbecalledtotakethepatienttoanemergencymedicalfacility.

Recommended • Avoidusingneedlesthatarelongerthanthesafeneedlingdepthforaparticularbodyarea.

• OnemethodtoreduceriskatGB21(Jianjing):Whileisolatingandliftingthetrapeziusmusclewithapincergripusingtheoppositehand,needleacrossthemuscleatGB21(Jianjing),takingcaretodirecttheneedleobliquelyandnotinferiorlytowardthelung.

Injury to Other Organs Injurytointernalorgansisareportedseriousadverseeventofacupuncture.(1,6,31)Heartinjuryisanextremelyrarecomplicationofacupuncture;however,fatalitieshavebeenreported.Xuetal.(6)reportfivecasesofheartinjuryincludingtwoofcardiactamponadeandthreeotherheartinjuriesduringa12yearperiod.ErnstandZhangreport26casesofcardiactamponadewith14fatalitiessince1956;howevercasesofself-injuryandaccidentalinjuryareincludedalongwithcardiacinjuryduringacupuncture.(48)Asanexample,acasethatisstillsometimescitedasan“acupuncturefatality”resultedfromaself-inflictedsewingneedleandnotfromactualacupuncturepractice.(49)OfthecasesreportedbyErnstandZhang,onlyoneisofaneedlepenetratingasternalforamen,threewereself-treatmentwhenthegoaloftreatmentwasunclear.Themajorityofcasesinvolvedmigrationofneedlesorpartsofneedlesbrokenoffinthebody.(48)Suchembeddedneedlesarenotpartofmodernacupuncture.Excessiveneedlelength(60mm)isdescribedascontributingtoanothercasereportandmustbeavoided.(50)

Althoughrare,theriskofsternalforamenmustbeconsidered.InsertionthroughacongenitaldefectinthesternumappearstobethemechanismofinjuryintwoofthecasesreportedbyErnstandZhang.(48,51,52)InacasereportedfromAustriain2000,anemaciated83-year-oldwomanwasneedledatRen17(Shanzhong).Theneedlewasinsertedbyanexperiencedacupuncturistthroughasternalforamen.Symptomsappearedwithin20minutes.Thereportdescribesthatthe30mmneedlemayhavebeeninsertedperpendicularlyinanemaciatedpatient.(52)PeukerandGrönemeyer(53)reportthattheincidenceofasternalforamenatthelevelofthefourthintercostalspaceexistsin5-8%ofthepopulation.ThisdemographicisconfirmedinrecentCTstudies.(54)Palpationcannotrevealthedefect(53)andthereisnocorrelationbetweenthedepthofsubcutaneousfatanddistancetoavitalorgan.(54)Whiletheplacementofinternalorgansdirectlyunderasternalforamenandthedepthfromskintoorgan

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varied,CTscanssuggestthat25mmisthemaximumsafeinsertiondepthtoavoidinjurytotheheart.(54)

Inadditiontodepth,angleofinsertionwhenneedlingthechestmustbeconsidered.ObliqueortransverseneedlingonpointslocatedonthechestandavoidinganupwarddirectionatRen15(Jiuwei)iscriticaltopreventheartinjury.

Symptomsofcardiactamponadeincludeanxiety,restlessness,lowbloodpressureandweakness,chestpainradiatingtotheneck,shoulder,backorabdomen,chestpainthatgetsworsewithdeepbreathingorcoughing,problemsbreathingorrapidbreathing,discomfortthatisrelievedbysittingorleaningforward,faintingorlight-headedness,palpitations,drowsiness,and/orweakorabsentperipheralpulses.

TherearereportsintheWesternliteratureofinjurytootherinternalorgansbutmostarenotrecent.Zhangetal.(31)reviewseriousAEsfromtheChineseliteratureandreport16casesofabdominalorganandtissueinjuryincludingperforationsofthegallbladder,bowels,andstomachwithperitonitis.Injurywasattributedtoneedlingtoodeeply;thepointscitedareST25(TianShu),Ren12(Zhongwan),andLR14(QiMen)inthetreatmentofabdominalpain,appendicitisorcholecystitis.

Reportingonanacupunctureneedlethatremainedinalungfor14years,Leweketal.reviewed25casesofmigrationofneedlefragmentsandtheyincludetotheliver,pancreas,stomach,colon,breast,kidney,andmusclesandspinalcord.(55)Additionally,therearecasereportsofforeignbodystonesformedaroundneedlefragmentsintheureter(56)andbladder.(57)Asmentionedabove,suchembeddedneedlesarenotpartofmodernacupuncture.

Beforeadministeringacupuncture,specialcareshouldbetakentoexaminethepatientforanysuspectedorganenlargement.Abnormalchangesintheinternalorgansmaycomefromavarietyofdiseases.Changesinheartsizemaybearesultofchronichypertensionandcongestiveheartfailure.Hepatomegalymaybearesultofanumberofdiseasesincludingalcoholism,chronicactivehepatitis,hepatocellularcarcinoma,infectiousmononucleosis,Reye’ssyndrome,primarybiliarycirrhosis,sarcoidosis,steatosis,ortumormetastases.Splenomegalymaybecausedbyinfectionssuchasinfectiousmononucleosis,AIDS,malaria,andanaplasmosis(formerlyknownasehrlichiosis);cancers,includingleukemiaandbothHodgkinsandnon-Hodgkinslymphoma;anddiseasesassociatedwithabnormalredcellssuchassicklecelldisease,thalassemia,andspherocytosis.

Puncturingtheliverorspleenmaycauseinternalbleeding,althoughsevereresponsesarerareandnocasesofliverorspleeninjuryhavebeenreportedinEnglishinthepasttwelveyears.(6)Symptomsofsuchorganinjuryincludeabdominalpain,rigidityoftheabdominalmuscles,

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and/orreboundpainuponpressure.Puncturingthekidneymaycausepaininthelumbarregion,tendernessandpainuponpercussionaroundthekidneyregion,andbloodyurine.

Central Nervous System Injury Acupuncture-relatedcentralnervoussysteminjuriesarereportedmoreofteninEasternliterature.(3,53)Xuetal.(6)reportninecasesofcentralnervoussysteminjuryoverthe12yearperiodreportedinthatdocument.Liketheheartinjurycasesreportedabove,afewspinalcordinjurieswerecausedbymigratingbrokenneedles.Deepneedlingmayalsocausedamagetothespinalcord.AccordingtoPeukerandGrönemeyer,“Thedistancefromthesurfaceoftheskintothespinalcordortherootsofthespinalnervesrangesfrom25to45mm,dependingontheconstitutionofthepatient.Deepneedlingofpointsoftheinnerlineofthebladdermeridian(BL11to20)wasparticularlylikelytocauselesionsofthespinalcordorthespinalnerveroots.”(53)

Safety Guidelines to Avoid Organ and Central Nervous System Injury Critical • Observesafeneedlingdepthandanglestoavoidcardiacinjury.

o Toavoidpenetrationatasternalforamen,useanobliqueangletoneedleonthesternum.

o Limitthedepthofacupunctureneedleinsertiontothesubcutaneouslayer.

• NeedlingDu22(Xinhui)inaninfantisprohibited.StronglyRecommended

• Allpatienthistoriesshouldincludeinformationaboutcurrentorpastdiseasesthatmightleadtoachangeinthesizeoftheorgans.

• Donotcupoverneedlesontheabdomentoavoidtissuecompressionthatcancauseneedlepenetrationtointernalorgans.

• Limitverticalmanipulationoftheneedlesontheabdomen.Recommended • Ifthereareindicationsorsuspicionsthatanorganmayhavebeen

punctured,emergencytransportshouldbecalledtotakethepatienttoanemergencymedicalfacility.

• Avoidusingneedlesthatarelongerthanthesafeneedlingdepthforanygivenbodyarea.

Traumatic Tissue Injury

Peripheral Nerves Peripheralnerveinjuriesarereportedinfrequently(53)andmayincludeaneedlefragmentwithinthecarpaltunnelcausingmedianneuropathy,mediansensoryneuropathyfromneedleinjury,(59)peronealnervepalsy,(60)andinonecaseresultingindropfoot.(61)FourcasesofperipheralnerveinjuryarereportedinChina,threerelatedtoneedlingofLI4(Hegu)onthehand.Includedinthisreportwastheobservationthataforcefulneedlemanipulationatthis

16

pointcancauseperipheralnerveinjury.(53)AcaseofBell’spalsy24hoursafteracupunctureisreportedbyRosted&Woolley.(62)

Blood Vessels TwocasesofvascularinjuryarereportedintheU.S.:acuteintracranialhemorrhageinapatientgivenacupunctureforneckpain(63)andcerebrospinalfluidfistulainapatienttreatedforlowbackpainwithembeddedneedles.(64)

Acupunctureneedlenickstoacapillaryorveinresultinginminorbleedingorsuperficialhematomaarenotuncommon.Injuriestobloodvesselsresultinginmoreseriouscomplications,suchascompartmentsyndrome,deepveinthrombosis,poplitealarteryocclusion,aneurysmandpseudoaneurysmaswellasarterialinjuryarerarebutarereported.

(4,65)Morerecentlyaseriousthighhematomaresultedfromacupuncturetreatmentinan82-year-oldwomantakingwarfarin.(66)HerINRwasstableat2.4;itappearstheadditionalriskfactorsinthiscaserelatedtodeepneedlingandtheageofthepatientcomplicatedbyanticoagulanttherapy.

Safety Guidelines to Avoid Traumatic Tissue Injury Critical • FollowSafetyGuidelinestoPreventBruising,BleedingandVascular

Injury.StronglyRecommended

• Toreduceriskofperipheralnerveinjury,avoidaggressiveneedlemanipulationinanatomicalareaswitharecordofrisksuchasthehandandwrist,ankleandfibularhead.

• Ifapatientexperiencesacuteseverepainfromneedlingapointdonotcontinuetomanipulatetheneedlebutwithdrawtoashallowerdepthorremoveitentirely.

Infections Infectionsmaybelocalorsystemic,duetoanautogenoussource(thepatient)orbeacrossinfection(fromthepractitionerorothers).OneinthreepeoplearecarriersofStaphylococcusaureus,and1in10isacarrierofMRSA.Likewise,Mycobacteriummaybepartofcommonskinflora.Acarriermayhavenosymptomsorindicationstheyareacarrierunlesstheyaretested,typicallywithswabsoftheskin,noseormouth.S.aureusorMRSAcaninfectwoundsandpreventhealing,causebloodinfection(septicemia),orinfectorgans,bone,heartvalve/liningorlung,and/orcreateaninternalabscess.Patientsareoftenhospitalized,mayrequiresurgery,monthsofIVantibioticsandmayexperiencelifelongsequelaeorevendeath.

Recentreportsofacupuncture-relatedinfectionareofskinandsofttissuesuchasmycobacteriumincludingMycobacteriumabscessusandStaphylococcusaureusincludingMRSA.Ofthe239casesreportedfortheperiodof2000-2011,193weremycobacteriuminfection.Thesourceofmostoftheseinfectionswastracedtoreuseofimproperlydisinfected

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needlesortherapeuticequipmentoruseofcontaminateddisinfectantorgelusedforrelatedprocedures.(6)

Whileinfectionsassociatedwithacupunctureneedlingarearareoccurrence,anydisruptionofthenormalbarrierstoinfection,suchaspuncturingthroughtheskinandepidermalflora,canallowapathogentoenterthebody.Thosewithareductioninnormalimmunefunctionmaythennotrespondadequatelytothepathogen,allowinganinfectiontostart.Reductioninnormalimmunefunctionmaytakeplaceduetoanumberoflifesituationsanddiseasessuchasinpersonswhohavesignificantstress,usecorticosteroidsandotherimmunesuppressingdrugs,orwhohavecancerorimmunesuppressingdiseasessuchasAIDS.Asotherconditionsanddiseasesmayalsocompromiseimmunefunction,acupuncturepractitionersshouldtakecaretouseCleanNeedleTechniquewithallpatientstopreventinfections.

Careshouldbetakentolimiteventherarebutmeasurableriskofinfectionassociatedwithneedling.TheCleanNeedleTechniquediscussedinPartIIofthismanualisdesignedtolimitexposureofpatientsfrombothautonomousandcrossinfections,andtolimitexposureofpractitionersandtheirstafffrominfectionswhicharepartofanymedically-relatedpractice.

SeePartIVforamorethoroughdiscussionofhealthcareassociatedinfections.

Safety Guidelines to Prevent Infection Critical

• FollowCleanNeedleTechnique.• FollowStandardPrecautions:Considerallpatientsasiftheyarecarriers

ofbloodbornepathogenssuchasHepatitis(HBV),HepatitisC(HCV),HIV,StaphorMRSA.

• FollowSafetyGuidelinesforHandSanitation.• FollowSafetyGuidelinesforPreparingandMaintainingaCleanField.• FollowSafetyGuidelinesforSkinPreparation.• Useonlysingle-usesterileneedlesandlancets.• Checkneedlesbeforeuseforsterilizationexpirationdates,breaksinthe

packagingoranyevidencethatairorwaterhasenteredtheneedlepackagingpriortouse.

• Wearglovesorfingercotsorotherwisecoverupanyareasofbrokenskinonthepractitioner’shands.

• Maintaincleanprocedureatalltimeswhilehandlingneedlesbeforeinsertion.Ifneedlesortubesbecomecontaminated,theyshouldbediscarded.

• Donotneedleintoanyskinlesion.Acupunctureneedlesshouldneverbeinsertedthroughinflamedorbrokenskin.

• Useonlysterileinstrumentswhenbreakingtheskinsurface(needles,plumblossoms,andlancets).

• Immediatelyisolateusedneedlesinanappropriatesharpscontainer.

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• Whenusingamulti-needlepackofsterilizedneedles,oncethepackagingisopenedforonepatientvisit,anyunusedneedlesmustbediscardedproperlyandnotsavedforanotherpatienttreatmentsession.

• Followguidelinesfordisinfectingreusableadjuncttherapytoolsaftereveryuse.

• Usenewtablepaper(orcleanlinenifusingclothcoverings)oneachtreatmenttableforeachnewpatientvisit.

• Wipedowneachtreatmentchairortablewithadisinfectantsolutionordisinfectantclothbetweeneachpatientvisit.

StronglyRecommended

• Guidetubesmustbesterileatthebeginningofthetreatmentandmustnotbeusedformorethanonepatient.

• Whenneedlestabilizationisneeded,thepractitionershouldusesterilecottonorsterilegauzetostabilizetheshaftoftheneedle.

• Ifyoustickyourselfwithausedorcontaminatedneedle,seekmedicaladvice.

• Cleanalltreatmentroomsurfaceswithapproveddisinfectantsdaily.Recommended • Whileitisacceptabletopalpatethecleanedareaofskintoprecisely

locatetheacupuncturepointaftertheskiniscleanedandbeforeneedling,thepractitionershouldnottracefingersorhandsacrossawideareaofskintolocateanacupuncturepointaftertheskiniscleanedandbeforeneedling.

• Whendesiredafterneedlewithdrawal,applypressuretotheacupuncturepointwithcleancottonorgauze.

• Cleanallofficecommonuseareaswithanapproveddisinfectantdaily.

Broken Needle Theadventofthesingle-usedisposablesterilestainlesssteelacupunctureneedlehassignificantlyreducedthepreviouslyuncommonbutoccasionallyoccurringbrokenneedle.Metalsaremadebrittlebytheheatingandcoolingassociatedwithautoclavesterilizationprocedures;moreover,thequalityofmetalmaterialsusedforneedleshasadvanced.Withsingle-useneedles,theriskofthebrokenneedleapproacheszero.However,manufacturingerrorsmaystillallowforsucheventsandthepractitionershouldbeawareofhowtohandlesuchasituation.NeitherWhite(3)norMcPherson(14)reportsanybrokenneedlesduringtheirprospectivestudies.Wittetal.reports2brokenneedlesoutof229,230patientstreated.(5)

Abrokenneedlemayoccurif:(a)therearecracksorerosionsontheshaftoftheneedle,especiallyatthejunctionwiththehandle;(b)thequalityoftheneedleispoor;(c)thepatienthaschangedpositiontotoogreatanextent;(d)thereisastrongspasmofthemuscle;(e)excessiveforceisusedinmanipulatingtheneedle;(f)theneedlehasbeenstruckbyanexternal

19

force;or(g)abentneedlehasbeenrigidlywithdrawn.Inanerawhenonlysingle-usedisposableneedlesshouldbeused,needlebreakagehasbecomeahighlyunlikelyoccurrence.

Tomanageabrokenneedle,theacupuncturistshouldremaincalmandadvisethepatientnottomovesoastoavoidcausingthebrokenpartoftheneedletodrawdeeper.Ifapartoftheneedleisstillexposedabovetheskin,removeitwithforceps.Ifitisonthesamelevelwiththeskin,pressthetissuesaroundthesitegentlyuntilthebrokenendisexposed,thentaketheneedleoutwithforceps.Ifitiscompletelyundertheskin,seekmedicalhelpimmediately.Donotcutthefleshtogetaccesstotheneedle.Removeallotherneedles.Callforemergencytransporttoahospitalormedicalfacilitywhereaphysiciancanremovetheneedleshaft.

Themosteffectivewaytopreventabrokenneedleiscompliancewithsingle-usedisposableneedles.Ifneedlesorpackagingappeardefectiveinanyway,donotusethoseneedlesforpatientcare.Disposeofthedefectiveneedleinasharpscontaineranduseanothersterileneedle.Usetheappropriateneedlesizeandlengthforthelocationandtechniquetobeused.

Safety Guidelines to Prevent Broken Needles Critical • Inspectneedlefordefectsinmanufacturingbeforeuse.StronglyRecommended

• Useonlysingle-usesterilizedneedles.• Neverinsertaneedletothehandle.

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23.KimuraA,KanazawaN,LiH,YoneiN,YamamotoY,FurukawaF.Influenceofchemicalpeelingontheskinstressresponsesystem.ExpDematol.2012;Suppl1(Jul):8-10.

24.VillarreaG,ZagorskiJ,WahlS.Inflammation:Acute.In:EncyclopediaofLifeSciences.29Jan;2003.AccessedJanuary2013.

25.PunchardN,WhelanCAI.InflammationEditorial.JInflamm.2004;1(1).26.SmithP,KuhnM,FranzMWTLWright,RobsonM.Initiatingtheinflammatoryphaseof

incisionalhealingpriortotissueinjury.JSurgRes.2000;91(1)(Jul):11-17.27.LightRW,ParsonsPE,FinlayG.Primaryspontaneouspneumothoraxinadults.In:UpToDate.

http://www.uptodate.com/contents/primary-spontaneous-pneumothorax-in-adults.WoltersKluwerHealth.Dec9;2014.AccessedJanuary16,2015.

28.CurrieGP,AllurieR,ChristieGL,LeggeJS.Pneumothorax:anupdate.PostgradMed.2007;83:461-465.

29.LightRW,KingTE,FinlayG.Secondaryspontaneouspneumothoraxinadults.In:UpToDate.http://www.uptodate.com/contents/secondary-spontaneous-pneumothorax-in-adults:WoltersKluwerHealth.Feb13;2014.AccessedJanuary16,2015.

30.SahnS,HeffnerJ.Spontaneouspneumothorax.NEnglJMed.2000;324:868-74.31.ZhangJ,ShangH,GaoX,ErnstE.Acupuncture-relatedadverseevents(AE):asystematic

reviewoftheChineseliterature.BulletinoftheWorldHealthOrganization.2010;88(August27):915-921C.

32.CantanR,Milesi-DefranceN,HardenbergK,VernetM,MessantI,FreyszM.[Bilateralpneumothoraxandtamponadeafteracupuncture].PresseMed.2003;32(6)(February22):311-312.

33.LamC,NgC,ChungC.Afatalcaseofiatrogenicbilateralpneumothoraxafteracupuncdture.[inChinese].HongKongJ.EmergMed.2009;216:262-4.

34.RamnarainD,BraamsR.[Bilateralpneumothoraxinayoungwomanafteracupuncture].NedTijdschrGeneeskd.2002;146(4)(January26):172-175.

35.SuJW,LimCH,ChuaYL.Bilateralpneumothoracesasacomplicationofacupuncture.SingaporeMedJ.2007;48(1)(January):32-33.

36.TerraRM,FernandezA,BammannRH,CastroACP,IshyA,JunqueiraJJM.[Pneumothoraxafteracupuncture:clinicalpresentationandmanagement].RevAssocMedBras.2007;53(6)(November):535-538.

37.ZhaoD,ZhangG.[Clinicalanalysison38casesofpneumothoraxinducedbyacupunctureoracupointinjection].ZhongguoZhenJiu.2009;29(3)(March31):239-42.

38.CummingsM,Ross-MarrsR,GerwinR.Pneumothoraxcomplicationofdeepdryneedlingdemonstration.AcupunctMed.2014;0(Oct3):1-3.

39.DingM,QiuY,JiangZ,TangLJC.Acupuncture-associatedpneumothorax.JAlternComplementMed.2013;19(6)(Jun):564-8.

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40.HamptonD,KanekoR,SimeonE,MorenA,RowellS,WattersJ.Acupuncture-relatedpneumothorac.MedAcupunct.2014;26(43):241-245.

41.HarrriotA,MehtaN,SeckoM,RomneyM.Sonographicdiagnosisofbilateralpneumothoraxfollowinganacupuncturesession.JClinUltrasound.2014;42(1)(January):27-9.

42.SmithP,PerkinsM.Gettothepoint:A44-year-oldfemalepresentstotheEmergencyDepartmentwithchestpain.Chest.2014;146(4_MeetingAbstracts)(331A)(Oct28).

43.TagamiR,MoriyaT,KinoshitaK,TanjoK.Bilateraltensionpneumothroaxrelatedtoacupuncture.AcupunctMed.2013;31(2):242-4.

44.McCutcheonL,YellandM.Iatrogenicpneumothorax:safetyconcernswhenusingacupunctureordryneedlinginthethoracicregion.Physicaltherapyreviews.2001;16(2):126-32.

45.CummingsM,Ross-MarrsR,GerwinR.Pneumothoraxcomplicationofdeepdryneedlingdemonstration:SupplementaryDataOnlineVideo.AcupunctMed.2014;http://aim.bmj.com/content/32/6/517/suppl/DC1;AccessedJan18,2014(Oct3).

46.MelchartD,WeidenhammerW,StrengAetal.Prospectiveinvestigationofadverseeffectsofacupuncturein97733patients.ArchInternMed.2004;164(1)(January12):104-105.

47.PeukerE.Casereportoftensionpneumothoraxrelatedtoacupuncture.AcupunctMed.2004;22(1)(March):40-43.

48.ErnstE,ZhangJ.Cardiactamponadecausedbyacupuncture:areviewoftheliterature.IntJCardiol.2011;149(3)(June16):287-289.

49.SchiffA.Afatalityduetoacupuncture.MedTimes(London).1965;93:630-1.50.HerA-Y,KimYH,RyuS-M,ChoJH.Cardiactamponadecomplicatedbyacupuncture:

hemopericardiumduetoshreddedcoronaryarteryinjury.YonseiMedJ.2013;54(3)(May1):788-790.

51.HalvorsenTB,AndaSS,NaessAB,LevangOW.Fatalcardiactamponadeafteracupuncturethroughcongenitalsternalforamen.Lancet.1995;345(8958)(May6):1175.

52.KirchgattererA,SchwarzCD,HollerE,PunzengruberC,HartlP,EberB.Cardiactamponadefollowingacupuncture.Chest.2000;117(5)(May):1510-1511.

53.PeukerE,GrönemeyerD.Rarebutseriouscomplicationsofacupuncture:traumaticlesions.AcupunctMed.2001;19(2):103-108.

54.GossnerJ.RelationshipofSternalForaminatoVitalStructuresoftheChest:AComputedTomographicStudy.AnatomyResearchInternational.2013;vol2013:ArticleID780193,4pages.

55.LewekP,LewekJ,KardasP.Anacupunctureneedleremaininginalungfor17years;acasestudyandreview.AcupunctMed.2012;30(3)(Sep):229-32.

56.AsoY,MurahashiI,YokoyamaM.Foreignbodystoneoftheureterasacomplicationofacupuncture:reportofacase.EurUrol.1979;5(1):57-59.

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57.IzumiK,TakizawaA,UdagawaK,MuraiT,MuraiM.BladderStoneSecondarytoMigrationofanAcupunctureNeedle.HinyokikaKiyo.2008;54:365-367.

58.SouthworthSR,HartwigRH.Foreignbodyinthemediannerve:acomplicationofacupuncture.JHandSurgBr.1990;15(1)(February):111-112.

59.LeeC,HyunJ,LeeS.Isolatedmediansensoryneuropathyafteracupuncture.ArchPhysicMed.2008;89(12):2379-81.

60.SatoM,KatsumotoH,KawamuraK,SugiyamaH,TakahashiT.Peronealnervepalsyfollowingacupuncturetreatment.Acasereport.JBoneJointSurgAm.2003;85-A(5):916-8.

61.SobelE,HuangEY,WietingCB.Dropfootasacomplicationofacupunctureinjuryandintraglutealinjection.JAMPodiatrMedAssoc.1997;87(2),52-59.

62.RostedP,WoolleyDR.Bell'sPalsyfollowingacupuncturetreatment--acasereport.AcupunctMed.2007;25(1-2)(June):47-48.

63.ChooD,YueG.Acuteintracranialhemorrhagecausedbyacupuncture.Headache.2000;40(5):397-8.

64.UllothJ,HainesS.Acupunctureneedlescausinglumbarcerebrospinalfluidfistula.Casereport.JNeurosurg.2007;60(6):567-69.

65.BergqvistD.Vascularinjuriescausedbyacupuncture.Asystematicreview.IntAngiol.2013;32(1)(February):1-8.

66.KenzS,WebbH,LagganS.Thighhaematomafollowingacupuncturetreatmentinapatientonwarfarin.BMJCaseReports.2012;pii:bcr2012006676(Oct19).

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2. Moxibustion

Safety/Adverse Events – A Review of the Literature InmodernU.S.AOMpractice,moxibustionismostoftenusedasacomplementtothepracticeofacupuncture.Moxibustionistheheatingofapointontheskinutilizingmoxainvariousforms.ThemostcommonlyusedherbmaterialusedformoxacomesfromArtemisiavulgaris,alsocalledmugwort.Practitionersuseanumberofdifferentmaterialsformoxibustion,includingvariousshapesofmugwortincludingloosemoxa,varioussizesofmoxacones,andthemorecommonlyusedmoxaroll,boththetraditionaltypeandthe“smokeless”type.Practitionersmayutilizemoxaconesormoxasticksforwarmmoxibustion,warmcylindermoxibustion,and,incertaincases,burning/scarringmoxa.

MostTCMpractitionersutilizemoxibustiontherapyalongwithneedlingacupuncturepointsforawiderangeofdisorders.AgeneraloverviewcanbefoundinthetextChineseAcupunctureandMoxibustion.(1)Theuseofmoxibustioniswidespreadandstudieshavereportedeffectivenessinawidevarietyofconditionsfrommusculoskeletalcomplaints,gastrointestinalsymptoms,gynecologicdisorders,breechpresentations,strokerehabilitation,andcomplementarycareforcancersymptoms,tothetreatmentofinfectiousdiseases.(2)Licensedacupuncturepractitionershaveextensivetraininginthemanyandvariedusesofmoxibustiontherapy.

Therehavebeenfewretrospectivestudiesofthesafetyofdirectandindirectmoxibustiontreatment.In2010Parketal.(2)attemptedtoreviewthemedicalliteratureandprovideanoverviewofadverseeventsassociatedwithmoxibustion.Whiledatawaslimited,theclinicaltrialstheyreviewedidentified“rubefaction,blistering,itchingsensations,discomfortduetosmoke,generalfatigue,stomachupsets,flare-ups,headaches,andburns”asadverseevents.Ingeneral,theyconcludedthatpractitionersshouldbepreparedtodealwithburns,allergicreactionsandinfectionsasprobableadverseeventsofmoxatherapies.Inthe2013report,Xuetal.(3)reportAEsassociatedwithmoxibustionwerefoundtobeprimarilybruising,burns,andcellulitis.

ProspectivestudiesofmoxibustiontherapyalonearenotavailableintheEnglishliterature.In1999,aJapanesestudy(4)failedtodifferentiatebetweenadverseeventsassociatedwithacupunctureneedlingandthatassociatedspecificallyfrommoxibustion.Theirconclusionwasthat“seriousorsevereadverseeventsarerareinstandardpractice.”

Whilepractitionerscanprobablyunderstandtheassociationofburnswithanytypeofheattherapy,thepossibilityofinfection,nauseaorallergiesassociatedwithmoxatherapyislessself-evident.Infectionscanbetheresultofburnsthatdisruptthenormalfunctionoftheskinandsubcutaneousbarrierstoinfection.Onecaseassociatedwithscarringmoxatherapyidentifiedanepidural(cervical)abscess,cellulitisandosteomyelitisinadiabeticwomanafter

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repeateddirectmoxatherapy.(5)Burnsfromanytherapeuticmodalityaremorecommonindiabeticpatients.(6)

Infectionsassociatedwithmoxibustionmayalsobearesultofotherpracticesthatareusedalongwiththemoxasuchasneedlingorscarringtherapies.(2)

Allergiestothemoxasmoke,orresponsetothevolatilesubstancessuchasborneolinthemoxasmokemaycreatenauseaorallergicreactions.“Undernormaloperatingconditionsneithervolatilenorcarbonmonoxide[associatedwithmoxasmoke]wouldpresentasafetyhazard.”(6)Withproperventilation,thetoxicityofmoxasmokeisprobablyminimal.(7,8)

ChinesemedicalliteraturealsoreportsonlyminimalAEsassociatedwithmoxibustiontechniques.AfewreportsintheChineseliteratureontheadverseeventsassociatedwithmoxibustionmainlydetailsomelocalAEssuchasburningoftheskin,andskinallergiesassociatedwithmoxibustionpractice.(9)

Effectsofmoxibustiononchemicalparametersofhealtharelimited,suggestingthatexceptforAEssuchasburns,moxibustionisarelativelysafeprocedure.Inastudypublishedin2011,researchersfoundthatindirectmoxibustionisgenerallyconsideredsafe.(10)

Onecasereportofhepatitisinthemedicalliteraturewasinaccuratelyidentifiedasbeingassociatedwithmoxause.Thisreportstatedthatapatient“presumablyacquiredhepatitisCthroughsharingofinfectedknivesduringtheprocessofscarificationorthroughmoxibustionifitinvolvedtheuseofneedles...”(11)

Contraindicationsfordirectorscarringmoxibustioninvolvethesensitiveareasofthebody,suchastheface(duetothepossibilityofburns,andalsotoavoidgettingsmokedirectlyintotheeyesornose),thenipplesandthegenitals(duetosensitivity)andwithinthehairline(ashaircanburn).O'ConnorandBenskyinAcupuncture:AComprehensiveText(12)reinforcetheneedtoavoidtheheadandfaceformoxibustionbyreportingthatancienttextsadvisedcautionorprohibitionwhenapplyingmoxibustiontothefollowingpoints:Shangxing(DU23),Chengqi(ST1),Sibai(ST2),Touwei(ST8),Jingming(BL1),Zanzhu(BL2),Sizhukong(SJ23),Heliao(LI19),Yingxiang(LI20),andRenying(ST9).

Preventing Moxibustion Adverse Events

Burns Practitionersperformingmoxibustionshouldavoidcausingburns(exceptwhenperformingscarringmoxibustion)andbeawarethateachpersonhasadifferenttolerancetoheat.Itisimportanttobeespeciallycarefulwithpersonswhohaveconditionswheresensitivityoflocal

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nervesmaybediminished,suchasinneuralinjury,diabetesmellitus,orpathologyresultinginparalysis,becausesuchpersonsareespeciallysusceptibletoburns.

Whenusingindirectmoxaontheneedle,besuretoprotectthepatient’sskinfromanyfallingmoxaorashes.Ifusingdirectmoxaorscarringtechniques,itissuggestedthatthepractitionerfullyexplainthetechniquetothepatientandaskthepatienttosignaninformed,writtenconsentformbeforeusingthistechnique.

Ifapatienthasbeenburned,infectionistheprimaryconcern.Iftheburnisaverysmallfirstdegreeburn,currentpracticeistoruncoolwaterovertheburn(neverice),andthenapplysterilegauzesecuredtotheskinwithmedicaltape.Over-the-counterburncreamsmayalsobeusedasperthepackagedirections.Ifaburnissevere,orifthereisaconcernwithinfection,referthepatienttoaphysician.

Burnstothepractitionercanalsooccurwhenproperprecautionsarenottaken.SeePartIIIfordetailsofsafemoxapractices.

Safety Guidelines to Prevent Moxa Burns Critical • Takeacarefulpatienthistorytoidentifyneuropathiesorother

conditionsthatmightlimitapatient’sresponsetopainortheabilitytosenseheat.

• Duringmoxatherapythepractitionermustremainintheroomatalltimes.

• Avoiddirectmoxibustionontheface,withinthehairline,orinotherhighlysensitiveareas.

• Anticipateandshieldapatientfromfallingashwhenutilizingneedle-topmoxa.

StronglyRecommended

• Thepractitionershouldnotattempttomulti-taskduringtheapplicationofmoxatherapies.

• Thepractitionershouldmonitortheskintemperatureandamountofheatgeneratedbymoxa,andnotrelysolelyonpatientfeedbackaboutheatsensationswhenutilizinganyformofmoxibustion.

Recommended• Roomsinwhichmoxaistobeusedshouldbeequippedwith

waterandafireextinguisher.

Secondary Infection from Moxa Burns Infectionsassociatedwithmoxibustionaresecondaryadverseeventsrelatedtoburns.Burn.Burnpreventioniscritical.Whenmorethan1cmofskinisinvolvedwithaburn,practitionersneedtoassesstheamountofskindamageandconsiderareferraltoamedicalpractitionerfortreatment.

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Safety Guidelines to Prevent Secondary Infection from Moxa Burns Critical • Preventmoxaburns.

• Payingcloseattentiontopatientcomfortandskinreactionsduringalltreatmentscanpreventseconddegreeburns,whicharemorelikelytobecomeinfectedduetodepthoftissuedamage.

• FollowSafetyGuidelinesforHandSanitationbeforeandaftertreatinganyburnsaspotentiallyinfectiousmaterialmaybepresent.

• Washallburnsthatdooccurwithcoolrunningwaterimmediately.

StronglyRecommended

• Measureandchartthediameterandlocationofanyburnsoccurringasaresultofmoxatherapies.

Recommended • Assesstheamountofdamageandrefertoawesternmedicalpractitionerifneeded.

Nausea or Other Adverse Reactions to Moxa Smoke Bothpractitionersandpatientsmayhaveareactiontoinhalingmoxasmoke.Suchreactionsareusuallytemporaryandcanbeminimizedbyproperventilationofthetreatmentroom.

Safety Guidelines to Prevent Adverse Reactions to Moxa Smoke Critical • Roomsinwhichmoxibustionisperformedmusthaveproper

ventilation.StronglyRecommended

• PractitionersshouldutilizeairfilterunitswhichincludeHEPAfilterswhenperformingmoxibustion.

Recommended • Considerotheroptionsfortreatmentinsteadofburningmoxaforpatientswithahistoryofsignificantasthmaorotherreactionstosmoke.

Other Heat Therapies InfraredandTDP(TedingDianciboPu)lampsareusedbypractitionerstowarmthepatient,orspecificareasofapatient.TDPlampsconsistofaheatingelementonanadjustablearmthatmaybeplacedabovethepatientandisusedtowarmthepatient’sskin.Theheatingelementinthelampmayreachatemperaturethatwillburnapatient.ItisimperativethataTDPlampbemonitoredcarefullywheninuse,andthatmovementsoftheheatingelementareprevented.Ithasbeenreportedthatsomelampsmayslowlylowerduringthecourseofatreatment,resultinginaburnovertheareabeingwarmed.Anydeviceissubjecttowearandtearovertimewhenused;itisspeculatedthatsuchwearmaycausemechanicalfailureoftheheatlampcausingthearmtodescendnearorontothepatient’sskin.Topreventsuchaburn,TDPlampsshouldbecarefullycheckedfordefectsbeforeuse.Defectiveordysfunctionalheatingdevices

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includingTDPlampsshouldnotbeusedinanyclinic.Intheeventofsuchaburn,theinjuredareashouldbeevaluatedbyaphysician.

TherearenoprospectivestudiesontheuseofheatlampsorotherheattherapiesinAOMpractice.OnestudyutilizingheattherapiesincancertreatmentidentifiedAEsof“thermallesions”fromthispractice.(13)Heatcanaffectskininavarietyofways,includingbiologicalandmolecularchanges(14)althoughtheseeffectsappearminimalwhenappliedintermittentlyinclinicalpractice.Significantadverseeventsofheatlampsandotherheattherapiesismostlikelylimitedtoburns,thesecondaryeffectsofburns(infection)andthepossibilityoffire.SeeaboveinformationaboutmoxibustionforcommonpracticestolimittheseAEs.

InoneretrospectivestudyofthefrequencyofburnsfromtherapeuticmodalitiesperformedinKorea,hotpacksweretwiceaslikelytocauseaburnaswastheapplicationofmoxibustion.Otherheattherapiesthatweresourcesofburnsinpatientcareincludedtheuseofelectricheatingpadsandradiantheat/heatlamps.(15)

Safety Guidelines for Heat Therapies Other than Moxa Critical • Heatlampsshouldnotbeusedoninfants,children,incapacitated

persons,orsleepingorunconsciouspersons.• Preventwater,moisture,liquidsormetalobjectsfromcomingin

contactwiththelamp.DoNOTusethislampinwetormoistenvironments.

• Donotuseifanypartofthelampiscracked.Donotallowanypartofthelamptotouchaccessoryequipment.

• Whenheatlampsareusedonpatientswhohaveareducedresponsetoheat,theuseofheatmustbemonitoredatalltimes.

StronglyRecommended

• Donotuseheatlampsincloseproximitytocombustiblematerials(litter,paper,etc.)ortomaterialsadverselyaffectedbyheatordrying.

• Takeacarefulpatienthistorytoidentifydiabetes,neuropathiesorotherconditionsthatmightlimitapatient’sresponsetopainortheabilitytosenseheat.

• Donotuseoversensitiveskinorpersonshavingpoorbloodcirculation.Sufficienttemperaturesaregeneratedthatmaycauseburns.

• Heattherapiesmustbecloselymonitoredbypractitioners.Recommended • Whenpatientinformationisunclear,requestanopinionfroma

physicianbeforeusingaheatlamponthelimbsofapatientwithdiabeticorotherneuropathies.

• Whenpatientshaveconditionsthatreducetheirabilitytofeelheat,thepractitionershouldcarefullymonitortheskintermperatureoftheareabeingtreatedbyaheatlamp.

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References 1.ChengXinnong(chiefeditor).ChineseAcupunctureandMoxibustion.ForeignLanguages

Press,Beijing;1987,pp.363-369.2.ParkJE,LeeSS,LeeMS,ChoiSM,ErnstE.Adverseeventsofmoxibustion:asystematic

review.ComplementTherMed.2010Oct;18(5):215-23.doi:10.1016/j.ctim.2010.07.001.Epub2010Aug19.

3.XuS,WangL,CooperE,ZhangM,ManheimerE,BermanB,ShenX,LaoL.AdverseEventsofAcupuncture:ASystematicReviewofCaseReports.Evidence-BasedComplementaryandAlternativeMedicineVolume2013http://dx.doi.org/10.1155/2013/581203.

4.YamashitaH,TsukayamaH,TannoY,NishijoK.Adverseeventsinacupunctureandmoxibustiontreatment:asix-yearsurveyatanationalclinicinJapan.JAlternComplementMed.1999Jun;5(3):229-36.

5.LeeKW,HanSJ,KimDJ,LeeMj.Spinalepiduralabscessassociatedwithmoxibustion-relatedinfectionofthefinger.JSpinalCordMed.2008;31(3):319-23.

6.MunJH,JeonJH,JungYJetal.Thefactorsassociatedwithcontactburnsfromtherapeuticmodalities.AnnRehabilMed.2012Oct;36(5):688-95.doi:10.5535/arm.2012.36.5.688.Epub2012Oct31

7.WheelerJ,CoppockB,ChenC.Doestheburningofmoxa(Artemisiavulgaris)intraditionalChinesemedicineconstituteahealthhazard?AcupunctMed.2009Mar;27(1):16-20.

8.HatsukariI,HitosugiN,OhnoR,etal.Partialpurificationofcytotoxicsubstancesfrommoxaextract.AnticancerRes.2002Sep-Oct;22(5):2777-82.

9.SonCG.Safetyof4-weekindirect-moxibustiontherapyatCV4andCV8.JAcupunctMeridianStud.2011Dec;4(4):262-5.doi:10.1016/j.jams.2011.09.018.Epub2011Oct19.

10.B.Zhao,G.Litscher,J.Li,L.Wang,Y.Cui,C.HuangandP.Liu,"EffectsofMoxa(ArtemisiaVulgaris)SmokeInhalationonHeartRateandItsVariability,"ChineseMedicine,Vol.2No.2,2011,pp.53-57.doi:10.4236/cm.2011.22010.

11.BardiaA,WilliamsonEE,BauerBA.ScarringmoxibustionandreligiousscarificationresultinginhepatitisCandhepatocellularcarcinoma.Lancet.2006May27;367(9524):1790.

12.O'ConnorJandBenskyD(translators).Acupuncture:AComprehensiveText.EastlandPress,Seattle,WA.1981.

13.WehnerH,vonArdenneA;KaltofenS.Whole-bodyhyperthermiawithwater-filteredinfraredradiation:technical-physicalaspectsandclinicalexperience.IntJHyperthermia;Volume:17,Issue:1,Pages:19-30

14.SchiekeSM,SchroederP,KrutmannJ.Cutaneouseffectsofinfraredradiation:fromclinicalobservationstomolecularresponsemechanisms.Photodermatology.Volume19,Issue5,pages228–234,October2003

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15.MunJH,JeonJH,JungYJetal.Thefactorsassociatedwithcontactburnsfromtherapeuticmodalities.AnnRehabilMed.2012Oct;36(5):688-95.doi:10.5535/arm.2012.36.5.688.Epub2012Oct31

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3. Cupping

Safety/Adverse Events – A Review of the Literature CuppingisacommonlyusedtherapeuticprocedureusedbyAOMandotherhealthcarepractitioners.Cuppingusesapartialvacuumthatcausesthetissuetotumefyandstretchintothecup.Cuppingintentionallycreatestherapeuticpetechiaeandecchymosisthatappearinroundor“nummular”areas.(1)

Therearethreetypesofcupping,eachwithdifferentsafetyprofiles:firecupping,suctioncupping,andwetcupping(cuppingaftertheuseofalancetforbloodwithdrawal).Firecuppingandsuctioncuppingarevariationsofdrycupping.BothdryandwetcuppingareusedintraditionalEastAsianmedicine,thetraditionalmedicineofGulfArabs(hijamah),(2)inEuropeancountries,andinearlyWesternmedicineanditslineageofearlyGreek,RomanandEgyptianmedicine.Cupsusedinthemodernsettingaremadeofglass,plastic,orsilicone.

Cuppingisutilizedbypractitionerstotreatconditionsincludingacuteorchronicpain;mildtosevereconditionssuchascolds,flu,andfever;respiratoryproblemssuchasasthma,bronchitis,andemphysema;functionalinternalorganproblems;musculoskeletalproblems;andinanycaseofrecurringorpersistentfixedpain.(1,3)“Since1950…cuppingtherapyhasbeenappliedasaformalmodalityinhospitalsthroughoutChinaandelsewhereintheworld.”(4)

Xueetal.(5)reportthatovera12-yearperiodmostAEsassociatedwithcuppingwereminorandwereprimarilykeloidscarring,burnsandbullae.OtherreviewssimilarlyreportnoseriousAEsfromcupping.(1,3,6)However,thereareadverseevents,seriousadverseeventsandnegligenterrorsreportedintheliteraturefromcuppingand,whilenotcommon,mostcanandmustbeavoided.

Fire Cupping Burnsfromfirecuppingarereportedintheliterature;theyareanavoidablemedicalerror/adverseevent.(6-11)Inthisprocedure,aballofburningcottonoralitalcoholswabisbrieflyplacedinsideaglasscuptoheattheairinside,whichthencreatesapartialvacuumasitcools.Glasscupsareused,asglassisimpervioustoheatatthelevelsusedforthisprocedure.Typically,cupsareleftonthepatient’sskinfor2-10minutes,butmaybeleftinplaceforupto20minutes,andleaveatemporaryreddishmarkthatisaresultofcutaneouspetechiaeandecchymosis.Unintentionalexpressionofbloodorfluidintocupsmayoccurasaresultoffirecuppingwhentheskinisnotintact,orfrompreviousneedling,localpimplesorotherlocalskinpathologies.

Burnsmaybearesultofplacingtheflametooclosetothelipofthefirecupsothattheedgebecomesveryhot,orfromdroppingtheburningmaterialintothefirecup,thenplacingthecup

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ontheskinwiththehotmaterialinsidethecup.Whilethislatterprocedurehasbeenusedtraditionally,moderncuppingshouldlimitthisprocess.

Suction Cupping Suctioncuppinginvolvestheuseofplasticorsiliconecupswithvalvesatthetopthatattachtohandpumps;thepumpscreatesuctionbyremovingaquantityofairafterthecupshavebeenplacedontheskin.Typicallycupsareonfor2-10minutes,butmaybeleftinplaceupto20minutesandleaveatemporaryreddishmarkthatisaresultofcutaneouspetechiaeandecchymosis.Unintentionalexpressionofbloodorfluidintocupsmayoccurasaresultofsuctioncuppingwhentheskinisnotintact,orfrompreviousneedling,localpimplesorotherlocalskinpathologies.

Wet Cupping Inthisprocedure,theskinispuncturedwithalancetorsterileneedles,suchasthoseusedforplumblossomtapping,beforethecupsareapplied.Wetcuppingmaybedonewitheithersuctioncupsorfirecups.Thetechnique,whichdrawsoutbloodandOPIM,carriesobviousriskofexposuretoandtransferofbloodbornepathogens.

Other Cupping Procedures Practitionersalsousecuppingtechniquesthatincludemovingorslidingcuppingduringwhichpractitionersgentlymovethecupalongalubricatedsurfacearea,channel,oralongmusclefibers;emptycupping,whichmeansthecupsareremovedaftersuctionwithoutdelay;orneedlecupping,duringwhichthepractitionerappliestheacupunctureneedlefirst,thenappliesthecupsovertheneedles.Therisksofthefirsttwotechniquesarequitelimited.Inthelasttechnique,therisksaremorerelatedtotheneedlingthanthecupping.Cuppingmaycompressthetissue,causingacupunctureneedlestopenetratemoredeeplywithneedlecupping,orsubcutaneoustissuesmaybepulledupwardwiththesameeffect,increasingtheriskofpneumothoraxorotherorganpunctureifdoneoverthethoracicregion.Ifneedlingcuppingisdoneoverotherareasofthebody,theremayberisktothecentralorperipheralnervesorbloodvessels.Needlecuppingshouldbeappliedwithcautionandwithneedlesinsertedatanobliqueangle.

Cupping Adverse Events

Skin Reactions Somereactionstocuppingmaybepartofthetherapeuticprocessbutbeinterpretedbyotherpractitionersorobserversas“harms”(12)orevenchildabuse.(13,14)Theseincludeswelling,petechiae,ecchymosis,andpersistenthyperpigmentation.Typicallythesereactionsresolveinafewdaysto2weeks.(1)Researchhasnotestablishedstandardsfortheappropriatetimeforcupstobeleftinplaceortheamountofvacuumsuctionthatisideal;excessivecuppingtimeor

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suctioncancreatebruisingandhyperpigmentationthatisuncomfortableandpersistsformuchlonger.

Fluidblisterscalledbullaearenotaninfrequentoutcomeofcupping.(14-17)Ifthesecontainbloodtheyarecalledhemorrhagicbullae,andarelesscommonandmaybemorelikelyinpatientsonanticoagulantmedicationsandsupplementsthatmayactasbloodthinners.Theycanformcrustingscabsastheyheal,whichcantakeupto2weeks.(18)Theopeningoftheskinbarrierovertimecreatesexposureandriskofinfection.Intheinadvertenteventofsuctionbullae,patientsshouldbeinstructedonuseofantibiotictopicalointment,andonkeepingtheareacleanandcovered,ifnecessary,untilhealed.

Otherunusualskinlesionsreportedinthecuppingliteraturearepanniculitisandkeloidscarring.Factitial(self-inflicted)panniculitis(fattylayerinflammation)canbeproducedbymechanical,physicalorchemicaltrauma.(19)Itpresentsasrednodules,inflammationwithinthecircularareawherecupswereapplied.Itistypicallyself-limitingandfadeslikeadeepbruisewithin6weeks,butcanbecomeinfectedandrequiresurgery.(16)Ifapatientdevelopsredsubcutaneousnodules,avoidfurthercuppingandreferformedicalobservation.

TwoarticlesintheliteratureestablishthatitispossibletoinduceKöebnerphenomenoninpsoriasispatients.(20,21)Thesearticlesdescribetheappearanceofpsoriasislesionsfrompressureortraumatothesurface.Historyorpresentationofpsoriasisinapatientmightcautionagainstaggressivecupping,orcuppingatall.

Onecaseintheliteraturereportedthedevelopmentofakeloidscarattheupperbackfromacuppingtreatmentforcough.(22)Thepatienthadnothadpreviouskeloidscarring,makingthisanunanticipatedadverseevent.Itisrecommendedtoproceedwithcaution,toavoidcuppingorstrongcuppinginpatientswhoalreadyhavekeloidscars.

Cardiovascular Cuppingisassociatedwithadverseeventsinvolvingthebloodandheart.Iron-deficiencyanemia(IDA)inmeninKoreanotidentifiedfromotherknowncausesissuggested(butnotestablished)asrelatedtowetcupping.(23)Leeetal.(24)doreportonasinglecaseofexcessivewetcuppingover6monthsinducingIDAwhereothercauseswereruledout.Thepatientrecoveredafterstoppingwetcuppingandsupplementingwithiron.Sohnetal.(25)reportonawomanwhoself-appliedwetcuppingover10years,andcreatedsevereirondeficiencyanemiaandanenlargedheart(cardiachypertrophy)thatregressedovertimeonceshestoppedwetcupping,andsupplementedwithprescriptionmedicineandiron.Someofhercardiacsymptomspersistedat3months.

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Kimetal.(26)reportonacaseofrepeateddrycuppingcausinganemiabutoffernoevidenceotherthanpersistinghyperpigmentation.(27)Theyalsoassertthattraditionalcuppingcausedadelayincarewhenthepatienthadalreadyconsultedconventionaldoctorsforbackpain.

ArarecomplicationofacquiredhemophiliaAwascausedbycuppingina58-year-oldwoman.(28)Itpresentedasextensiveandcompressivebruisingwhichledtopendingcompartmentsyndromeofherleftthigh2daysaftercupping,resultinginhospitalization.AcquiredhemophiliaAisveryrarebutcandevelopinassociationwithautoimmunedisease,allergicdrugreactions,malignancies,andpregnancywithhigherriskindepressionandanxiety.Forourpurposestonote,thepatientwascuppedonthemedialaspectsofthethighandarm.

Vasovagalsyncope,arareAEofcupping,(16)ismorelikelytooccurwithunderlyingconditionsthatmayincreasetheriskforsyncope(diabetes,renaldisease,seizuredisorders,fastingorlowbloodsugar).

Aninterestingcaseofstroke14hoursaftercuppingwasattributedtocuppingpointsinthelocationofapplication.Cupswereappliedtotheneckclosetoanartery.Apre-existingconditionofpartialarterialocclusionwasnotidentified.Theforceofcuppingwasthoughttohaveeitherelevatedbloodpressurecreatinghemorrhageorstroke(leastlikely),ortohaveprecipitatedanintimaltearoftheliningoftheartery,orhavecreatedsufficientlocalstressastodisturba“thincap”atanocclusionsite.(29)Considerationmustbegiventoapplyingcupsovertheareasoftheneckthatareclosetoarteries.

Infections Infectionhasbeenreportedasanadverseeventofcupping.Leeetal.(30)describeacaseofcervicalepiduralabscess(C1-C3)fromacupuncturewithcuppingthatresolvedwithoralantibiotictreatment.Jungetal.(31)reportacaseofherpessimplexfromacupunctureandcuppingwheretheherpeslesiondevelopedinacircularpatternthatmatchedthecircumferenceofthecups,andattheacupuncturepuncturesitesthathadbeenapplied.Thepatienthadnopersonalorfamilyhistoryofrecurrentcutaneousherpessimplexvirus(HSV).HSVcanbespreadbyabradedskin.TraditionalcuppingwasalsooneriskfactorforhighprevalenceofHTLV-IinfectioninNortheastIran,alongwithbloodtransfusionandhospitalization.(32)Turlayetal.(33)describealumbarabscessfromscarificationwetcupping.Thesecasespointtothepossibilityoftransferofbloodbornepathogensfromcups.Honetal.(34)reportacaseofan11-year-oldgirlwhodevelopedStaphylococcusaureusinfectionfromcupping,resultinginhospitalization.Thepatientwasbeingtreatedforchroniceczema.ColonizationofS.aureusiscommonlyseeninchroniceczemapatients.

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Preventing Cupping Adverse Events

Burns Burnsareassociatedwithfirecuppingonly.Generalsafepracticesforuseofanopenflameshouldbefollowed.

Safety Guidelines to Avoid Fire Cupping Burns Critical • Takeacarefulpatienthistorytoidentifydiabetes,neuropathies,or

otherconditionsthatmightlimitapatient’sresponsetopainortheabilitytosenseheat.Assessthispatientcarefullywhenutilizingfirecupping.

StronglyRecommended

• Theburningmaterialmustbeplacedinthedeepestpartofthecup,notneartherim.

• Removetheburningmaterialbeforeapplyingthecuptothepatient’sskin.

• Neverretaintheburningmaterialinsidethecupwhenthecupisplacedontotheskin.

Infections Thesameproceduresarerecommendedasinpreparationforacupuncture:followSafetyGuidelinesforEstablishingandMaintainingaCleanField,forHandSanitationandSkinPreparation.Wearpersonalprotectiveequipment(PPE)(glovesandprotectiveeyewear)whenbloodorOPIMmaybepresent,ifperformingwetcupping,orcuppingafterneedling.

Avoidcuppingoverlesions,rashes,injuriesorbreaksinskinbarrier.ColonizationofpathogenssuchasStaphylococcusaureusisacommoncomplicationofatopicconditionssuchaseczema.(35)Whiletherearestudiesontheuseofcuppingforherpeszosterandotherskinlesions(6)practitionersshouldbespecificallytrainedincuppingforactiveskinlesionsbeforeapplyingcups.

SafetyGuidelinesforWetCuppingadvisesthatpractitionersmustwearglovesandprotectiveeyewearwhenengaginginwetcupping.Eachareatobewetcuppedshouldbethoroughlycleaned.Skincanbecleanedwith70%isopropylalcoholorsoapandwateroranothermethod,butmustbecleanedimmediatelybeforeperformingwetcupping.Theskinatthesiteshouldbepuncturedusingsterilelancets,pre-sterilizedtraditionalthree-edgedneedles,oraplumblossomtool,withanewlancetbeingusedforeachpunctureandthenimmediatelydiscardedinapropersharpscontainer.Applythecupsthathavebeenproperlydisinfectedforuseovernonintactskinandretainasneededforthedesiredeffect.

36

Whenremovingcupsthatcontainblood,allowthevacuumtobecompromisedslowlythenremovethecup.ThepractitionershouldutilizePPEincludingglovesandeyeprotectionwhenbloodispresentinacupandthecupisbeingliftedtoberemoved.Someofthebloodcanaerosolizeorsplash,exposingthepractitioner’shands,wrists,eyesandothersurfaces.Cleanthesiteofthepunctureswithanappropriateskincleanser.Discardtheextravasatedbloodcollectedbycottonswab,gauze,papertowelorclothinthebiohazardtrash.Thecupitselfmaybediscardedinthebiohazardtrashafterasingle-useor,ifintendedforreuse,mustbecleanedusingsoapandwaterandthensterilized.(1)

Safety Guidelines to Prevent Cupping-Related Infections Critical

• FollowStandardPrecautions.• FollowSafetyGuidelinesforEstablishingandMaintainingaClean

Field.• FollowSafetyGuidelinesforHandSanitation.• Cuppingshouldbeappliedonclearskinonly.Donotapplycupsover

anyactivelesions.• Whenperformingwetcupping,usePPEsuchasglovesandprotective

eyewear.• Iflubricantsareused,decantaportionintoasecondarydisposable

containerorontoasurfacesuchasapapertowelforuseonasinglepatient.Dippingbackintotheoriginallubricantcontainerorre-touchingthespoutofapumpcontainermustbeavoided.

StronglyRecommended

• Ifspecificallycuppingoveractiveherpeszosterlesions,dosoonlywithadvancedtraininginhowtosafelytreatlesionswithcups.

Standards for Reuse of Cupping Devices TheCDCestablisheslevelsofcriticalityformedicalinstrumentsintendedforreusetopreventinfection.(36).RecommendationsareestablishedbytheFDAforrequiredlevelsofdisinfectiondependingoninstrumentcriticality.(37)Recentobservationalstudiesreportthatthemechanicaloperationfromcuppingmayprovidesufficientpressureastocausetheleakingoffluidandbloodfromthesurface.(1)Accordingtotheauthors,unintentionalexpressionofbloodorfluidintocupsmayresultfromopenblemishesorpimples,andmayormaynotrelatetoexcessivesuctionforce,skinfragility,orhydration.(1,38)

Cuppingdevicesarecommonlyreusedonmultiplepatientsandifthecupisintendedtobeusedonnonintactskin,itwouldneedtobedisinfectedbasedontheCDClevelof“semi-criticalinstrumentsintendedforreuse.”(36)Cups,likeanysemi-criticalreusablemedicaldevice,mustbecleanedanddisinfectedusingahighleveldisinfection(HLD)solution.AnumberofchemicalsclearedbytheFoodandDrugAdministration(FDA)aredependablehigh-leveldisinfectantsformedicaldevices.(37)Itiscriticalthatthepractitionerchoosesthechemicaldisinfectantthatis

37

indicatedfortheintendeduseofthedevice,andfollowslabelinstructions,includinguseofPPEwhiledisinfectingthedevices.SeePartVIformoreinformationaboutcleaningreusablemedicaldevices.

Becausetheskin,whichisanormalbarriertocrossinfection,hasbeenpiercedandisnolongerintact,cupsusedforwetcuppingareunquestionablysemi-criticalreusabledevices.(36)Insuchcases,therequirementistouseadisposablecup(anddisposeofitinthebiohazardtrash),or,ifintendedforreuse,washthecupwithsoapandwater,andthendisinfectitusingahigh-leveldisinfectant,accordingtolabelinstructions.(1,36)Thesecupscanalternativelybesterilizedusinganautoclave.Allsafetyproceduresandpackaginginstructionsmustbefollowedforcupdisinfection.Duetotheircorrosivenature,somehigh-leveldisinfectionsolutionsareharmfulorfatalifswallowed.Donotgetineyes,onskin,oronclothing.Useventilation,propercontainers,safetyglasses,andglovesasperlabelinstructions.

Practitionersshouldcarefullyconsiderwhattypeofdisinfectingsolutiontoutilize.Manycommercialproductshavesimilarproductnames.Thepractitionermustcarefullyreadaboutaproduct’sinstructionsofuse,andhazardsofuseanddisposalwhenchoosingtheappropriateproduct.Formoreinformationconcerninghigh-leveldisinfectantsformedicaldevicesseehttp://www.fda.gov/medicaldevices/deviceregulationandguidance/reprocessingofreusablemedicaldevices/ucm437347.htm.(37)

Cleaning and Disinfecting Cups Atthetimeofthewritingofthismanual,theliteratureisunclearaboutthelevelofdisinfectionrequiredforcups.Ifcuppingisperformedonintactskinonly,cupswouldbetreatedasnon-criticalreusablemedicaldevicesthatneedtobecleanedwithsoapandwater,andthendisinfectedinanappropriateintermediate-leveldisinfectantinaccordancewithlabelinstructions.Cupsshouldberinsedanddriedwithcleantowels,andplacedinaclean,closedcontainer.Whenevercupshavebeenorwillbeplacedovernonintactskin,theyneedtobetreatedassemi-criticalreusabledevices.Inthesecases,thecupsneedtobecleanedwithsoapandwatertoremovethelubricant(ifused)andbiologicalmaterialbeforedisinfectingwithahigh-leveldisinfectantinaccordancewithlabelinstructions.Ifthecupswillbeusedonnonintactskin,theyshouldrinsedwithsterile,distilledorfilteredwater.Afterrinsing,dryandstoreinamannerthatpreventsrecontamination.(36)

Thecurrentcontroversyisabouthowoftentheskinbarrieriscompromisedwhencuppingoverintactskin.ResearchersfromBethIsraelMedicalCenterhaveindicatedthatmicroscopicamountsofbloodandOPIMareregularlypresentincuppingprocedures.(1,38)However,fewinfectionsarereportedintheliteraturereviewsofcuppingAEs.(3,4,5,6)Cuppingoverintactskinisamodalityoftreatmentusedsafelyworldwidebylayandlicensedpractitioners.Inthe2013reviewbyXuetal.,therewereonly10reportsofAEs:“Insixcases,therewasno

38

informationonpractitionertraining;intheotherfour,treatmentwasself-administered.”Ofthose10reports,nonewereofinfections.(5)Theonecasereportwedohaveofherpeticlesioninfectionisbasedoncuppingoverzosterlesions,notintactskin.(31)Atthistime,therearenoreportsoflicensedacupuncturistsorotherpractitionersfromtheU.S.whousecupping,suchasmassagetherapists,chiropractorsorphysicaltherapists,causinginfectionswithcuppingoverintactskin.Morestudiesneedtobeperformedtodeterminehowfrequentlytheintactskinisdisruptedincuppingproceduresnotassociatedwithbleedingtechniques.

Furtherissuessurroundthesafetyofusinghigh-leveldisinfectingsolutionsintheclinicalsetting.(39-41)Manyarecausticandrequireventilationhoodsandothersafetyproceduresnotreadilyavailabletoaprivatepractitioner.Afewsolutionsareapprovedforclinicaluseincludingthosethatcontainatleast7.5%hydrogenperoxidesolutionalongwithotherchemicalsbecausesuchsolutionsdonotrequirespecialventilation.(38)However,nonearewithoutrisktothepractitionerorhealthcarepersonnelcompletingthedisinfectiontasks.Choosingtheappropriatechemicalsolutionandfollowinglabelinstructionsiscriticalnotonlytopreventinfection,butalsoforsafeusebythepractitioner.

Theindividualpractitionermustgaugetheconditionofthepatient,whetherornottheareatobecuppedhasnonintactskin,andtheextenttowhichtheirtechniqueofcuppingdisturbstheintactnatureoftheskin’ssurface.Bloodbeingextruded,oropenblisterscreatedduringcuppingareobvioussignsthatthepractitioner’stechniquedisruptstheskinbarrier.Thepractitionermustkeepinmindthatvisualinspectionalonemaynotbeadequatetoassessthedegreethatskinhasbeendisruptedbycupping.Becausethepractitionercannotknowthattheskinhasbecomedisrupteduntilafterithasbecomedisrupted,andtakingintoconsiderationthepotentialrisktopatients,itistheeditor’sopinionthatisprudenttoconsiderhigh-leveldisinfectionofallcupsuntiladditionalstudiesarecompletedtodemonstratethedegreetowhichcuppingcompromisestheskinbarrier.Havingonemethodofdisinfectionincreasesthepracticalconsiderationsthatthepractitionerwillalwayshavepreparedandbeusingdevicesthathavebeenproperlydisinfected.

Safety Guidelines for Cup Disinfection Critical • Cleanallcupsofalllubricantsandbiologicalmaterialusingsoapand

waterbeforedisinfecting.• DisinfectallcupsusinganappropriateFDA-clearedintermediateto

high-leveldisinfectingsolutioninaccordancewithlabelinstructions.• UseappropriatePPEwhilecleaninganddisinfectingcups.

StronglyRecommended

• Disinfectallcupsusingahigh-leveldisinfectingsolutionfollowingpackagedirectionsforsemi-criticaldevices.

Recommended • Usedisposablecupsforwetcuppinganddisposeofusedwetcupsinthebiohazardtrash.

39

Extensive Bruising & Other Skin Lesions Whilepetechiaeandecchymosisareexpectedaftercupping,extensivebruisingcanresultfromeitherapplyingthecupsfortoolongorwithtoostrongofavacuum.ExtensivebruisingisariskwithpatientswhohavebleedingdisorderssuchashemophiliaorVonWillebrand’sdiseaseand/orcertainsupplements.

Practitionersmusttakeathoroughhistory,includingbleedingdisordersandmedicationhistory,beforeapplyingcups.Cupusingcautioninpatientswithahistoryofbleedingdisorders,orwhoarecurrentlytakingbloodthinningmedicationsorsomesupplements.Avoidwetcuppingforpatientswithahistoryofbleedingdisorders,bloodthinningmedications,orsomesupplements.Applycupswithcaution,conservatively,andcontinuallyobservetheprocesstogaugewhentoremovecups.

Limittheretentiontimeofcupstothatofthephysicaltoleranceofthepatient,andtheintendedappearanceoftransitorytherapeuticpetechiaeandecchymosis.Observetheprocessofcuppingtoavoidbullaeblisters.

Takeapatienthistorytoestablishthepresenceorabsenceofkeloidsandpsoriasis.ExplaintheriskofkeloidformationtoallpatientsandofKöebnerphenomenonforpatientswithpsoriasis.

Safety Guidelines for Preventing Cupping Skin Lesions Critical Takeacarefulpatienthistoryto:

• Screenpatientsforthepotentialforreactiveskinlesionssuchaskeloidscarring(previouskeloids)andKöebnerphenomenon(historyofpsoriasis).

• ScreenforbleedingdisordersincludinghemophiliaandVonWillebrand’sdisease.

StronglyRecommended

• Limittheretentiontimeofcupstothatofthephysicaltoleranceofthepatient,andtheintendedappearanceoftransitorytherapeuticpetechiaeandecchymosis.Observetheprocessofcuppingtoavoidbullaeformation.

Unintended Deep Penetration of the Needle Duringneedlecupping,whenapplyingcupsoverinsertedneedles,beawarethattheneedlemaytravelbeyondasafedepthduetothecompressionofthetissue.Thisriskisonlyforneedlecupping.Allstandardneedleandcuppingguidelinesmustalsobefollowed.

40

Safety Guidelines for Needle Cupping StronglyRecommended

• Applyoverneedlesthatareinsertedobliquelyinthethoracicregiontoavoidpneumothorax.

Safety Guidelines to Prevent Cupping Adverse Events Critical • Cuppingshouldnotbeapplied48hoursbeforeor24hoursafter

chemotherapytreatment.StronglyRecommended

• Ifapatientistakinganticoagulantandantiplatelettherapies,cuppingshouldbeappliedwithanawarenessofpatientconditions;thecuppingprocessshouldbecarefullyobserved.

• Limittheretentiontimeofcupstothatofthephysicaltoleranceofthepatient,andtheintendedappearanceoftransitorytherapeuticpetechiaeandecchymosis.

• Applicationofcuppingforchildrenshouldbedoneinthepresenceofaparentorassignedguardian.

Recommended • Thereisariskthatcuppingpetechiaeandecchymosismaybemisinterpretedasillness,injuryorabuse.Itiscriticaltoexplainthetherapeuticintentionofcuppingaswellastheintendedtherapeuticpetechiae/ecchymosis,andthetimelineoftheirresolution.Ahandoutexplainingcuppinginclinicalpracticemayprotectthepatientfromthestressofmisinterpretation.

References 1.NielsenA,KliglerB,KollBS.Safetyprotocolsforguasha(press-stroking)andbaguan

(cupping).ComplementTherMed.2012;20(5)(October):340-344.2.AbinaliHA.TraditionalmedicineamongGulfArabs:PartIIBlood-letting.HeartViews.

2004;58(20):74-85.3.CaoH,HanM,LiXetal.ClinicalResearchEvidenceofCuppingTherapyinChina:ASystematic

Literature.BMCComplementAlternMed.2010;10(1)(November16):70.4.CaoH,LiX,LiuJ.Anupdatedreviewoftheefficacyofcuppingtherapy.PLoSOne.

2012;7(2):31793.5.XuS,WangL,CooperEetal.Adverseeventsofacupuncture:asystematicreviewofcase

reports.EvidBasedComplementAlternatMed.2013;2013:581203.6.CaoH,ZhuC,LiuJ.Wetcuppingtherapyfortreatmentofherpeszoster:asystematicreview

ofrandomizedcontrolledtrials.AlternTherHealthMed.2010;16(6)(Nov-Dec):48-54.7.IblherN,StarkB.Cuppingtreatmentandassociatedburnrisk:aplasticsurgeon'sperspective.

JBurnCareRes.2007;28(2)(April):355-358.8.KoseAA,KarabagliY,CetinC.Anunusualcauseofburnsduetocupping:complicationofa

folkmedicineremedy.Burns.2006;32(1)(February):126-127.9.KulahciY,SeverC,SahinC,EvincR.Burncausedbycuppingtherapy.JBurnCareRes.

2011;32(2)(April):31.

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10.SagiA,Ben-MeirP,BibiC.Burnhazardfromcupping--anancientuniversalmedicationstillinpractice.BurnsInclThermInj.1988;14(4)(August):323-325.

11.SeicolHH.ConsequencesofCupping,totheEditor.NEJM.1997;336:1109-1110.12.FrancoG,CalcaterraR,ValenzanoM,PadoveseV,FazioR,MorroneA.Cupping-relatedskin

lesions.Skinmed.2012;10(5)(October):315-318.13.ManberH,KanzlerM.ConsequencesofCupping.NEJM.1996;335:1281.14.PengC-Z,HowC-K.Bullaesecondarytoprolongedcupping.AmJMedSci.2013;346(1)

(July):65.15.LinC-W,WangJT-J,ChoyC-S,TungH-H.Iatrogenicbullaefollowingcuppingtherapy.J

AlternComplementMed.2009;15(11)(November):1243-1245.16.MoonS-H,HanH-H,RhieJ-W.Factitiouspanniculitisinducedbycuppingtherapy.J

CraniofacSurg.2011;22(6)(November):2412-2414.17.TuncezF,BagciY,KurtipekGS,ErkekE.Suctionbullaeasacomplicationofprolonged

cupping.ClinExpDermatol.2006;31(2)(March):300-301.18.J,BelinchonI,BanulsJ,PastorN,BetllochI.[Skinlesionsfromtheapplicationofsuction

cupsfortherapeuticpurposes].ActasDermosifiliogr.2006;97(3)(April):212-214.19.LeeJ,AhnS,LeeS.Factitialpanniculitisinducedbycuppingandacupuncture.Cutis.

1995;55:217-218.20.VenderR,VenderR.Paradoxical,cupping-inducedlocalizedpsoriasis:akoebner

phenomenon.JCutanMedSurg.2014;18(0)(Dec1):1-3.21.YuRX,HuiY,LiCR.Köebnerphenomenoninducedbycuppingtherapyinapsoriasispatient.

DermatolOnlineJ.2013;19(6)(Jun15):18575.22.BirolA,ErkekE,KurtipekGS,KocakM.Keloidsecondarytotherapeuticcupping:anunusual

complication.JEurAcadDermatolVenereol.2005;19(4)(July):507.23.YunGW,YangYJ,SongICetal.Aprospectiveevaluationofadultmenwithiron-deficiency

anemiainKorea.InternMed.2011;50(13):1371-1375.24.LeeHJ,ParkNH,YunHJ,KimS,JoDY.Cuppingtherapy-inducedirondeficiencyanemiaina

healthyman.AmJMed.2008;121(8)(August):5-6.25.SohnI-S,JinE-S,ChoJ-Metal.Bloodletting-inducedcardiomyopathy:reversiblecardiac

hypertrophyinsevereanemiafromlong-termbloodlettingwithcupping.EurJEchocardiogr.2008;9(5)(September):585-586.

26.KimKH,KimT-H,HwangboM,YangGY.AnaemiaandskinpigmentationafterexcessivecuppingtherapybyanunqualifiedtherapistinKorea:acasereport.AcupunctMed.2012;30(3)(September):227-228.

27.NielsenA,KliglerB,MichalsenA,DobosG.Diddrycuppingcauseanaemia?AcupunctMed.2013March13.

28.WengY-M,HsiaoC-T.AcquiredhemophiliaAassociatedwiththerapeuticcupping.AmJEmergMed.2008;26(8)(October):970-971.

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29.Blunt,StaviaBandLee,HeowPueh.Can“traditional“cuppingtreatmentcauseastroke?MedHypotheses.2010May;74(5):945-9.doi:http://dx.doi.org/10.1016/j.mehy.2009.11.037.Epub2009Dec23.

30.LeeJ-H,ChoJ-H,JoD-J.Cervicalepiduralabscessaftercuppingandacupuncture.ComplementTherMed.2012;20(4)(August):228-231.

31.JungY-J,KimJ-H,LeeH-Jetal.Aherpessimplexvirusinfectionsecondarytoacupunctureandcupping.AnnDermatol.2011;23(1)(February):67-69.

32.RafatpanahH,Hedayati-MoghaddamM,FathimoghadamFetal.HighprevalenceofHTLV-IinfectioninMashhad,NortheastIran:Apopulation-basedseroepidemiologysurvey.JClinVirol.2011;52(3)(November16):172-6.

33.TurlayMG,TurqutK,OguzlurkH.Unexpectedlumbarabscessduetoscarificationwetcupping:Acasereport.ComplementTherMed.2014;22(2)(Aug):645-7.

34.HonKL,LukD,LeongK,LeungA.CuppingtherapyMaybeHarmfulforEczema:aPubMedSearch.CaseRepPediatr.2013;605829(Oct27).

35.HonKL,NipSY,CheungKL.Atragiccaseofatopiceczema:malnutritionandinfectionsdespitemultivitaminsandsupplements.IranJAllergyAsthmaImmunol.2012;11(3)(September):267-270.

36.RutalaWA,WeberDJ,GuidelineforDisinfectionandSterilizationinHealthcareFacilities,2008.CentersforDiseaseControlandPreventionHealthcareInfectionControlPracticesAdvisoryCommittee(HICPAC).http://www.cdc.gov/hicpac/pdf/guidelines/Disinfection_Nov_2008.pdfReviewedDecember29,2009.AccessedJanuary18,2015.

37.FoodandDrugAdministration.Reprocessingofreusablemedicaldevices,FDA-clearedsterilantsandhighleveldisinfectantswithgeneralclaimsforprocessingreusablemedicalanddentaldevices—March2009.Sept11,2014.http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/ReprocessingofReusableMedicalDevices/ucm133514.htm(AccessedJan18,2015).

38.NielsenA,KliglerB,KollBS.Addendum:SafetyprotocolsforGuasha(press-stroking)andBaguan(cupping).ComplementTherMed.2014;22(3):446-448.

39.RutalaWA,ClontzEP,WeberDJ,HoffmannKK.Disinfectionpracticesforendoscopesandothersemicriticalitems.Infect.ControlHosp.Epidemiol.1991;12:282-8.

40.PhillipsJ,HulkaB,HulkaJ,KeithD,KeithL.Laparoscopicprocedures:TheAmericanAssociationofGynecologicLaparoscopists'MembershipSurveyfor1975.J.Reprod.Med.1977;18:227-32.

41.MuscarellaLF.Currentinstrumentreprocessingpractices:Resultsofanationalsurvey.GastrointestinalNursing2001;24:253-60.

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4. Electroacupuncture (EA)

Safety/Adverse Events – A Review of the Literature Electroacupuncture(EA)isusedbymanyacupuncturistsasanadjunctivetherapyforconditionsassociatedwithqi,blood,orphlegmstagnation.Priortotheadventofmodernelectricalappliances,handmanipulationoftheneedleswasusedtostronglystimulateqiflow.EAisusedtoreplaceprolongedneedlemanipulationforconditionsinwhichthereisanaccumulationofqi,suchasinchronicpainsyndromes,orincaseswheretheqiisdifficulttostimulate.(1)

Thereareveryfewstudiesofthepotentialadverseeventsofelectroacupuncture(EA).Onerecentreviewoftheliteraturefrom1979-2010foundonly44incidencesofAEsreportedduringthattimeframeineitherEnglishorChinesedatabases.(2)WhileanumberoftheAEswereprobablyassociatedwiththeacupuncture(faintness,hyperventilation)afewwereassociatedwiththeapplicationofanelectricalcurrent(electricalinjury,atrioventricularblock,dislocationofthewristjointfrommusclespasmandothers).(2)

Areportfromaonepractitionerconcludedthat“mostofthesafetyimplicationsrelatedtotheapplicationofEAaretheoretical,andtherearefewreportsintheliteratureofseriousadverseeventsthatrelatetotheelectricalstimulusasopposedtothetraumaofneedling.”(3)Zhaoetal.(4)reportnoadverseeventsinuseofEAintheirreportof60patientsreceivingEAtherapyformusclespasticityafterbraininjury.

TheremaybeincreasedrisksassociatedwiththeneedlingtechniquesneededforEA.ApractitionermustbeawareofguidelinesforinsertiondepthwhenusingEA.BoththedepthanddirectionofinsertionoftheneedlesisoftenadjustedbypractitionersfortheapplicationofEAinordertoensurethattheneedlescansupporttheweightoftheelectricalleadsandclipsfortheperiodofstimulationwithoutfallingout.EAisoftenappliedfor20–30minutesandmayinvolvestrongmusclecontraction.Boththeuseofincreaseddepthofinsertionandtheneedtoalterinsertionangleatcertainpointsrequirethepractitionertohaveanexcellentgraspoftheanatomyunderlyingthepointsinorderforsafeneedling.

NeedletypeandsizeisalsoimportantwithEA.CertaintypesofmetalshouldbeavoidedforuseinEAsuchassilverneedles,whicharesofterthanstainlesssteelandmayelectrolyzeinthebodyveryquicklyresultinginatoxicreaction.AdditionalstudiesneedtobedonetoidentifythebesttypesofneedlestouseduringEA.Itmaybeadvisabletoavoidneedleswithaplastichandleduetodiminishedconduction;and,thereisatheoreticalconcernaboutverynarrowgaugeneedlesandpossiblebreakagefromelectricalconduction.Stainlesssteelneedlesaresafetousewithelectricalstimulation.

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Excessive Current ThecurrentusedfortherapeuticEArangesfromabout0.5to6mA.Inanotherwisehealthysubjectwithnoimplantedelectricaldevices,themedicalliteratureassociatedwiththeuseofnervestimulatingdevicessuggeststhatthislevelofcurrentshouldbesafe.(5,6)

Higherlevelsofcurrentmaycausesignificantspasmsoflocalmuscles;skeletal,cardiacandsmoothmusclefiberscanallbestimulatedthroughtheuseofelectricalcurrentsleadingtoinadvertentmusclespasms.ThelevelofelectricalstimulationshouldremainjustbelowthelevelofpainasperceivedbythepatientandmusclecontractionshouldbeavoidedinmostapplicationsofEA.WhilethereareapplicationsofEAthatinvolvemusclecontractionaspartofthetherapy(suchastreatmentforpalsy),suchtreatmentsneedtobecloselymonitored.

Anatomical Considerations A2008studyofthesafetyofEAreported,“Whentheneedlesareplacedincloselyadjacentacupuncturepointsinalimb,thereislittleornodetectablespreadofthecurrentsalongthelimborintothechest.Bycontrast,whentheneedlesareplacedfarapart,theelectricalcurrentsspreadwidely.”(7)EAshouldbeavoidedinthefollowinglocationstopreventtheoreticalAEs:

1. Anteriortriangleoftheneck.Duetothelocationofthecarotidsinuswhichregulatesbloodpressure,thelaryngealmusclesassociatedwithbreathing,andthevagusnerve(cranialnerve10),EAshouldnotbeutilizedinthisarea.

2. Posteriorcervicalarea.ThepresenceofthebrainstemmayprohibittheuseofEA.3. Crossingthespine.EAmayinterferewithnormalnerveconduction.Pleasenotethatthe

“forbidden"areadoesnotextendtotheskull.TheuseofEAovertheskulldoesnotappeartocarrythesamerisksasEAacrossthespine.CurrentstudiesthathaveshownnoadverseeffectsofEAarelimitedtolocalizedtreatmentsuchasyintang-Du20,Du20-GB20,EAtoSiShenCong,oroveralocallesion.

4. Crossingtheheart.EAmayaffectthefunctionoftheelectricalsystemintheheartandthecontractionofthecardiacmuscle.

5. Inanypatientwithimplantedmedicaldevices:ICDs(implantablecardioverterdefibrillator)andpacemakers.

Adverseevents(orpotentiallyadverseevents)relatedtotheuseofEAhavebeenreported;thesehavemostlyrelatedtocardiaceffects(angina,cardiacarrest,interferencewithademandpacemaker).(7,8,9)Inonereport,however,theuseofEAinthelimbsinsomeonewithapacemakerdidnotinterferewiththeactionofthecardiacpacemaker,andtheauthorsofthatstudysuggestthatthisrestrictionbere-thought.“TheresultsofthiscasestudysuggestthatEAmightbeasafealternativeforpatientswithapacemaker....Everypatientshouldbeconsideredwithcare,individually.”(10)

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negativechargeatthecathoderesultsinanalkalineenvironmentandliquefactionofproteins.Apositivechargeattheanoderesultsinanacidicenvironmentandcoagulationofproteins.(11)TheuseandfunctionofthetwopolesofEAfordifferentAOMapplicationsneedsfurtherresearchandelucidation.

Preventing EA Adverse Events TherearenocommonadverseeventsassociatedwithEAreportedintheEnglishliterature.UncommonAEscanmostlybepreventedbypropertrainingandanawarenessofcontraindicationsforthetherapy.

Certaintypesofmetalshouldbeavoidedforuseinelectroacupuncturesuchassilverneedles,whicharesofterthanstainlesssteelandmayelectrolyzeinthebodyveryquicklyresultinginatoxicreaction.Stainlesssteelneedlesaresafetousewithelectricalstimulation.(3)

Safety Guidelines for Preventing EA Adverse Events StronglyRecommended

• Electricalstimulationshouldnotbeappliedfromonesideofthechestacrosstotheothersideofthechest(fronttobackorsidetoside)intheregionoftheheart.Acircuitshouldnotcrossthemidsagittallineofthepatient.

Recommended • AvoidapplyingEAnearthebrainstem.• Avoidcrossingthespinewiththeelectricalstimulus.• Consultwiththeprimaryphysicianofanypatientwithahistoryofa

seizuredisorderbeforeinstitutingEA.

Injuries Due to Muscle Contraction Excessiveelectricalcurrentcancausesignificantmusclespasmswhichmaythencauselocaltissueorbonedamage.EAshouldneverbeemployedinsuchamannerastocausecontinuous,strongmusclespasms.

Safety Guidelines for Preventing Excessive Muscle Contraction During EA Critical • EAshouldnotbeusedoninfants,children,incapacitated,sleepingor

unconsciouspersons.• TurnuptheamperageoftheEAmachineslowlyandaskforconstant

feedbackfromthepatientaboutsensationofpain;electricalstimulationshouldbeturnedoffbeforeneedlesareremovedfromthebody.

• Thelevelofstimulusshouldneverapproachthesensationofpain.StronglyRecommended

• ApplyEAinsuchamannerastoavoidmusclecontractionexceptinthosecaseswheremusclestimulationistheexpectedoutcome.

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Electrical Injury Guidelinesforuseofelectricalsafetymustbefollowed.(Seehttps://www.osha.gov/dte/grant_materials/fy09/sh-18794-09/electrical_safety_manual.pdfforanoverviewofelectricalsafety)

Safety Guidelines for Preventing Electrical Injury During EA Critical • Preventwater,moisture,liquidsormetalobjectsfromcomingin

contactwiththepatientortreatmenttable.DoNOTuseEAinwetormoistenvironments.

• DonotuseifanypartoftheEAmachineiscrackedorotherwisedamaged.

• Donotuseifthewiresorleadsarenotingoodcondition.

Interference with a Cardiac Pacemaker Electricalstimulationcaninterferewiththefunctioningofpacemakers.Patienthistoriesmustbespecificforrulingoutthatyourpatienthasapacemaker.

Safety Guidelines for Preventing Interference with a Cardiac Pacemaker During EA Critical AvoiduseofEAonthetrunkofanyonewithanimplantedcardiacdevice,

includingapacemaker.StronglyRecommended

EAshouldnotbeusedonanypartofthebodyofpatientswithpacemakersorotherelectronicimplants.

References 1.AudetteJF,RyanAH.Theroleofacupunctureinpainmanagement.PhysMedRehabilClinN

Am;15(2004)749–772.ZhengW,ZhangJ,ShangH.Electro-Acupuncture-Relatedadverseevents(AE):ASystematic

Review.MedicalAcupuncture.June2012,24(2):77-81.doi:10.1089/acu.2011.0858.3.CummingsM.Safetyaspectsofelectroacupuncture.AcupunctureinMedicine2011Jun29(2):

83-529(2)83-5.20114.ZhaoW,WangC,LiZetal.EfficacyandSafetyofTranscutaneousElectricalAcupoint

StimulationtoTreatMuscleSpasticityfollowingBrainInjury:ADouble–Blinded,Multicenter,RCT.PLoSOne.2015Feb2;10(2):e0116976.doi:10.1371/journal.pone.0116976.

5.ElectricalSafetyTestingReferenceGuide.QuadTech,Inc.4thEdition,May2002,P/N030120/A4http://www.psma.com/ul_files/forums/safety/estguide2.pdfAccessedDecember2012

6.HadzicA,VlokaJ,HadzicN,ThysDM,SantosAC.Nervestimulatorsusedforperipheralnerveblocksvaryintheirelectricalcharacteristics.Anesthesiology2003;98-969-74

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7.ThompsonJW,CummingsM.InvestigatingthesafetyofelectroacupuncturewithaPicoscope.AcupunctMed.2008Sep;26(3):133-9.

8.LauEW,BirnieDH,LemeryR,etal.AcupuncturetriggeringinappropriateICDshocks.Europace2005;7:85–6.

9.WhiteA.Acumulativereviewoftherangeandincidenceofsignificantadverseeventsassociatedwithacupuncture.AcupunctMed2004;22:122–133.http://aim.bmj.com/content/22/3/122.full.pdf

10.VasilakosDG,FyntanidouBP.Electroacupunctureonapatientwithpacemaker:acasereport.AcupunctMed.2011Jun;29(2):152-3.doi:10.1136/aim.2010.003863.Epub2011Mar

11.LowJ,ReedA.ElectrotherapyExplained:PrinciplesandPractice.Oxford:Butterworth-Heinemann1991.

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5. Therapeutic Blood Withdrawal

Safety/Adverse Events – A Review of the Literature Therapeuticbloodwithdrawalisreferredtointheliteratureas“bloodletting”(MeSHterm:“Punctureofaveintodrawbloodfortherapeuticpurpose”),“pricking,”“bleeding,”orthe“useofthethree-edgeneedle.”Forthepurposesofthisreview,wewillusetheterm“bleeding”tocoverallvariationsoftherapeuticbloodwithdrawal.

Bleedingisanoriginalformofmedicinefoundineveryearlyculture,includingearlyWesternmedicine.(1)Thereisevidence,inchronologicaliterationsoftheNeiJingSuWen,thatacupunctureitselfevolvedfrombloodletting.(2)InAOM,bleedingisdoneremovingonlydropsofblooduntilitsqualityandcolorlightens.Itispossiblethatevenminorbleedingorhematomasatanacupunctureneedlesitemightbeconsideredpartofthetherapy.(3)

Thebleedingofspecificpointsisanacupuncturetherapythatcontinuestobeusedtotreat,forinstance,fevers,pain,oritching.(4)

Thereisincreasinginterest,includingarticlesandstudies,onacupuncturetherapybloodletting.APubMedsearchon“acupuncturebloodletting”had97results,manyintheChineseliteraturewithsomeinEnglish.(http://www.ncbi.nlm.nih.gov/pubmed/?term=acupuncture+bloodletting).Bloodlettingisstudiedasastand-alonetherapyorpairedwithacupuncture,cupping,guasha,moxibustionorinmultiplecombinationsoftherapies.AreviewofMedlineandCochranedatabaseswiththeterms"bloodlettingpuncture"and“needlepricking”yieldedonlylimitedcasestudiesandstudiesinChinese,manyofwhichcombinebleedingtherapywithEAandacupunctureorcupping.NoAEswerereportedinanyofthestudiesavailableinEnglish.

TherearenooverviewsofsafetyoradverseeventsinEnglishregardingbleedingtherapies.Butintheirsystematicreviewonadverseeventsofauriculartherapy,Tanetal.(5)reportonminorinfectionsassociatedwithauricularbloodletting.Theliteraturedoesestablishthattheuseoflancetsfordrawingbloodfromtheheelsofinfantsforlabtestingcarriesariskofinfection,thoughrare.(6)Asystematicreviewofwetcuppingforherpeszosterreportednoadverseeventsinanyofthetrials.(7)However,therearecasereportsofinfectionrelatedtowetcupping(seecuppingsection).

Areviewoftheliteratureregardingtheuseoflancetsforcapillarybloodcollectionwassimilarlylimited.Studiesfocusedonlimitingpainandproducingenoughbloodforpropertesting,notonanyadverseevents.(8)OnereportoftransmissionofHBVfromamulti-uselancingdevicepointsouttheneedforusingsingle-useonlydevicesforbleedingtechniques.ThisstudyidentifiedthatanidenticalHBVviralstrainwaspresentforpatientsusingamulti-patient

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lancingdevice,demonstratingthatmultiplepatientswerecrosscontaminatedwithHBVwhenlancetsforbloodlettingwerereused.(9)

Onlypre-sterilizedsingle-usedisposablelancets,ratherthandevicesdesignedforhomeorofficebloodsugarmonitoring,shouldbeusedinacupuncturepractice.Nopartofanylancingdeviceshouldbereusedonotherpatientsorreusedatmultiplesitesonasinglepatient.Sinceblooddropletsmaycollectwithinthefingerstickorlancingdevice,eachnewpuncturepresentsariskforcrossinfection.Lancetscannotbeusedformultiplepatientsevenwhentheyarechangedforeachnewpuncture.

AccordingtotheCDC,“Fingerstickdevices,alsocalledlancingdevices,shouldneverbeshared,evenwithclosefamilyandfriends.Thisguidanceincludesboththelancet(i.e.,thesharpinstrumentthatactuallypuncturestheskin)andthepen-likedevicethathousesthelancet.Neithershouldbeusedformorethanoneperson.”http://www.cdc.gov/injectionsafety/providers/blood-glucose-monitoring_faqs.html

LancingDevice:

Oncethelancethasbeenused,discarditinasharpscontainerimmediately.Single-usespringloadedlancetscanbeusedanddiscardedbuttheyaremoredifficulttocontrolintermsofspecificpointlocationanddepth.

Preventing Acupuncture Bleeding Therapy Adverse Effects Aswithacupunctureneedling,bleedingcarriesariskofinfection,localpain,bleeding,andbruising;safetyguidelinesforpreventingtheseadverseeventsarelistedinthepreviousacupuncturesection.Thisincludesscreeningpatientsformedicationsorsupplementsthatmaythintheblood,suchasanticoagulantandantiplatelettherapiesandpainmedicationssuchasNSAIDS,aswellassomesupplements.

Becausethelancetsbreaktheskinsurface,bloodandOPIMarepresentonthelancetsandmaybeasourceofneedlestickinjuries.Practitionersmusttakecaretolimittheriskofneedlestickinjuries.Retractablesingle-uselancetsmayallowbleedingtechniquestobepracticedwith

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reducedrisktothepractitioner.Retractabledevicesneedtobenewforeachnewpatienttopreventcrosscontaminationwithbloodbornepathogens.

Safety Guidelines for Acupuncture Bleeding Therapy Critical

• FollowSafetyGuidelinesforHandSanitation.• FollowSafetyGuidelinesforSkinPreparation.• Practitionersmusttakeathoroughhistoryincludingbleedingdisorders,

medication,andsupplementhistorybeforeusingbleedingtechniques.• Personalprotectiveequipment(PPE)isrequired.Wearglovesatall

timesasbloodandOPIMwillbepresent.• Inspectareatobetreatedforevidenceofinflammation,lesion,

infection,orabreakintheskinbarrier.Donotbleedintheseareas.• Lancingdevicesmustbelimitedinusetoasinglepatient.• Lancetscannotbereusedafterasingleinsertion;notonanothersite.• Lancetsshouldbeusedonlyonceandthendiscardedinasharps

container.Recommended • Utilizeeyeprotection,suchasgoggles,whenperformingbleeding

techniques.• Utilizelancetsengineeredtoretractafterusetosignificantlyreducethe

riskofneedlestickinjuries.

References 1.HallerJS.AmericanMedicineinTransition1840-1910.Urbana:UniversityofIllinoisPress;

1981.2.EplerDCJr.BloodlettinginearlyChinesemedicineanditsrelationtotheoriginof

acupuncture.BulletinoftheHistoryofMedicine.1980;54(3)(Fall):337-67.3.RammeB.[Minorhemorrhagesandpainatthepuncturesitearepartofthetherapy.Medical

acupuncturehasnosevereadverseeffects!].MMWFortschrMed.2009;151(42)(Oct15):6.

4.ChengXinnong(chiefeditor).ChineseAcupunctureandMoxibustion.ForeignLanguagesPress,Beijing;1987.

5.TanJ-Y,MolassiotisA,WangT,SuenL.AdvereseEventsofAuricularTherapy:ASystematicReview.EvidBasedComplementAlternatMed.2014;2014:506758.

6.OnesimoR,FiorettiM,PiliS,MonacoS,RomagnoliC,FundaroC.Isheelprickassafeaswethink?BMJCaseRep.2011Oct16:pii:bcr0820114677.

7.CaoH,ZhuC,LiuJ.Wetcuppingtherapyfortreatmentofherpeszoster:asystematicreviewofrandomizedcontrolledtrials.AlternTherHealthMed.2010;16(6):48-54.

8.WarunekD,StankovicAK.Evaluationoflancetsforpainperceptionandcapillarybloodvolumeforglucosemonitoring.ClinLabSci.2008Fall;21(4):215-8.

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9.LaniniS,GarbugliaA,PuroVetal.HospitalclusterofHBVinfection:molecularevidenceofpatient-to-patienttransmissionthroughlancingdevice.PLoSOne.2012;7(3):e33122.doi:10.1371/journal.pone.0033122.Epub2012Mar6.

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6. Gua Sha

Safety/Adverse Events – A Review of the Literature GuashaisatraditionalEastAsianhealingtechniquedefinedasthe“closely-timedunidirectionalpress-strokingofthebodysurfacewithasmooth-edgedinstrumenttointentionallyraisetransitorytherapeuticpetechiaeandecchymosis(sha)representingextravasatedbloodinthesubcutis.”(1,2)Thepetechiaeandecchymosisresolvein2-4days.

Guashaisusedinthetreatmentofpain,painonpalpation,andaccompanied“blanchingthatisslowtofade”indicatingshainthetissue.Guashatreatsbothacuteandchronicpain,acuterespiratoryinfection,influenza,andfever,aswellasinternalorgandiseaseswheretheidentifiedferrohememetabolismcanreduceinflammationandofferimmuneprotection.(3).

TraditionalguashatoolshaveincludedChinesesoupspoons,edge-worncoins,variousbonedevices,piecesofhonedjade,variousstainlesssteeldevices,orsimple,round,smooth-edgedmetalcaps.Thelatterisrecommendedasasingle-usedisposableinstrumentoronethatcanbeeasilycleanedanddecontaminated.(1).Lubricantssuchasoil,balms,orwaterareappliedtotheskinpriortoguasha.Guashaisthenappliedincloselytimedpressstrokesuntilpetechiaeandecchymosisappear.Pressstrokingisthencontinuedatthenextstrokelinesequentiallyuntiltheentireregionofinterestiscomplete.(1)

Similartechniquesareusedbyotherhealthcarepractitionersandareidentifiedas“instrumentassistedsofttissuetechniques.”Risksassociatedwithsuchtechniqueswouldbecomparabletothoseofguasha.

RecentarticlessearchingtheMedlineandChineselanguagedatabasesforguashaAEfindnoreportsoftransferofbloodbornepathogens,butciteexposuretobloodbornepathogensasapotentialrisk.(3)Theprimaryreportedriskwithguashaisthemistakingofthepetechiaeforsignsofdisease,injury,orabusebyotherpractitioners.(3)Therefore,communicationbecomesasafetyissue,andprecautionsarerecommendedtoinformpatientsduringandafterguasha.

Guashahasbeenshowntobeeffectiveinrandomizedtrialsforneckpain,(4)neckandbackpain,(5)andbreastengorgement/mastitis.(6)NoseriousAEswerereportedinthesetrials.Guashahasbeenshowntoincreasesurfacemicroperfusion(2)andupregulatehemeoxygenase-1(HO-1)throughwhatiscalledferrohememetabolism.(7)Asthebloodcellsthathavebeenextravasatedareabsorbed,themetabolizingofferrohemeupregulatesgeneticexpressionofHO-1,creatingananti-inflammatoryandimmuneprotectiveeffect.(8)

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Preventing Gua Sha Adverse Events Therearenocommonadverseeventsreportedforguasha.(9,10)Generalguidelinestopreventriskofexposuretobloodbornepathogensshouldbefollowed.

Guashaiscontraindicatedoverrashorbrokenskin,swelling,inflammation,burn,orsunburn.Guashaisindicatedforinflammationandtissueinjury,butnotdirectlyatthesiteofactiveinflammationorinjurytotheskinorunderlyingtissue.GuashaisnotcontraindicatedforpatientswithastableINRwhoaretakinganticoagulantmedication.Theuseofguashaforthosecurrentlytakinganti-coagulantmedication,NSAIDs,VitaminE,orfishoilsorforthosewhohavebleedingdisordersshouldbelimitedtothosepractitionerswiththenecessarybackgroundtoevaluatethesubcutaneousbleedingandtissueresponse.

Becausetheintendedtherapeuticgoalofchemotherapyforcancerisapoptosis,andbecauseguasha’supregulationofHO-1isanti-apoptotic,(8)itisrecommendedtoavoidapplyingguasha(orcupping)for48hoursbeforeand24hoursafterchemotherapy.

Safety Guidelines for Gua Sha Critical • FollowStandardPrecautions.

• FollowSafetyGuidelinesforEstablishingandMaintainingaCleanField.

• FollowSafetyGuidelinesforHandSanitation.• Takeacarefulpatienthistorytoidentifyifthepatientistaking

medicationsthatthintheblood,suchasanticoagulantandantiplatelettherapies,painmedicationssuchasNSAIDSandsupplementssuchasvitaminEandfishoils.Guashaisnotcontraindicatedbutshouldbeappliedwithawarenessofthepatient’scondition.

• Guashashouldnotbeapplied48hoursbeforeor24hoursafterchemotherapytreatment.

• Whenreusingguashatools,selectonlytoolsthataredisposableorthathavebeenproperlydisinfected.

• Iflubricantsareused,decantaportionintoasecondarydisposablecontainerorontoasurfacesuchasapapertowelforuseonasinglepatient.Dippingbackintotheoriginallubricantcontainerorre-touchingthespoutofapumpcontainermustbeavoided.

• Guashashouldbeappliedonclearskinonly.Donotapplyguashaoveranyactiverash,lesion,inflammation,infection,orbreakintheskinbarrier.

• Donotguashaoverswellingorrecenttrauma,includingoverburnsorsunburns.

StronglyRecommended

• Anyapplicationofguashaforchildrenshouldbedoneinthepresenceofaparentorassignedguardian.

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Recommended • Explainthetherapeuticintentionofguashaaswellasthetimelinefortheresolutionofintendedtherapeuticpetechiaewithahandoutonguasha.

Disinfection of Gua Sha Devices Atthetimeofthewritingofthismanual,theliteratureisunclearaboutthelevelofdisinfectionrequiredforguashadevices.Whenusedonintactskinonly,guashadeviceswouldqualifyasnon-criticalreusablemedicaldevices.TheCDCdefinitionsofnon-criticaldevicescanbefoundinGuidelinesforDisinfectionandSterilizationinHealthcareFacilities.(11)Asnon-criticaldevices,reusableguashaspoonsandotherdeviceswouldbecleanedoflubricantsandbiologicalmaterialwithsoapandwater,andthendisinfectedinanappropriateintermediate-leveldisinfectant,inaccordancewiththelabelinstruction.Theyshouldberinsedanddriedwithcleantowels,andplacedinaclean,closedcontainer.Wheneverguashahasbeenorwillbeusedovernonintactskin,thetoolsneedtobetreatedassemi-criticalreusabledevices.Inthesecases,theguashatoolsneedtobecleanedandscrubbedwithsoapandwatertoremovethelubricant(ifused)andbiologicalmaterialbeforedisinfectingwithahigh-leveldisinfectantinaccordancewiththelabelinstruction.Ifthetoolswillbeusedonnonintactskin,theyshouldberinsedwithsterile,distilled,orfilteredwater.Afterrinsing,dryandstoreinamannerthatpreventsrecontamination.(11)PractitionersmuststrictlyfollowFDAandmanufacturerguidelinesfortheuseofanyhigh-levelchemicaldisinfectant.(12)Iftheguashadevicesareheat-stable,terminalprocessingofsterilizationinanautoclavemaybeused.Single-use,disposableguashatoolsmayalsobeconsidered.

Thereisacurrentcontroversyregardinghowoftentheskinbarrieriscompromisedduringguasha.ResearchersfromBethIsraelMedicalCenterhaveindicatedthattheintentionalorunintentionalexpressionofbloodorfluidontoguashadevicesdemonstratesthepotentialexposureto,andriskoftransferof,bloodbornepathogensand/orOPIM.(1)However,noinfectionsarereportedintheliteraturereviewsofguashaAEs.(9,10)Guasha,likecupping,isamodalityoftreatmentusedworldwidebylayandlicensedprofessionals.Similartoolsareusedinthemassagetherapy,chiropractic,andphysicaltherapyprofessions,withnoadverseeventreports.Morestudiesareneededtodeterminehowfrequentlytheintactskinisdisruptedinguasha.

Furtherissuessurroundthesafetyofusinghigh-leveldisinfectingsolutionsintheclinicalsetting.(12-14)Manyarecaustic,andrequireventilationhoodsandothersafetyproceduresnotreadilyavailabletoaprivatepractitioner.Afewsolutionsareapprovedforclinicaluseincludingthosethatcontainatleast7.5%hydrogenperoxidesolutionalongwithotherchemicals,becausesuchsolutionsdonotrequirespecialventilation.(3)However,nonearewithoutrisktothepractitionerorhealthcarepersonnelcompletingthedisinfectiontasks.

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Choosingtheappropriatechemicalsolutionandfollowinglabelinstructionsiscriticalnotonlytopreventinfection,butalsoforsafeusebythepractitioner.

Eachindividualpractitionermustgaugetheconditionofthepatientandtheextenttowhichtheirtechniqueofguashadisturbstheintactnatureoftheskin’ssurface.Bloodbeingextrudedduringguashaisanobvioussignthatthepractitioner’stechniquedisruptstheskinbarrier.Thepractitionermustkeepinmindthatvisualinspectionalonemaynotbeadequatetoassessthedegreethatskinhasbeendisruptedbyguasha.Becausethepractitionercannotknowthattheskinhasbecomedisrupteduntilafterithasbecomedisrupted,andtakingintoconsiderationthepotentialrisktopatients,itistheeditor’sopinionthatisprudenttoconsiderhigh-leveldisinfectionofallguashatoolsuntiladditionalstudiesarecompletedtodemonstratetheextenttowhichguashacompromisestheskinbarrier.Havingonemethodofdisinfectionincreasesthepracticalconsiderationsthatthepractitionerwillalwayshavepreparedandbeusingdevicesthathavebeenproperlydisinfected.Single-usedisposabletoolsmayalsobeconsidered.

Safety Guidelines for Disinfection of Gua Sha Tools Critical • Cleanalltoolsofalllubricantsandbiologicalmaterialusingsoapand

waterbeforedisinfecting.• DisinfectalltoolsusinganappropriateFDA-clearedintermediate-to

high-leveldisinfectingsolution,inaccordancewithlabelinstructions.• UseappropriatePPEwhilecleaninganddisinfectingguashatools.

StronglyRecommended

• DisinfectalltoolsusinganFDA-clearedhigh-leveldisinfectingsolutionforsemi-criticaldevices,inaccordancewithlabelinstructions.

References 1.NielsenA,KliglerB,KollBS.SafetyprotocolsforGuasha(press-stroking)andBaguan

(cupping).ComplementTherMed.2012;20(5)(October):340-344.2.NielsenA,KnoblauchNTM,DobosGJ,MichalsenA,KaptchukTJ.Theeffectof‘Guasha’

treatmentonthemicrocirculationofsurfacetissue:apilotstudyinhealthysubjects.Explore(NY).2007;3:456-466.

3.NielsenA,KliglerB,KollBS.Addendum:SafetyprotocolsforGuasha(press-stroking)andBaguan(cupping).ComplementTherMed.2014;22(3):446-448

4.BraunM,SchwickertM,NielsenA,etal.EffectivenessofTraditionalChinese“GuaSha”TherapyinPatientswithChronicNeckPain;aRandomizedControlledTrial.PainMed.2011;12(3)(January28):362-9.

5.LaucheR,WubbelingK,LudtkeRetal.Randomizedcontrolledpilotstudy:PainintensityandpressurepainthresholdsinpatientswithneckandlowbackpainbeforeandaftertraditionalEastAsian‘Guasha’therapy.AmJChinMed.2012;40(5):905-917.

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6.ChiuJ-Y,GauM-L,KuoS-Y,ChangY-H,KuoS-C,TuH-C.EffectsofGua-Shatherapyonbreastengorgement:arandomizedcontrolledtrial.JNursRes.2010;18(1)(March):1-10.

7.KwongKK,KloetzerL,WongKKetal.Bioluminescenceimagingofhemeoxygenase-1upregulationintheGuaShaprocedure.JVisExp.2009Aug28;(30).Pii:1385,doi:10.3791/1385.

8.XiaZ,ZhongW,MeyrowitzJ,ZhangZ.TheroleofHemeOxygenase-1inTCell-MediatedImmunity:TheAllEncompassingEnzyme.CurrPharmDesing.2008;14:454-464.

9.LeeMS,ChoiTY,KimJI,andChoiSM.UsingGuashatotreatmusculoskeletalpain:asystematicreviewofcontrolledclinicaltrials.ChinMed.2010Jan29;5:5.Doi:10.1186/1749-8546-5-5

10.NielsenA.GuaSha,aTraditionalTechniqueforModernPractice.2ndedition.Edinburgh:ChurchillLivingstone;2012:158pgs.

11.RutalaWA,WeberDJ,GuidelineforDisinfectionandSterilizationinHealthcareFacilities,2008.CentersforDiseaseControlandPreventionHealthcareInfectionControlPracticesAdvisoryCommittee(HICPAC).http://www.cdc.gov/hicpac/pdf/guidelines/Disinfection_Nov_2008.pdfReviewedDecember29,2009.AccessedJanuary18,2015.

12.U.S.FoodandDrugAdministrationReprocessingofreusablemedicaldevices,FDA-clearedsterilantsandhighleveldisinfectantswithgeneralclaimsforprocessingreusablemedicalanddentaldevices—March2009.http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/ReprocessingofReusableMedicalDevices/ucm133514.htm.UpdatedSeptember11,2014.AccessedJan18,2015.

13.PhillipsJ,HulkaB,HulkaJ,KeithD,KeithL.Laparoscopicprocedures:TheAmericanAssociationofGynecologicLaparoscopists’MembershipSurveyfor1975.J.Reprod.Med.1977;18:227-32.

14.MuscarellaLF.Currentinstrumentreprocessingpractices:Resultsofanationalsurvey.GastrointestinalNursing2001;24:253-60.

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7. Plum Blossom Needling

Safety/Adverse Events – A Review of the Literature Plumblossomneedlesareusedforcutaneousacupuncturetreatments.Thesedeviceshaveanumberofneedleprojectionscarriedwithinasinglehammer-likedevicewhichstriketheskininamuchbroaderareathandosinglefiliformacupunctureneedles.Duetotheshapeofthesharpprojectionsinthedevice,theinstrumentisoftenreferredtoasa“seven-star”hammer.Ingeneral,thesedevicesdonotpuncturesubcutaneoustissuebutratherstimulatethesuperficialorcutaneousacupuncturechannels.(1)

Therearecurrently40studyarticlesonplumblossomtherapyinPubMed,almostallinChinese.AEsarenotreported.Thereisonetextonplumblossomtherapy(2)andamentionintheO’ConnorandBenskytext.(1)Averyfewstudies,mostlyinChinese,reportedinformationaboutadverseeventsandinallcases,noAEswereidentified.(3,4,5)

Usingplumblossom/sevenstarneedlingfortreatmentofavarietyofpainsyndromesincludingneuropathiescanbefoundinthemedicaldatabases.ButasmostofthesearticlesarewritteninChinese,theireffectonU.S.practicesisquitelimited.(6-9)

Preventing Plum Blossom Needling Adverse Events WhilenoAEsassociatedwithplumblossom/sevenstarhammertreatmentsarereportedintheliterature,theuseofthisdeviceisnotwithoutrisk.Becausetheindividualneedle-likeprojectionsmaybreaktheskinsurfaceandareusedoverabroadareaofskinratherthanasinglediscretepoint,transientpathogenscanbemovedfromoneareatoanother.Also,whilebleedingisgenerallytobeavoided,bloodandOPIMmaybebroughttothesurfaceandreleasedintotheair.

Safety Guidelines for Plum Blossom (Seven Star) Therapy Critical • FollowSafetyGuidelinesforEstablishingandMaintainingaClean

Field.• FollowSafetyGuidelinesforSkinPreparation.• FollowSafetyGuidelinesforHandSanitation.• Theareatobetreatedwithplumblossommustbecleanandfree

ofanyskinlesionsortraumaticinjury.(9)• Personalprotectiveequipment(PPE)isrequired;wearglovesatall

timesasbloodandOPIMwillbepresent.• Useonlysingle-usesterileplumblossom/sevenstarneedlesor

deviceswithsingle-useremovableheads.• Theheadoftheplumblossomdevicemustbesterile.Donottouch

thetipsoftheneedlesatthedevicehead.• Discardusedplumblossomneedlesinasharpscontainer

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immediatelyafteruse.Toremoveareplaceablehead,usehemostatsortweezers.Ifasingle-usedeviceisused,discardtheentiredeviceinthesharpscontainer.

• Ifareusablehandleisused,itmustbesterilizedbeforethenextsingle-useremovable“head”isapplied.

StronglyRecommended

• Avoidraisingthehandholdingthehammertoohigh,ortappingtooforcefullytopreventpuncturingtheskin.

• Avoid“flinging”thehammeraroundtopreventparticulatesprayofbloodorOPIM.

Recommended • Practitionersshouldconsiderutilizingeyeprotectionwhileusingtheplumblossomdevice.

References 1.O'ConnorJandBenskyD(translators).Acupuncture:AComprehensiveText.EastlandPress,

Seattle,WA.1981,p.417.2.KuangAnMenHospital.PlumBlossom'NeedleTherapy.HongKong:Medicine&Health

Publishing;1978.3.WuL,ZhangGL,YangYX.[ClinicalstudyonelectricalPlumBlossomneedlefortreatmentof

amblyopiainchildren].ZhongguoZhongXiYiJieHeZaZhi.2011Mar;31(3):342-5.4.YangJX,XiangKW,ZhangYX.[Treatmentofherpeszosterwithcottonsheetmoxibustion:

multicentralrandomizedcontrolledtrial].ZhongguoZhenJiu.2012May;32(5):417-21.5.ZhongJ,LinC,FangG,LiJJ,ChenP.[ObservationontherapeuticeffectofPlum

Blossomneedlecombinedwithmedicatedthreadmoxibustionoftraditionalzhuangnationalitymedicineonpostherpeticneuralgia].ZhongguoZhenJiu.2010Sep;30(9):773-6.

6.FengH,ZhangYF,DingM.[AnalysisoftherapeutticeffectoflowerlimbsensationdisorderafterlumbardischerniationoperationtreatedwithPlumBlossomneedlealongmeridians].ZhongguoZhenJiu.2012Feb;32(2):129-3

7.ZhongJ,LinC,FangG,LiJJ,ChenP.[ObservationontherapeuticeffectofPlumBlossomneedlecombinedwithmedicatedthreadmoxibustionoftraditionalzhuangnationalitymedicineonpostherpeticneuralgia].ZhongguoZhenJiu.2010Sep;30(9):773-6

8.SunYZ,LiuTT.[Comparisonoftherapeuticeffectsofacupunctureandmoxibustionondiabeticperipheralneuropathies].ZhongguoZhenJiu.2005Aug;25(8):539-41.

9.YueZ.,ZhenhuiY.UlcerativecolitistreatedbyacupunctureatJiajipoints(EX-B2)andtappingwithPlumBlossomneedleatSanjiaoshu(BL22)andDachangshu(BL25)--areportof43cases.JTraditChinMed.2005Jun;25(2):83-4.

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8. Press Tacks and Intradermal Needles

Safety/Adverse Events – A Review of the Literature Presstacksandintradermalneedlesareusedfortechniquesdescribingsuperficialneedleinsertionwheretheneedlesareretainedinthebodywithoutremovalforonetoseveraldays.Presstacks(enpishin),whicharetypicallyleftintheearforonetofivedays,areaformofauriculartherapy.Reportsofearstaplingforweightloss,avariantofauricularacupuncture,indicateintradermalretentionformuchlonger.(1)Intradermalneedles(hainishin)areinsertedsuperficially,andretainedatvariousbodypoints.Intradermalneedlingisalsocalledmicroneedletherapy,andisusedasaformofaesthetictreatment.

Auricular Therapy/Press Tacks Auriculartherapyconsistsofpresstacks,electricalstimulation,bloodletting,oracupressureachievedwiththetapingofSemenvaccarriaseedsorsmallmagneticpelletstoearpoints.Inasystematicreviewwithmeta-analysis,auricularacupressureandauricularacupuncturewerefoundtobeeffectiveforpain,(2)andinpreventingandtreatingpelvicandbackpaininpregnancy.(3)AsystematicreviewofRCTsshowedpromiseforauriculartherapyintreatingchemotherapy-inducednauseaandvomitingincancerpatients(4)andinaseparatesystematicreview,auriculartreatmentwasaseffectiveasdrugtherapyforperioperativeanxiety.(5)

Therearemultiplecasereportsintheliteratureofchondritis(inflammationofcartilage)(6,7)andperichondritis(inflammationandinfectionoftheoverlyingskinandperichondriumoftheear)fromauricularneedles.(8-14)

Inarecentsystematicreviewnoseriousadverseeventsweredetectedandreportedevents,suchastendernessorpainatinsertionsite,dizziness,localdiscomfort,minorbleedingandnauseaforpresstacks,skinirritation,localdiscomfort,andpainforauricularelectroacupunctureandminorinfectionforauricularbloodletting,wereminor.(15)Theauthorsofthereviewpostulatedthattheinfectedcaseswerereported20-30yearsago,andthatsingle-usesterileneedlesand“awarenessofstricthygienicprocedures”havecontributedtothelowincidenceofinfectionintheirsystematicreview.(15)

Earstaplingtechniqueshavebeenadaptedfromauricularacupunctureinthetreatmentofobesity.However,sincethestaplesmayberetainedfor2-4months,thereisanincreasedriskofcomplicationsandinfection.(1,16,17)QualifiedtrainingandstrictCNTpracticeshouldbefollowedtoavoidinfection.

Intradermal Needling Intradermalneedling(Hinaishin)consistsofsuperficialinsertionandtemporaryretentionofsmallneedles,typicallyaffixedtotheskinwithtape.Preoperativeintradermalacupuncturefor

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thoracotomyhasshownequivocalresults.(18,19)Microneedlingforfacialrejuvenationhasbecomemorewidelyusedwithoutdatatosupportsafety,andtherearesomereportsofcomplicationsandriskofcomplicationssuchasallergicgranulomatousreaction,hypersensitivity(20)andMycobacteriuminfection.(21,22)QualifiedtrainingandstrictCNTguidelinesmustbefollowed;patientself-administrationofintradermalormicroneedlesshouldbediscouraged.

Becausetweezersareusedforneedleplacementandbecausetheytouchthepatient’sintactskin,theycanbedisinfectedwithhospitalgradesurfacedisinfectantwipes.

Safety Guidelines for the Use of Press Tacks or Intradermal Needling Critical • FollowCleanNeedleTechnique.

• FollowStandardPrecautions.• FollowSafetyGuidelinesforEstablishingandMaintainingaClean

Field.• FollowSafetyGuidelinesforSkinPreparation.• Cleanskinbeforeinsertingapresstack.Skincanbecleanedwith

70%isopropylalcohol,soapandwater,oranothermethod.• Inspectareatobetreatedforevidenceofinflammation,lesion,

infection,orabreakinskinbarrier.Donotinsertneedlesintotheseareas.

• Onlyusesingle-usesterileinstruments,includingpresstacks,whenbreakingtheskinsurface.

• Maintaincleanprocedureatalltimeswhilehandlingintradermalneedlespriortoinsertion.Ifneedlesbecomecontaminated,theyshouldbediscarded.

• Donotreinsertapresstack,intradermal,ormicroneedlethathasalreadybeeninsertedintheskin.

• Instructpatientstoneverreinsertapresstack,intradermal,microneedlethathasalreadybeeninsertedintheskin.

• Immediatelyisolateusedpresstacksinanappropriatesharpscontainer.

StronglyRecommended

• Requestpatientsreturntotheofficesothatthepractitionercanremovethepresstacksattheendofretentionofpresstacks;orprovidethepatientwithasharpscontainertouseathomewhenremovingthepresstacksorintradermalneedles.

• Advisepatientsonsaferemovalanddisposalofpresstacksorintradermalneedles.

• Provideeachpatientwithdirectcontactinformationintheeventofcomplicationsorquestions.

• Instructeachpatienttoobserveandrespondtosignsofneedlecomplicationssuchastenderness,redness,pain,inflammation,or

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possibleinfection. • Discourageuseofpatientself-administeredpresstacks,

intradermal,ormicroneedles.Recommended • Forimmunocompromisedorimmunosuppressedpatients,

considertheuseofearseedsormagnetsinsteadofpresstacksorintradermalneedlesforauriculartherapy.

• Takeacarefulpatienthistorytoidentifyifthepatientisallergictothemedicaltapeusedinthisprocedure.

• Afterintradermalneedlewithdrawal,applypressuretotheacupuncturepointwithcleancottonorgauze.

References1.WinterL,SpiefelJ.Earstapling:ariskyandunprovenprocedureforappetitesuppressionand

weightloss.EarNoseThroatJ.2010;89(11):E20-2.2.YehC,ChiangY,HoffmanSetal.Efficacyofauriculartherapyforpainmanagement:a

systematicreviewandmeta-analysis.EvidBasedComplementAlternatMed.2014;2014:934670.

3.PennickV,LiddleS.Interventionsforpreventingandtreatingpelvicandbackpaininpregnancy.CochraneDatabaseSystRev.2013;8(CD001139)(Aug1).

4.TanJ-Y,MolassiotisA,WangT,SuenL.CurrentEvidenceonAuricularTherapyforChemotherapy-InducedNauseaandVomitinginCancerPatients:ASystematicReviewofRandomizedControlledTrials.EvidBasedComplementAlternatMed.2014;2014:430796

5.PilkingtonK,KirkwoodG,RampesH,CummingsM,RichardsonJ.Acupunctureforanxietyandanxietydisorders-asystematicliteraturereview.AcupunctureinMedicine.2007;25(1-2):1-10.

6.AllisonG,KravitzE.Letter:Auricularchondritissecondarytoacupuncture.NEnglJMed.1975;293(15)(October9):780.

7.GilbertJG.Auricularcomplicationofacupuncture.NZMedJ.1987;100(819)(March11):141-142.

8.BaltimoreR,MolyP.Perichondritisoftheearasacomplicationofacupuncture.ArchOtolaryngol.1976;102(9):572-3.

9.DavisO,PowellW.Auricularperichondritissecondarytoacupuncture.ArchOtolaryngol.1985;111(11):770-1.

10.JohansenM,NielsenKO.[Perichondritisoftheearcausedbyacupuncture].UgeskrLaeger.1990;152(3)(January15):172-173.

11.RamosS,PintoL,[Auricularperichondritisduetoacupuncture].[duetoacupuncture].RevistaBrasilieradeOtorrinolaringologia.1997;63(6):1-589.

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12.SorensenT.[Auricularperichondritiscausedbyacupuncturetherapy].UgeskrLaeger.1990;152(11)(March12):752-753.

13.TrautermannHG,TrautermannH.[Perichondritisoftheearauricleafteracupuncture(author'stransl)].HNO.1981;29(9)(September):312-313.

14.Warwick-BrownNP,RichardsAE.Perichondritisoftheearfollowingacupuncture.JLaryngolOtol.1986;100(10)(October):1177-1179.

15.TanJ-Y,MolassiotisA,WangT,SuenL.AdverseEventsofAuricularTherapy:ASystematicReview.EvidBasedComplementAlternatMed.2014;2014:506758

16.BulkheadS,TonkinsonB,NowlinT.Auriculotherapycomplications:Earstaplinggonebad.Otolaryngology--HeadandNeckSurgery.2007;137:215.

17.MorganA.Pseudomonasaeruginosainfectionduetoacupuncturalearstapling.AmJInfectControl.2008;36(819):602.

18.DengG,RuschV,VickersAetal.Randomizedcontrolledtrialofaspecialacupuncturetechniqueforpainafterthoracotomy.JThoracCardiovascSurg.2008;136(6):1464-1469.

19.KotaniN,HashimotoH,SatoSea.Preoperativeintradermalacupuncturereducespostoperativepain,nauseaandvomiting,analgesicrequirement,andsympathoadrenalresponses.Anesthesiol.2001;95:349-356.

20.Soltani-ArabshahiR,WongJ,DuffyK,PowellD.Facialallergicgranulomatousreactionandsystemichypersensitivityassociatedwithmicroneedletherapyforskinrejuvenation.JAMADermatol.2014;150(1)(Jan):68-72.

21.NohT,WoonC,LeeM,ChoiJ,LeeS,ChangS.InfectionwithMycobacteriumfortuitumduringacupointembeddingtherapy.JAmAcadDerm.2013;70(6):e134-5.

22.TangP,WalshS,MUrrayCetal.Outbreakofacupuncture-associatedcutaneousMycobacteriumabscessusinfections.JCutanMedSurg.2006;10(4)(Jul-Aug):166-9.

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9. Ear Seeds

Safety/Adverse Events – A Review of the Literature Earseeds(sometimesalsoreferredtoas“pressballs”)areusedtostimulateacupuncturepoints,usuallyontheauricleoftheear,withoutbreakingtheskin.Mostaremadefrommetalssuchassurgicalstainlesssteelormagnets.Traditionally,seedsfromplantssuchasCaryophyllusaromaticus(clove)andVaccariahispanica(cowherb),wereusedthusgivingthename“vaccaria”toallsuchearseeds.Thesemetal(ornaturallyoccurring)seedscanbeusedtostimulatepointsinotherareasofthebody,suchasatNeiguan(P6)fornauseaofpregnancyandmotionsickness.

TherearenoprospectivestudiesorretrospectivereviewsintheEnglishliteratureregardingthesafetyoftheuseofearseeds/vaccaria.Thereareafewstudieswhichreviewedtheusesofandtherapeuticeffectsofearseedsforbackpain,(1)weightloss,(2)andconstipation.(3)

Thesestudiesreviewedpatientacceptanceandtherapeuticoutcomeswithseedsbeingleftinforupto7days.NonereportedAEsorpatientintolerance.

Preventing Ear Seed Adverse Events TherearenocommonAEsassociatedwiththeuseofearseeds/vaccaria.Generalcleantechniquesandvigilancetoavoiduseoftheseedswherethereisanactiveskininfectionortraumashouldbesufficienttomaintainthesafetyrecordofvaccariatreatments.

Safety Guidelines for the Use of Ear Seeds Recommended Takeacarefulpatienthistorytoidentifyifthepatientisallergictothe

medicaltapeusedinthisprocedure.

References 1.YehCH,ChienLC,ChiangYC,HuangLC.Auricularpointacupressureforchroniclowbackpain:

afeasibilitystudyfor1-weektreatment.EvidBasedComplementAlternatMed.2012;2012:383257.doi:10.1155/2012/383257.Epub2012Jul1.

2.HsiehCH.Theeffectsofauricularacupressureonweightlossandserumlipidlevelsinoverweightadolescents.AmJChinMed.2010;38(4):675-82.

3.ZhouXX,ZhongY,TengJ.[Senilehabitualconstipationtreatedwithauriculartherapybasedonthepattern/syndromedifferentiation:arandomizedcontrolledtrial].ZhongguoZhenJiu.2012Dec;32(12):1090-2.

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10. Tui Na

Safety/Adverse Events – A Review of the Literature TuinaisamanualtherapywhichusesChinesemassageandmanipulationtechniques.TherearenoprospectivestudiesorretrospectivereviewsintheEnglishliteratureregardingthesafetyoftheuseoftuina.TuinaisextensivelyusedinChinaforavarietyofpainandmusculoskeletalsyndromes.Arecentstudywhichreviewedtheusesofandtherapeuticeffectsoftuinaforpain(1)andParkinson’sdisease(2)foundnoadverseeventsorreactionsassociatedwithtuinatherapy.

Similarly,aCochranereviewoftheuseofmassage(nottuina)forneckpain(3)reportedinfrequentreportsofpost-treatmentpainandrareoccurrencesoflowbloodpressurefollowingmassageassideeffects.

Arecentpractitionerjournalarticlelistedthefollowingcontraindicationstotuina:(4)

• Wounds• Dematoses• Diseaseswithhemorrhagictendencies• Acuteinfectiousdiseases• Diseasesofthebrain,heart,liver,kidney,andotherviscera• Menstruationandpregnancy

ThislistissimilartothatusedbymassagetherapistssincethetimeofJHKelloggwhoin1895listedthefollowingcontraindicationstomassage:(5)

Massageiscontra-indicatedinnearlyallformsofskindisease,exceptinthickenedconditionoftheskinleftbehindbychroniceczema.Itisalsocontra-indicatedinacutecasesofapoplexyandintheearlystagesofneuritis,whenirritabilitystillexists,andshouldneverbeadministeredtoabscesses,tumorsortubercularjoints.

Amorerecentarticleoncreatingstandardsformassageinthehospitalsettingalsoelucidatedsimilarprecautions:(6)

Contraindicationsandcautions:UndertheUMHSpolicy,therapeuticmassageislocallycontraindicatedinornearareasofinfection,tumors,orincisions.Othercontraindicationsincludebutarenotlimitedtoimpairmentbyalcoholordrugs,thepresenceofcontagiousrashes,andfailureofthepatienttoconsenttomassagetherapy.

ThereareafewofcasesreportedAEs(complications)associatedwithtuinaintheChineselanguagemedicalliterature.Mostofthesecasesareduetoimproperuseofforceduringthetui

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napracticewhichledtosuchAEsassofttissueinjury,peripheralnerveinjury,visceralinjury,dislocationofajoint,bonefracture,epiduralhemorrhage,injuryofcentralnervesystemespeciallycervicalspineinjury,etc.(7-10)Itisclearthatwhilethesearerareoccurrences,properunderstandingofanatomyandphysiologyisneededtopreventAEsassociatedwiththeover-useofforce.

Preventing Tui Na Adverse Events TherearenocommonAEsassociatedwiththeuseoftuina.Generalcleantechniquesandvigilancetoavoidusingtuinawherethereareactiveskininfections,openwounds,fractures,oracutetrauma,andconsultationwithotherphysicianswhenusingthetechniqueaftersurgeryorduringtreatmentsforcancershouldbesufficienttomaintainthesafetyrecordofthisprocedure.

Safety Guidelines for Tui Na Critical • FollowSafetyGuidelinesforHandSanitation.

• Neverapplytuinatoareasthathavedermatitis,activelesionsorotherwounds.

StronglyRecommended

• Provideappropriatepressureandadjusttuinatreatmentsaccordingtoage,location,bodyconstitutionandmedicalhistory.

References 1.PangJ,TangHL,GaoLF,WangKL,LeiLM,LiuZW,GanW,LuY,ZhouHF,LiJS,ZhangQM.

[RandomizedcontrolledtrialoneffectofTuinafortreatmentofsub-healthpeopleofsomaticpain].ZhongguoZhenJiu.2010Jan;30(1):55-9.

2.Walton-Hadlock,J.PrimaryParkinson'sdisease:TheuseofTuinaandacupunctureinaccordwithanevolvinghypothesisofitscausefromtheperspectiveofChinesetraditionalmedicine.AmericanJournalofAcupuncture1998;26(2-3):163-177

3.PatelKC,GrossA,GrahamN,GoldsmithCH,EzzoJ,MorienA,PelosoPM.Massageformechanicalneckdisorders.CochraneDatabaseSystRev.2012Sep12;9:CD004871.doi:10.1002/14651858.CD004871.pub4.

4.Indications,ContraindicationsandPointsforAttentioninTuina.http://tcmdiscovery.com/Tuina-Massage/info/20080913_214.htmlAccessedDecember2012.

5.Kellog,JH.TheArtofMassage.ModernMedicinePublishingCo.,BattleCreek,MI.,1895.P.201

6.MyklebustM,IlerJ.Policyfortherapeuticmassageinanacademichealthcenter:amodelforstandardpolicydevelopment.JAlternComplementMed.2007May;13(4):471-5.

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7.Chi,Shulan,etal.淑兰，等．急性腰扭伤按摩致腰部血肿一例．颈腰痛杂志，1995；16(2)：90. Acaseofhematomaatthewaistassociatedwithmassagefortreatingacutelumbarsprain.TheJournalofCervicodyniaandLumbodynia,Vol.16,no.2,p.90,1995.[ArticleinChinese]

8.Zhu,Yonghui.朱永辉．颈椎按摩致瘫痪1例报告．岭南急诊医学杂志，2001,6(1)：69. Acasereportofparalysisassociatedwithmassageatcervicalspine.LingnanJournalofEmergencyMedicine,Vol.6,no.1,p.69,2001.[ArticleinChinese]

9.Zeng,Shengming.曾胜明．推拿治疗肩周炎致肋骨骨折一例．中国疗养医学，2001；lO(1)：3. AcaseofribfracturesassociatedwithTuina(Chinesemassage)treatmentforfrozenshoulder.ChineseJournalofConvalescentMedicine,Vol.10,No.1,p.3,2001.[ArticleinChinese]

10.Xiong,Guanyu.熊冠宇．手法治疗颈椎病致脑干梗塞l例．河南中医，2003；23(1 0)：7. Acaseofbrainsteminfarctionassociatedwithmanualtherapyforcervicalspondylosis.”HenanTraditionalChineseMedicine,Vol.23,no.10,p.7,2003.[ArticleinChinese]

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11. Other Acupuncture-Related Tools

Manaka/Japanese Acupuncture Tools

A Review of the Literature ThereisnoevidenceintheEnglishlanguagemedicaldatabasesthatthereareanyAEsassociatedwitheitherManakapumpingchordsorManakahammertreatments.

Preventing Adverse Events TherearenocommonAEsassociatedwiththeuseofManakaproducts.GeneralcleantechniquesandvigilancetoavoiduseoftheManakapumpingchordsorManakahammerwherethereisanactiveskininfectionortraumashouldbesufficienttomaintainthesafetyrecordofthesetreatments.

Shonishin Pediatric Japanese Acupuncture Tools

A Review of the Literature ThereisnoevidenceintheEnglishlanguagemedicaldatabasesthatthereareanyAEsassociatedwithShonishintreatments.

Preventing Common Adverse Events TherearenocommonAEsassociatedwiththeuseofShonishinproducts.Generalcleantechniques,properdisinfectionofsuchdevicesasnoncriticaldevices,andvigilancetoavoiduseoftheanyreusablemedicaldevicewherethereisanactiveskininfectionortraumashouldbesufficienttomaintainthesafetyrecordofthesetreatments.

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Part II: Best Practices for Acupuncture - CNT

Thereareawidevarietyofapplicationsandtechniquesforallacupunctureprocedures.Manyfolloworaltraditions.ThefollowingrecommendationsutilizepracticesasdescribedinChineseAcupunctureandMoxibustion(1)andAcupuncture–AComprehensiveText(2),andapplysafetypracticesbasedontheevidencefromPartI.Thereareanynumberofothermethodswithsafetyprotocolsapplicabletovariousstylesofacupuncturepractices.Thissectionisnotmeanttobeexhaustiveorprohibitive,butrathertobeinstructive.Schoolsandpractitionersareencouragedtoimplementadditionalandalternativemethodstoreduceriskutilizingadditionalandalternativeneedlingtechniques,moxaapplications,andpracticesutilizingotherAOMclinicaltraditions.See,forinstance,thediscussionofToyoharicontactneedlingacupuncture.

Forthepurposesofthismanual,thefollowingtermswillbeutilizedtohelppractitionersapplybestpracticestotheirpersonalpractices:critical,stronglyrecommendedandrecommended.SeetheIntroductionforexplanationoftheseterms.

1. CNT Protocol CleanNeedleTechnique(CNT)isthestandardbywhichacupuncturistspreventoccupationalexposuretohealthcareassociatedpathogens,includingbloodbornepathogensandsurfacepathogens,andreducetheriskforsomeotheradverseeventsassociatedwithacupuncture.CNTconsistsofthefollowingcomponents:

1. Handsanitation.2. Establishingandmaintainingacleanfield.3. Skinpreparation.4. Isolationofcontaminatedsharps.5. Standardprecautions.6. Theuseofsterilesingle-useneedlesandotherinstrumentsthatmaybreaktheskin,

suchasseven-starhammers,presstacks/intradermalneedles,andlancets.

Inaddition,asneeded:

7. Followappropriateemergencyproceduresintheeventofaneedlestickincidentorsomeotherclinicalaccidentinthecourseofanacupuncturetreatment.

Itshouldbestatedattheoutsetthatamorecomprehensiveriskmanagementprotocolisbeyondthescopeofthismanual.Anyriskmanagementcourseshouldbeadaptedtotheuniquerequirementsofthespecificacupuncturetreatmentenvironmentinwhichtheacupuncturististreatingpatients.

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CleanNeedleTechniquemustbedistinguishedfromsteriletechnique.Sterileoraseptictechnique,whichisusedinsurgicalproceduresandmanylaboratoryprocedures,involvesproceduresthatarekeptsterilebytheappropriateuseofsterilesuppliesandthemaintenanceofasterilefield.Whileacupunctureinvolvestheuseofsterileacupunctureneedlesthatmustbemaintainedinasterileconditionpriortotheacupunctureprocedure,CNTisacleanratherthansterileprocedure.

Theinsertionsiteiscleanratherthansterile.Handsareinacleanconditionratherthancoveredwithsterilegloves.Glovesdonotneedtobewornexceptunderspecificconditionswhereexposureofthepractitionertobloodorotherpotentiallyinfectedbodyfluidsispossible.

Glovesareworn:

1. Whenbleedingoccurs,orislikelytooccur(e.g.,duringbleedingtechniques,wetcuppingandseven-star/plumblossomtreatments).

2. Whenneedlinginthegenitalregionorinthemouth.3. Whilepalpatingnearanareawheretherearelesionsonthepatient’sskin.4. Intheeventthatthereareskinlesionsoropenwoundsontheacupuncturist’shands.5. WhencleaningbloodorOPIMfromasurface.

Hand Sanitation HandwashingisacriticalcomponentoftheCNTprotocol.Washinghandswithsoapandwateristhebestwaytoreducethenumberofmicrobesontheminmostsituations.Ifsoapandwaterarenotavailable,useanalcohol-basedhandsanitizerthatcontainsatleast60%alcohol.(3)Makesuretouseenoughsanitizerthatthehandsarecompletelycoveredandwet.Washhandsratherthanusehandsanitizerifhandsarevisiblydirty.

Safety Guidelines for Hand Sanitation Critical • Followinstructionsfor“HowtoWashHands”or“HowtoUseHand

Sanitizer.”• Ifusinghandsanitizer,usesanitizerthatcontainsatleast60%alcohol

uponenteringaroomwithapatientandaftertouchingortreatingapatient.

• DONOTusealcohol-basedhandproductstowashhandsafterexposureofnon-intactskintobloodorbodyfluids;insuchcases,washhandswithsoapandrunningwater,thendrythemusingsingle-usepapertowels.

• Washhandsuponenteringapatient’sroom.• Washhandsimmediatelypriortoinsertingacupunctureneedlesor

performingotherclinicalprocedures.Ifhandscomeintocontactwithsuchitemsasclothes,keyboards,hair,skin,pens,orcharts,rewash

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hands.• Washhandsaftertouchingortreatingapatient.• Washhandsbeforeandaftereating.• Washhandswithsoapandwaterafterusingtherestroom.• Washhandsaftercoughingorsneezing.• Gloveforprocedureswheretheremaybeexposuretobloodorbody

fluid.• Removeglovesimmediatelyafterexposure.Washhandsorsanitize.

How to Wash Hands(4)

Critical • Wetyourhandswithclean,runningwater(neutralorwarm)andapplysoap.

• Latheryourhandsbyrubbingthemtogetherwiththesoap.Besuretolatherthebacksofyourhands,betweenyourfingers,andunderyournails.

• Scrubyourhandsfor10-15seconds.• Rinseyourhandswellunderclean,runningwater,withyourhandslower

thanyourelbows.• Dryyourhandsusingacleanpapertowel.• Turnoffthefaucetusingapapertowel.• Openanydoorsbetweenyouandyourpatientsusingapapertowel,orre-

cleanhandsuponenteringthepatient’sroom.

How to Use Hand Sanitizer(3)

Critical • Applytheproducttothepalmofonehand(readthelabeltolearnthecorrectamount).

• Rubyourhandstogether.• Rubtheproductoverallsurfacesofyourhandsandfingersuntilyour

handsaredry.

Preparing and Maintaining a Clean Field Acleanfieldistheareathathasbeenpreparedtocontaintheequipmentnecessaryforacupunctureinsuchawayastoreducethepossiblecontaminationofsterileneedlesandothercleanorsterileequipment.

Safety Guidelines for Preparing and Maintaining a Clean Field Critical • FollowSafetyGuidelinesforHandSanitation.

• Selectaclean,dry,flatsurfacetoserveasthesettingforthe

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cleanfield.Atreatmenttableisnotsuitable.• Establishanewcleanfieldforeachpatient.• Placematerialssuchasacupunctureneedlesinblisterpackson

thecleanfield.• Placecleancottonballsorunopenedswabsonthefield.If

desired,theseitemsmaybekeptinacleanjarnearthecleanfield.

• Cleanthesurfaceusedforthecleanfieldwithalow-leveldisinfectantatleastoncedaily.

StronglyRecommended

• Placecleancottonballsorunopenedswabsonthecleanfield.Ifdesired,theseitemsmaybekeptinacleanjarnearthecleanfield.

• Keepsterileitemsnearthecenterofthecleanfieldwithcleanitemsnearertheedges.

• Cleanblisterpacksofsterileneedlesmaybehandledandreplacedbackontothecleanfield.

• Cleanpreviouslysterilizedguidetubesmaybehandledandreplacedbackontothecleanfield.

Skin Preparation

Acupunctureneedlesshouldbeusedonlywheretheskiniscleanandfreeofdisease.Needlesshouldneverbeinsertedthroughclothing.Acupunctureneedlesshouldneverbeinsertedthroughinflamed,irritated,diseased,orbrokenskin.Otherwise,infectionscanbecarrieddirectlyintothebodypastthebrokenskinbarrier.Theareastobeneedledshouldbecleanpriortotreatment.Alcoholswabbingisrecommendedbutnotessentialbeforeacupunctureneedleinsertionaslongasanareaisclean.Ifswabbinganarea,70%alcoholorethanolisrequired.Skincanbecleanedwith70%isopropylalcohol,soapandwater,orothermethodsasdeterminedbythepractitionerorclinicadministrator.Whilesoapandwatermaybeacceptable,manypatientscomeinfortreatmentafterworkandtreatmentisoftengiventoareasofthebodywheresoapandwaterarenotpracticalintheoffice.Inmostcases,itispracticaltocleantheskintobeneedledwithanalcohol-impregnatedswab.Ifbodyparts(e.g.,thefeet)aregrosslydirty,theyshouldbewashedwithsoapandwateroranappropriatecleansingcloth.Thepractitionermaythendeterminewhethertheskinalsoneedstobeswabbedasneededwithanalcoholswaborothercleansingagent.

AccordingtotheWorldHealthOrganization,bothsoapandwaterand60-70%isopropyl(orethanol)alcoholisadequateforpreparingapatient’sskinforproceduressuchasneedleinsertion.(5)Isopropylalcoholataconcentrationabove70%isunacceptablebecauseitevaporatestooquicklytohaveanantisepticeffect.

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Therearenostudieswhichcompareskinpreparationpriortoacupunctureneedleinsertionwithnoskinpreparation.Theclosestinformationavailablepertainstoskinpreparationpriortoinjections,(6)suchasinsulininjectionsfordiabeticsandvaccinations.Researchconductedasearlyasthe1960sbyDann(7)andKoivisto&Felig(8)withdiabeticpatientsindicatedthatalthoughskinpreparationwithalcoholpriortoinjectionmarkedlyreducedskinbacterialcounts,suchtreatmentisnotnecessarytopreventinfectionatinjectionsites.(9)

Manypractitionersbelieveitfollowsbestpracticeguidelinestocleantheskinpriortoinjectiontoreducetheriskofcontaminationfromthepatient’stransientskinflora.TheNIH,initspatientinstructions,clearlystates,“Sincetheskinisthebody’sfirstdefenseagainstinfection,itmustbecleansedthoroughlybeforeaneedleisinserted.”(10)

Skinthatiscurrentlyinflamed,orwhichhasanactivelesionshouldnotbeusedforneedleinsertion.Theseareasoftencarryhigherriskforinfection.AccordingtoNIHguidelines,“injectionsarenotgiveniftheskinisburned,hardened,inflamed,swollen,ordamaged...”(10)

Theevidencesuggeststhatboththepractitioner’shandsandthepatient’sskinattheacupuncturepointneedtobecleanpriortoadministrationofaneedle,whetherthatneedleisbeinginsertedtoanintradermal,subcutaneous,orintramusculardepth.Riskassessmentofpotentiallycontaminatedskinshouldbeconductedtoensureappropriatecleaningoftheskinisundertakenwhererequired.Inotherwords,ifsoiled,thepatient’sskinshouldbecleanedpriortoneedleinsertion.Thereisnoclearevidencethatskincleansingwithsoapandwater,alcoholswabs,orantibacterialsubstanceslikechlorhexidineisbetterorworsethantheotheroptions.Evenifskinisvisiblyclean,milddisinfectionmaystillbeperformedpriortoneedleinsertionasallOPIM(otherpotentiallyinfectiousmaterials)arenotnecessarilyvisibletothenakedeye.

Iftheinsertionsiteiscleanedwithanalcoholswab,itshouldbeallowedtodrypriortoneedleinsertiontopreventpainfromalcoholbeinginsertedundertheskinalongwiththeacupunctureneedle.

Somestatesmandatedtheuseofanantisepticswabbeforeinsertionofanacupunctureneedleintheirpracticeactsand/orrules.Thismanualshouldnotbeinterpretedasadvisingagainstapracticeoutlinedinstatelaw.Practitionershaveadutytoinvestigateandcomplywithstateregulation.Foramoredetaileddiscussionofthistopic,seeCCAOM’spositionpaperonskinpreparationinPartIVofthismanual.

Alcohol Swab Method Swabthepointsandallowthealcoholontheskintodry.Thesameswabmaybeusedforseveralpoints.Anewswabshouldbeusediftheswabbeginstochangecolor,becomesvisibly

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dirty,becomesdry,orhascomeintocontactwithanyskinbreak,lesion,inflammationorinfection.Thealcoholshouldbeallowedtodrytoreducethepotentialfordiscomfortduringneedling.Aseparateswabshouldbeusedforareasofhighbacterialload,suchasaxillaorgroin.

Safety Guidelines for Skin Preparation Critical • FollowSafetyGuidelinesforHandSanitation.

• Inspectareatobetreatedforvisibledirtorsoiling.Soapandwaterwashingisrequiredforvisiblysoiledareas.

• Inspectareatobetreatedforevidenceofinflammation,lesion,andinfectionorbreakinskinbarrier.Donotinsertneedlesintotheseareas.

• Alcoholswabbingcontinuestoberecommendedforintramuscularneedlepenetration.(5)

• Ifalcoholswabsareused,70%isopropylorethanolalcoholisrequired.

• Ifalcoholswabbingisusedtocleanpointsbeforeneedleinsertion,allowthealcoholontheskintodry.

• Donotuseaswabatanyadditionalsiteifithascomeintocontactwithskinthathasvisibleinflammation,lesion,andinfectionorbreakinskinbarrier.

• Aseparateswabshouldbeusedforareasofthebodythathavehighbacterialload.

• Donotreuseanalcoholswabonanotherpatient.StronglyRecommended

• Donotpre-soakcottonwoolinacontainerasthesebecomehighlycontaminatedwithhandandenvironmentalbacteria.

• Thesamealcoholswabmaybeusedforcleaningseveralpointsitesaslongastheswabitselfhasnotdried,hasnotchangedcolororbecomevisiblydirtyandhasonlycomeintocontactwithintactskin.

Recommended • Alcoholswabbingofareastobetreatedwithintradermalorsubcutaneousmethodsisrecommendedbutnotessentialaslongastheareaappearstobeclean.(5)

• Investigateandfollowlocalandstateregulationconcerningskinpreparation.

Isolation of Used Sharps AnothercriticalcomponentofCNTistheisolationofusedsharps.Sharpsshouldbeisolatedinasharpscontainerspecificallydesignedforthisuse.Appropriatecontainersareavailablecommercially.Sharpscontainersaremadeofamaterialimpervioustoneedlesandfluids,suchasplastic,andaredesignedtoreceivecontaminatedsharpswithoutbeingabletoretrievethem

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afterthesharpsareplacedinthecontainer.Thesecontainersarelabeledastocontentsandbearthebiohazardsymbol.

Standard Precautions StandardPrecautionsareoutlinedbytheCentersforDiseaseControl.(11)ForthoseusedtothetermUniversalPrecautions,StandardPrecautionscombinethemajorfeaturesofUniversalPrecautions(UP)andBodySubstanceIsolation(BSI),andarebasedontheprinciplethatallblood,bodyfluids,secretions,excretionsexceptsweat,non-intactskin,andmucousmembranesmaycontaintransmissibleinfectiousagents.StandardPrecautionsincludeagroupofinfectionpreventionpracticesthatapplytoallpatients,regardlessofsuspectedorconfirmedinfectionstatus,inanysettinginwhichhealthcareisdelivered.Theseinclude:handhygiene;useofgloves,gown,mask,eyeprotection,orfaceshield,dependingontheanticipatedexposure;andsafeinjectionpractices.(TheCDCswitchedfromthetermUniversalPrecautionstoStandardPrecautionsin2007.)

StandardPrecautionsarewidelyusedtopreventexposuretopotentiallyinfectiousmaterialsinthecourseofclinicalwork,includingacupuncture.Theseprecautionsaresummarizedbelow:

1. Assumeallpatientsareapotentialsourceofinfection.2. Utilizecorrectandfrequenthandwashing.3. Allhealthcarepractitionersmustunderstandtheappropriateuseofpersonalprotective

equipment(PPE)suchasgloves,eyeprotection,andmasks.4. Healthcarefacilitiesapplyappropriateengineeringcontrols,suchasproperlyequipped

handwashingstations.5. Isolationofsharpsinappropriatesharpscontainers.6. Isolationofcontaminatedmedicalwasteinaredbagorotherappropriatecontainer.7. Correctuseofdisinfectants.8. Appropriatecautionwhenhandlingsharps,includingacupunctureneedles,seven-star

hammers,andlancets.

Basic Steps of the Clean Needle Technique for Acupuncture 1. TheproviderfollowsSafetyGuidelinesonHandSanitation.2. Acleanfieldissetuponastablesurfacenearthetreatmenttable.Thecleanfieldmay

consistofapieceofpapertoweling,tablepaper,acleanmetaltrayeitherpreparedwithapaperbarrierorcleanedwithanappropriatedisinfectantbetweeneachpatientvisit,oracleanfieldpurchasedforthispurpose.

3. Needles,intheiroriginalpackaging,areplacedonthecenterofthecleanfield.

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4. Non-sterilecottonballsandskincleansingmaterials(e.g.,alcoholswabs)areplacedeithernearbythetreatmenttableinacleancontainerorontheperipheryofthecleanfield.

5. Sharpsandtrashcontainersareplacedawayfromthecleanfield.6. Theacupuncturepointsonthepatient’sskinshouldbeclean.ForthepurposesofClean

NeedleTechnique,skincanbecleanedwith70%isopropylalcohol,soapandwater,oranothermethodbutmustbecleanwheninsertinganeedleorlancet.

7. Ifusingalcoholtocleantheskin,useanewswab/cottonballwheneverthealcoholswabbecomesdirtyorcontaminatedoristoodrytoleaveathinlayerofalcoholsolutionontheskin.Theinsertionpointcanthenbepalpatedwiththewashedfinger.

8. Theneedleshouldbeinsertedwithouttouchingitssterileshaft.Shouldtheneedlebelong,suchasathreetosixinchneedle,theshaftmaybeheldwithsterilegauzeorsterilecottonbetweenthefingersandtheneedleshaft.Inserttheneedleonlyonce.Intheeventthattheneedlelocationischanged,theneedleshouldbewithdrawnandplacedinthesharpscontainer.Anewneedlemustbeusedforeachinsertion.

9. Theneedleisthenstimulatedfortherapeuticeffect.10. Aftertheappropriateamountoftime,theneedleshouldbewithdrawnandplacedina

sharpscontainer.Donotplacetheneedleinatrayforlatertransfertothesharpscontainerasthisincreasestheriskofanaccidentalneedlestick.Donothandtheusedneedletoanassistant.Thistransferalsoincreasestheriskofexposurebyaccidentalneedlestick.

11. Attheendoftreatment,thepractitionerwasheshisorherhandsandcleansupthecleanfield,includingreplacingordisposingofunusedsupplies.Intheeventthatthepractitionerhasusedsome,butnotall,oftheneedlesinamulti-packofacupunctureneedles,allunusedneedlesmustalsobedisposedofinthesharpscontainer.Openedneedlepacksmaynotbeusedforadifferentpatientoratreatmentatalatertime.

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2. CNT Basic Principles CleanNeedleTechnique(CNT)includesthefollowingbasicprinciples:

1. Alwayswashhandsbetweenpatients,andbeforeandafterneedling.2. Alwaysestablishacleanfieldbeforeperformingacupuncture.3. Alwaysusesterilesingle-useneedlesandotherinstrumentsthatmaybreaktheskin,

suchasseven-starhammers,presstacks/intradermalneedles,andlancets.4. Alwaysimmediatelyisolateusedneedlesandothersharps.5. FollowStandardPrecautions.

Besidestheobviousnecessityforsterileneedles,lancets,andseven-starhammers,handwashingisthesinglemostimportantactioninpreventingcross-infection.Handsshouldbewashedwithliquidsoapunderrunningwaterbetweenpatients,aswellasbeforeandafterperformingacupunctureorotherprocedures,andwheneverthepractitioner’shandsmayhavebecomecontaminatedwithpotentiallyinfectiousmaterial.(SeesectiononhandwashinginPartVofthismanual.)Potentialsourcesofcontaminationincludetouchingthehair,clothes,oruncleanskinofthepatient(orpractitioner);paperwork;computersorphones;oranyotheruncleansurfaceorobjectinthetreatmentenvironment.ThemaingoalofStandardPrecautionsissafetyandspecificallythepreventionofexposuretoandtransmissionofnosocomialdisease.

Intheeventthatitisimpracticalorimpossibleforthepractitionertowashhisorherhandswithsoapandwater,analcohol-basedhandsanitizermaymaybesubstituted.Alcohol-basedhandsanitizersareeffectiveforreducingthepresenceofpotentiallyinfectiousagentsbutwillnotbeeffectiveintheeventthatthepractitioner’shandsaresoiled.Whenthepractitioner’shandsaresoiled,washinghandswithsoapandwaterremainsthebestwaytoremovecontamination.TheCDCalsoallowsfortheuseofdisinfectinghandwipeswhensoapandwaterhandwashingisnotanoption.Forproperuseofalcohol-basedhandsanitizersanddisinfectinghandwipes,pleaseseethemanufacturer’sinstructions.

Contaminatedneedlesarethegreatestsourceofinfectionrisktothepractitionerandpatient.Itisessentialtominimizehandlingofusedneedlesduringdisposal.Thesebasicprincipleswillbediscussedinthesectionsthatfollow.ItisessentialtobemeticulousinfollowingallaspectsofCleanNeedleTechniqueprotocolandStandardPrecautions.Thisincludestheuseofsterileneedles,handwashingbetweentreatments,andisolationofusedsharps.Skinandmucusmembranecontactsfrequentlycanbepreventedwiththeuseofbarrierprecautionssuchasgloves,masks,gowns,andgoggleswhennecessary;however,thegreatestriskofbloodbornepathogentransmissioncomesfromneedlestickinjuries.SuchaccidentsarenotpreventedbybarriersbutinsteadrequirestrictadherencetoCNTprotocolsbypractitioners,includingtheimmediateisolationofusedsharps,thecontinuingrecognitionoftheneedtohandleall

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patientsasiftheywerepotentiallyinfectious,andtheneedtotrainallstaffincleanneedleprotocolsandStandardPrecautions.

PrecautionsarethesameforhepatitisandAIDSaswellasforotherdiseasesthatmightbetransmittedbyneedlestickaccidents.Healthcareworkersareadvisedtodevelopstandardandhabitualproceduresforallpatientsthatprovidethenecessaryprotectionagainstthetransmissionofpotentiallyinfectiousagents.(12)

Setting Up the Clean Field Acleanfieldistheareathathasbeenpreparedtocontaintheequipmentnecessaryforacupunctureinsuchawayastoreducethepossiblecontaminationofsterileneedlesandothercleanorsterileequipment.

Acleanfieldforacupunctureneedlingisestablishedinthetreatmentsettingbyplacingacleanpapertowel,cleantablepaperorothercleanbarrierthatwillserveasacleanfieldonanappropriateworksurface.(Ifatrayisusedasthecleanfield,itmustbecleanedwithanappropriatedisinfectantbetweeneachpatientvisitorcoveredwithcleanpaperorotherbarrierforeachpatientvisit.)Thisfieldshouldbeusedforneedles(beforeuse)andanycleanitemsthepractitionerneedscloseathandforneedlingandotherprocedures.Thecleanfieldshouldbechangedaftereachtreatmentsession.Theworksurfaceusedforthecleanfieldshouldbecleanedatleastoncedailyusingappropriatelow-leveldisinfectants.

PhotobyDarleneEastonandMorrisHoughton.

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Inspecting Needle Packaging Prior to Use Priortouse,acupuncturepractitionersneedtoinspectthepackagingofanysingle-usesterileneedles(andothersterilesharps)toensurethattheprotectivebarrierhasnotbeenbreachedordamagedbyexposuretowater.Theexpirationdateofallneedlesinaclinicshouldbecheckedregularly(i.e.,monthly)andallexpiredneedlesbediscarded.Discardanypackageofneedlesthathasbeenpunctured,tornordamaged,orpasttheexpirationdateofsterilization.

Whenusingacupunctureneedlesfrompackagesthatcontainmorethanoneneedle,allneedlesleftoverattheendofatreatmentmustalsobetreatedasnon-sterilesharpsandmustthereforebediscardedinanappropriatesharpscontainer.Anyunusedbutunsterileneedlesshouldnotbesetasideforuselaterinthedayonadifferentpatientorforuseonthesamepatientonadifferentday.Theyshouldbetreatedascontaminatedsharpsanddiscardedappropriately.Thisshouldnotpreventapractitionerfromusingthemulti-needlepackagesifthatishisorherpreference;propercleantechniquecanstillbefollowedusingthistypeofneedlepackaging.

Skin Preparation

Acupunctureneedlesshouldbeusedonlywheretheskiniscleanandfreeofdisease.Needlesshouldneverbeinserted throughclothing.Acupunctureneedlesshouldneverbeinsertedthroughinflamed,irritated,diseased,orbrokenskin.Otherwise,infectionscanbecarrieddirectlyintothebodypastthebrokenskinbarrier.Theareastobeneedledshouldbecleanpriortotreatment.Alcoholswabbingisrecommendedbutnotessentialbeforeacupunctureneedleinsertionaslongasanareaisclean.Ifswabbinganarea,70%alcoholorethanolisrequired.Skincanbecleanedwith70%isopropylalcohol,soapandwater,oranothermethodasdeterminedbythepractitionerorclinicadministrator.SeeSafetyGuidelinesforSkinPreparation.

Palpating the Point Itisacceptablecleantechniquetopalpatetheacupuncturepointaftercleaningtheskin,aslongasthehandsarecleanandhavenotbeencontaminated.However,itisstronglyrecommendedthatbeforepickinguptheneedleorpalpatingthepoint,thehandsshouldbewashedwithsoapandwateroranalcohol-basedhandsanitizeriftheyhavebeencontaminatedsincethelasthandwashingbysomeactivitysuchasarrangingclothingortakingnotes.Afterthissecondcleaningofthehands,nothingshouldbetouchedbuttheneedlehandle,guidetube,andtheskinoverthepoint.Ifanythingelseistouched,thefingersshouldbecleanedagainasdescribedabovebeforeproceeding.

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Inserting Needle to Correct Depth Whilethereisnoabsolutestandardforthedepthofacupunctureneedling,therearestudiesonmethodsofestablishingsafedepths(13)andrecommendationsfromreliablepracticetextbooks.(1,2,14)Followingaresomegeneralguidelinesandrecommendations:

1. Followthesuggestedneedledepthsindicatedinstandardtexts,beingsuretoallowforvariationinbodysize,age,underlyingdiseaseandriskfactors.Forinstance,inpuncturingthepointRen12(Zhongwan),astrongsensationmaybeobtainedwhenadepthof0.5inchisreachedinathinpatient.Ontheotherhand,sensationmayonlybeinducedwhentheneedleisinsertedtoadeeperlevelforanobesepatient.Clinicalcarefulanalysisshouldbemadeofeachpatient.Forchildren,needledepthsshouldbelessthanforanadult.

2. Safeneedlingdepthofthethoracicregiontoavoidpneumothoraxandcardiactamponadeonmostpatientscanbeaslittleas10-20mm.Limitingthedepthofacupunctureneedleinsertiontothesubcutaneouslayeriscriticalandavoidinguseofneedlesthatarelongerthanthesafeneedlingdepthforaparticularbodyareaisstronglyrecommended.(SeeSafetyGuidelinestoAvoidaPneumothorax,OrganInjury,andTraumaticTissueInjury)

3. Softtissueabdominaldepthsinanadultcanvaryfrom2-4cm.andwillbelessifthepatientisthinorthetissueiscompressedbypalpation.(15)

Can I touch the needle during needle insertion?

Ifyouneedtosupporttheshaftoftheneedleduringneedleinsertion,eitherbecauseyouareusingathinneedle(e.g.,0.15mmwidth)oralongneedle(e.g.,morethan25mmlength)orboth,youmustuseasterilebarrierbetweenyourfingersandtheshaftoftheneedle.Whilewashingyourhandsremovesmostofthetransientbacteriafromtheskinofthehandsandfingers,itdoesnotdislodgetheresidentbacteria.Somepeoplecarryresidentbacteriaontheirskinthatispathogenictootherpeople,suchasMRSA.(SeeinformationaboutHealthcareAssociatedInfections,PartIV,formoreinformationaboutskinbacteria;andPartVofthisManualformoreinformationabouthandwashing.)Anyobjectthatpiercestheskinmustbesterile.Tosupporttheshaftoftheneedle,whennecessary,usesterilegauzeorsterilecottonbetweenyourfingersandtheneedleshaft;thendiscardthegauzeorcottonaftercompletingtheneedleinsertion.Thiswillgreatlyreducethepossibilityofcrossinfections(practitionertopatient)fromacupunctureneedling.Whilemanyolderpractitionersdoholdtheneedleshaftwiththeirclean(butnotsterile)hands,thispracticeistobestronglydiscouragedinthosefollowingtherulesofbestpractices.

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Needle Removal Therearenospecificstandardsregardingneedleremovaltechniques.Whilesomewillfindusingaone-handedmethod(usethesamehandtowithdrawtheneedleandcoverthepointwithcotton)lesslikelytocauseaneedlestickthana2-handedmethod(usedifferenthandsforneedleremovalandcoveringthepointwithacottonball),nospecificstudieshaveshowneithermethodasbeingsuperior.

Similarly,therearenostudiesidentifyingthesafestmethodforneedleremoval.Whileitisclearthatremovedneedlesneedtobeplacedimmediatelyintoasharpscontainer,thereisnoevidenceindicatingthatneedlesmustberemovedandplacedinasharpscontaineroneatatime.Limitingtimeanddistancebetweenremovingtheneedleandplacingusedneedlesinasharpscontainerisstronglyrecommended.Walkingaroundorgesticulatingwithusedneedlesinyourhandsneedstobeavoidedasmuchaspossible.

Alwaysuseacottonballorotherclean,absorbentmaterials(swab,gauze)forcoveringtheholeafterneedleremoval;neveruseyourhandorfinger.Somebloodmaybepresent,especiallyintheearoronthescalpandbestpracticesdictatethatforsafety,abarrierbetweenthepractitioner’shandsandtheopenareaofskinisbesttoreducethelikelihoodoftransferofpathogensfromthepatienttothepractitionerorviceversa.

Dealing with Blood to Blood Contact Acupuncturepractitionersandofficepersonnelareatriskforexposuretobloodbornepathogens,includinghepatitisBvirus(HBV),hepatitisCvirus(HCV),andhumanimmunodeficiencyvirus(HIV).Exposuresoccurthroughneedlesticksorcutsfromothersharpinstrumentscontaminatedwithaninfectedpatient'sbloodorthroughcontactoftheeye,nose,mouth,orskinwithapatient'sblood.ThevastmajorityofbloodtobloodcontactsresultingfromAOMproceduresdonotresultininfection.Ofthebloodbornepathogens,HBVisthemostlikelytobepassedbyneedlestickexposure.HBVinfectionisusuallypreventablethroughavaccineseries.However,theonlysuremethodofpreventingHIVandHCVisabstinencefromactivitiesthatinvolvetheexchangeofpotentiallyinfectedbodyfluids.Inthehealthcareworkplace,accidentalcontactwithpotentiallycontaminatedbloodorbodyfluidsmaybeunavoidable.However,strictobservanceofStandardPrecautionscanpreventsinfectionfromexposure,includingbloodbornepathogenssuchasHBV,HCV,andHIV.(16)

Managing Used Needles Usedinstrumentsthathavepenetratedtheskinmustbeisolatedimmediatelyinanappropriatesharpscontainer.Usedneedles,lancetsandtheheadofasevenstar/plumblossomhammershouldnotbereused,orsterilizedforreuse.Usedneedlespresentriskforpractitioners,staff,andchildrenwaitingfortheirparents.

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Whenusingneedlesfrompackagesthatcontainmorethanoneneedle,allneedlesleftoverattheendofatreatmentmustalsobetreatedasnon-sterilesharpsandmustthereforealsobediscardedinanappropriatesharpscontainer.Theseunusedbutunsterileneedlesshouldnotbesetasideforuselaterinthedayonadifferentpatientorforuseonthesamepatientonadifferentday.Theyshouldbetreatedascontaminatedsharps.

Asharpscontainerfortheusedneedlesshouldberightbesidethetreatmenttable,onaflat,stablesurface(notdirectlyonthetreatmenttable)sothatthereisnodelayinplacingusedsharpsinthecontainerandawayfrompotentialaccidentalcontact.Alternatively,sharpscontainerscanbesecurelyfastenedtoawallclosetothetreatmenttable.Sharpscontainersshouldbeofofficialconstructionandlabeledwiththebiohazardsymbol.

Sharpscontainersshouldbereplacedregularlyandnotbefilledabovethefillmarkorfilledinsuchawaythatusedneedlesarestickingoutofthetop.Replaceacontainerwhenitisthree-quartersfull;donotattempttopushdownthecontentssothatmoremaybeplacedinside.Thisiscriticalforstaffaswellaspractitioners,asstudiesdocumentthatasignificantpercentageofstaffexperienceneedlestickswhilecleaningupsharpscontainers.(17)

Counting Needles Onewaytoensurethatneedlesarenotleftinapatientorleftontreatmenttablesorfloorswheretheymaycauseaneedlestickinjurytoofficepersonnelistocountthenumberofneedlesusedduringatreatmentandthencountthenumberofneedlesremovedanddiscardedafteratreatmentiscompleted.Theseneedlecountscanbedocumentedinthepatient’schart.Attheendofatreatment,ifoneormoreneedlesarenotlocatedduringneedleremoval,thepractitionershouldcheckthetreatmenttableandflooraroundthetableforneedlesthatmayhavefallenoutduringthetreatmentsession.

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3. CNT in an Office Setting First,uponenteringtheroomwithapatient,washorcleanhands.Thenproceedwithclinicalintakeandpulse/tonguediagnosis.Washhandsagainasneededpriortopalpatinganyareasforpainorlesions.

Treatment Protocol in an Office Setting 1. Selectaclean,dry,flatsurfacetoserveasthesettingforthecleanfield.(Note:The

selectedlocationCANNOTbethetreatmenttableasthepatientmaymovehisorherbody!)[critical]

2. Washhandsforatleast10-15secondsunderrunningwater,latheringwellwithsoap.Liquidsoapisrecommendedratherthanbarsoap,whichmaybecomecontaminated.Or,ifsoapandwaterareunavailable,cleanhandswiththealcohol-basedhandsanitizer.[critical]

3. Placeacleanpapertowel,cleantablepaperorotherbarrierthatwillserveasacleanfieldontheworksurfaceinawaythatdoesnotcompromisethecleanlinessofthesurfacethatwillserveasthecleanfield.[stronglyrecommended]

4. Setoutthematerialsneededforatreatment.Sterileitemssuchasacupunctureneedlesinblisterpacks(intheiroriginalpackaging)shouldbeplacedonthecenterofthecleanfieldfirst.Itisacceptabletoutilizeeitherindividuallywrappedneedlesorneedlesinmulti-packsaslongastheyaresterile,single-useneedles.[recommended]

5. Cleanitemssuchascottonballsandunopenedswabsmayeitherbeplacedonthecleanfieldorkeptinjarsorcontainersnearthecleanfieldsoastobeathandforthepractitioner.[recommended]

6. Ensuretheskinattheacupuncturepointstobeusedisclean.If70%alcoholswabsareused,allowthealcoholtodry.[stronglyrecommended]

7. Ifapractitionermustplacetheneedleinsideaguidetube,theneedleshouldbedroppedintothetube,handlefirst,tominimizetheriskofcontaminatingthepointoftheneedle.[stronglyrecommended]

8. Insert,manipulate,andwithdrawtheneedlewithouttouchingtheshaftoftheneedlethatentersthepatient’sskinatanytime.[critical]Ifaguidetubeistobereused,itshouldbeplacedonthecleanfieldbetweenuses.[stronglyrecommended]

9. Iftheneedleislongorthinandcannotbeinsertedwithouttouchingtheshaft,thepractitionershouldusesterilegauzeorcottontoholdtheshaftoftheneedleduringneedleinsertionandmanipulation.[stronglyrecommended]Theneedleshaftshouldneverbetouchedwiththebarehand,evenifthathandhasbeencleaned.

10. Ifthepractitionermissesthepointonthefirstinsertionandhastore-needle,anewneedlemustbeused.Practitionersmaynotreinsertaneedlebecauseonceaneedlehasbeeninserted,itisnolongersterileandmustbedisposedof.[critical]

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11. Countthenumberofneedlesused,includingthosediscardedduetoimproperneedleplacement.[stronglyrecommended]

12. Retainneedlesandstimulateasneededfortherapeuticeffect.13. Removeneedles,puttingusedneedlesimmediatelyintoanappropriatesharps

container.[critical]14. Ifthepractitionerwishestocovertheskinwhereaneedlehasbeenremoved,aclean,

drycottonballshouldbeused.[stronglyrecommended]Thecottonballneednotbesterile.

15. Countthenumberofneedleswithdrawnfromthepatient.Confirmthatthesamenumberofneedlesinsertedhasbeenwithdrawnanddiscarded.[stronglyrecommended]

16. Disposeofallcottonballsandalcoholswabsastheyareused,placingthemimmediatelyinanappropriatetrashcontainer.Theyarenottobeplacedonthecleanfieldafteruse.[critical]

17. Wash/cleansehandsbeforeleavingthetreatmentroom.[stronglyrecommended]

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4. CNT for House Calls/Travel Setting

Travel Kit /Travel Kit Carrier Thetravelkitshouldbecarriedinanappropriatehard-sidedcontainerorplasticcaselargeenoughtocarryalltherecommendedequipment.Thekitmustbehard-sidedinsideandoutsothatallsurfacescanbethoroughlycleaned.Itmusthaveatightclosure.Plasticbagsorsoft-sidedcontainersarenotacceptablebecausetheyarenotpuncture-proof.(Examplesofacceptablecontainerswouldincludeafishingtacklebox,toolbox,amake-uporartbox,oraplasticcraftsupplybox.Anexampleofanunacceptablecasewouldincludealeatherbriefcasewithaflaptopthatleavesagapatthesides.)Thecontainertobeusedmustbeabletoaccommodateasharpscontainer.

Clean Items Thefollowingitemsshouldbeplacedinsideagallon-sizeziplockplasticbag.Notethatsomeoftheseitemswillbeplacedinsidetheirownsmallerbag(i.e.,cottonballsandpapertowels)andthattheseitemsmustremainintheirownbagwhentheyareplacedinsidethelargerbag.

• Sealedpackagesofsterile,disposablesingle-useacupunctureneedlesofthelengthandgaugerequiredbythepractitioner.(Itisrecommendedthattravelkitscontainatleast20needles;forpurposesoftheCNTcourse,CCAOMrequiresthatparticipantsbringatleasttwenty1inchandtwenty1.5inchneedlestotheCNTpracticalexam.)

• Commerciallypreparedcleanfields,cleanpapertoweling,oranyothercleansurface(suchasatray).Thiswillserveasacleanfieldandmustbepackedinitsownziplockplasticbagorcontainer.

• Clean,drycottonballs(atleast20)packedintheirownziplockplasticbag.Cottonballsneednotbesterile.

• Fivecommerciallysealedindividual2x2inchgauzepads.Thesewillbeusedtoholdtheshaftoftheneedleifsupportisneededuponinsertion.

• Onepairofglovesinacommercially-sealedpacketorinitsownplasticziplockbag.Thinglovesusedformedicalexaminationorsurgeryaresoldinmostdrugstoresandarebestsuitedfortravelkits.(Keepinmindthatsomepeopleareallergictolatex.)Theseglovesareusedincaseofemergencies.Forexample,theglovesmaybeneededtocleanupaccidentalspillsofcontaminatedneedlesorwaste.TheymayalsobeusedaccordingtoOSHAguidelinessuchaswhenbloodislikelytobepresentduringatreatment(e.g.,bleedingtechniques).

• 70%isopropylalcoholpreppadsincommerciallysealedpackets(atleast30).

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Non-Clean Items Thefollowingtwoitemsinthekitarekeptintwoseparategallon-sizedziplockplasticbagsinsidethetravelcontainersoastokeepthemseparatefromthecleanequipment:

• Asmallpaperbagwithaplasticlinertoreceivetrash(usedcottonballs,etc.).Thisbagshouldbeclearlymarkedininkas“Waste”or“Trash.”

• Asmall,red,commercialsharpscontainer.Thiscontainermustbeimpervious,unbreakable,clearlymarked"Contaminated,"andbeartheofficialbiohazardsymbol.Thesecontainerscanbepurchasedinamedicalsupplystoreorfromanacupuncturesupplycompany.(Note:anythingthatqualifiesasmedicalwaste,suchasblood-soakedcottonballswouldneedtoberemovedbyamedicalwastedisposalfirmandwouldthereforeneedtobediscardedinthesharpscontainerfortravelkituseonly.OSHAdefinescottonballssoakedwithbloodthatcanbewrungoutasbeingmedicalwaste;lessbloodthanthatshouldbeconsideredtrashandshouldbeplacedinthetrashbag.(17,18,19)

Afteruse,theseitemsshouldbereplacedintheirindividualgallon-sizedziplockbags.Thesebagsshouldthenbesecurelysealedandplacedinsidethetravelcontainer.

Travel Kit Items Not in Bags • Hemostatortweezers(usedtoremovebrokenorstuckneedlesortopickupneedles

fromthefloorifdropped).• Alcohol-basedhandsanitizer

PhotobyDarleneEastonandMorrisHoughton.

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Hand Cleanser Abottleofalcohol-basedhandsanitizershouldalsobeincludedinthetravelkit.Thisshouldnotbeplacedineitherthecleanitemsbagorthebagsforthenon-cleanitems,butshouldbeplacedindependentlyinsidethetravelcarrier.Suchcleansershavebeenfoundtobeeffectiveinreducingcontaminationonthepractitioner’shandsifsoapandwaterarenotreadilyavailableatthetreatmentsite.

Travel Sharps Container Eachstatehasdifferentrulesregardingsharpscontainersforuseathomeandforuseinmedicaloffices.Manystatesrequiretheuseofcommerciallypreparedsharpscontainersformedicalpersonnel.Contactyourlocalhealthdepartmentorseethewebsitehttp://www.safeneedledisposal.org/forinformationbystateregardingsharpsdisposalregulations.InALLstates,useofacommerciallypreparedsharpscontainerwillmeettheregulationsforsharpsdisposal.Ifanon-commercialcontainerislegalforuse(suchasapillbottlewithascrew-oncap),besuretomarkthecontainerwiththebiohazardsymbolanddisposeofthecontainerfollowingallrulesforbiohazardouswaste.

Preparing the Kit Thekitshouldbepreparedinsuchawaythatallitemsinitremainclean.

1. Thehard-sidedcontainermustbewashedinsideandoutinhot,soapywateranddriedwithacleanpapertowel.Ziplockbagsshouldbefreshfromthepackageandfreeofripsandholes.

2. Handsshouldbewashedbeforeassemblingthekit.3. Papertowelingshouldbetakendirectlyfromitspackageandplacedinasmallziplock

plasticbagtoensurecontinuedcleanliness.Acommerciallyavailablecleanfieldwillcomeindividuallywrapped.

4. Cottonballsshouldbetakendirectlyfromthestockbagandplacedinasmallplasticbagorothercontainer.

5. Pre-packagedalcoholswabsshouldbetakendirectlyfromtheiroriginalboxandplacedinthekit.Iftheindividualpackageshavebeensittingonashelf,theoutersurfacesofthepacketsarenolongerconsideredclean.

6. Disposableneedlesshouldbeplacedintothetravelkitdirectlyfromtheoriginalbox.

Treatment Protocol in a Travel Setting 1. Selectaclean,dry,flatsurfacetoserveasthesettingforthecleanfield.Ifnecessary,

cleanitwithsoapandwateranddryitthoroughly.[recommended]2. Openthetravelkitandremovethealcohol-basedhandsanitizer.Setitupnearwhere

thecleanfieldwillbeplaced,sothatitiseasilyaccessible.

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3. Washhandsforatleast10-15secondsunderrunningwater,latheringwellwithsoap.Liquidsoapisrecommendedratherthanbarsoap,whichmaybecomecontaminated.Or,ifsoapandwaterareunavailable,disinfecthandswiththealcohol-basedhandsanitizerthatshouldbeincludedinthetravelkit.[critical]

4. Removethecleanpapertowelthatwillserveasacleanfield.Placeitontheclean,dryworksurfaceinawaythatdoesnotcompromisethecleanlinessofthesurfacethatwillserveasthecleanfield.[stronglyrecommended]Forexample,acleanfoldedtowelshouldbehandledbythefourcornersinordernottocontaminatethecenterofthefield.Ifalcoholisspilledorwetcottonisdroppedonapreviouslycleanfield,itcannolongerbeconsideredcleansincecontaminantscanwickintothefield.Anewcleanfieldmustbeestablishedbeforeproceeding.

5. Setoutthematerialsfromthetravelkit.Sterileitemssuchasacupunctureneedlesinblisterpacks(intheiroriginalpackaging)shouldbeplacedonthecenterofthecleanfieldfirst.[stronglyrecommended]Cleanitemssuchascottonballsandunopenedswabsshouldbeplacedonthecleanfieldneartheedgesofthefield.Thewastebagandtheopenedsharpscontainershouldbeplacedlast,outsidethecleanfield,insuchawaythatyouwillnotneedtocrossthecleanfieldtodiscardausedneedleorwaste.[recommended]

6. Ensuretheskinattheacupuncturepointstobeusedisclean.If70%alcoholswabsareused,allowthealcoholtodry.[stronglyrecommended]

7. Ifapractitionermustplacetheneedleinsideaguidetube,theneedleshouldbedroppedintothetube,handlefirst,tominimizetheriskofcontaminatingthepointoftheneedle.[stronglyrecommended]

8. Insert,manipulate,andwithdrawtheneedlewithouttouchingtheshaftoftheneedlethatentersthepatient’sskinatanytime.[critical]Ifaguidetubeistobereused,itshouldbeplacedonthecleanfieldbetweenuses,sinceithasbeenhandledandisnolongersterile.[stronglyrecommended]

9. Ifthepractitionermissesthepointonthefirstinsertionandhastore-needle,anewneedlemustbeused.[critical]Practitionersmaynotreinsertaneedlebecauseonceaneedlehasbeeninserted,itisnolongersterileandmustbedisposedof.

10. Countthenumberofneedlesused,includingthosediscardedduetoimproperneedleplacement.[stronglyrecommended]

11. Retainneedlesandstimulateasneededfortherapeuticeffect.12. Removeneedles,puttingusedneedlesimmediatelyintoanappropriatesharps

container.[critical]13. Ifthepractitionerwishestocovertheskinwhereaneedlehasbeenremoved,aclean,

drycottonballshouldbeused.[stronglyrecommended]Thecottonballneednotbesterile.Awetcottonballorswabcanwickupbloodorotherpotentialinfectious

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material,bringingitintocontactwiththepractitioner’sfingersandincreasingtheriskofcross-infection.

14. Countthenumberofneedleswithdrawnfromthepatient.Confirmthatthesamenumberofneedlesinsertedhasbeenwithdrawnanddiscarded.[stronglyrecommended]

15. Disposeofallcottonballsandanyalcoholswabsastheyareused,placingthemimmediatelyintheplastic-linedpaperwastebagcarriedforthatpurpose.Theyarenottobeplacedonthecleanfieldafteruseandarenottobesetdownanywhereelsebutinthewastebag.Closethewastebagsecurelyafterthelastusedmaterialsareplacedinside.

16. Closethelidofthesharpscontainersecurelywhenyouaredonewiththetreatment.[critical]

17. Washhandsimmediatelyafterremovingneedlesandbeforehandlinganythingelse.[stronglyrecommended]

18. Packequipmentcorrectly,placingthesharpscontainerandwastebagintotheirseparateziplockbagasthelaststepinpackingthekit.

19. Washhandssincethesharpscontainerandwastebagwerethelastitemshandled.[stronglyrecommended]

Itisimportanttokeepinmindthatfundamentally,thereisnodifferencebetweencleanprotocolintheofficeandinatravelsituation.Thebiomedicalrequirementsforsafetyarethesame.

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5. CNT in a Community Acupuncture Clinic or NADA Setting TheCleanNeedleprotocolisessentiallythesameforeveryacupuncturepatientinanysetting.Thecriticalitemsremainthesame:alwaysestablishacleanfield,alwayswashhandsbeforeeveryacupuncturetreatment,alwaysusesingle-usedisposablesterilefiliformneedles,followStandardPrecautions,andalwaysimmediatelyisolateusedsharpsinappropriatecontainers.InacommunityacupuncturesettingorNADAtreatmentsetting,multiplepatientsmaybetreatedatthesametimeinthesameroomwhilesittinginchairs.Whiletheremaynotbeaspecifictypeofchairthatisbestforthissetting,thepractitionerneedstoconsiderthatallchairsurfacesneedtobecleanedbetweenpatientvisits;useofclothchairsmakesthismoredifficult.Additionally,ifasheetortablepaperisusedasabarrieronthetreatmentchairs,theseneedtobechangedforeachnewpatient.Armrestsorothersurfacesthatareexposedtobareskinduringtreatmentsshouldbecleanedbetweeneachpatientsession.Notethatifcareisnottakentoaccountforallneedlesusedinthesesetting,seatcushionshidemanyfallenneedles.Thosepersonscleaningtreatmentsurfacesmustbeassuredthatallneedlesareaccountedforbeforecleaningtreatmentchairs.

Treatment Protocol in a Community Clinic or NADA Setting 1. Selectaclean,dry,flatsurfacetoserveasthesettingforthecleanfield.(Note:The

selectedlocationCANNOTbethetreatmenttable!)ForcommunityacupunctureorNADA,aninstrumenttray,instrumentcartoratableinacentrallocationisappropriate.Ifdesired,asmallbasinorcontainerforusedmaterials(cottonballs,alcoholswabsandguidetubes)maybeplacedonthesametraynearthecleanfield.Thiscontainershouldnottouchthecleanfield.[stronglyrecommended]

2. Washhandsforatleast10-15secondsunderrunningwater,latheringwellwithsoap.Liquidsoapisrecommendedratherthanbarsoap,whichmaybecomecontaminated.Or,ifsoapandwaterareunavailable,cleanhandswiththealcohol-basedhandsanitizer.[critical]

3. Placeacleanpapertowel,cleantablepaperorotherbarrierthatwillserveasacleanfieldontheworksurfaceinawaythatdoesnotcompromisethecleanlinessofthesurfacethatwillserveasthecleanfield.[stronglyrecommended]

4. Setoutthematerialsneededforallthetreatmentstobeperformedinasinglesession.Sterileitemssuchasacupunctureneedlesinblisterpacksshouldbeplacedonthecenterofthecleanfieldfirst.[stronglyrecommended]Cottonballs,gauze,andothermaterialsshouldbeplacedclosertotheedgesofthefield.[recommended]

5. Cleanitemssuchascottonballsandunopenedswabsmayeitherbeplacedonthecleanfieldorkeptinjarsorcontainersnearthecleanfieldsoastobeathandforthepractitioner.[recommended]

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6. Ensuretheskinattheacupuncturepointstobeusedisclean.If70%alcoholswabsareused,allowthealcoholtodry.[stronglyrecommended]

7. Ifapractitionermustplacetheneedleinsideaguidetube,theneedleshouldbedroppedintothetube,handlefirst,tominimizetheriskofcontaminatingthepointoftheneedle.[stronglyrecommended]

8. Inserttheneedleswithouttouchingtheshaftoftheneedlethatwillbeinsertedintothepatient’sskin.[critical]Ifaguidetubeistobereused,itshouldbeplacedonthecleanfieldbetweenuses,sinceithasbeenhandledandisnolongersterile.[stronglyrecommended]

9. Ifthepractitionermissesthepointonthefirstinsertionandhastore-needle,anewneedlemustbeused.[critical]Practitionersmaynotreinsertaneedlebecauseonceaneedlehasbeeninserted;itisnolongersterileandmustbedisposedof.[stronglyrecommended]

10. Usehandcleanserbetweeneachpatienttreatment.[stronglyrecommended]11. Ensuretheskinattheacupuncturepointstobeusedisclean.[critical]12. Repeatsteps8-11foreachpatientbeingtreatedduringasinglesession.13. Removeneedlesfromthepatientoneatatime,puttingusedneedlesimmediatelyinto

anappropriatesharpscontainer.[critical]14. Ifthepractitionerwishestocovertheskinwhereaneedlehasbeenremoved,aclean,

drycottonballshouldbeused.Thecottonballneednotbesterile.[stronglyrecommended]

15. Disposeofallcottonballsandalcoholswabsastheyareused,placingthemimmediatelyinacontaineronthetreatmentcartorinanappropriatetrashcontainer.Theyarenottobeplacedonthecleanfieldafteruse.[recommended]

16. Wash/cleansehandsbeforeleavingthetreatmentroom.[stronglyrecommended]

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6. CNT in a Public Health Setting Thereisagrowinguseofacupunctureinpublichealthsettingssuchasaddictiontreatmentfacilities,clinicsthattreatlargenumbersofHBV,HCV,andHIVpatients,andclinicswithhighpopulationsofpatientsatriskofTB,aswellasininstitutionssuchasjails,publichospitals,communitycenters,andothersocialagenciesthathavegrouptreatmentroomswhereseveralpatientssitandreceiveearorbodyacupuncture.

Patientsmayarrivetogetherorseparately,butusuallydonothaveindividualappointments.Manyoftheseroomsdonothaveasink.Somemayhaveaccesstoonenearby,butitisnotalwaysguaranteed.Manyofthesesettingsaimattreatingpersonswhoaredrug-and/oralcohol-addictedandwhopresentwithrelatedandfrequentlymultiplehealthandsocialproblemssuchasTB,HIVinfection,mentalillness,homelessness,hungerormalnutrition,orpoverty.Theseindividualsfrequentlypresentwithalonghistoryofillnessandadebilitatedimmunesystem.Staffperformingacupuncturetreatmentsareappropriatelytrainedacupuncturistsand/oracupuncturechemicaldependencyspecialists,dependingonstateregulations.Thereareoftenotherprovidersfromdifferentdisciplinesinvolvedsuchasphysicians,socialworkers,nurses,counselors,communityworkers,physicianassistants,andnursepractitioners.Thecharacteristicsoftheseclinicsmandatesomespecialdiscussion.

Handwashing Handwashingisoneofthemostproblematictopicswithinapublichealthorgrouptreatmentsetting.Itisnotrealistictoexpectthatthepractitionerwillwashhisorherhandsinasinkaftereachtreatmentduetothevolumeofpatientstobetreated,thetimeandlogisticsthatwouldberequired,andfrequently,thelackoffacilitiesforhandwashing.Itiscritical,however,thatpractitionersutilizealcohol-basedhandsanitizersordisinfectingwipesbetweeneachpatienttreatment.ItisalsostronglyrecommendedbyCDCthatpractitioners:

1. Washhandswithsoapandwateronarrivalandbeforeleavingwork,beforeeating,andafterrestroomuse.[critical]

2. Ifhandsaredirtywithsomeorganicmattersuchasblood,theymustbewashedwithrunningwaterandsoap.[critical]

3. Analcohol-basedhandsanitizershouldbeusedbetweentreatments,providedthatonlytheneedles,sterilepackages,andothermaterialsneededforthetreatmentweretouched.[stronglyrecommended]

4. Handsmustbecleansedbetweenpatienttreatments.[critical]5. Analcohol-basedhandsanitizerorhandwipecanbeutilizedasneededduring

treatmentsandbetweenpatienttreatments.[recommended]

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6. Glovesshouldbeavailableinthetreatmentareaandshouldbewornwhenthereisanopenwoundonthepractitioner’shandorthereisriskofbloodorOPIMcontamination,suchassignificantbleedingfromanauricularacupuncturepoint.[critical]

7. Practitionersshouldwashtheirhandsimmediatelywithsoapandwateraftercriticalinstances,suchascontactwithbloodorabreakinthecleanfieldbetweenorduringtreatments.[critical](20)

8. Practitionersmusthaveappropriatehandcleansersavailabletothematalltimesinthepublichealthtreatmentenvironment.[critical]

Acupuncture Equipment Disposableneedlesarerecommendedforallacupuncturetreatments.Somestatesmandatethatonlydisposableneedlescanbeutilizedbypractitioners,includingthoseworkinginpublichealthfacilitiestreatingchemicaldependency.Guidetubesarenotrecommendedforauricularacupuncture.Asalways,careshouldbetakentomonitorpressneedlesforpotentialinfections.

Positioning the Patient Whenthepatientissittingup,itisimportanttomakesurethat,wherepossible,thepatienthashisorherheadandnecksupported,thatthelegsandarmsarenotcrossed,andthatthepersoniscomfortablyseated.Patientsshouldbeencouragedtousethebathroompriortotreatment.Ifapatientdoesneedtousetherestroomduringtreatment,allneedlesshouldberemovedandthenreplacedwhenheorshereturns.

Removing Needles Whenapractitionerisremovingneedles,itiscriticalforasharpscontainertobeintheimmediatevicinity,preferablywherethecontainerissecureandcannotbeknockedover.Inmanypublichealthsettingsitisimportantthatneedlesbeaccountedforbycountingtheneedlesused.Insettingssuchasjails,thepatientsoftenmaynotleaveuntilallneedlesareaccountedfor.Insomedetoxclinicspatientsremovetheirownneedles.Intheseinstancesthepractitionershouldalwayscheckforneedlesthatmayhavedroppedandforbleedingthatmayhaveoccurred.Inallcases,practitionersshouldcheckchairsandsurroundingareasforfallenneedlesbefore,during,andaftereachsession,andaftereachpatient’sneedlesareremoved.Ifaneedlefallsoutoftheearontotheclothingofthepatientduringtreatment,itshouldberemovedwithaminimumofdisturbance.Practitionersshouldinstructpatientsnottohandleneedlesiftheneedlesfalloutorafterremovingthemasthismaycreateasituationinwhichaneedlestickinjurymayoccur.Itisalsocriticalthatpractitionersbeabletoidentifythenumberofneedlesusedandthenumberproperlydiscardedinapublichealthsetting.

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Potential Complications Ifapatientfaintswhilesittingup,allneedlesshouldberemovedimmediately,legselevatedandtheheadlowered.Itisalsorecommendedthatpatientsbeplacedsafelyonthefloorifpossible,makingsurethattheairwaysarenotobstructed.AcupuncturistsmayuseafingertopressDu26(Renzhong)tohelprevivethepatient;callingformedicalhelpmaybenecessaryinsomecases.

Delayedbleedingiscommon.Practitionersmustbeawareofthispossibility.Patientsshouldbemonitoredafterneedleremovalandbeforeleavingthepremises.

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7. Toyohari Acupuncture Contactneedling(ornon-insertionneedling)issometimesutilizedinJapanesemeridiantherapyandhasbeendevelopedindepthinToyohariacupuncture.Inthisstyleofacupuncture,“Theneedledoesnotpenetrateintothebody;theneedletipisheldattheskinsurfaceorperhapstouchestheskinbutdoesnotpenetratetheskin.”(21)Whenperformingcontactneedling,theneedlemaybeplacedbetweenthecleanthumbandindexfingerofthenon-dominanthand,whicharerestingontheskinattheacupuncturepoint.Thisiscalledthe“oshide”inJapanesemeridiantherapy.(22)Sincetheshaftoftheneedleisnotpenetratingtheskin,theneedleshaftdoesnothavetobeprotectedassterile.However,thepractitioner’shands,andespeciallythefingers,mustbeclean.Handwashingmusttakeplaceimmediatelybeforecontactneedlingaswithneedlingwithinsertion.Whenpractitionersperformthistechnique,thethumbandindexfingerofthenon-dominanthandmustbeonthepatient’sskinandtheneedleisheldbetweenthefingersbecausethechangesintheqiatthetipoftheneedlemustbefelttodothistechniqueproperly.(22,23)

Modifications to Standard Clean Needle Technique for Contact Needling Thestandardsofhandwashing,settingupacleanfield,immediatelyisolatingusedsharpsandfollowingStandardPrecautionsremainthesameaswithallacupunctureneedlingtechniques.Thevariationhereisthattheshaftoftheneedlemaybetouchedbythepractitioner’sfingersinthisstyle.

InToyohariacupuncture,theneedleitselfdoesnotpenetratetheskin.Therefore,whenperformingcontactneedling,theneedleremovalcanbefollowedwithplacingacleanfingeronthespotwheretheneedlehadbeenincontactwiththeskin,sincethereisnochanceofbloodorOPIMbeingpresentwhenusingthistechnique.(21)

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8. Summary of Safety Recommendations for Clean Needle Technique

• Critical:FollowCleanNeedleTechnique.• Critical:Alwaysestablishacleanfieldbeforestartingacupunctureoranytechnique

whichbreakstheskin.• Critical:Onlyusesingle-usesterileinstrumentswhenbreakingtheskinsurface(needles

andlancets).• Critical:Alwayswashhandsimmediatelypriortostartingacupunctureoranytechnique

whichbreakstheskin.• Critical:Donottouchthetiporshaftoftheacupunctureneedlethatwillenterthe

patient’sskinpriortoorduringneedleinsertionwithanythingwhichisnotitselfsterile.• Critical:Donotneedleintoanyskinlesion.Acupunctureneedlesshouldneverbe

insertedthroughinflamedorbrokenskin.• Critical:Immediatelyisolateusedneedlesinanappropriatesharpscontainer.• Critical:Usenewtablepaperoneachtreatmenttableforeachnewpatientvisit.• Critical:Wipedowneachtreatmentchairortablewithanapproveddisinfectant

solutionordisinfectantclothbetweeneachpatientvisit.• Critical:Wearglovesorfingercots,orotherwisecoverupanyareasofbrokenskinon

thepractitioner’shands.• Critical:Checkneedlespriortouseforsterilizationexpirationdates,breaksinthe

packaging,oranyevidencethatairorwaterhasenteredtheneedlepackagingpriortouse.

• Critical:Maintaincleanprocedureatalltimeswhilehandlingneedlespriortoinsertion.Ifneedlesortubesbecomecontaminated,theyshouldbediscarded.

• Critical:Needlemanipulationmustbeperformedwithoutthepractitionercomingintocontactwiththepartoftheshaftoftheneedlethatwillenterthepatient’sskin.

• Critical:Neverinsertaneedleallthewaytothehandle.• Critical:Whenusingamulti-needlepackofsterilizedneedles,oncethepackagingis

openedforonepatientvisit,anyunusedneedlesmustbediscardedproperlyandnotsavedforanotherpatienttreatmentsession.

• Critical:AllpatientsneedtobetreatedasiftheyarecarriersofbloodbornepathogenssuchasHepatitisBorHIV.

• Critical:Ensurethatthepartofthebodytobetreatedisclean.• Critical:Obtainamedicalhistoryfromapatientregardinglungfunction,lungdiseases

andsmokinghistorybeforeneedlingthethorax.Assessthephysiqueofthepatient.Atrophyorpoormuscledevelopmentinthethoraxmayincreasetheriskofpneumothorax.

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• Critical:Identifythoseacupuncturepointswhichlieoverornexttomajorvessels.• Critical:Ifalcoholisusedtocleantheacupuncturesites,allowalcoholtodrybefore

needling.• StronglyRecommended:Countandwritedownthenumberofneedlesused,including

thosediscardedduetoimproperneedleplacement.Countthenumberofneedleswithdrawnfromthepatient.Confirmthatthesamenumberofneedlesinsertedhasbeenwithdrawnanddiscarded.

• StronglyRecommended:Documentneedlecountsinthepatientchart.• StronglyRecommended:Ensurethatthepatient’sskiniscleanbeforeinsertinganeedle

orlancet.Skincanbecleanedwith70%isopropylalcoholorsoapandwaterorothermethod;if70%alcoholisused,allowalcoholtodrybeforeneedling.

• StronglyRecommended:Useonlysingle-usesterilefiliformneedlesforacupuncturetreatments.

• StronglyRecommended:Whenneedlestabilizationisneeded,thepractitionershouldusesterilecottonorsterilegauzetostabilizetheshaftoftheneedle.

• StronglyRecommended:Palpatesubcutaneousstructures,includingmajorvessels,beforepreparinganacupuncturesiteforneedleinsertion.

• StronglyRecommended:Identifytheproperdepthofneedleinsertionandutilizeproperstimulationtechniquesforneedlesplacedbelowthesubcutaneouslevel.

• StronglyRecommended:AngleacupunctureneedlesobliquelywheninsertingneedlesfromthetopoftheshoulderstotheT-10areaontheback,ortobelowthexiphoidlevelonthechest.

• StronglyRecommended:Limitthedepthofacupunctureneedleinsertiontothesubcutaneouslayerandinitialperimysiumoftheintercostalmuscles.

• StronglyRecommended:Neverinsertaneedletothehandle.• StronglyRecommended:Allpatienthistoriesshouldincludeinformationaboutcurrent

orpastdiseasesthatmightleadtoachangeinthesizeoftheorgans.• StronglyRecommended:Iftherearesignsthatanorganmayhavebeenpunctured,

emergencytransportshouldbecalledtotakethepatienttoanemergencyfacility.• StronglyRecommended:WashhandsoruseCDC-approvedhandcleanseruponentering

apatientroomandaftercompletinganypatienttreatment.• StronglyRecommended:Guidetubesmustbesterileatthebeginningofthetreatment

andmustnotbeusedformorethanonepatient.• StronglyRecommended:Establishanewcleanfieldforeachnewpatient.• StronglyRecommended:Replaceanyclothtablecoveringsaftereachpatientvisit.• StronglyRecommended:Utilizegloveswhenremovingneedlesfromlocationswhere

bleedingislikely.

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• StronglyRecommended:Afterneedleremoval,applypressuretotheacupuncturepointwithcleancottonorgauze.

• StronglyRecommended:Cleanalltreatmentroomsurfaceswithapproveddisinfectantsdaily.

• StronglyRecommended:Ifyoustickyourselfwithausedorcontaminatedneedle,seekmedicaladviceimmediately.

• Recommended:Cleanallcommonuseareaswithanapproveddisinfectantdaily.• Recommended:Practitionersshouldremovealljewelryandartificialnailspriorto

handwashing.• Recommended:Explainacupunctureproceduresindetailandanswerallpatient

questionsabouttheprocedurestobeperformedpriortoacupuncturetoallayconcernsandnervousness.Makesurethepatientisawareofthelikelyeffectsofacupuncture.

• Recommended:Informpatientsthattheyshouldeat1-2hourspriortoacupuncturetreatments.

• Recommended:Whileitisacceptabletopalpatethecleanedareaofskintopreciselylocatetheacupuncturepointaftertheskiniscleanedandbeforeneedling,thepractitionershouldnottracefingersorhandsacrossawideareaofskintolocateanacupuncturepointaftertheskiniscleanedandbeforeneedling.

• Recommended:Palpatesubcutaneousstructures,includingbloodvessels,tendons,musclesandbones,beforepreparingthesiteforinsertion.

• Recommended:Limitneedlemanipulationduringthefirstacupuncturetreatmentoruntilclinicalassessmentofthepatient’sresponsetoacupuncturehasbeenestablished.

• Recommended:Remindpatientstoremainstillduringacupuncturetreatments.• Recommended:Needlemanipulationshouldbelimitedorbi-directionalwhentwirlingis

involvedasindicatedbydesiredtherapeuticeffecttolimitthelikelihoodofastuckneedle.

• Recommended:Ifaneedleisstuckwhenattemptingremoval,try(1)twistingtheneedleintheoppositedirectionfromtheinitialstimulation;(2)stimulatingthemeridiannearthestuckneedlewithsimplefingerpressure;(3)tappingnearthestuckneedle;(4)insertinganotherneedlenearbythestickneedle;or(5)waitafewminutesthentrytoremovetheneedleagain.

• Recommended:Afterneedlewithdrawal,applypressuretotheacupuncturepointwithcleancottonorgauze.

• Recommended:Havethesamepractitionerremovetheneedlesastheonewhoinsertedtheneedlesforbettermemorycuesaboutpossiblehiddenneedlesites.

• Recommended:Keepused/emptyneedlepacketsinthetreatmentroomuntiltheendofthepatient’streatment;confirmallneedlesremovedfromthepackagingare

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accountedforeitherbyremovalfromthepatient,discardedunused,ordiscardedaftercontamination.

• Recommended:Ifunexpectedaggravationofsymptomsoccursasaresultofacupuncturetreatment,considerconsultationwithorreferraltoanotherpractitionerforfurtherevaluationpriortoperformingadditionalacupuncturetreatments.

• Recommended:Investigateandfollowlocalandstateregulationconcerningskinpreparation.

References 1.ChengXinnong(chiefeditor).ChineseAcupunctureandMoxibustion.ForeignLanguages

Press,Beijing;1987.2.O'ConnorJandBenskyD(translators).Acupuncture:AComprehensiveText.EastlandPress,

Seattle,WA.1981.3.CentersforDiseaseControlandPrevention.ShowMetheScience-WhentoUseHand

SanitizerinHandwashing:CleanHandsSaveLiveshttp://www.cdc.gov/handwashing/show-me-the-science-hand-sanitizer.html.ReviewedOctober17;2014.AccessedJanuary3,2014.

4.CentersforDiseaseControlandPrevention.When&HowtoWashYourHandsinHandwashing:CleanHandsSaveLives.http://www.cdc.gov/handwashing/when-how-handwashing.html.ReviewedOctober17,2014.AccessedJanuary3,2014.

5.WorldHealthOrganization.WHObestpracticesforinjectionsandrelatedprocedurestoolkit.http://whqlibdoc.who.int/publications/2010/9789241599252_eng.pdf.PublishedMarch2010.AccessedDecember2012.

6.KhawajaR,SikandarR,QureshiR,JarenoR.RoutineSkinPreparationwith70%IsopropylAlcoholSwab:IsitNecessarybeforeanInjection?QuasiStudy.JLiaquatUMedHealthSciences(JLUMHS).2013;12(2)(May-Aug):109-14.

7.DannTC.Routineskinpreparationbeforeinjection:anunnecessaryprocedure.Lancet1969;2:96-7

8.KoivistoJA,FeligP.Isskinpreparationnecessarybeforeinsulininjection?Lancet1978;1:1072-1073

9.McCarthyJA,CovarrubisB,SinkP.Isthetraditionalalcoholwipenecessarybeforeaninsulininjection?DiabetesCare1993;16(1);402

10.NationalInstitutesofHealth.PatientEducation:Givingasubcutaneousinjection.http://www.cc.nih.gov/ccc/patient_education/pepubs/subq.pdf.Published6/2012.AccessedSeptember2013.

11.CentersforDiseaseControlandPrevention,HealthcareInfectionControlPracticesAdvisoryCommittee(HICPAC).2007GuidelineforIsolationPrecautions:PreventingTransmissionofInfectiousAgentsinHealthcareSettings.PartIII:PrecautionstoPreventTransmission

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ofInfectiousAgents.http://www.cdc.gov/hicpac/2007ip/2007ip_part3.html.ReviewedDecember29,2009.AccessedNovember2012.

12.WorldHealthOrganization.Minimizinginfectionthroughimprovedinfectioncontrol.http://www.who.int/patientsafety/education/curriculum/who_mc_topic-9.pdf.WHOGlobalPatientSafetyChallenge:CleanCareisSaferCareandtheHôpitauxUniversitairesdeGenève.AccessedNovember2012.

13.LinJ-G,ChouP-C,ChuH-Y.AnExplorationoftheNeedlingDepthinAcupuncture:TheSafeNeedlingDepthandTheNeedlingDepthofClinicalEfficacy.Evidence-BasedComplAltMed.2013;2013:21.

14.Deadman,P.,Al-Khafaji,M.AManualofAcupuncture.JournalofChineseMedicinePublications;2001

15.PeukerE,GronemeyerD.Rarebutseriouscomplicationsofacupuncture:traumaticlesions.AcupunctMed.2001;19(2):103-108.

16.CentersforDiseaseControlandPrevention.CDCExposuretoBlood,WhatHealthcarePersonnelNeedtoKnow.http://www.cdc.gov/HAI/pdfs/bbp/Exp_to_Blood.pdf.UpdatedJuly2003.AccessedDecember2012.

17.CentersforDiseaseControlandPrevention,NationalInstituteforOccupationalSafetyandHealth.Selecting,EvaluatingandUsingSharpsDisposalContainers.www.cdc.gov/niosh/docs/97-111/pdfs/97-111.pdf.PublishedJanuary1998.AccessedApril2013.

18.OccupationalSafetyandHealthStandards.1910.1030Bloodbornepathogens.https://www.osha.gov/pls/oshaweb/owadisp.show_document?p_table=STANDARDS&p_id=10051.AccessedDecember2012.

19.CentersforDiseaseControlandPrevention,HealthcareInfectionControlPracticesAdvisoryCommittee(HICPAC).Guidelinesforenvironmentalinfectioncontrolinhealth-carefacilities:recommendationsofCDCandtheHealthcareInfectionControlPracticesAdvisoryCommittee(HICPAC).http://www.cdc.gov/hicpac/pdf/guidelines/eic_in_hcf_03.pdf.Published2003.AccessedDecember2012.

20.CentersforDiseaseControlandPrevention.HandHygieneBasicsinHandHygieneinHealthcareSettings.http://www.cdc.gov/handhygiene/Basics.html.ReviewedMay1,2014.AccessedJanuary2015.

21.Birch,S.TraditionalNeedlingTechniquesasPracticalConstructionsfromReadingHistoricalDescriptions.TheEuropeanJournalofOrientalMedicine;20137(3)p27.

22.Denmai,Shudo.EffectivePointLocation:FindingActiveAcupuncturePoints.2003,Seattle:EastlandPress.

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23.Birch,S.GraspingtheSleepingTiger’sTail:PerspectivesonAcupuncturefromtheEdgeoftheAbyss.NorthAmericanJournalofOrientalMedicine.2004,November11(32)pp.20-23.

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Part III: Best Practices for Related AOM Office Procedures

Inthehealthcarefield,bestpracticesareproceduresthatcouldbefollowedtolimitdangerstothepatients,practitionerandstaff.Bestpracticescanberevisedasneededtokeepupwiththelatestresearch.Bestpracticeguidelinesproducedspecificallyforpracticinghealthprofessionalsarebasedonthebestavailableresearchevidenceasreportedinsystematicreviews,casereports,referencetexts,andothersourcesofevidence.

ThefollowingrecommendationsutilizepracticesasdescribedinChineseAcupunctureandMoxibustion(1)andAcupuncture–AComprehensiveText,(2)andapplysafetypracticesbasedontheevidencefromPartIofthismanualtoAOMclinicalpracticeprocedures.Thebestpracticeguidelinesbelowoutlinecriticalproceduresandofferoptionsforrecommendedprocedures.

ThereareanumberofothermethodswithsafetyprotocolsapplicabletovariousstylesofAOMofficeprocedures.Thissectionisnotmeanttobeexhaustiveorprohibitive,butrathertobeinstructive.Schoolsandpractitionersareencouragedtoimplementadditionalandalternativemethodstoreducerisk,utilizingadditionalandalternativetechniquesformoxaandotherpracticesutilizingAOMclinicaltraditions.

AsnotedinPartI,unlikeacupunctureneedling,manyoftheseprocedureshavereceivedfarlessscrutinyinthemedicalliterature.FewprospectiveorretrospectivestudieshavebeenconductedtoenumeratethesafetyissuesassociatedwithAOMclinicalpracticesotherthanneedling.Thebestpracticesnotedhereinhavebeendesignedbasedontheliteratureavailable,traditionalAOMtrainingorhavebeenadaptedfrommedicalpracticesutilizingsimilarprocesses.

EachofthefollowingrecommendationsisonlyoneversionofbestpracticesthatcouldbeutilizedwhereinapractitionerappliesthecriticalandstronglyrecommendedcautionstoeachAOMpractice.Thesearenotmeanttoidentifystandardpracticesforanyofthesetechniques.Practitionersneedtodeterminetheirownmethodologiestoimplementclinicalbestpracticesgiventheinformationavailableinthismanual,themedicalandAOMliterature,andothersourcesofinformationthatapplytotheirspecificstyleofpractice.

Forthepurposesofthismanual,thefollowingtermswillbeutilizedtohelppractitionersapplybestpracticestotheirpersonalpractices:critical,stronglyrecommendedandrecommended.Seetheintroductionforanexplanationoftheseterms.

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1. Moxibustion

Moxibustion Overview Moxibustionistheburningofmugwort(Artemesiavulgaris)herb(moxa)onorneartheskin,withorwithoutacupunctureneedlesforthepurposeofwarmingtissuesinordertostimulatecirculationofqiandblood,transformfluids,orwarmtheyang.Moxamayalsobeusedtoresolveheattoxinsanddriveheatoutward,nourishyin,descendtheqi,andtootherwisebalancethemeridians,substancesandzang-fudependinguponthelocationandtypeofmoxibustionperformed.Theeffectivenessofmoxibustionhasbeenshowninawiderangeofconditionsfrommusculoskeletaldisorders,gynecologicconditions,anddigestivecomplaintstothetreatmentofHerpeszosterandotherinfections.

Moxibustionmayoccasionallycauseburningandblisteringoftheskin(firstorseconddegreeburns).Patientsmustalwaysbeaskedforconsentbeforeapractitionerappliesmoxibustiontechniques.

Practitionersperformingmoxibustionshouldavoidcausingunnecessaryburns(seescarringmoxabelowfortheexceptiontothisrule)andbeawarethateachpersonhasadifferenttolerancetoheat.Itisimportanttobeespeciallycarefulwithpersonswhohaveconditionswheresensitivityoflocalnervesmaybediminished,suchasinneuralinjury,diabetesmellitus,orpathologyresultinginparalysis,becausesuchpersonsareespeciallysusceptibletoburns.EvenchemicalheatdevicessuchasHotSpotsandheatlampshavebeenknowntoburndiabeticpatients.

Whenusingindirectmoxaontheneedle,besuretoprotectthepatient’sskinfromanyfallingmoxaorashes.Ifusingdirectmoxa,itissuggestedthatthepractitionerfullyexplainthetechniquetothepatientandaskthepatienttosignaninformed,writtenconsentformbeforeusingthistechnique.

Ifapatienthasbeenburned,infectionistheprimaryconcern.Iftheburnisaverysmallfirstdegreeburn,currentpracticeistoruncoolwaterovertheburn(neverice),andthenapplysterilegauze.(Ifthisisnotpossible,useanover-the-counterburncreamfollowedbytheapplicationofsterilegauze.)Ifaburnissevere,orifthereisaconcernwithinfection,referthepatienttoaphysician.

Therisksofexposuretomoxasmokeareprobablysimilartothatforanyothersmoke,andtotalexposuretime,particularlywhenitinvolvesprolongedexposure,isthekeyconcern.Occasionaluseofordinarymoxawouldbeassociatedwithlowrisk,whileroutineexposuretomoxasmokeduringmuchofthedaywouldbeamoderaterisk.Therefore,usingaspaceinwhichthereis

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properventilation(ortheuseofaHEPAfilter)isappropriatewhenmoxibustionisbeingperformed.

Theriskofsettingafireduringmoxatherapiesissmallbutpossible.Allnecessaryfiresafetyprotocolsshouldbefollowed.Itisstronglyrecommendedthatroomsinwhichmoxatreatmentsaretobeperformedbeequippedwitheitherfireextinguishersorsprinklersystems.Watershouldbepresentandavailabletoextinguishsmallburnsontreatmentsurfacesorpatientsduringallmoxatherapies.Practitionersshouldnotwalkfromroomtoroomwithlitmoxamaterials.Instead,moxashouldbelitascloseaspossibletothetreatmenttableorchairandextinguishedassoonastreatmentisconcluded.Lightingofmoxashouldbedonewithoutanopenflamecomingclosetothepatient’shair,skinorclothing.Inthemethodsdiscussedbelow,anincensestickisusedtolightthemoxa;othermethodsforlightingthemoxawithoututilizinganopenflamecanbeutilizedbasedonpractitionerpreference.

General Moxibustion Precautions • Critical:Practitionersmustwashhandsthoroughlybeforestartingmoxibustion,and

beforeandaftertreatinganyburnsasOPIMmaybepresent.• Critical:Preventseconddegreeburnsfrommoxabypayingcloseattentiontoapatient’s

comfortandskinreactionsduringalltreatments.• Critical:Takeacarefulpatienthistorytoidentifyneuropathiesorotherconditionsthat

mightlimitapatient’sresponsetopainortheabilitytosenseheat.• Critical:Duringmoxatherapythepractitionermustremainintheroomatalltimes.• Critical:Anticipateandshieldapatient’sskinfromfallingashwhenutilizingneedle-top

moxa.• Critical:Avoidmoxibustiononthefaceorinthehairline.• Critical:Roomsinwhichmoxibustionisbeingperformedmusthaveproperventilation.• StronglyRecommended:Thepractitionershouldnotattempttomulti-taskduringthe

applicationofmoxatherapies.• StronglyRecommended:Thepractitionershouldmonitortheskintemperatureand

amountofheatgeneratedbymoxaandnotrelysolelyonpatientfeedbackaboutheatsensationswhenutilizinganyformofmoxibustion.

• StronglyRecommended:Measureandchartthediameterandlocationofanyburnsoccurringasaresultofmoxatherapies.

• StronglyRecommended:PractitionersutilizeairfilterunitswhichincludeHEPAfilterswhenperformingmoxibustion.

• Recommended:Roomsinwhichmoxaistobeusedshouldbeequippedwithwaterandafireextinguisher.

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• Recommended:Consideroptionsotherthanmoxaforpatientswithahistoryofsignificantasthmaorotherreactionstosmoke.

Moxa Best Practice Guidelines AfterreviewingtheliteratureaboutmoxibustionsafetyandusingtheinformationaboutthepossibleAEsassociatedwithmoxatherapies,thefollowingbestpracticeguidelineshavebeendeveloped.Asstatedatthestartofthissectionofthemanual,theseproceduresaredesignedtolimitdangerstothepatients,practitionerandstaff.Inallcases,thefollowingprocedurescanberevisedasneededtokeepupwiththelatestresearchandmodifiedasneededforspecificstylesofpracticeaslongassafetyremainsthepriority.

Direct Moxibustion - Technique for Non-Scarring Moxibustion with Moxa Cones Amoxaconeisplacedonapointandignited.Whenabout2/3ofitisburntorthepatientfeelsaburningdiscomfort,themoxaisremoved.

Method 1. Athoroughpatienthistoryisperformedtoidentifyanyconditionsthatbeingperformed

thatmightlimitapatient’sresponsetopainortheabilitytosenseheat[critical]ormayincreaseareactiontothemoxasmoke.[recommended]

2. Properventilationisassuredthroughuseofwindowsorairfiltersorotherairfilteringprocess.[critical]

3. Moxaconesarepreparedpriortolightinganymoxa.4. Allequipmentisplacedonastablesurfacedirectlynexttothetreatmenttable

Equipment:moxacones,tweezers/hemostat(ifdesired),cupofwater(ifdesired),ashtray(ifdesired),lubricantorskinlotion,lighter,incensestick,andotherequipmentasneeded.

5. Thepractitionerwasheshisorherhands.[critical]6. Theareatowhichmoxawillbeappliedispreparedwithskinlotionorlubricant,if

desired,basedonthetypeofmoxapractice.7. Thefirstconeofmoxa,unlit,isappliedtotheskinlocation.8. Amaterialsuchasanincensestickislighted,usingthelighter,awayfromthepatient.

Othermaterialscanbeusedaslongasanopenflameiskeptsomedistancefromthepatient’sskin.[recommended]

9. Ifdesired,ahemostatortweezersmaybeappliedtothemoxaandtheincense(orothermaterial)isthenusedtolightthemoxa.[recommended]Practitionersmayalsochoosetousetheirfingersformoxaapplicationandwithdrawalbasedonpersonalpreferenceandtraining.

10. Thepractitionermonitorstheskintemperatureandamountofheatgeneratedbythemoxacone.[stronglyrecommended]

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11. Whenabout2/3ofthemoxaisburntorthepatientfeelsaburningdiscomfort,removetheconeandplacethemoxainthecupofwaterorashtray;thissteppreventsthepatient’sskinfrombeingburnedandpreventsthestill-burningmoxafromburningthepractitioner,patient,orfurnitureandkeepsburningashoutofthetrash.[recommended]

12. Usefingersorthehemostats/tweezerstoplacethenextconeontheskinandrepeatasnecessary.

Singleormultipleconesarecontinuouslyburnttocauseanincreaseinbloodflow/flushatthelocalsite,butnoblistershouldbeformed.

Safety Considerations 1. Alwayshaveaccesstowaterto:

a. Beabletosnuffanyburningashthatfalls.b. Coolanysmallburnstothepatient’sorpractitioner’sskinimmediately.c. Beareceptacleforburntmoxa,unlessasuitableashtrayorothernon-flammable

receptacleispreferred.2. Neverleaveapatientalonewhenmoxaisbeingapplied.3. Makesurenoclothingisclosetotheareabeingtreatedwithmoxibustion.4. Payverycloseattentiontothepatientduringmoxibustionapplication–donotlookaway

fromthepatientormoxa,writeinthechart,ortalktoanyonebesidesthepatientduringmoxibustionapplication.

5. Considerusingahemostat/tweezers/forcepstoapplyandremovethemoxacones.Thispreventsthepractitioner’sfingersfrombeingburnedandreducestheriskofdroppingburningmoxaontothepatientortreatmentsurface.

6. Oncethetreatmentiscomplete,thecupofwaterwiththeburntmoxashouldbeflusheddownthesink.Donotputmoxaashdirectlyintoatrashcanasthismayigniteatrashfire.

7. Neverapplydirectmoxatothefaceorwithinthehairline.

Direct Moxibustion - Technique for Scarring Moxibustion with Moxa Cones Amoxaconeisplacedonapointandignited.Inthismethod,themoxaisnotremoveduntilafterithasburneddowntotheendorablisterforms.

Method 1. Athoroughpatienthistoryisperformedtoidentifyanyconditionsthatbeingperformed

thatmightlimitapatient’sresponsetopainortheabilitytosenseheat[critical]ormayincreaseareactiontothemoxasmoke.[recommended]

2. Properventilationisassuredthroughuseofwindowsorairfiltersorotherairfilteringprocess.[critical]

3. Moxaconesarepreparedpriortolightinganymoxa.[recommended]

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4. AllequipmentisplacedonastablesurfacedirectlynexttothetreatmenttableEquipment:moxacones,hemostat/forceps/tweezers,cupofwater(ifdesired),ashtray(ifdesired),lubricantorskinlotion,lighter,incensestick,andotherequipmentasneeded.[recommended]

5. Thepractitionerwasheshisorherhands.[critical]6. Theareatowhichmoxawillbeappliedispreparedwithskinlotionorlubricant,if

desired,basedonthetypeofmoxapractice.7. Thefirstconeofmoxa,unlit,isappliedtotheskinatthepointorlocationchosenbythe

practitioner.[recommended]8. Amaterialsuchasanincensestickislighted,usingthelighter,awayfromthepatient.

Othermaterialscanbeusedaslongasanopenflameiskeptsomedistancefromthepatient’sskin.[recommended]

9. Ifdesired,ahemostatortweezersmaybeappliedtothemoxaandtheincense(orothermaterial)isthenusedtolightthemoxa.[recommended]Practitionersmayalsochoosetousetheirfingersformoxaapplicationandwithdrawalbasedonpersonalpreferenceandtraining.

10. Thepractitionermonitorstheskintemperatureandamountofheatgeneratedbythemoxacone.[stronglyrecommended]

11. Whentheconeofmoxahasburneddown,orthereisavisibleblister,removetheconeandplacethemoxainthecupofwaterorashtray.

12. Usefingersorthehemostats/tweezerstoplacethenextconeontheskinandrepeatasnecessarytoachievethedesiredeffect.

13. Onceasmallblisterhasformed,theburnmustbetreatedproperly:Cooltheburnwithcoldrunningwateruntilthepainisrelieved;applysterilegauzeandusesurgicaltapetokeepthegauzeinplace;alternately,acommerciallypreparedbandagemaybeusedtocovertheburnedarea.[critical]

Asmanyasthreeormoreconesofmoxaarecontinuouslyburnttocausetheformationofasmallblister.Thismethodisveryinfrequentlyusedexceptforsevereconditions.

Safety Considerations 1. Alwayshaveaccesstowaterto:

a. Beabletosnuffanyburningashthatfalls.b. Coolanysmallburnstothepatient’sorpractitioner’sskinimmediately.c. Beareceptacleforburntmoxa,unlessasuitableashtrayorothernon-

flammablereceptacleispreferred.2. Neverleaveapatientalonewhenmoxaisbeingapplied.3. Makesurenoclothingisclosetotheareabeingtreatedwithmoxibustion.

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4. Payverycloseattentiontothepatientduringmoxibustionapplication–donotlookawayfromthepatientormoxa,writeinthechart,ortalktoanyonebesidesthepatientduringmoxibustionapplication.

5. Considerusingahemostat/tweezers/forcepstoapplyandremovethemoxacones.Thispreventsthepractitioner’sfingersfrombeingburnedandreducestheriskofdroppingburningmoxaontothepatientortreatmentsurface.

6. Oncethetreatmentiscomplete,thecupofwaterwiththeburntmoxashouldbeflusheddownthesink.Donotputmoxaashdirectlyintoatrashcanasthismayigniteatrashfire.

7. Neverapplydirectmoxatothefaceorwithinthehairline.

Indirect Moxibustion – Technique with Interposed Moxibustion Theignitedmoxaconedoesnotcontacttheskindirectly,butisinsulatedfromtheskinbyalayerofginger,salt,garlic,oraconitecake.Dependingonthetechniqueused,thiskindofmoxamayinduceblistering,butitismostfrequentlyusedfornon-scarringmoxibustion.

Method 1. Asinglemoxaconeispreparedpriortouse.2. Athoroughpatienthistoryisperformedtoidentifyanyconditionsthatmightlimita

patient’sresponsetopainortheabilitytosenseheat[critical]ormayincreaseareactiontothemoxasmoke.[recommended]

3. Properventilationisassuredthroughuseofwindowsorairfiltersorotherairfilteringprocess.[critical]

4. Allequipmentisplacedonastablesurfacedirectlynexttothetreatmenttable.Equipment:moxacones,hemostat/forceps/tweezers,herbalinsulation(aconitecake,garlic,andginger),cupofwater(ifdesired),ashtray(ifdesired),lubricantorskinlotion,lighter,incensestick,andotherequipmentasneeded.[recommended]

5. Thepractitionerwasheshisorherhands.[critical]6. Theareatowhichmoxawillbeappliedispreparedwithskinlotionorlubricant,if

desiredbasedonthetypeofmoxapractice.7. Theherbalinsulationisthenappliedtotheareatobeheated.8. Theconeofmoxa,unlit,isappliedtotheherbalinsulator.9. Ifdesired,ahemostatortweezersmaybeappliedtothemoxaandtheincense(orother

material)isthenusedtolightthemoxa.[recommended]Practitionersmayalsochoosetousetheirfingersformoxaapplicationandwithdrawalbasedonpersonalpreferenceandtraining.

10. Amaterialsuchasanincensestickislighted,usingthelighter,awayfromthepatient.Othermaterialscanbeusedaslongasanopenflameiskeptsomedistancefromthepatient’sskin.[recommended]

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11. Whenabout2/3ofthemoxaisburntorthepatientfeelsaburningdiscomfort,removetheconeandinsulatorandplacethemoxainthecupofwaterorashtray.[recommended]

Safety Considerations 1. Alwayshaveaccesstowaterto:

a. Beabletosnuffanyburningashthatfalls.b. Coolanysmallburnstothepatient’sorpractitioner’sskinimmediately.c. Beareceptacleforburntmoxa,unlessasuitableashtrayorothernon-

flammablereceptacleispreferred.2. Neverleaveapatientalonewhenmoxaisbeingapplied.3. Makesurenoclothingisclosetotheareabeingtreatedwithmoxibustion.4. Payverycloseattentiontothepatientduringmoxibustionapplication–donotlook

awayfromthepatientormoxa,writeinthechart,ortalktoanyonebesidesthepatientduringmoxibustionapplication.

5. Considerusingahemostat/tweezers/forcepstoapplyandremovethemoxacones.Thispreventsthepractitioner’sfingersfrombeingburnedandreducestheriskofdroppingburningmoxaontothepatientortreatmentsurface.

6. Oncethetreatmentiscomplete,thecupofwaterwiththeburntmoxashouldbeflusheddownthesink.Donotputmoxaashdirectlyintoatrashcanasthismayigniteatrashfire.

7. Neverapplyinterposedmoxatothefaceorwithinthehairline.

Indirect Moxibustion - Warming Needle Moxibustion Thismethodusesbothaneedleandmoxa.Aftertheacupuncturepointisneedledandstimulatedasdesiredorneededforthearrivalofqi,asmallsectionofamoxastick(about2cmlong)oramoxaconeisplacedonthehandleoftheneedle.Themoxastickisthenignitedfromitsbottomandallowedtoburnout.

Themethodbelowusesnoadditionalmaterialtosecurethemoxaontheneedle.Instead,aprotectivecoverofcardboardisplacedontheskintoavoidburningashesfromfallingonthepatient.Othermethodsanddeviceshavebeenutilizedsafelytopreventthemoxafromfallingonthepatient.Thespecificmethodordevicetobeusedcanbechosenbasedonsafetyevidenceandpractitionerpreferences.

Method 1. Moxasticksorconesarepreparedpriortolightinganymoxa.2. Allequipmentisplacedonastablesurfacedirectlynexttothetreatmenttable.

Equipment:moxasticksorloosemoxatomakecones,tweezers/forceps/hemostat,cup

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ofwater(ifdesired),ashtray(ifdesired),protectiveskincover,lighter,andincensestick.[recommended]

3. Thepractitionerwasheshisorherhands.[critical]4. AcleanneedletrayispreparedasdiscussedintheCNTsectionofthismanual.[critical]5. TheacupunctureisperformedfollowingCNTguidelines.[critical]6. Insertmetal-onlyneedlestothedepthrequiredtoretaintheneedleuprightsecurely.

Donotuseplastictippedneedlesastheplasticmaymeltduringthemoxatherapy.[recommended]

7. Adiscofinsulatorcardboardorothermaterialisplacedonthepatient’sskinaroundthebaseoftheneedle.Alternately,adeviceorinsulatormaterialisattachedtotheneedlebelowwherethemoxawillsit.Bothmethodspreventashfromfallingonthepatient’sskin.[stronglyrecommended]

8. Asmallstickorconeofmoxaisplacedonthehandleoftheneedle.9. Theincenseislighted,usingthelighter,awayfromthepatient.[recommended]10. Theincenseisusedtolightthemoxa,whichhasbeenplacedonthehandleofthe

needle.[recommended]11. Whenabout2/3ofthemoxaisburntorthepatientfeelsawarmsensationaroundthe

needle,removetheconeandplacethemoxainthecupofwaterorashtray.[recommended]

12. Shouldthepatientindicatethatthereisanuncomfortableamountofheat,usethetweezersorhemostattoimmediatelyremovetheneedleandmoxa.Thehotneedlemustberemovedwithaninstrument,sinceitwillbetoohottomanipulatesafelybyhand.[recommended]

Safety Considerations 1. Alwayshaveaccesstowaterto:

a. Beabletosnuffanyburningashthatfalls.b. Coolanysmallburnstothepatient’sorpractitioner’sskinimmediately.c. Beareceptacleforburntmoxa,unlessasuitableashtrayorothernon-flammable

receptacleispreferred.2. Neverleaveapatientalonewhenmoxaisbeingapplied.3. Makesurenoclothingisclosetotheareabeingtreatedwithmoxibustion.4. Payverycloseattentiontothepatientduringmoxibustionapplication–donotlook

awayfromthepatientormoxa,writeinthechart,ortalktoanyonebesidesthepatientduringmoxibustionapplication.

5. Considerusingahemostat/tweezers/forcepstoapplyandremovethemoxacones.Thispreventsthepractitioner’sfingersfrombeingburnedandreducestheriskofdroppingburningmoxaontothepatientortreatmentsurface.

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6. Oncethetreatmentiscomplete,thecupofwaterwiththeburntmoxashouldbeflusheddownthesink.Donotputmoxaashdirectlyintoatrashcanasthismayigniteatrashfire.

7. Neverapplywarmingneedlemoxatotheface.

Indirect Moxa – Technique with Moxa Stick Moxasticksmaybeusedeither(1)byholdingthemoxa2-3cmoverthesitetobetreatedtobringmildwarmthtothearea/pointforupto15minutes,oruntiltheskinbecomesslightlyredorwarmtothepractitioner’stouch;or(2)theignitedmoxastickismovedupanddownoverthepointornearoraroundanacupunctureneedle.

Becausemoxastickscanbeverydifficulttobelitproperly,forpractitionersafety,itisrecommendedthatacandle,orfireplaceflametorchbeused.Inthemethodbelow,acandleisused.Othermethodsthatkeeptheflameawayfromthepatientandthepractitioner’sfingersmaybeutilizedbasedonpractitionerpreference.

Method 1. Allequipmentisplacedonastablesurfacedirectlynexttothetreatmenttable.

Equipment:moxastick,moxaextinguisher,cupofwater(ifdesired),lighter,andcandle.[recommended]

2. Thepractitionerwasheshisorherhands.[critical]3. Lightthecandleusingthelighter.Thenlightthemoxastickusingthecandle.

[recommended]4. Immediatelyextinguishthecandleoncethemoxaislit.[recommended]5. Applymoxausingoneofthemethodsabove.6. Everyfewminutes,tapanyashfromthemoxastickintothemoxaextinguisherto

preventfallingashfromfallingonthepatientorthetable.[stronglyrecommended]7. Whenthepatientfeelswarmth,removethestickandapplytothenextpointtobe

warmed,asneeded.[recommended]8. Aftertherequisitepointshavebeenwarmedasindicatedforthetreatmentdesired,

placethemoxastickintheextinguisher,litenddownward.[critical]9. Usethecupofwater,ifnecessary,toextinguishashthatfallsoutsideofthemoxa

extinguishertray.[recommended]

Safety Considerations 1. Alwayshavewateronhandto:

a. Beabletosnuffanyburningashthatfalls.b. Coolanysmallburnstothepatient’sorpractitioner’sskinimmediately.

2. Neverleaveapatientalonewhenmoxaisbeingapplied.

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3. Payverycloseattentiontothepatientduringmoxibustionapplication–donotlookawayfromthepatientormoxa,writeinthechart,ortalktoanyonebesidesthepatientduringmoxibustionapplication.

4. Tapmoxatoremoveashasneeded;avoidscrapingtheashfromthemoxastickasthismayloosentheburningtipofmoxawhichthenmayfallonthepatientortreatmentsurface.

5. Oncethetreatmentiscomplete,moxashouldberetainedinthemoxaextinguisherforatleastonehourtoensurethatthemoxaisfullyextinguished.

6. Themoxaintheextinguishercanberemovedfromtheextinguisherafter1hour,wetdowninasinkandthenthrownawayinmetalcansorotherashreceptacles,butnotintheregulartrashtopreventtrashfires.

Moxa Disposal Topreventburnsandfires,allmoxanotflusheddownasinkmustbeproperlydisposedofinmetalorothercontainersspecificallydesignedforashes.

1. Makesureallusedmoxasticksarecontainedinanappropriateextinguisherfornolessthan1hourafteruse.

2. Putallusedmoxaandmoxasticksthathavenotbeenflusheddownthesinkinametalbucketwithatightfittingmetallid,afterthe1hourextinguishingperiodiscomplete.Analternativeistouseametalsmokingreceptacledesignedforusedcigarettedisposal.

3. When¾full,themetalbucket(orreceptacle)canthenhaveitscoversecuredtightlyandthebucketcanthenbedisposedofintheregulartrash.

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2. Heat Lamps

Best Practice Protocols for Heat Lamps Heatlampsaredesignedforuseinapplicationsspecificallyrequiringashort-waveinfraredradiationsource.Infraredradiationfromthislampcausessurfacestobeheated.Formostofthecommonlyusedcommercialheatlamps(suchasTDPlamps),lampsshouldneverbeplacedcloserthan12inchestoanypersonorsurface.Someheatinglampsaredesignedformuchlowertemperaturesandmaybebroughtclosertothepatient’sskinsurfaceifthatcanbeaccomplishedsafelyandaccordingtothemanufacturer’smanuals.

Method Forusewhenheatingisneededoverageneralareafortherapeuticwarming.

1. Checklampforanydefects.[critical]2. Checktheareatobetreatedforskinlesions.[stronglyrecommended]3. Makesureallclothingandcombustiblematerialsaremovedsufficientlyoutofthearea

tobeheated.[stronglyrecommended]4. Pluglampintothewallsocket.5. Positionlampheadatleast12inchesfromtheareatobeheated.[strongly

recommended]6. Turnontheheatlampthensettimefornomorethan10-15minutes.[recommended]7. Becausetheheatofthelampmaycausetheheadoftheunittodroptowardthe

patient,neverleavetheimmediateareaofapatientbeingtreatedwithaheatlamp.[stronglyrecommended]

8. Checktheareabeingheatedatleastonceevery5minutestobesurethattheskindoesnotbecometoohotorthatthelamparmpositionhasnotchanged.[stronglyrecommended]

9. Unplugthelamponcetheheatingperiodhasended.[recommended]

Safety Considerations • Critical:Heattherapiesmustbecloselymonitoredbypractitioners.• Critical:Heatlampsshouldnotbeusedoninfants,children,incapacitated,sleeping,or

unconsciouspersons.• Critical:Whenheatlampsareusedonpatientswhohaveareducedresponsetoheat,

theuseofheatmustbemonitoredatalltimes.• Critical:Preventwater,moisture,liquidsormetalobjectsfromcomingincontactwith

thelamp.Donotuseaheatlampinwetormoistenvironments.• Critical:Donotuseifanypartofthelampiscracked.Donotallowanypartofthelamp

totouchaccessoryequipment.

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• StronglyRecommended:Heatlampsshouldnotbeusedunlessthepatientandpractitionercancommunicateaboutthelevelofheatpresentduringtheentiredurationofuse.

• StronglyRecommended:Donotuseover-sensitiveskinorpersonshavingpoorbloodcirculation.Sufficienttemperaturesaregeneratedthatmaycauseburns.

• StronglyRecommended:Takeacarefulpatienthistorytoidentifydiabetes,neuropathies,orotherconditionsthatmightlimitapatient’sresponsetopainortheabilitytosenseheat.

• StronglyRecommended:Donotusethisheatsourceincloseproximitytocombustiblematerials(litter,paper,etc.)ortomaterialsadverselyaffectedbyheatordrying.

• Recommended:Whentreatingpatientswithneuropathies,thepractitionershouldmonitorthepatient’sskintemperatureandtheamountofheatgeneratedbyaheatlampandnotrelysolelyonpatientfeedbackaboutheatsensations.

• Recommended:Whenapatient’sinformationisunclear,requestanopinionfromaphysicianbeforeusingaheatlamponthelimbsofapatientwithdiabeticorotherneuropathies.

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3. Cupping

Cupping Overview Cupping(baguanfad)isatherapeuticprocedureusedbyAOMandotherhealthcarepractitionersaroundtheworld.Cupping,oneoftheoldestmethodsoftraditionalChinesemedicine,isaccomplishedbyhavingacupappliedtotheskin;thepressureinthecupisreducedbyusingachangeinheatorbysuctioningoutair,sothattheskinandsuperficialmusclelayerisdrawnintoandheldinthecup.Cuppingusesapartialvacuumtointentionallycreatetherapeuticpetechiaeandecchymosisinthedermis.Thereareanumberofcuppingstyles,includingsuctioncupping,firecupping,emptycupping,slidingorglidingcupping.Bestpracticeguidelinesareprovidedforthreeofthesestyles:firecupping,suctioncupping,andwetcuppingorcuppingaftertheuseofalancetforbloodwithdrawal.

General Recommendations for Cupping • Critical:FollowStandardPrecautions.• Critical:FollowSafetyGuidelinesforEstablishingandMaintainingaCleanField.• Critical:FollowSafetyGuidelinesforHandSanitation.• Critical:Cuppingshouldnotbeapplied48hoursbeforeor24hoursafterchemotherapy

treatment.• Critical:Cupoverclearskinonly.Donotcupoveranactiveskinlesion,moles,swelling,

trauma,inflammation,infection,orburns(includingsunburn).• Critical:Practitionersmusttakeathoroughhistory,includingbleedingdisordersand

medicationhistory,beforeapplyingcups.• Critical:Practitionersmusttakeathoroughhistorytoidentifydiabetes,neuropathiesor

otherconditionsthatmightlimitapatient’sresponsetopainwhenplanningtoutilizefirecupping.

• Critical:ScreenpatientsforhistoryofreactiveskinlesionssuchaskeloidscarringorKöebnerphenomenon.

• Critical:Assesscarefullytheuseoffirecuppingonpatientswhohaveadecreasedresponsetopain(e.g.,thosewithdiabetesorneuropathies).

• Critical:Practitionersmustwashhandsbeforestartingtheprocedureandagainafterremovinggloves(ifused).

• Critical:Personalprotectiveequipment(PPE)-wearglovesandeyeprotectionatalltimeswhenbloodorOPIMmaybepresent(wetcupping,cuppingafterneedling).

• Critical:Eachareatobewetcuppedmustbecleanedimmediatelybeforecuppingbythepractitioner.

• Critical:Lancetsusedforwetcuppingshouldbesterile,usedonlyonce,thendiscardedinapropersharpscontainer.

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• Critical:IfbloodorotherOPIMarepresent,collectwithcottonswab,gauze,papertowel,orclothanddisposeinbiohazardtrash.

• Critical:WhenbloodorotherOPIMarepresent,allowthevacuumtobecompromisedslowly,andthenremovethecup.

• Critical:Iflubricantsareusedforglidingcuppingormovingcupping,decantaportionforuse.Donotdipbackintolubricantcontainerortouchthespoutofapumpcontainerwhilecupping.

• Critical:UseappropriatePPEwhilecleaninganddisinfectingcups.• Critical:Cleanallcupsofalllubricantsandbiologicalmaterialusingsoapandwater

beforedisinfecting.• Critical:DisinfectallcupsusinganappropriateFDA-clearedintermediate-tohigh-level

disinfectingsolutioninaccordancewithlabelinstructions.• StronglyRecommended:Usecautionifcuppingpatientscurrentlytakinganti-coagulant

medications.• StronglyRecommended:Cuppingoverneedlesmaycauseneedlestotravelbeyonda

safedepth.Eitherinserttheneedleobliquely,oravoidthetherapyinareaswithunderlyingorgans.

• StronglyRecommended:Placeburningmaterialintothedeepestpartofcup,andneverretaintheburningmaterialinsidethecupswhenthecupsareplacedontotheskin.

• StronglyRecommended:Observecarefulandlimitretentiontimetothephysicaltoleranceofthepatient.

• StronglyRecommended:Disinfectallcupsusingahigh-leveldisinfectingsolutionfollowingpackagedirectionsforsemi-criticaldevices.

• StronglyRecommended:Explaintherapeuticintentionofcuppingandpresentatimelineofresolution.Cupchildrenonlyinthepresenceofaparentorassignedguardian.

• Recommended:Usedisposablecupsforwetcuppinganddisposeofusedwetcupsinthebiohazardtrash.

• Recommended:Ahandoutexplainingcuppinginclinicalpractice,includingskinchangesandatimelinefortheirresolution,mayprotectthepatientfromthestressofmisinterpretation.

Sample Best Practice Protocols for Cupping Afterreviewingtheliteratureaboutcuppingsafety(PartIofthismanual),thesafetyrecommendationsabove,andusingtheinformationaboutthepossibleAEsassociatedwithcuppingtherapies,thefollowingbestpracticeguidelineshavebeendeveloped.Asstatedatthestartofthissectionofthemanual,theseproceduresaredesignedtolimitdangerstopatients,practitionersandstaff.Inallcases,thefollowingprocedurescanberevisedasneededtokeepupwiththelatestresearchandmodifiedasneededforspecificstylesofpracticeaslongassafetyremainsthepriority.

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Fire Cupping Method Thisprocedureinvolvestheuseofanopenflamenearapatient.Thismay,ifthetechniqueisnotdonesmoothly,occasionallycauseburningandblisteringoftheskin(firstorseconddegreeburn).Inaddition,thecuppingmayleaveredorbruise-likecircularmarkswherethecupsareapplied.Thepatientshouldbeeducatedthatthesemarksarecommonplacewiththistechnique.Thepatientshouldalsobeinformedthattheyshouldkeepthecuppedareaprotectedfromwindorcolddrafts.Itisstronglyrecommendedthatpatientsbeaskedforconsentbeforeapplyingcuppingtechniques.

1. Allequipmentisplacedonastablesurfacedirectlynexttothetreatmenttable.Equipment:cuppingjar,hemostat,lighter,cottonball,alcohol,andburncream.[recommended]

2. Thepractitionerwasheshisorherhands.[critical]3. Iftheareatowhichcuppingwillbeappliedneedstobecleaned,cleaningcanbe

accomplishedwithalcohol,soapandwater,oranothercleansingtechnique[critical]4. Theflameapparatusispreparedbyclampingacottonballinthehemostatandthen

slightlymoisteningthecottonwithalcohol.Alternately,analcoholswabmaybeused.5. Thejarisheldwiththemouthfacingperpendicularlytotheskinsurfaceinthenon-

dominanthand.[stronglyrecommended]6. Theflameapparatusislitandtheninonesinglemotion:

a. Theflameisintroduceddeepintothecupquicklyandpulledawayatthesametimethatthecupisthenappliedtotheskinsurface[critical]

b. Thehemostatisremovedobliquelyawayfromthepatient’sskinsurfaceinordertoensuresafety.[stronglyrecommended]

c. Theflameisextinguished.[critical]d. Oncetheflamehasbeenextinguishedandtheflameapparatusremovedtothe

equipmentsurface,thepractitionerwilldeterminethelevelofsuctioninducedandwillretainthecupfor2-10minutesormoreorrepeattheaboveproceduretocreateastrongervacuum.

7. Thecupisremovedwhenthetherapyisdonebygentlypryingthejaredgeupfromtheskinordepressingtheskinnexttotherimofthecuptodefeatthevacuum.Thecupisthenputasideandprocessedforcleaninganddisinfecting.[stronglyrecommended]

Safety Considerations • Aliveflameisutilizedandsoallproperprecautionsasindicatedelsewhereinthis

manualmustbefollowed,includingsettingupequipmentonaworksurfacethatisnotflammablenear,butnoton,thetreatmenttable.[critical]

• Theworkspacemustbekeptclearofobstructions.[stronglyrecommended]

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• Haveaccesstowatertoputouttheflameifnecessaryortocooltheskinifasmallburndoesoccur.[recommended]

• Payverycloseattentiontothepatientduringthecupapplication.[stronglyrecommended]

• Haveafireextinguisheronhandinaroominwhichyouareusingfire-throwingcupping.[recommended]

• Inordertopreventskininjury,checktherimofeachcupbeforeuseandmakesurethatthereisnobrokenorcrackedarea.[critical]

Suction Cupping Cuppingmayleaveredorbruise-likecircularmarkswherethecupsareapplied.Thepatientshouldbeeducatedthatthesemarksarecommonplacewiththistechnique.Thepatientshouldalsobeinformedthatheorsheshouldkeepthecuppedareaprotectedfromwindorcolddrafts.Itisstronglyrecommendedthatpatientsbeaskedforconsentbeforeapplyingcuppingtechniques.

Asthismethodusesnoflame,burnsarenotanadverseeventassociatedwiththismethodofcupping.

Method 1. Allequipmentisplacedonastablesurfacedirectlynexttothetreatmenttable.

Equipment:cuppingjars,pumpextractor,lubricant.[recommended]2. Thepractitionerwasheshisorherhands.[critical]3. Iftheareatowhichcuppingwillbeappliedneedstobecleaned,usealcohol,soapand

water,oranothercleansingtechnique.[stronglyrecommended]4. Asmallamountoflotionorlubricantisappliedtotheskin.[recommended]5. Placethecupontheskin,attachthepumpextractor,andremoveenoughairtobring

someskinintothecup.6. Thecupisremovedwhenthetherapyisdonebyreleasingthesuctionvalvetodefeat

thevacuum.Thecupisthenputasideandprocessedforcleaninganddisinfecting.[recommended]

Wet Cupping Thismethodinvolvesbothblood-lettingandcupping.Bestpracticesforbothpartsofthistreatmentareincorporatedbelow.

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Method 1. Allequipmentisplacedonastablesurfacedirectlynexttothetreatmenttable.

Equipment:cuppingjars,lubricant,andacleanfieldwithlancets,cottonballs,alcoholswabs,sterilegauze,sharpscontainer,andskincleanser.[recommended]

2. Thepractitionerwasheshisorherhands.[critical]3. Practitionersmustuseglovesandshouldalsoutilizeeyeprotectiontopreventexposure

toblood.[critical]4. Theareatowhichcuppingwillbeappliediscleanedwithalcohol(ormaybethoroughly

cleanedwithappropriatematerialssuchassoapandwater).[critical]5. Theskinatthesiteshouldbepuncturedusingsterilelancets,withanewlancetbeing

usedforeachpuncture.[critical]Discardthelancetsdirectlyintothesharpscontainerafteruse.[critical]

6. Applythecups(pumporflamecuppingasdescribedabove)andretainforthedesiredlengthoftherapy.

7. Ifthepractitionerhasremovedeitherglovesorgoggles,putthepersonalprotectiveequipment(PPE)backonforcupremoval.[critical]

8. Allowthevacuumtobecompromisedslowlythenremovethecup,takingcaretopreventbodyfluidfromspreadingorsplashing.[critical]

9. Immediatelyisolatethecups.10. Stopanycontinuedbleedingthroughuseofappropriatepressureusingsterilegauze.

[critical]11. Cleanupanybleedingthathasoccurred.Cleanthesiteofthepunctureswithan

appropriateskincleanser.[stronglyrecommended]12. Discardextravasatedbloodinthebiohazardtrash.[critical]13. Immediatelywashcupswithsoapandwater.14. Removegoggles,gownandgloves.DisposeofPPEasindicatedbytheclinic’sOSHA

standard.15. Washhandswithsoapandwater.[critical]16. Removecupstoprocessingareaforinstrumentdecontamination.17. CleanthecupsofanybiologicalmaterialwithsoapandwaterandlubricantTHEN

sterilizethecups.[critical]Or,discardcontaminatedcupsinthebiohazardtrash.[recommended]

18. Sterilizewithaautoclaveorbyfollowinglabelinstructionforhigh-leveldisinfectionsolution(forexample,immersefor6hoursin7.3%hydrogenperoxidesolution).[critical]

19. Cleanequipmentsurfaceandtablewithanappropriatedisinfectantsolution.[critical]

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4. Therapeutic Blood Withdrawal

Bleeding Overview InChineseAcupunctureandMoxibustion,(1)theuseofthethree-edgedneedle(lance)issaidtohavebeenhistoricallyusedforhighfever,mentaldisorders,sorethroat,andlocalcongestionorswelling.Modernpractitionersmayusebleedingtechniquestoclearheatsyndromes,stronglydispersepoints,andstronglystimulatespecificpoints.Astotechnique,thepointtobebledisprickedsuperficially,just0.05-0.1cun(inches)deep,whichshouldbelightandsuperficialandtheamountofbleedingtobe"determinedbythepathologicalcondition."Ingeneral,acupuncturistsshouldusecautionifemployingbleedingtherapyforpersonswhohaveweaknessoftheiryinoryangqi,ableedingdisorder,aweakconstitution,orwhotakeanticoagulantmedication.

General Recommendations for Bleeding Techniques • Critical:Personalprotectiveequipment(PPE)-wearglovesatalltimesasbloodand

OPIMwillbepresent.• Critical:Lancingdevicesmustbelimitedinusetoasinglepatient.• Critical:Lancetsshouldbeusedonlyonce,andthendiscardedinapropersharps

container.• Critical:Lancetsshouldbeusedonlyonceandcannotbereinsertedintoanothersite

onthesameoradifferentpatient.• Critical:Practitionersmusttakeathoroughhistory,includingbleedingdisordersand

medicationhistory,beforeusingbleedingtechniques.• Critical:Donotbleedinanareaofanactiveskinlesion.• Recommended:Utilizeeyeprotection,suchasgoggles,whenperformingbleeding

techniques.• Recommended:Utilizesingle-uselancetsengineeredtoretractafteruseto

significantlyreducetheriskofneedlestickinjuries.

Sample Best Practice Protocol for Bleeding Acupuncture Points Afterreviewingtheliteratureaboutbleedingsafety(inPartIofthismanual),thesafetyrecommendationsabove,andtheinformationaboutthepossibleAEsassociatedwithbleedingpractices,thefollowingbestpracticeguidelineshavebeendeveloped.Asstatedatthestartofthissectionofthemanual,theseproceduresaredesignedtolimitdangerstopatients,practitionersandstaff.Inallcases,thefollowingprocedurescanberevisedasneededtokeepupwiththelatestresearchandmodifiedasneededforspecificstylesofpracticeaslongassafetyremainsthepriority.

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Method 1. Selectaclean,dry,flatsurfacetoserveasthesettingforthecleanfield.(Note:The

selectedlocationCANNOTbethetreatmenttable!)[stronglyrecommended]2. Washhandsforatleast10-15secondsunderrunningwater,latheringwellwithsoap.

Or,ifsoapandwaterareunavailable,cleanhandswithanalcohol-basedhandsanitizer.[critical]

3. Placeacleanpapertowel,cleantablepaperorotherbarrierthatwillserveasacleanfieldontheworksurfaceinawaythatdoesnotcompromisethecleanlinessofthesurfacethatwillserveasthecleanfield.[critical]

4. Setoutthematerialsneededforatreatment.Lancetsshouldbeplacedonthecenterofthecleanfieldfirst.[recommended]

5. Cleanitemssuchascottonballsandunopenedalcoholswabsmayeitherbeplacedonthecleanfieldorkeptinjarsorcontainersnearthecleanfieldsoastobeathandforthepractitioner.[recommended]

6. Putongloves[critical]andgogglesorothereyeprotectionasindicatedbythesafetycommitteeorofficeratyourclinic.[recommended]

7. Ensurethatthepatient’sskiniscleanbeforeinsertingalancet.Skincanbecleanedwith70%isopropylalcohol,soapandwater,oranothermethod.[critical]Ifusinganalcoholswab,allowthealcoholtodry.[critical]

8. Pulltheskintautneartheareatobelanced.[recommended]9. Pressthelancetquicklyintothepoint.Somepractitionerspositionthelancetbevelside

downoverandjustlateraltotheintendedpoint,thenrollthelancetoverandintothepointinordertoavoidthediscomfortofasuddendeepneedlestick.Usearetractablesingle-uselancetifthemethodbeingusedallowsfortheuseofsuch.[recommended]Suchdevicestendtoproduceadeeperneedlestickandmaycausemorepatientdiscomfortbutmaylimitneedlestickrisk.However,retractabledevicesmustbeusedonasinglepatientanddiscarded.

10. Disposeofthelancetimmediatelyintoanappropriatesharpscontainer.[critical]11. “Milk”or“squeeze”enoughbloodfromthelancedpointasindicatedfortheresultyou

expect.12. Useasterilecottonballorgauzetoremovebloodfromthelancedarea.

[recommended]13. Disposeofthecottonballinthebiohazardtrash.[stronglyrecommended]14. Reexamineneedledsitesasecondtimeforsignsofbleedingorhematoma,andapply

pressurewithasterilecottonballorgauzeifnecessary.[recommended]15. Cleanthesiteofthelancedskinandcoverwithabandageasnecessaryifitisstill

bleeding.[stronglyrecommended]16. Removeglovesandgoggles.DisposeofPPEasindicatedbytheclinic’sOSHAstandard.

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17. Washhandsimmediatelyaftercompletingtheprocedureandremovinggloves.[critical]

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5. Plum Blossom/Seven Star Needle

Plum Blossom Overview Plumblossom/sevenstarneedles(orcutaneousacupuncture)isdescribedinAcupuncture:AComprehensiveText(2)asbeingusefultotreatthecutaneouschannelsandinternaldiseasesassociatedwiththemeridianoverwhichtheskinwillbetapped.SevenstarneedlingisusedinAOMpracticesforthetreatmentofavarietyofpainsyndromes.

General Recommendations for Plum Blossom • Critical:FollowSafetyGuidelinesforEstablishingandMaintainingaCleanField.• Critical:FollowSafetyGuidelinesforHandSanitation.• Critical:FollowSafetyGuidelinesforSkinPreparation.• Critical:PPEisrequired–wearglovesatalltimesasbloodandOPIMwillbepresent.• Critical:Theareatobetreatedmustbecleanandfreeofanyskinlesionsortraumatic

injury.• Critical:Theareaofpatient’sskintobetreatedmustbecleanpriortotreatment.• Critical:Theheadoftheplumblossomdevicemustbesterile.Donottouchthetipsof

theneedles.• Critical:Useonlysingle-usesterileplumblossomneedles.• Critical:Usedplumblossomneedlesmustbediscardedintoapropersharpscontainer

immediatelyafteruse.• StronglyRecommended:Avoidbringingthehandholdingthehammeruptoohighor

tappingtooforcefullysoastopreventpuncturingtheskin.• StronglyRecommended:Avoidflingingthehammeraroundsoastopreventthespread

ofbloodorOPIM.• Recommended:Practitionersshouldwearglovesandeyeprotectionwhileusingthe

plumblossomdevice.

Best Practice Protocols for Plum Blossom Afterreviewingtheliteratureaboutplumblossomsafety(PartIofthismanual),thesafetyrecommendationsabove,andusingtheinformationaboutthepossibleAEsassociatedwithsevenstarneedlingpractices,thefollowingbestpracticeguidelineshavebeendeveloped.Asstatedatthestartofthissectionofthemanual,theseproceduresaredesignedtolimitdangerstopatients,practitioners,andstaff.Inallcases,thefollowingprocedurescanberevisedasneededtokeepupwiththelatestresearchandmodifiedasneededforspecificstylesofpracticeaslongassafetyremainsthepriority.

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Method 1. Selectaclean,dry,flatsurfacetoserveasthesettingforthecleanfield.(Note:The

selectedlocationCANNOTbethetreatmenttable!)[stronglyrecommended]2. Washhandsforatleast10-15secondsunderrunningwater,latheringwellwithsoap.

Or,ifsoapandwaterareunavailable,cleanhandswithanalcohol-basedhandsanitizer.[critical]

3. Placeacleanpapertowel,cleantablepaperorotherbarrierthatwillserveasacleanfieldontheworksurfaceinawaythatdoesnotcompromisethecleanlinessofthesurfacethatwillserveasthecleanfield.[recommended]

4. Setoutthematerialsneededforatreatment.Sevenstarhammersshouldbeplacedonthecenterofthecleanfieldfirst.[recommended]

5. Cleanitemssuchascottonballsandunopenedalcoholswabsmayeitherbeplacedonthecleanfieldorkeptinjarsorcontainersnearthecleanfieldsoastobeathandforthepractitioner.[recommended]

6. Putongloves[critical]andgogglesorothereyeprotection.[recommended]7. Ensurethatthepatient’sskiniscleanbeforeutilizingtheplumblossomneedle.[critical]

Skincanbecleanedwith70%isopropylalcohol,soapandwater,oranothermethod.Ifusinganalcoholswab,allowthealcoholtodry.[critical]

8. Thesevenstarhammerisheld1-2inchesabovethesurfaceoftheskinandtappedrapidlyalongtheareatobestimulated.Avoidbringingthehandholdingthehammeruptoohighortappingtooforcefullysoastopreventpuncturingtheskin.AvoidflingingthehammeraroundsoastopreventspreadofbloodorOPIM.[recommended]

9. Whentheskinbecomesred,orproperreactionhasbeenobserved,stoputilizingtheplumblossomdevice.[recommended]

10. Disposeoftheplumblossomhammerimmediatelyintoanappropriatesharpscontainer.[critical]

11. Cleanthesiteofthetreatmentandcoverwithabandageasnecessary(ifbleeding).[recommended]

12. Removeglovesandgoggles.DisposeofusedPPEasindicatedbytheclinic’sOSHAdocument.

13. Washhandsimmediatelyaftercompletingtheprocedureandremovinggloves.[critical]

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6. Gua Sha

Gua Sha Overview Guashaistheprocessofclosely-timedunidirectionalpress-strokingofthebodysurfacewithasmooth-edgedinstrumenttointentionallyraisetransitorytherapeuticpetechiaeandecchymosisrepresentingextravasatedbloodinthesubcutis.Guashaisnotassociatedwithsignificantadverseeventsexceptmisinterpretationoftherapeuticpetechiaeasillness,injury,orabusebyotherpractitioners.Studywithaqualifiedguashainstructorisrecommendedtolearnpreciselyhowandwheretoguashaandhowtouseguashainaclinicalpractice.(SeePartIfortheliteraturereview.)

Summary of Gua Sha Recommendations • Critical:FollowStandardPrecautions.• Critical:FollowSafetyGuidelinesforEstablishingandMaintainingaCleanField.• Critical:FollowSafetyGuidelinesforHandSanitation.• Critical:Practitionersmusttakeathoroughpatienthistory,includingbleedingdisorders

andmedicationhistory,beforeutilizingguashainordertoplanforanyexcessivepetechiaeproduction.

• Critical:Guashashouldnotbeapplied48hoursbeforeor24hoursafterchemotherapytreatment.

• Critical:Ifreusableguashadevicesarebeingused,theymustbecleanedoflubricantandbiologicalmaterialandthendisinfectedusinganapprovedintermediate-orhigh-leveldisinfectingsolutionfollowingpackagedirectionsforreusablemedicaldevices.

• Critical:Lubricantsshouldbedispensedfromapumporsqueezebottletopreventcontaminatingthelubricantreserve.Donottouchthespoutofthepumporthenozzleofthesqueezebottle.

• Critical:Guashashouldbeappliedtoclearskinonly.Donotapplytoactiverash,lesion,inflammation,infection,moles,swelling,trauma,burns(includingsunburn),orbreaksintheskinbarrier.

• Critical:UseappropriatePPEwhilecleaninganddisinfectingreusableguashatools.• StronglyRecommended:Anyapplicationofguashaforchildrenshouldbedoneinthe

presenceofaparentorguardian.• StronglyRecommended:Disinfectallguashadevicesusingahigh-leveldisinfecting

solution,followingpackagedirectionsforthedisinfectionofsemi-criticalreusablemedicaldevices.

• Recommended:Immediatelypriortothepracticeofguasha,theexpectedresultofpetechiaeshouldbeexplainedtothepatient.

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• Recommended:Considerhavingahandoutexplainingexpectedguashaeffectsandskinchangestogivetopatientsbeforeapplyingguasha.

Gua Sha Best Practice Protocols Afterreviewingtheliteratureaboutguashasafety(PartIofthismanual),thesafetyrecommendationsabove,andusingtheinformationaboutthepossibleAEsassociatedwithguashapractices,thefollowingbestpracticeguidelineshavebeendeveloped.Asstatedatthestartofthissectionofthemanual,theseproceduresaredesignedtolimitdangerstopatients,practitionersandstaff.Inallcases,thefollowingprocedurescanberevisedasneededtokeepupwiththelatestresearchandmodifiedasneededforspecificstylesofpracticeaslongassafetyremainsthepriority.

Itispossibletospreadirritationorinfectionfromoneareatoanotherwhenpracticingguasha.Itisalsopossibletocontaminatebothacontaineroflubricantusedformultiplepatientsandtheguashatoolitself,andthenspreadthatcontaminationthroughtheuseofguashatomultiplepatients.Therefore,themethodforbestpracticeinguashaisasfollows:

Method 1. Prepareyourtools:

a. Setaclean,disinfectedmulti-useguashatool(oracleandisposabletool)onacleanfield.[recommended]

b. Putasmallamountoflubricantinadisposablepapercup(usingatonguedepressororanotherdisposabledevicesuchasaplasticknife),orsetasqueezebottleoflubricantathandbutnotonthecleanfield.[stronglyrecommended]

2. Washyourhands.[critical]3. Ensuretheareatobetreatedisfreeofcuts,inflammation,infection,swelling,trauma,

burns,andactivelesionsthroughvisualinspection.[critical]4. Reiteratethefactthatpetechiaewillberaisedandbruisingiscommon;getaverbal

confirmationthatthepatientunderstandstheexpectedskindiscolorationfromthetreatment.[recommended]

5. Applyguashatoareatobetreated.6. Discardanylubricantinthecup(ifused)andanydisposableguashatool(ifadisposable

toolisused).[recommended]7. Washhands.[critical]8. Inspectthepatient’sskinagainforreactiontotheguashatreatment,remindhimorher

tokeeptheareacoveredandwarm.[recommended]9. Washanddisinfectanyreusableguashatools.[critical]

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7. Acupoint Injection Therapies Thereareafewstatesinwhichacupuncturistsmayuseinjections(suchassaline,B-12orherbalextracts)tostimulateacupuncturesites.AccordingtoAcupuncture:AComprehensiveText,(2)theseinjectionsmaybegivenatfront(Mu)orback(Shu)points,or“pointsofpositiveresponse.”

Forthosepractitionerswhowishtoutilizeinjectiontherapiesandforwhomthescopeofpracticeallowsinjections,thefollowingresourcesaresuggested:

WHOBestPracticesforInjectionTherapiesandRelatedProceduresToolkit:(5)http://whqlibdoc.who.int/publications/2010/9789241599252_eng.pdfCDC:http://www.cdc.gov/injectionsafety/CDCsRole.html(6)andhttp://www.oneandonlycampaign.org(7)AccordingtotheWHO:(5)“Methodsforreducingexposureandpreventinginfectiontransmissionincludehandhygiene,barrierprotection(gloves),minimalmanipulationofsharpinstruments(includinginjectionequipment),andappropriatesegregationanddisposalofsharpswaste(note:sharpsareitemssuchasneedlesthathavecorners,edgesorprojectionscapableofcuttingorpiercingtheskin).

Injectionsareunsafewhengivenwithunsterileorimproperequipmentortechnique.Itisimportanttoavoidcontaminationofinjectablemedications.Physicallyseparatingcleanandcontaminatedequipmentandsupplieshelpstopreventcross-contamination.Forexample,immediatedisposalofausedsyringeandneedleinasafetyboxplacedwithinarm’sreachisthefirststepinsafewastemanagement.”

TheCDChaspublishedtheresultsoftheinvestigationoffourlargeoutbreaksofHBVandHCVamongpatientsinambulatorycarecentersandidentifiedthatnotonlyisproperinjectiontechniquerequired,butbasicprinciplesofaseptictechniquemustbeadheredtoforthepreparationofinjectionsyringes.(8)TheCDCrecommendstheuseofsingle-dosevialsofinjectablemedicationinsteadofmultiple-dosevials.Wheremultipledosevialsareused,theuseofaseparatepreparationworkarea,awayfromthepatienttreatmentroomisrequired.

Thefollowingpracticesarestronglyrecommendedtoensurethesafetyofinjections:

• Properhandhygiene.• Useofgloveswhereappropriate.• Useofothersingle-usepersonalprotectiveequipment.• Utilizationofasepticpracticesinsyringepreparation.

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• Patientskinpreparationandskinpathogenreductiontechniques(useoftopicalantiseptics).

• Theuseofsingle-usedisposablesterileinjectionequipment.• Theimmediateisolationofusedsyringesinapropersharpscontainer.

Risksofinjectiontherapiesaresimilartothoseofneedlingandincludepain,bruising,bleeding,infections,injurytoorgansandnervetissue,patientdizzinessorfainting.However,thereareadditionalrisksofinfectionorskinreactionduetoinjectionofmaterialundertheskin.Itiscriticalthatallmaterialtobeinjectedbemanufacturedspecificallyforthatpurposeandbemaintainedinasterilestatepriortouse.

AccordingtotheCDC,“OnlywhenpatientsandprovidersbothinsistonOneNeedle,OneSyringe,OnlyOneTimeforeachandeveryinjectionwilltheriskofcontractinginfectiousdiseasethroughinjectionsbeeliminated.”(7)

Ingeneral,practitionersshouldusethesameCleanNeedleTechniqueset-upforinjections.Additionalprecautionsareneededforthesubstancestobeinjected.Thesesubstancesmustbepreparedforinjectionandremainsterilebeforeuse.

Whenusingasterilesingle-usesyringeorhypodermicneedle:

• Useanewdeviceforeachprocedure,includingforthereconstitutionofaunitofmedication.[critical]

• Inspectthepackagingofthedevicetoensurethattheprotectivebarrierhasnotbeenbreached.[critical]

• Discardthedeviceifthepackagehasbeenpunctured,tornordamagedbyexposuretowater,orwhentheexpirationdatehaspassed.[critical]

Acupoint Injection Therapy Best Practice Protocols 1. Keeptheinjectionpreparationareafreeofcluttersoallsurfacescanbeeasilycleaned.2. Beforestartingtheinjectionsession,andwheneverthereiscontaminationwithblood

orbodyfluids,cleanthepreparationsurfaceswithEPA-registeredlowtointermediateleveldisinfectant.[critical]

3. Assembleallequipmentneededfortheinjection:• Useasterilesingle-useneedlesandsyringes• Reconstitutionsolutionsuchassterilewaterorspecificmedication• Alcoholswaborcottonwool• Sharpscontainer

4. PutonPPE(gloves).[stronglyrecommended]5. Readthelabelcheckingthemedicationandexpirationdates.[critical]

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6. Swipethetopofthemedicationvial/bottlewith70%alcohol.[critical]7. Ifusingamulti-dosevial,theairequivalenttothedoseshouldbedrawnupintothe

syringefirstandinjectedintothevialtofacilitateeasierwithdrawal.Donotinjectairintoasingle-dosevialorampule.

8. Oncetheloadedsyringeandneedlehavebeenwithdrawnfromamulti-dosevial,administertheinjectionassoonaspossible.[critical]

9. Ifairbubblesareseeninthesyringe,holditwiththeneedleuppermost,tapthebarreltobringthemtothetopandthenremovethebubblesbypushingtheplungertoexpeltheair.

10. Doublechecktoensurethecorrectamountofsolutionisinthesyringe.11. Preparethepatient’sskinwith70%alcohol.12. Allowtheskintodry.13. Insertthesyringetothedepthrequiredforthetypeoftherapyorwhereqisensationis

notedfollowingguidelinesforsafeinsertiondepth.14. Foranintramuscularinjection,drawbackonthesyringetocheckforevidenceof

bleeding(ifbleedingispresent,removetheneedleandbeginprocedureagainwithanewdeviceandnewmedication).

15. Ifnobloodflashback,injectthesolutionatamoderaterate.16. Withdrawneedleandimmediatelydisposeoftheneedleinthesharpscontainer

withoutre-capping.17. Covertheinjectionsitewithacottonballfor5-20seconds.18. Useanewsterilesyringeandneedleforeachinsertionintoamulti-dosevial.[critical]It

isstronglyrecommendedthatsingle-usevialsofinjectablesolutionsbeutilizedwheneverpossible.

Safety Considerations • DONOTallowtheneedletotouchanycontaminatedsurface.• DONOTreuseasyringe,eveniftheneedleischanged.• DONOTtouchthemedicationvialdiaphragmafterdisinfectionwiththe60–70%alcohol

(isopropylalcoholorethanol).• DONOTenterseveralmultidosevialswiththesameneedleandsyringe.• DONOTre-enteravialwithaneedleorsyringeusedonapatient.• Avoidinjectioninhairroots,scars,molesandotherskinabnormalities.• Avoidinjectionintoanyareaofskinwithanactivelesion.• Keepinjectablesolutionatroomtemperaturepriortoinjection.• Useneedlesofshorterlengthandsmallerdiameterwheneverpossible.• Useanewneedleforeachinjection.• Inserttheneedleinaquicksmoothmovementthroughtheskin.

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• Injectslowlyandevenly.Ensurethattheplungerofthesyringehasbeenfullydepressedbeforewithdrawingthesyringefromtheskin.

• Injectonlywhenthealcoholusedtocleantheskinhasfullydried.

Summary of Safety Recommendations for Clean Injection Technique • Critical:FollowCleanNeedleTechnique.• Critical:Alwaysestablishacleanfieldbeforestartinganinjection.• Critical:Onlyusesingle-usesterileinjectioninstruments.• Critical:Alwayswashhandsimmediatelypriortostartinganinjection.• Critical:Onlyusesterile,preparedmedications,includingsterilewaterandherbal

preparations,meantforinjectionuse;NEVERusehome-preparedsubstancesforinjections.

• Critical:Allmaterialtobeinjectedmustbemanufacturedspecificallyforthatpurposeandbemaintainedinasterilestatepriortouse.

• Critical:Donotinjectintoanyskinlesion.• Critical:Immediatelyisolateusedneedlesinanappropriatesharpscontainer.• Critical:Donotinjectsubstancesdirectlyintoabloodvessel.• Critical:Wearglovesforallinjectionprocedures.• Critical:Checksyringespriortouseforsterilizationexpirationdates,breaksinthe

packagingoranyevidencethatairorwaterhasenteredthepackagingpriortouse.• Critical:Allpatientsneedtobetreatedasiftheyarecarriersofbloodbornepathogens

suchasHepatitisBorHIV.• Critical:Ensurethatthepartofthebodytobetreatedisclean.• StronglyRecommended:Cleanskinwith70%isopropylalcoholpriortoinsertinga

syringe.• StronglyRecommended:Usesinglevialsofinjectablesolutionswheneverpossible.

References 1.ChengXinnong(chiefeditor).ChineseAcupunctureandMoxibustion.ForeignLanguages

Press,Beijing;19872.O'ConnorJandBenskyD(translators).Acupuncture:AComprehensiveText.EastlandPress,

Seattle,WA.1981.3.RutalaWA,WeberDJ,GuidelineforDisinfectionandSterilizationinHealthcareFacilities,

2008.CentersforDiseaseControlandPreventionHealthcareInfectionControlPracticesAdvisoryCommittee(HICPAC).http://www.cdc.gov/hicpac/pdf/guidelines/Disinfection_Nov_2008.pdfReviewedDecember29,2009.AccessedJanuary18,2015.

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4.NielsenA,KliglerB,KollBS.Addendum:SafetyprotocolsforGuasha(press-stroking)andBaguan(cupping).ComplementTherMed.2014;22(3):446-448.

5.WorldHealthOrganization.WHObestpracticesforinjectionsandrelatedprocedurestoolkit.http://whqlibdoc.who.int/publications/2010/9789241599252_eng.pdfWHOLibraryCataloguing-in-PublicationData..PublishedMarch2010..

6.CentersforDiseaseControlandPrevention.InjectionSafety.http://www.cdc.gov/injectionsafety/CDCsRole.htmlAccessedJanuary2013.

7.CentersforDiseaseControlandPreventionOneandOnlyCampaign.http://www.oneandonlycampaign.org/safe_injection_practices.AccessedJanuary2013.

8.CentersforDiseaseControlandPrevention.SafeInjectionPracticetoPreventTransmissionofInfectionstoPatients.http://www.cdc.gov/injectionsafety/IP07_standardPrecaution.html.ReviewedApril1,2012.AccessedJanuary2015.

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Part IV – Infections Associated with Acupuncture and Related Healthcare Practices

1. Pathogens Itisessentialthatpractitionersunderstandthemechanismsofdiseasetransmissionandknowthecharacteristicsofinfectiousdiseases,particularlybloodbornepathogenssuchashepatitisandHIV,skininfectionsfromStaphylococcusandStreptococcusandothercommonhealthcareassociatedinfections(HAI).Itisimperativeforanacupuncturisttoconsiderthesafetyofpatients,clinicians,andothermembersoftheclinicstaff.KnowledgeofthemechanismsandcharacteristicsofcommonHAIandadherencetoCleanNeedleTechniquewillreducetheriskofthespreadofbloodborneandsurfacepathogens.

Readersofthismanualshouldnotethattherearehundredsofpathogensthatarenotaddressedherein.Acupuncturepractitionersmustkeepabreastofdevelopmentsinhealthcareassociatedinfectionsandstateandnationalstandardstocontrolsuchinfectionsinclinicalsettings.

2. Mechanisms of Disease Transmission Afundamentalroleoftheimmunesystemistodifferentiateselffromnon-self.Thisdifferentiationallowstheimmunesystemtoattackforeignorpathogenicvirusesandbacteriawhileprotectingthebody’sownconstituents.Failureofthisabilitytodifferentiateselffromnon-selfmayresultinvariousinfectionsandautoimmunedisorders.Thepresenceofvirusesorbacteriaactivatesimmunefactorstorespondtopathogenicorganisms.Theimmunesystemconsistsofhumoralandcellularcomponents.Humoralcomponentsconsistoftheconstitutivecomplementproteinsystemandimmunoglobins.Theseproteinsarefoundintheliquidfractionoftheblood,aswellasinothertissues.Cellularcomponentsincludeneutrophils,macrophages/monocytes,aswellasBcellsandTcells.Theimmuneresponse,includingtheresponsetoinfection,resultsfromthecomplexinteractionbetweenthehumoralandcellularcomponentsoftheimmunesystem.

Thebodyisconstantlyexposedtoinfectiousagents,someofwhicharenormallyfoundinoronspecificareasofthebody,especiallyontheskin,inthemouth,respiratorypassageways,urinarytract,colon,andmucousmembranesoftheeyes.Manyoftheseorganismsthatarenormallypresentarecapableofcausingdiseaseiftheygainaccesstoothertissuesoriftheimmunesystemisineffectiveincontrollingtheinfectiousagent.Inaddition,apersonisintermittentlyexposedtovirulentbacteriaandvirusesfromoutsidethebodythatcancausespecificdiseases,suchaspneumonia,streptococcalandstaphylococcalinfections.Theseinfectiousagentsmaybeveryinvasiveandovercomethenaturalbarrierstoinfection.

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Naturalbarriersincludeintactskinandmucousmembranesofthenose,throat,urethra,andrectum.Naturalbarriersalsoincludestomachacid(gastricacidprovidesnonspecificimmunitytoingestedbacterialpathogens)andahealthyrespiratorymucosa,whichcanexpelinhaledpathogens.Otherfactorsintheimmuneresponsethatprotectthebodyfrominvasionandinfectionaretheactivityoftheepithelialskinlayerandmucusmembranes,andthecleansingeffectsoftears,urine,andvaginalsecretions.

Microbescanenterthebodythroughabreakintheskin,suchasacutorwound,orthroughanorifice(mouth,nose,urethra,etc.).Anyinfectiousagentcancauseinfectionifitgainsaccesstotissuesandspacesinthebodywhereitisallowedtoproliferateandinitiateanimmuneresponse.Therearemanypotentialsourcesofinfectiousdiseasesinanacupuncturepracticesetting.Theseincludecontaminantsontheskinofpractitioners’andpatients’hands,blood,saliva,sweat,nasalandotherbodilysecretions,dust,clothing,andhair.Infectionsassociatedwithacupuncturemaybeclassifiedintotwotypesaccordingtothesourceofthediseaseagent–autogenousandcross-infections.

Autogenous Infections Autogenous(fromtheLatin“auto”–selfand“genous”–generated)infectionsarecreatedwhenpathogensalreadypresentinapersonaremovedintothebodyortoanotherlocationwithinthebodywheretheyarepathogens.Anexampleofthisisimpetigowherenormalskinbacteriaenterintosubcutaneousareasthroughabreakintheskinandsetupapustule.Whiletherearenospecificstudiesidentifyingwhenacupuncturemaycauseanautogenousinfection,theincidenceoflocalizedskininfectionsasconsequenceofacupunctureislowbutpersistentandimpliesapossibleautogenoussource.(1,2)

Oneofthedangersofreusinganeedleduringtreatmentisthetransferofaninfectiousagentfromonelocationtoanother.Organismsthatmayexistinlargequantitiesinoneareacanleadtopotentiallylifethreateninginfectionsinotherlocations.Escherichiacoli(E.coli),acommonintestinalorganism,maycauseseriousinfectionsintheurinarybladder,aregionwheretheorganismisnotnormallyfound.IntestinalorganismssuchasE.colicancauselife-threateningperitonitisfollowinginjurytothebowel.Asanotherexample,thecommonskinorganismStaphylococcusepidermidiscancauseseriousinfectionswhenthisotherwisecommonbacteriumbeginsproliferatinginopenwounds.

Cross-Infections Theseinfectionsarecausedbypathogensacquiredfromanotherpersonorbytheenvironment.Theymaybeacquireddirectly(e.g.,fromcontactbetweenpatientandpractitioner),orbytransfer(e.g.,carriedfromonepatienttoanotherontheunwashedhandsofthepractitionerorcontaminatedimplements).Cross-infectionsmaybeacquiredbythe

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practitionerandofficepersonnelaswellasbypatients.Someofthemostseriousorganismsthatareassociatedwithcross-infectionsincludethehepatitisBvirus,HIV,andmethicillin-resistantstaphaureus(MRSA).TuberculosisisalsoasignificantpublichealthconcernintheUnitedStates,includingstrainsofMycobacteriumtuberculosisresistanttoantitubercularantibiotics.

Undernormalcircumstancesnaturalbarrierspreventtheinfectiousagentorvirusfromgainingaccesstoanewhostandcausinganinfection.Butwhenthenaturaldefensesareweakened,ortheinfectiousagenthasalargeenoughquantity,orbioload,tooverwhelmthebody’sdefenses,theorganismorvirusinquestioncancausedisease.Asapractitioner,theacupuncturistmustalwaysbealerttothepotentialfortransferringdisease-causingagentstopatients.

Aninfectiousagentcantravelfromonehosttoanotherinavarietyofways,includingbeingcarriedondustordropletsofmoistureintheair,beingtransferredinbodyfluids,andbymechanicaltransferfromonesurfacetoanother.Thedensityofaninfectiousagentisoneofthefactorsinriskofcrossinfection.Whilealowbioloadmaybecontrolledbythebody’sproperlyfunctioning,ahighbioloadmayoverwhelmtheimmunesystem,moreeasilyresultinginaninfection.Forexample,thehepatitisBvirusisahigh-densityvirus,oneofthefactorsthatfacilitatethetransferofthisorganismfrompersontoperson.

3. Bloodborne Pathogens

Hepatitis Areviewoftheliteraturesuggeststhathepatitismaybeacomplicationofacupuncture.WhilereportsofhepatitisrelatedtoacupunctureintheU.S.arelimitedtoreportspriorto1988,thereareanumberofretrospectivestudiesandreportsofhepatitisrelatedtoacupunctureinotherpartsoftheworld.(3,4,5)

Therearecurrentlyfiverecognizedtypesofhepatitisviruseswhicharelabeledalphabeticallyas:A,B,C,D,andE.HepatitisAandEaretransmittedmainlythroughfecalcontaminatedfoodandwater.Theothersaretransmittedbybloodorsexualcontact.HepatitisissuchaconcerninhealthcaresettingstheOccupationalSafetyandHealthAdministration(OSHA)hasadoptedspecificlanguageregardingthetransmissionofhepatitisandrecommendationsfortrainingandvaccinationofat-riskstaffmembers.TheCDCstronglyrecommendsthatallhealthcareworkersbevaccinatedforthehepatitisBvirus(HBV).WhenanemployeeishiredforapositionwherethereisariskofinfectionwithHBV,OSHArequiresthattheemployermustoffervaccinationtothathealthcareworkeratnocharge.IftheemployeerefusestobevaccinatedforHBV,thisemployeeshouldberequiredtocompleteandsignadocumentstatingthatheorsheunderstandstherisksofnotbeingvaccinatedandisrefusingthevaccinationinspiteoftheriskofHBVinfection.(SeeSection6foranoverviewofOSHAregulations.)

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Hepatitis A (HAV) HepatitisA(HAV),formerlycalledinfectioushepatitisorshort-incubationhepatitis,isacommoninfectioninconditionsofpoorsanitationandovercrowding.Althoughtransmissionismainlythroughfecalcontaminatedfoodandwater,contaminatedbloodonhandscanposeapotentialhazardinacupuncturepractice.Additionally,inthoseclinicsthatpreparemedicinalteasorotherfoodsforpatients,anawarenessofthetransmissionroutesandpreventionpracticesiscritical.IninstitutionalorincarceratedsettingsHAVmayspreadfrompersontopersonthroughsexualcontact.GoodpersonalhygieneandpropersanitationcanhelppreventthetransmissionofHAV.TheincubationperiodofHAVis15to50days,withanaverageincubationperiodof28days.(6)

UnlikehepatitisB(HBV)orC(HCV),HAVinfectionresultsintheabruptonsetofsymptoms.Symptomsincludeabdominaldiscomfort,lossofappetite,fatigue,nausea,darkurine,andjaundice.Symptomsusuallylastlessthan2months.Althoughthereisnochronicinfection,approximately15%ofpeopleinfectedwithHAVhaveaprolongedorrelapsingcourseofillnesslastingaslongas6-9months.IndividualswhohavehadHAVcannotbere-infected.

IntheUnitedStates,hepatitisAhasoccurredinlargenationwideepidemicsapproximatelyevery10years,withthelastincreaseincasesin1989.(7)TheHAVinfectionratehasdeclinedsteadilysincethelastpeakin1995,whentherewere356,000cases.Historically,children2through18yearsofagehavehadthehighestratesofhepatitisA(15to20casesper100,000intheearlytomid-1990s).Since2002,ratesamongchildrenhavedeclinedandtheincidenceofhepatitisAisnowsimilarinallagegroups.(7)CreditforthechangesisgiventotheissuanceofroutinechildhoodvaccinationsforHAVsince1999.Fortunately,mostcasesofHAVarerelativelymild,complicationsareuncommon,andchroniccarrierstatesarenotknown.ThereisavaccinationforHAV.TheHAVvaccineisrecommendedforpeopleincommunitieswhereoutbreaksofhepatitisAareoccurringandforanyonewhohasbeenexposedtohepatitisAvirus.TheCDCdoesnotroutinelyrecommendHAVvaccinationforhealthcareworkerssincetheyarenotatincreasedrisk.(8)Routineinfectioncontrolprecautions,particularlyhandwashing,willpreventtransmission.

Hepatitis A Survival in the Environment TheHepatitisAvirusisextremelyhearty.HAVcanliveoutsidethebodyformonths,dependingontheenvironmentalconditions.Thevirusiskilledbyheatingto>185degreesF(>85degreesC)foroneminute.However,theviruscanstillbespreadfromcookedfoodifitiscontaminatedaftercooking.Adequatechlorinationofwater,asrecommendedintheUnitedStates,killsHAVthatentersthewatersupply.Seehttp://www.cdc.gov/hepatitis/hav/havfaq.htm.

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Hepatitis B (HBV) HepatitisBiscausedbythehepatitisBvirus(HBV),adouble-strandedDNA-containingvirus.Between1990and2005theincidenceofacutehepatitisBdeclined79%.Amongpersonsaged6yearsorolder,0.27%hadchronicHBVinfection(correspondingtoapproximately704,000personsnationwide.(9,10)

Inadults,ongoingHBVtransmissionoccursprimarilyamongunvaccinatedpersonswithbehavioralrisksforHBVtransmission(e.g.,heterosexualswithmultiplesexpartners,injection-drugusers[IDUs],andmenwhohavesexwithmen[MSM])andamonghouseholdcontactsandsexpartnersofpersonswithchronicHBVinfection.(11)

Anestimated700,000-1.4millionpersonsintheUnitedStateshavechronicHBVinfection.(12)

HepatitisBvirus(HBV,“serumhepatitis”or“long-incubationhepatitis”)isoneofthebloodbornepathogenspresentingasignificantriskofinfectionintheacupunctureclinicenvironment.HBVisthesecondsub-typeofhepatitisforwhichavaccineexists.HBVcancauselifelonginfection,cirrhosisoftheliver,livercancer,liverfailure,anddeath.Althoughchronicinfectionismorelikelytodevelopinpersonsinfectedasinfantsoryoungchildren,ratesofnewinfectionsandacutediseasearehighestinadults.PersonswithchronicdiseasethenserveasareservoirforcontinuedHBVtransmission.(13)HealthcarepersonnelwhohavereceivedHBVvaccineanddevelopedimmunitytothevirusareatvirtuallynoriskforHBVinfection.(14)

Transmission of HBV HBVisspreadthroughcontactwithcontaminatedbloodandbodyfluids.Infectedindividualsandthosecaringforthem,sharinglivingspace,orparticipatinginhighriskbehaviors(unprotectedsexwithmultiplepartnersanddruguse)shouldfollowcarefulinfectionpreventionprocedures.Theinfectedpersonshouldnotshareanyitemsthatmaybecontaminatedwithblood,includingrazorsandtoothbrushes.(Bothrazorsandtoothbrushesareregularlycontaminatedwithmicroscopicamountsofbloodandneedtobetreatedascontaminated.)Barrierprecautionssuchasglovesforhandlingwaste,orcondomsanddentaldamswheninvolvedinsexualactivities,shouldbeutilized.

Forthosewhohaveapersonalhistoryofchronic,activedisease,illicitdrugsandalcoholshouldbeavoidedtoreducetheriskoflong-termcomplicationsofHBV,suchaslivercirrhosis.Goodcleaningofthepatient’senvironmentandpersonalcareitemsisimportant.TheseprecautionarymeasuresshouldbefolloweduntilthepersontestsnegativeforactiveHBVinfection.

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HBV Survival in the Environment HBVcansurviveoutsidethebodyatleast7daysandstillbecapableofcausinginfection.http://www.cdc.gov/hepatitis/hbv/hbvfaq.htm.

Individuals at Risk of HBV Infection Itisestimatedthatthereareanestimated800,000-1.4millionpeopleintheUnitedStateswhohavechronicHBVinfection.(13)Thenumberofnewinfectionshasdeclinedyearlysincethe1980s.Routinevaccinationistheprimaryreasonforthisdecline.(13)

IndividualsatriskforHBVinfectionthroughoccupationalexposuresarethosewhoarenotimmunetoHBVandwhocomeintofrequentcontactwithbloodandbloodproducts.Healthcareworkerssuchasacupuncturists,physicians,dentists,nurses,bloodbankworkers,paramedicalpersonnel,andlaboratorystaffhaveasignificantriskofoccupationalexposureandareatriskofHBVinfectionifnotvaccinated.Otherswhoareatriskincludethosewhocomeincontactwithbloodorbodilyfluidsfromanindividualwithahighriskofinfection.TheriskofHBVinfectionintheworkplaceisprimarilyrelatedtothedegreeofcontactwithbloodintheworkplaceandtotheHBVstatusofthesourceperson.

WhileHBVcanbetreated,theriskofchronichepatitisissignificant,andpreventionremainsthemostimportantwaytoreducethepotentialforanegativeoutcome.Intheworkplace,theriskofcontractinghepatitisBisassociatedwithcontactwithinfectedbodyfluidssuchasblood.TheriskofahealthcareworkerdevelopinghepatitisfollowingexposuretoHBVis22%-31%.Theriskofdevelopingserologicevidenceofinfectionis37%-62%.(15)

OneofthemostcommonmodesofHBVtransmissioninthehealthcaresettingistheunintentionalinjuryofahealthcareworkerfromaneedlestickorcutbyacontaminatedinstrument.TherateofHBVtransmissiontosusceptiblehealthcareworkersrangesfrom6%to30%afterasingleneedlestickexposuretoanHBV-infectedpatient,butisvirtuallyzeroifthathealthcareworkerhasbeenimmunizedagainstHBV.(15)HepatitisBsurfaceantigen(HBsAg)positiveindividualswhoareHepatitisB“e”antigen(HBeAG)positivehavemorevirusintheirbloodandaremorelikelytotransmitdisease.ThepresenceofHBeAgsuggeststhatHBVisinanacutestageandshouldbeconsideredhighlyinfectious.ThenumbersofoccupationallyspreadHBVhavedeclinedsincethe1980sfromover10,000annuallytobelow400in2001.Reportsofinfectionsin2006wereinfrequent.In1992,theCDCbeganacomprehensivestrategytoeliminateHBVtransmissionintheUnitedStates,includingthroughvaccination.In2005itwasnotedinfollow-upsurveillancethat75%ofhealthcareworkershavebeenvaccinated.(15)

Othergroupsatriskincludethosewholiveincrowdedorunsanitaryconditions(includingprisonersandcertainimmigrantpopulations),havemultiplesexualcontacts,menwhohavehomosexualcontact,liveinthesamehousewithsomeonewhohaschronicHBV,havesexwith

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someoneinfectedwithHBV,havehemophilia,areapatientorworkinahomeforthedevelopmentallydisabled,traveltoareaswherehepatitisBisendemic,areinjectiondrugusers,orhaveseveraloftheseriskfactors.(13)

Exposure to HBV HBVistransmittedthroughpercutaneousorparenteralcontactwithinfectedblood,bodyfluids,andbysexualintercourse.HBVisonlyspreadwhenblood,semenorotherbodilyfluids(OPIM)enterthebodyofanotherpersonthroughanorifice,abreakintheskinorthroughmucusmembranes.HBVmayalsobetransmittedperinatally.HBVisnotspreadthroughsharingeatingutensils,casualcontact,orbreastfeeding.Itisnotspreadbycontaminatedwaterorfood.HBVisabletoremainonanysurfaceitcomesintocontactwithforaboutaweek,e.g.,table-tops,razorblades,bloodstains,withoutlosinginfectivity.HBVdoesnotcrosstheskinorthemucousmembranebarrier.Somebreakinthisbarrier,whichcanbeminimalandinsignificant,isrequiredfortransmission.(12,16)

HealthcareworkerswhoarenotimmuneareatahigherriskforHBVthanthegeneralpublicduetotheirpotentialforfrequentoccupationalexposuretoandbloodproducts,aswellasotherbodyfluids.

HepatitisBmustberecognizedasanoccupationalhazardforacupuncturists,asitisforotherhealthcareprofessionalswhoseprocedurescommonlyincludethepenetrationoftheskinorcauseexposuretobloodandotherbodyfluids.Invasiveprocedures,wherethereisconsiderableriskofexposuretocontaminatedbloodandbodyfluids,posethegreatestriskofoccupationalinfectionfromHBV.TheCDCstronglyrecommendsthatallpersonnelworkinginsuchareasshouldscrupulouslyfollowStandardPrecautions.Disposableequipmentandprotectiveclothingshouldbeusedwhenappropriate,andappropriatedisinfectionprotocolsemployed.

Intheeventofexposure,hepatitisBimmuneglobulinandhepatitisBvaccinehavebeenshowntobeeffectiveresponses.Forthehealthcareworker,multipledosesofhepatitisBimmuneglobulinorhepatitisBvaccinealoneis70%-75%effectiveinpreventingsequelaeofHBVexposure.(15)

HBV Vaccination AvaccineagainsthepatitisBwasdevelopedin1981.Anyhealthyadultwithanintactimmunesystemwilllikelyrespondtooneseriesofthevaccine.Atthistimeitisclearthatimmunityclearlylastswellovertwentyyears,butsincethevaccinehasonlybeeninexistencesince1981,nooneyetknowsexactlyhowlongimmunitywilllast.Thereisnotestingrecommendedbeforevaccination;but1-2monthsfollowingcompletionoftheseries,atiterisrecommendedtoassesstheresponse.Ifthereisaresponse,nofurtherboostersorseriesarerecommended.If

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thereisnoresponse,thenasecondseriesmaybegivenandwillusuallybesuccessful.Therearealownumberofnon-respondersevenafterthesecondseries;nofurthervaccineisrecommendedforthem.(17)

Vaccinationisrecommendedforpersonnelperforminginvasiveprocedures,cleaningcontaminatedequipment,orperformingdutiesinanareawherethereisariskofexposure.TheCDCrecommendsthatallhealthcareworkersbevaccinatedagainstHBV.OSHArequiresallemployerstoofferHBVvaccinationtopersonnelperforminginvasiveproceduresorcleaningcontaminatedequipment.(14)InOctober1997,theAdvisoryCommitteeonImmunizationPracticesexpandeditshepatitisBvaccinationrecommendationstoincludeallchildrenaged0-18years.

The HBV Infection Process TheincubationperiodforHBVis45to160days.(6)Duringthisperiod,theinfectiousvirusappearsintheblood,anditmayappearinthefecesandsemen.Duringthisperiodtheinfectionmaybespreadtootherpeopleeventhoughnosymptomsarepresent.HBVearlysymptomsoftenbeginwithmildflu-likesignsandsymptomssuchasafever(in60%ofcases),generalmalaise,ortheinsidiousonsetofanorexiaandabdominalpain.Othersymptomsmayincludechills,nausea,jointpains,rash,anddiarrhea.Typicallythesesymptomslastfromtwotosixweeks.Thesesymptomsarefrequentlyfollowedbyaperiodofextremefatigueanddepressionthatcanextendforseveralmonths.

Practitionersshouldbeawarethatsomeindividualsinfectedwiththevirusdevelopmildsymptomsorareasymptomatic.Approximately30%ofthoseinfectedhavenosignsorsymptoms.(17)ChildrenwithHBVareoftenasymptomatic.However,asymptomaticpatientsareasinfectiousasthosewhoaresymptomatic.OnlyabloodtestwilltellwhetheranindividualisinfectedwithHBV.

Fully70%ofpeoplewhohaverecoveredfromthesymptomaticstageofthediseasearestillinfectiousforthreemonthsormoreaftersymptomshavesubsided.AmonginfantswhoacquireHBVinfectionfromtheirmothersatbirth,upto90%becomechronicallyinfected.Theolderyouarewheninfected,thelowertherateofchronicinfection,with25%–50%ofchildreninfectedatage1–5yearsbecomingchronicallyinfected,andamongolderchildrenandadultsapproximately6-10%ofallacuteHBVinfectionsprogresstochronicinfection.(6)

IfapractitionerbecomesinfectedwithHBV,heorshemayunknowinglytransmitHBVtopatientsorofficestaffthroughtransmissionofbloodfromcutsoropensores.Professionallyandlegallytheramificationsofthisformoftransmissionareenormous.HighstandardsofhygieneandCleanNeedleTechniquewillgreatlyreducetheriskofHBVinfectionforpractitioners,aswellaspatients.ApractitionerwithacuteHBVshouldnotpracticeduringthe

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infectiousperiod.Ifaproviderisfoundtobeinfected,heorsheshouldconsultwithaphysicianbeforegoingbacktowork.(14)

Treatment of HBV WhileHBVcanbetreated,theriskofchronichepatitisissignificant,andpreventionremainsthemostimportantwaytoreducethepotentialforanegativeoutcome.Intheworkplace,theriskofcontractinghepatitisBisassociatedwithcontactwithinfectedbodyfluidssuchasblood.TheriskofahealthcareworkerdevelopinghepatitisfollowingexposuretoHBVis22%-31%.Theriskofdevelopingserologicevidenceofinfectionis37%-62%.Thisriskissignificantlyhigherthantheapproximately0.3%citedforHIV.(15)

Intheeventofexposure,hepatitisBimmuneglobulinandhepatitisBvaccinehavebeenshowntobeeffectiveresponses.Forthehealthcareworker,multipledosesofhepatitisBimmuneglobulinorhepatitisBvaccinealoneis70%-75%effective.(14-19)

Combiningthesetwotreatmentsincreasesefficacy.TheHBVvaccineissafeandeffective.

Hepatitis C (HCV) HepatitisCvirus(HCV)infectionisthemostcommonchronicbloodborneviralinfectionintheUnitedStates.Firstidentifiedin1988,HCVisthecausativeagentforwhatwasformerlyknownasnon-Anon-Bhepatitis,andisestimatedtohaveinfectedasmanyas242,000Americansannuallyduringthe1980s.Manyofthoseinfectedarenotawareoftheirinfection,resultinginchronicliverdiseasethatmaynotbecomeapparentfor10-20years.

HCVisaviruscontainingasinglestrandofRNAthatismosteffectivelytransmittedbypercutaneouscontactthroughinjectiondruguseorexposuretoinfectedbloodorbloodproducts.

Today,mostpeoplebecomeinfectedwiththehepatitisCvirusbysharingneedlesorotherequipmenttoinjectdrugs.Before1992,whenwidespreadscreeningofthebloodsupplybeganintheUnitedStates,HepatitisCwasalsocommonlyspreadthroughbloodtransfusionsandorgantransplants.(20)

WhileHCVmaybetransmittedthroughsexualcontact,contractingaHCVinfectionthroughthisrouteisconsiderablylessefficient.Theriskoftransmissionfromsexualcontactisbelievedtobeverylow.Theriskincreasesforthosewhohavemultiplesexpartners,haveasexuallytransmitteddisease,engagein“roughsex”,orareinfectedwithHIV.(21)

In2013,therewereanestimated29,718newhepatitisCvirusinfectionsintheUnitedStates.TheCDCestimatesthat2.7-3.9millionpeopleintheUnitedStateshavechronicHepatitisC

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infection.Manypeoplewhoareinfectedneverhavesymptomsandthereforenevercometotheattentionofmedicalorpublichealthofficials.(21)

PeakratesofHCVoccurredinthe1980s,andhavedeclinedduetoareductionininfectionsresultingfrominjectiondruguse.Whilenewinfectionsarelowerthan1980peakinfectionrates,HCVinfectionisstillthemostcommonblood-borneinfectionintheUnitedStates.(20)

Theriskofseroconversionafterpercutaneousoccupationalexposureisapproximately1.8%ifthesourcebloodisseropositiveforHCV.ThisisconsiderablyhigherthantheriskofpercutaneousoccupationalexposureduetoHIVseropositivebloodandlowerthantheriskofseroconversionafterpercutaneousoccupationalexposuretoHBVseropositivefluids.(15)

Acute Symptoms of Hepatitis C ThosewhomanifestsymptomsofacutehepatitisCwillexperiencesymptomssimilartotheothercasesofacutehepatitis,includingflu-likesymptoms,jointaches,jaundiceand/ormildskinrash.Othersymptomsincludealossofappetite,abdominalpain,darker-than-normalurinecolorandlightorgreycoloredstools.Practitionersshouldbeawarethatlessthan30%ofthoseinfectedwithhepatitisCmanifestacutediseasesymptoms.

Risk Factors for HCV Infection Individualswhoinjectdrugs,eveniftheydidsoonlyononeoccasionmanyyearspreviously,havethehighestriskofHCVinfection.Individualswithahistoryofinjectiondruguserepresent60%ofthoseinfected.HCVisrapidlyacquiredfollowinginjectiondrugusethroughsharingneedlesandotherequipment.Asmanyas80%ofinjectiondrugusersarefoundtobeinfectedwithHCVandareoftenco-infectedwithHIV(30-50%).(22)OtherrisksofHCVinfectionincludetransfusionsandtransplantsbeforethescreeningthatiscurrentlyinplace(before1992)and,toalesserdegree,sexualcontact(15%).ThereisariskofoccupationalexposureforHCV,particularlywherethereisexposuretolargeamountsofblood,suchashemodialysisandsurgeries.HCVisspreadfrommothertobaby.About10%ofthoseinfectedhavenorecognizablesourceofinfection.WhileitispossibleforHCVtobetransmittedfrompercutaneousexposuretoblood,exposuressuchasacupuncture,tattooing,orbodypiercinghavenotbeenshowntoplacepeopleatincreasedriskforHCVinfection.HCVismostefficientlytransmittedbyexposuresthatinvolvedirectpassageofbloodthroughtheskin,particularlywithhollow-boreneedles.

WhiletheriskofoccupationalexposureleadingtoHCVseroconversionmaybelimitedtoneedleswithalumen,itisimportanttostatethataswithHIVandHBV,exposurefollowinganeedlestickinvolvinganacupunctureneedlemustbetreatedasapossiblesourceofinfection.

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HCVhasbeenassociatedwithacupunctureinsomeretrospectivestudiesofacupunctureAEs.(5,23)

HCV Survival in the Environment ThehepatitisCvirus(HCV)canremainviableoutsidethebodyfor4-5days.(24)

Consequences of HCV Infection About15-25%ofthoseinfectedcleartheirHCVinfectionwithoutfurtherproblems.Theremainder(75-85%)willdevelopchronicinfectionandapproximately60-70%willgoontodevelopchronichepatitis.(Achronicinfectionisthechronicpresenceoftheagent,HCV,andthepatient’simmuneresponse.Chronichepatitisischronicinflammationoftheliverthatmaybecausedbychronicinfection.Whiletheyoftengotogether,theyaredefineddifferentlyandassuchasnotinterchangeable.)Cirrhosisoftheliveroccursinatleast5-20%ofpatientsovera20-30yearperiodandhepatocellularcarcinoma(livercancer)occursin1-5%ofcases.HCV-associatedchronicliverdiseaseisthemostfrequentindicationforlivertransplantationamongadults.(6,25)DrugtreatmentisanimportantadjuncttocareformanypersonswithHCV.Thereisnovaccineforthisdisease.PeopleinfectedwithHCVshouldbevaccinatedforHAVandHBVtopreventfurthercomplicationsoftheirdisease.

TheincubationperiodofHCVis14-180days,withmostcasesoccurring5to10weeksafterexposure.(6,25)Theperiodofcommunicabilityextendsfromoneweekafterexposurethroughthechronicstage.Theonsetisinsidiousandaccompaniedbyanorexia,nausea,vomiting,andjaundice.ThecourseissimilartoHBVbutmoreprolonged.

TherapyforhepatitisCisarapidlychangingareaofbiomedicalclinicalpractice.Treatmentdecisionsarebasedonliverenzymelevels,genotypeoftheinfectingvirus,andconditionoftheliver,includingtheextentofscarring.Current treatment mostcommonlyincludesdrugcocktailsutilizingSOVALDI®(sofosbuvir)andHarvoni(ledipasvir/sofosbuvir).(26)

Hepatitis D (HDV) HDV,sometimesknownasdeltahepatitis,isadefectivevirusthatrequiresconcurrentHBVinfectionfordevelopmentofdisease.IntheU.S.,mostcasesofhepatitisDoccurininjectiondrugusersandhemophiliacs.TransmissionofhepatitisDisthroughpercutaneousormucosalcontactwithinfectiousblood.ThereisnovaccineforHDV;however,sincetheHDVvirusrequiresthepresenceofHBV,vaccinationagainstHBViseffectiveagainstHDVrelateddisease.TheoutcomeofsimultaneousHBVandHDVisnodifferentfromtheoutcomeofHBValone.However,whenchronicHBVinfectionisaccompaniedbyHDV,itmayleadtosevere,fulminatinghepatitisortransformamildorasymptomaticchronicHBVintoamoreseverediseaseprocess,oradiseaseprocessthatmaybeacceleratedduetoincreasedscarringofthe

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liver.PreventionofHepatitisDinpersonswhoarenotalreadyHBV-infectedcanbeaccomplishedthroughHepatitisBvaccination.(27)

HDV Survival in the Environment HDVisfoundwithHBV.HBVcanbecapableofcausinginfectionforaweek.MostexpertsbelievethatHDVdoesnotlastaslongbutitisbesttotakethesameprecautionsaswithHBV.

Hepatitis E (HEV) HepatitisE,likehepatitisA,isspreadbyfecal-oraltransmission(28).Mostoutbreaksarefoundindevelopingcountries,wheredrinkingwateriscontaminatedbyfecesfrominfectedanimalsandhumans.HEVisrarelyseenintheU.S.,withtheexceptionoftravelerstodevelopingcountries,particularlySouthAsiaandNorthAfrica.InfectionfrompersontopersonislessfrequentthanwithhepatitisA.Theincubationperiodis15to60days,withanaverageof40days.Thetimeperiodis15to60days,withanaverageof40days.Thetimeperiodofcommunicabilityisunknown.Thediseaseischaracterizedbysuddenonsetoffever,malaise,nausea,andanorexia.Thediseasevariesinseverityfromamildillnesslasting7to14daystoaseverelydisablingdiseaselastingseveralmonths.Jaundicemaybepresent.Pregnantwomenhaveamortalityrateof20%.Thereisnoevidenceofachronicinfectioninlong-termfollow-upofpatientswithHEV.ThereisnovaccineforHEV.

Chronic Carriers of Hepatitis Chroniccarriersareindividualswhocontinuetoshedhepatitisvirusthroughbodilyfluidsandexcretionslongafterinfection.Theyareclassifiedintotwocategories:ChronicPersistentandChronicActive.Achronicpersistentcarrierisasymptomaticorhasminimalsymptomsbutcancontinuetoinfectothers.Achronicactivecarrierhasprogressivesymptomaticdiseasethatcontinuestodamagetheliver.Symptomsincludemalaise,weightloss,lossofappetite,andoftenjaundice.PatientswithhepatitisAandEneverdevelopchronicstates.HepatitisBbecomeschronicin5to10%ofinfections(thisratevariesdependingontheageofthepatient),HCVin75-85%ofinfections.Togetagoodhepatitishistoryaspartofthepatientintake,askaboutcontactwithbloodproductssuchastransfusions,dialysis,andinjectiondruguse.Patientswhohavereceivedtransfusionsordialysisbefore1990orwhohaveahistoryofinjectiondrugusepresentanincreasedrisk.Also,manypatientsinapublichealthcaresetting,suchaschemicaldependency,HIV,andTBclinics,mayhaveahistoryofsomeformofhepatitis,butmaynotknowwhattypeandmaynotknowwhethertheyarechroniccarriers.TheuseofCleanNeedleTechniqueandStandardPrecautionsistheonlyeffectivewaytopreventtransmissionofviralhepatitisdiseases.

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Prevention of Hepatitis OneofthemostcompellingreasonsforthedevelopmentoftheCleanNeedleTechniqueprotocolin1984wastoprovideguidelinestopreventthetransmissionofhepatitiswithinacupunctureclinicsettings.Sincethattime,theincidenceofhepatitisBthroughacupuncturehasdramaticallydecreased.(2,3)ContinuingstrictadherencetoCleanNeedleTechniqueisessentialinordertopreventtransmissionofHBVorarelatedvirustopatients,practitionersandstaff.

ThelackofanyevidenceoftransmissionofviraldiseasefromacupunctureneedlesintheU.S.since1990canbedirectlyassociatedwiththeintroductionofCNTcourseandtheuseofsingle-usedisposablesterileneedles.

Table 1: Summary of Hepatitis Characteristics (Seehttp://www.cdc.gov/hepatitis/resources/professionals/pdfs/abctable.pdf)fordetailsaboutHepatitisA,BandC)

Hepatitis Incubation Transmission Onset Vaccine Chronic

A 15-50days Fecal-oral Abrupt Yes No

B 45-160days Bloodborne Insidious Yes Dependsonagegroup(6-10%inadults;higherinchildren)

C 14-180days Bloodborne Insidious No 75-85%

D Unknown Percutaneousormucosalcontactwithinfectious

blood

Insidious No Unknown

E 15-60days Fecal-oral Abrupt No No

Human Immunodeficiency Disease (HIV) Thehumanimmunodeficiencyvirus(HIV)isanRNA-containingvirusthatinhumansleadstoaconstellationofproblemsextendingfromdecliningimmunefunctionthatleadstoanend-stagesyndromeinuntreatedpatients,calledtheacquiredimmunedeficiencysyndrome(AIDS).Thesemedicalproblemsmaybeexacerbatedbyco-infectionwithotherdisease-causingagentssuchastheherpesviruses.HIVcontinuestobeagrowingmedicalchallengeworldwide.Mathersand

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Loncarindicatethatoverthe25yearperiodfrom2006to2030,between89millionand117millionpeoplewilldieofHIV/AIDS.(29)

TheCentersforDiseaseControlandPrevention(CDC)reportsthatin2012,41,505casesofHIVwerediagnosedintheUnitedStates.(30)

Todate,therearenoconfirmedcasesofoccupationalHIVtransmissionfollowinganaccidentalneedlestickinvolvinganacupunctureneedleintheUnitedStates.Therewasacasereportfrom2003ofapatientinThailandindicatingthatacupuncturewastheonlyknownriskfortheseroconversionofapreviouslyHIVseronegative60year-oldfemale.(31)

ScientistshaveidentifiedatypeofchimpanzeeinWestAfricaasthesourceoftheHIVthatinfectshumans.Thevirusmostlikelyjumpedtohumanswhentheyhuntedthesechimpanzeesformeatandcameintocontactwiththeirinfectedblood.OverseveralyearsthevirusspreadacrossAfricaandlaterintootherpartsoftheworld.TwotypesofHIVhavebeenidentified:HIV-1andHIV-2.Althoughtheyhavesimilarepidemiologicalandpathologicalcharacteristics,theyaredifferentserologicallyandgeographically.Generally,HIV-2hasaslower,somewhatmildercourse.Itseemstobelessinfectiousearlyoninthedisease,butbecomesmoreinfectiousovertime.ItispredominatelyfoundinWestAfrica.CasesareseeninfrequentlyintheU.S.andusuallyhavesomeassociationwithWestAfrica.HIV-1isthemorevirulentvirusandismoreeasilytransmitted.ItisthecauseofthemajorityofHIVinfectionsglobally.(32)

HIV Transmission Blood-to-bloodcontactisthemostdirectmethodoftransmittingHIV(aswellasHBV).Wheninfectedbloodentersthebloodstreamofanuninfectedindividual,thereisaprobabilityofinfection,althoughthisriskismuchlowerthanthatforHBV.Prospectivestudiesofhealthcareworkers(HCWs)haveestimatedthattheaverageriskforHIVtransmissionafterapercutaneousexposureisapproximately0.3%,theriskofHBVtransmissionis6to30%,andtheriskofHCVtransmissionisapproximately1.8%.(33)Themostcommonmodeoftransmissionispercutaneousexposurethatoccursfromcontaminatedinstruments(mostlyfromsuturingandneedlesticks),orcontactofcontaminatedbloodwithnon-intactskin.Therisk,however,isextremelylowifStandardPrecautionsarefollowed.StandardPrecautions,asdefinedbytheCDC,includetheuseofbarriersasgloves,masks,gowns,goggles,andpreventiontechniquesappropriatetotheparticularhealthcaresetting,dependingonthespecificrisksinvolved.(34)

ThereisnoevidencethatHIVisspreadbycasualcontact.Casualcontactconsistsofanyactivitythatdoesnotinvolvetheexchangeofbodyfluidssuchasblood,semen,orvaginalsecretions.Non-riskcasualcontactincludesshakinghands,touching,hugging,holdinghands,orkissing.TheuseofobjectshandledortouchedbyanHIV-infectedperson(forexample,atelephoneortoiletseat)hasalsonotbeenshowntospreadthevirus.

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HIV Survival in the Environment HIVdoesnotsurvivelongoutsidethehumanbody(suchasonsurfaces),anditcannotreproduceoutsideofthebody.Outsideofthebody,thevirusdieswithinminuteswithoutthetemperaturenecessaryforitssurvival.http://www.cdc.gov/hiv/basics/transmission.html

Risk of Transmission through Invasive Procedures Ingeneral,theriskforHIVtransmissionbetweenpatientsandhealthcareworkersisverylow.(29,31)AdherencetoCDC-recommendedproceduresforStandardPrecautionsreducestherisksignificantly.Practitionersshouldpreventdirectbloodcontactandcarryoutproperdisinfectionproceduresasdescribedinthismanualandatthewebsite:http://www.cdc.gov/HAI/settings/outpatient/outpatient-care-gl-standared-precautions.html

Individuals at Risk of HIV Infection ThefirstcasesofAIDSintheUnitedStateswerereportedin1981.Bytheendof1981,atotalof316casesofthisnewlydiscoveredsyndromewerereportedtotheCDC.Duringthe1980sasmanyas150,000peoplebecameHIVinfectedeachyear.Bytheearly1990stheinfectionratedroppedtoabout40,000eachyear.Attheendof2009,anestimated1,148,200personsaged13andolderwerelivingwithHIVinfectionintheUnitedStates,including207,600(18.1%)personswhoseinfectionshadnotbeendiagnosed.(35)ThenumberofAIDScasesbegantofalldramaticallyin1996withtheadventofproteaseinhibitors.

ItisimportanttonotethatthepopulationdistributionofHIVhaschanged.InitiallyHIVwasfoundprimarilyamongmenwhohadsexwithmen,injectiondrugusers,sexworkers,andtransfusionrecipients.TodayHIVisnolongerlimitedtotheseinitialpopulations.Recently,morecasesareassociatedwithunprotectedsexbetweenmixedgendercouples.Duetosuccessfulprotocolsforperinatalcases,newbornsareacquiringHIVfromtheirmothersmuchlessfrequently.EffortstotestallexpectantmothersandstartthosefoundHIVpositiveonantiretroviralmedicationhavebeensuccessful.However,anyonewhoengagesinat-riskbehaviors(mainlysexwithaninfectedpartnerwithoutbarriermethodsandneedlesharing)orisinaprofessionwithariskofbloodexposure(suchashealthcareworkers)isindangerofcontractingHIV.

HIVseroconversioninhealthcareworkersisrare,butStandardPrecautionsmustbemaintained.Ofthosehealthcarepersonnelforwhomcaseinvestigationswerecompletedfrom1981-2010,57haddocumentedseroconversiontoHIVfollowingoccupationalexposures.Theroutesofinfectionincluded48thatwereduetopunctureorcutinjuries.Forty-ninehealthcarepersonnelwereexposedtoHIV-infectedblood;threetoconcentratedvirusinalaboratory;onetovisiblybloodyfluid;andfourtoanunspecifiedfluid.(36)

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TheCDCisalsoawareof143othercasesofHIVinfectionoradiagnosisofAIDSamonghealthcareworkerswhohavenotreportedotherriskfactorsforHIVinfectionandwhoreportahistoryofoccupationalexposuretoblood,bodyfluids,orHIV-infectedlaboratorymaterial,butforwhomseroconversionafterexposurewasnotdocumented.InordertopreventHIVinfection,itiscriticaltouseStandardPrecautionswitheverypatient.(36)

Thereremainsasignificantriskofinfectioninthehealthcareworkplace.In1996,therewere786,885percutaneousandmucocutaneousexposurestopotentiallyinfectioussubstancesamonghealthcareworkers(HCWs)intheUnitedStates.(37)

BecauseofthelongincubationperiodofHIV(anaverageof8-10yearsfrominfectiontothedevelopmentofAIDSinindividualsnotoneffectiveantiretroviraltherapy),thevastmajorityofHIV-infectedindividualshavenosymptomsandmaynotknowtheyareinfected.However,anyoneinfectedwithHIVmaybeabletotransmitthevirustoothersthroughbodilyfluids,includingblood,semen,orvaginalsecretions,regardlessofwhetherornottheyhavedevelopedAIDS.Itisbeneficialtoroutinelyincorporateriskassessmentstrategiesintothepatientevaluationtodeterminethelikelihoodofexposureto,orthepresenceof,HBVorHIVinfectionssuchas:

1. Patient’shistoryregardingexposuretobloodandbloodproducts.(“Haveyouhadabloodtransfusion?”)

2. Patient’shistoryofdruguse.(“Whatdrugshaveyouusedinthepasttenyears?”)3. Patient’ssexualhistory/historyofsexuallytransmitteddiseases.(“Howmanysex

partnershaveyouhadinthelasttwoyears?”)

Testing Voluntarytestingisencouraged.Rapidtestscanbedonenowwithresultsbeingavailablewithin20minutes.AspartofitsstrategicplantoreduceHIV,theCDChasrecommendedthateveryonebetweentheagesof13and64betestedatleastonceasabaseline.(38)Anyonefallingintohighriskcategoriescancontinuetobetestedregularlyaspartofroutinemedicalcare.Testingisespeciallyimportantforthosewhofallintothefollowingcategories:

1. Personsinprofessionswithahighriskofexposure.2. Personswhohavehadasexuallytransmitteddisease.3. Thosewhohaveahistoryofinjectiondruguseandsharedneedles.4. Menwhohavehadsexwithothermensince1978.5. Menandwomenwhohavetradedsexformoney,food,drugs,orotheritems.6. Peoplewhohavehadmultiplesexpartnersandusedintravenousinjecteddrugs.7. Sexualorneedle-sharingpartnersoftheabove.8. Anywomanthinkingofbecomingpregnant.

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ForspecificinformationontestingforHIVcheckwithyourlocalhealthdepartment.

Reporting AuniformcasedefinitionandcasereportformisnowusedinallfiftystatesforthereportingofdiagnosedcasesofAIDS.RevisionsinthedefinitionofclinicalAIDShavebroadenedtherangeofAIDS-indicatordiseasesandconditions.UsingHIVdiagnostictestshasimprovedthesensitivityandspecificityofthedefinitionoverthepast20years.

The HIV Infection Process HIVtargetsseveralcelltypes,includingtheCD4(T4)lymphocyte,whichinterruptsthecell-mediatedresponsetoantigens.(39)ThisT4lymphocytepopulationinturnreplicatesHIV.DamageresultsinalowerCD4(T4)cellcountleadingtoareductionofthiscellpopulation,producingimmunedeficiency.SincetheCD4(T4)lymphocyteplaysacrucialroleinregulationoftheimmunesystem,depletionofthesecellsduetoHIVinfectionreducestheimmuneresponse.

HIVcausesprogressivedamagetothehumanimmunesystemoveralongperiod,makingtheindividualvulnerabletoahostofinfectionsandmalignancies.ThesyndromeknownasAcquiredImmuneDeficiencySyndrome(AIDS)representsthelatestageofHIVinfection.ThissyndromeisassessedwhenthepatientisHIVseropositiveandhasanabsoluteCD4countoflessthan200cellspermicroliter,oroneormoreAIDSdefiningillnesses,suchasPneumocystiscarniipneumonia,cryptosporidiosis,orKaposi’ssarcoma.

InfectionwithHIVcanpresentalongacontinuumrangingfromasymptomatictosymptomatic.Patientscanexhibitoneormoreofthesymptomsassociatedwithimpairedimmunefunction.InitialHIVinfectionissometimesfollowedwithin2to4weeksbyafebrileillnessresemblingmononucleosisorinfluenzawhichresolvesspontaneouslyandwhichmanypeopledonotnoteassignificantatthetime.Itisduringthisearlytimethatpeopleareveryinfectious.SomepeopleinfectedwithHIVremainrelativelyhealthyformanyyearsbeforethesymptomsofHIVinfectionappear.ApproximatelyhalfofthepeoplewithHIVdevelopAIDSwithin10yearsafterbecominginfected.ThemostcommonsymptomsofHIVincludefever,malaise,bodyaches,maculopapularrash,lymphadenopathy,andheadache.Othersymptomsincludepersistentfeverandnightsweats;rapid,unexplainedweightloss;chronicdiarrheanotexplainedbyothercauses;persistentcoughthatisnotassociatedwithsmokingorinfluenza;andflatorraisedpigmentedlesionsontheskinrangingincolorfromfaintpinktored,brown,orblue.Manyofthesesymptomsarenon-specificandareseeninotherconditions.DataindicatethatmostpeopleinfectedwithHIVeventuallydevelopAIDS.Theseindividualsdevelopopportunisticinfectionsandneoplasticdisordersrarelyseeninindividualswithahealthyimmunesystem.Theseinfectionsincludeesophagealcandidiasis,cytomegalovirus,Kaposi’ssarcoma,and

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Pneumocystiscariniipneumonia,themostcommonopportunisticinfectionandcauseofdeathinAIDSpatients.

TheclinicalpresentationsofAIDSpatientsvaryextensively.IndividualsmaypresentwithHIVwastingdisease,whichischaracterizedbysevere,involuntaryweightloss,chronicdiarrhea,constantorintermittentweakness,andfeverfor30daysorlonger.IfHIVinfectscellsinthecerebrospinalfluid,individualsmaydevelopHIVencephalopathy,myelopathy,ordementiawithsymptomsrangingfromapathyanddepressiontomemoryloss,motordysfunction,anddeath.

Presently,itisnotknownwhysomepeopleinfectedwiththeHIVvirusdevelopsymptomsmorequicklythanothers.Researchershaveproposedthatcertainco-factorssuchasstress,poornutrition,alcoholordrugabuse,andcertainsexuallytransmitteddiseases(STDS),suchassyphilisorhepatitis,maytriggerthevirustomorerapidlyreplicateorplaceotherstressorsonthebodysystems.ItisclearthatwhenHIVisidentifiedearlyandgoodhealthcareisprovided,includingantiretroviraltreatmentregimens,HIVcanbemanagedasalongtermchronicmedicalcondition.Todaytherearemanyinfectedindividualslivingverylonglives.(38)

Treatment of HIV AIDSrepresentstheendstageoftheclinicalspectrumofHIV.AtthepresenttimethereisnocureorvaccineforAIDS,althoughavarietyofmedicationsarebeingusedtoslowtheprogressionofthediseaseandtreatsomeoftheopportunisticinfections.(38)

ThenumberofdrugsandthevarietyoftreatmentapproacheshavegrownexponentiallysincetheapprovalofAZTin1987.ThosepractitionerswhoroutinelyworkwithHIVpositiveandAIDSpatientsshouldkeepabreastofthedrugcombinationsbeingusedfortreatment,theirsideeffectsandanyherb-druginteractions.Thelistofthosedrugs,sideeffectsandinteractionsarechangedandupdatedregularly;inclusionofanupdatedlistinthismanualisnotfeasible.

Additional Risks to Healthcare Workers (HCWs) AnadditionalrisktopractitionersworkingwithpersonswithHIVisthatsomeofthecommonsecondaryinfectionsinthispopulationarethemselvescontagious.Thesemayincludetuberculosis,staphylococcalinfections,herpesviruses,andhepatitis.(38).Appropriatecontrolprecautionsshouldbetakenandmayincludemasksincaseofrespiratoryinfectionandglovesincaseofskinlesions.StandardPrecautionsshouldbepracticedwithallpatients.ItisimperativetoassumeanypatientmaybeHIVseropositiveandtouseStandardPrecautionswithallpatients.

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4. Other Healthcare Associated Infections Healthcare-associatedinfections(HAIs)areinfectionsthatpatientsdevelopduringthecourseofreceivinghealthcaretreatmentforotherconditions.Theycanhappenfollowingtreatmentinhealthcarefacilitiesincludinghospitalsaswellasoutpatientcentersandcommunityclinics.Theycanbecausedbyawidevarietyofbacteria,fungi,andviruses.SomeofthemorecommonHAIsthatmayberelatedtotherapeuticneedlingandotherclinicalproceduresarediscussedbelow.

Tuberculosis Tuberculosis(TB)iscausedbythebacteriumMycobacteriumtuberculosis.Thisorganismisanacid-fastbacteriumwithawaxycoat,istransmittedthroughtheair,andhasalongincubationperiodofupto12weeks.(40,41)

Atotalof9.421TBcases(arateof2.96casesper100,000persons)werereportedintheUnitedStatesin2014.BoththenumberofTBcasesreportedandthecaseratedecreased;thisrepresentsa1.5%and2.2%decline,respectively,comparedto2013.ThenumberofreportedTBcasesin2014wasthelowestrecordedsincenationalreportingbeganin1953.(42)

WhileTBinfectionratesareindeclineintheUnitedStates,itremainsasignificantsourceofriskinthehealthcareenvironment.Jensenetal.(41)listthefollowingpopulationswhoareespeciallyatriskforTB:

• Foreign-bornpersons,includingchildren,especiallythosewhohavearrivedintheUnitedStateswithin5yearsaftermovingfromgeographicareaswithahighincidenceofTBdisease(e.g.,Africa,Asia,EasternEurope,LatinAmerica,andRussia)orwhofrequentlytraveltocountrieswithahighprevalenceofTBdisease.

• Residentsandemployeesofcongregatesettingsthatarehighrisk(e.g.,correctionalfacilities,long-term-carefacilities[LTCFs],andhomelessshelters).

• Healthcareworkers(HCWs)whoservepatientswhoareathighrisk.• HCWswithunprotectedexposuretoapatientwithTBdiseasebeforetheidentification

ofTBandinstitutionofcorrectairborneprecautionsforthispatient.• Certainpopulationswhoaremedicallyunderservedandwhohavelowincome,as

definedlocally.• PopulationsathighriskwhoaredefinedlocallyashavinganincreasedincidenceofTB

disease.• Infants,children,andadolescentsexposedtoadultsinhigh-riskcategories.

Personswhoareinfectedaremorelikelytoprogresstoactivediseaseiftheywereinfectedwithintheprevioustwoyears,areHIVseropositiveorinsomeotherway

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immunocompromised,aninfantorchildlessthanfouryearsofage,haveoneofseveraldisorderssuchassilicosisordiabetesmellitus,orhaveahistoryofimproperlytreatedTB.

ThepresenceofHIVcontributestotheTBinfectionrate,possiblybyreducingimmunityandthereforeresistancetoTBinfection.AnotherfactorthatincreasesthepotentialforharmfromTBisthepresenceofstrainsofTBthatareresistanttomultipleantitubercularantibiotics.Since1993,whentheTBsurveillancesystemwasexpandedtoincludedrug-susceptibilityresults,reportedmultidrug-resistant(MDR)TBcaseshavedecreasedintheUnitedStates.AmongTBcasesintheUnitedStateswithinitialdrug-susceptibilitytestingresultswhodidnothavepriortreatment,thepercentageofprimaryMDRTBcaseschangedslightlyfrom1.2%(86cases)in2012to1.4%(95cases)in2013.(42)

WhilemoststrainsofM.tuberculosiscanbetreatedbyantitubercularantibiotics,thetreatmenttakesninemonthstocomplete,andintheeventthestrainofM.tuberculosisinvolvedisdrugresistant,treatmentmaybedifficultandtakelonger.Aswiththevirallymediateddiseasesdiscussedpreviously,TBismosteffectivelymanagedbypreventinginfection.PreventingthetransmissionofTBisdonebythefollowing:

1. Healthcareworkers(HCWs)includingacupuncturistsshouldhaveanannualskintestforTB.Thistestshouldberepeatedaftertwoweeksiftheprevioustestwasnotwithinoneyear.Analternativetest,theQuantiFERONbloodtestisnowapprovedforTBtesting.Thistesthastheadvantagethatonlyonecontactisrequired,resultsareavailablemorerapidly,andisnotimpactedbypriorBCG(bacilliCalmette-Guerin)vaccination.

2. IndividualswhowerevaccinatedforTBorhaveahistoryofapositiveskintestshouldgetachestx-rayandanannualphysicalexamination.

3. Ifapatientpresentsinyourclinicwithachroniccoughofunknownorigin,thepatientshouldbeaskedtowearamask.Itisagoodpolicytohavemasksavailableforanypatientwithacoughofunknownorigintopreventtransmissionofairbornepathogens,includingTB.

4. IfyoususpectyourpatientmayhaveTB,thepatientmustbereferredtoaphysicianfordiagnosisandtreatment.

Anumberofsmallstudieshavebeencompletedlookingattheeffectsofacupunctureandmoxibustiononthetreatmentorsymptomsoftuberculosis,oftenwithgoodresults.Whiletherearenoreportsoftuberculosistransmissioninalicensedpractitioner’spracticelocation,thereisonecaseoftuberculosisbeingcausedbyanillegalacupuncturist,(43)highlightingtheneedtounderstandandidentifythisdisease.

TransmissionofMycobacteriumtuberculosisisarecognizedrisktopatientsandhealthcarepersonnelinhealthcarefacilities.Transmissionismostlikelytooccurfrompatientswhohave

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unrecognizedpulmonarytuberculosisortuberculosisrelatedtotheirlarynx,arenotoneffectiveanti-tuberculosistherapy,andhavenotbeenplacedintuberculosisisolation.TransmissionofMycobacteriumtuberculosisinhealthcaresettingshasbeenassociatedwithclosecontactwithpersonswhohaveinfectioustuberculosis.(44)

TB Survival Outside Host M.tuberculosiscansurviveformonthsondryinanimatesurfacesandcansurviveinsoilfor4weeks,andintheenvironmentformorethan74days.Exposuretolightinactivatesthebacterium.(45)

Acupuncture TB Safety Ultimatelythemostimportantcomponentinaclinicalsafetyprogramissafepracticeonthepartofthepractitioner.Thesafeuseofsharps,preventionoftransmissionofbloodbornepathogens,andotherappropriateriskmanagementtechniquespreventharmtothepractitioner,hisorherfamilymembers,andthepublic.UtilizingrespiratoryetiquetteandStandardPracticeswilllimitexposureofthepractitionerandpatientstoTB.Safepracticeremainsthemostimportantobligationfortheacupuncturist.CleanNeedleTechniqueandStandardPracticesareavitalpartofsafepracticefortheacupuncturist.

Skin Infections Prospectiveandretrospectivestudiesofacupuncturesafetypointtoasmallnumberoflocalizedskininfectionsoccurringasaresultofacupuncture.(1)

CommonresidentbacteriaoftheskinincludeStaphylococcusandStreptococcusspecies.Impetigoandotherlocalskininfectionscanoccurwhenabreakintheskinallowsthestaphorstreptoenterthedermisorlowerstructures.(46)

Staphylococcus Staphylococcusspeciesaregram–positivebacterianormallyfoundontheskin.“Staph”bacteria,suchasStaphylococcusepidermidisorStaphylococcusaureus,arecommonbacterialcontaminantsfoundontheskinthatcanenterthebodyofapractitionerorpatient.Thistypeofcontaminationisthoughttooccurwhenthebacteriaontheskinispassedintothebodythroughinsertionofaneedleintotheskin.(47)

Skininfectionscausedbystaphareusuallyredandpainful.Somestartaspainfulbumpsthatseemlikespiderbites,butquicklybecomeabscesses(boils)filledwithpus.(48)

Staphylococcusaureusaccountsformorethanhalfofthereportedcasesofacupuncture-relatedbacterialinfectionsoftheskin.(49)

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Individualcasereportsofstaphinfectionsafteracupunctureincludecasesofpericardialabscess,(50)necrotizingfasciitis,(51)bacteremia,(52)andspinalsubduralempyema.(53)

PreventingStaphylococcusinfectionsinvolvesstandardpracticesofhandwashingandavoidingneedlingorotherproceduresinareaswithactiveskinlesions.

Methicillin-Resistant Staphylococcus Aureus (MRSA) ThebacteriumStaphylococcusaureusisagrampositive,coagulasepositiveaerobiccoccusassociatedwithwoundinfectionsandothermedicallysignificantinfections.Onestrainofstaphaureus,resistanttotheantibioticmethicillin(methicillin-resistantStaphylococcusaureus,MRSA)hasbecomeasignificantsourceofantibioticresistantinfections.(54,55)Thisorganismisspreadbyskin-to-skincontactandcanbereadilytransmittedfrompatientstohealthcareproviders,staffandotherpatients.Between25%and30%ofthepopulationmaybecarriersofMRSA.(55)WhilethemajorityofMRSAinfectionsappeartobenosocomial(infectionsacquiredfromthehealthcaresetting),12%arecommunity-acquired.(55)

Prevention ItisimperativetopreventthespreadofMRSAtopatientsandco-workers.Appropriatepreventionstrategiesincludethefollowing:(56,57)

1. Appropriatehandwashingandtheuseofhandcleansers.2. Theuseofbarrierprotectionsuchasgloves,labcoatsorgowns,andfacemasksas

necessary.3. Properhandlingofpotentiallycontaminatedmaterialssuchassharps,disposable

suppliessuchascottonandgauze,andsoiledorblood-stainedlinen.4. Avoidcontactwithdrainingwounds,pimple-likelesions,orotherskinlesionsthatmay

beasiteofinfection.5. AvoidacupunctureandotherAOMtechniquesininflamedorinfectedskinregions.6. UseofCleanNeedleTechnique.7. Scrupuloususeoftheappropriatedisinfectants.8. Referralofpatientsthatmaybeinfectedtoaphysicianforappropriatetreatment.

MRSAhasbeenreportedafteracupuncturetreatmentsandmaycausesignificantdamage.(2,58)InonecasestudythetransmissionofMRSAwasclearlyfromthemedicalpractitionertothepatients.(59)TherearesignificantrisksassociatedwithtreatingapatientthathaslesionsconsistentwithMRSA,includingdrainingwounds,suppuratinglesions,orpustulesthathavenotbeenassessedbyaphysician.Therearealsorisksassociatedwithtreatingpatientswhenthepractitionercurrentlyhasactiveskinlesionsthathavenotbeenassessedbyamedicalprofessional.Itisimperativethatanassessmentofanyactiveskinlesionsineitherapatientor

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practitionerbemadeassoonaspossible.ItisappropriatetodelayAOMtreatmentuntilsuchanassessmentismadeandappropriateantibiotictherapyinitiated.

MRSA Survival in the Environment MoststudiessuggestthatMRSAcanliveupto90daysoninanimateobjectsanddrysurfaces.MRSAbacteriacanremainviableonsurfaceslongerthanotherbacteriaandvirusesbecausetheycansurvivewithoutmoisture.(24)MRSAcansurvivelongeronhardsurfacesthansoftsurfacesbutcanbeinactivatedusingappropriateEPA-approveddisinfectingsolutions.

Streptococcus GroupAStreptococcus(GAS)isabacteriumoftenfoundinthethroatandontheskin.GASdiseasemayoccurwhenbacteriafromthethroatorskinenterspartsofthebodywherebacteriausuallyarenotfound,suchassubcutaneoustissues,theblood,orthelungs.Thesebacteriaarespreadthroughdirectcontactwithmucusfromthenoseorthroatofpersonswhoareinfectedorthroughcontactwithinfectedwoundsorsoresontheskin.(60)

StrepAmaycauseaskininfectionsuchasimpetigoorotherskininfections.PyogenicskininfectionsassociatedwithacupuncturemaybeStreptococcalinfections.Whilerare(approximately50casesreportedgloballyinthe1970sand1980s)(61)Streptococcalinfectionsmayoccurasaresultofacupuncture.

PreventingStreptococcalinfectionsinvolvesstandardpracticesofhandwashing,StandardPracticesandavoidingneedlingorotherproceduresinareaswithactiveskinlesions.(62)

Mycobacteria Other than Tuberculosis (MOT) (Mycobacteriumabscessus,Mycobacteriumfortuitum,Mycobacteriumhaemophilum)

Mycobacteriumabscessuscanbefoundinwater,soil,anddust.Ithasbeenknowntocontaminatemedicationsandproducts,includingmedicaldevices.Healthcare-associatedMycobacteriumabscessuscancauseinfectionsoftheskinandthesofttissuesundertheskin.Itcanalsocauselunginfectionsinpersonswithvariouschroniclungdiseases.(61)

Mycobacteriaotherthantuberculosis(MOT)areofspecialsignificancetotheacupuncturistbecauseofanumberofreportsofAOM-associatedskinlesionscausedbyMOT.MOT-relatedskindiseaseshavebeenreportedinoutbreaksassociatedwithspecificacupunctureclinicsinCanadaandKorea.(2)TherecognitionandmanagementofMOTdiseasesareinthedomainofthedermatologist.(63)MOTareslow-growingbacteriathatcancausediseaseinbothimmunocompetentandimmunocompromisedpatients.Themostcommonclinicalpresentationsofinfectionaretheappearanceofsuppurativeandulceratedskinnodules.(64)

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MOTarewidelydistributedintheenvironment,particularlyinwetsoil,marshland,streams,riversandestuaries.(65)MOTaregenerallyfoundintheenvironmentasfree-livingorganismsandthereforemaypersistinwetordryenvironmentsforasignificantperiodoftime.

Mycobacterium(MOT)infectionshavebeenreportedasrelatedtoacupuncture“probablyassociatedwiththeinadequatesterilizationoftheneedlesorthepuncturesite.”(66)MycobacteriuminfectionsareprobablynotassociatedwithacupuncturewhenthepractitionerfollowsallcriticalcomponentsoftheCNTprotocols.However,anumberofcaseshavebeendiscussedintheliterature.(2,66-70)Itislikelythatsomeoftheseinfectionsassociatedwithacupuncturearearesultofdirtcarriedinbypatientsandthenleftbehindontowelsusedforhotpacks,treatmenttablelinensandothercloththathasnotbeenchangedbetweeneachandeverypatientvisit.

PreventingMycobacteriumotherthanTuberculosis(MOT)intheclinic:

1. Appropriatehandwashingandtheuseofalcohol-basedhandcleansers.2. ScrupuloususeofCNTprocedures.3. Properhandlingofpotentiallycontaminatedmaterialssuchassharps,anddisposable

suppliessuchascottonandgauze.4. Scrupuloususeoftheappropriatedisinfectantsforthetreatmentroomandtreatment

tables.5. Meticulousreplacementofanysheetsortowelsbetweeneachandeverypatientvisit.6. Referralofpatientsthatmaybeinfectedtoaphysicianforappropriatetreatment.

Herpes Simplex Twoserotypesofherpessimplexvirus(HSV)havebeenidentified:HSV-1andHSV-2.HSV-1isusuallyassociatedwithorallesions(i.e.,coldsores),althoughbothHSV-1andHSV-2maybefoundinoralorgenitalmucosallesions.HSV-1istypicallytransmittedbysalivaorbytheinfectiononhandsofhealthcarepersonnel.(70)HSVcanbetransmittedbydirectcontactwithepithelialormucosalsurfaces.HSVcanbetransmittedbyingestion,parenteralinjection,dropletexposureofthemucousmembranes(eyes,noseormouth),andinhalationofaerosolizedmaterials.(70,71)

BothformsofHSVarecharacterizedbyrecurringlesions.Aftertheinitialinfection,whichisoftenthemostsevereoutbreak,theviruswillgointoquiescenceforvaryinglengthsoftime.Thenextstageisaprodromalstage,whichmayincludelocalizeditching,painortinglingatthesiteoftheinfection.Atthispoint,thevirusisbeingshedandotherscanbecomeinfected.Thelaststageiscalledanoutbreak.Outbreaksarecharacterizedbythesamesymptomsinthesamelocationastheinitialattack,buttendtowardbecomingmilderovertime.Ifblistersform,

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theywilltypicallyhealin7-10days.ThepersonwithHSVisstillsheddingvirusatthispointandcanspreadtheinfectionthroughtouch.TheHSVviralcyclewillthenstartagain.

Acupuncture,moxibustion,cuppingandotherAOMprocedureshavebeenassociatedwithdecreasingthepainandimprovinghealthofthosewithherpes-relatedlesions.(72-74)

AcupunctureandcuppingmayalsobeassociatedwithspreadingtheHSVifStandardPrecautionsarenottaken.(75)

TopreventtransmissionoftheHSVvirus,StandardPrecautionsshouldbefollowed.Practitionersshouldrefrainfromtouchingactivelesionsandavoidtreatmentproceduresintheareaofanylesions.Sincepatients’handscontactpracticelocationsurfaces,andtheviruscouldreachanobjectthatistouchedbyanotherperson,allsurfacesmustbedisinfecteddaily.(76,77)TheHSV1andHSV2viruscansurviveforseveralhoursonworksurfaces,suchastreatmenttablesandcountertops.(76)

Influenza Influenzaisprimarilyacommunity-basedinfectionthatistransmittedinhouseholdsandcommunitysettings,includinghealthcareclinics.

Healthcare-associatedinfluenzainfectionscanoccurinanyhealthcaresettingandaremostcommonwheninfluenzaisalsocirculatinginthecommunity.Therefore,infectioncontrolmeasuresneedtobeutilizedinallacupuncturepracticelocationstoreducetransmissionoftheinfluenzavirus.(78)

Formoreinformationvisit:

InfectionControlinhealthcareFacilities(http://www.cdc.gov/flu/professionals/infectioncontrol/index.htm)

Influenza Survival in the Environment Influenzavirusescansurviveintheenvironmentforupto24hours.(79)Propercleaningisrequiredtopreventtransferfromtreatmentsurfacestopatients,staffandfamilymembers.

Acupuncturecanbeeffectiveintreatingorhelpingpreventupperrespiratoryinfections.(80,81)However,havingpatientsacutelyillinahealthcaresettingincreasestheriskoftransmissionofthevirustohealthcareworkersandotherpatients.StandardPrecautionsneedtobefollowedintermsofhandwashingandtreatmentroomdisinfection.

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CDC Fundamental Elements to Prevent Influenza Transmission Preventingtransmissionofinfluenzavirusandotherinfectiousagentswithinhealthcaresettingsrequiresamulti-facetedapproach.Spreadofinfluenzaviruscanoccuramongpatients,healthcareworkers,officestaff,andvisitors.Thecorepreventionstrategiesinclude:(78)

• InfluenzavaccinationofHCWsandat-riskpublicannually.• Implementationofrespiratoryhygieneandcoughetiquette.• ImplementationofStandardPrecautions.• Adherencetoinfectioncontrolprecautionsforallpatient-careactivitiesandaerosol-

generatingprocedures.• Implementingenvironmentalandengineeringinfectioncontrolmeasures.

Healthcareworkersmuststayhomewhenacutelyill.Inmostcases,personnelshouldnotbeactivelyseeingpatientsuntilfreeoffeverforatleast24hourswithouttheuseofNSAIDs.

Norovirus Norovirusesareagroupofvirusesthatcausegastroenteritis,causinganacuteonsetofseverevomitinganddiarrhea.Thisvirusisverycontagiousandcanspreadrapidlythroughouthealthcarefacilities.(82)Peoplecanbecomeinfectedwiththevirusinseveralways:

• Havingdirectcontactwithanotherpersonwhoisinfected(ahealthcareworker,visitor,oranotherpatient).

• Eatingfoodordrinkingliquidsthatarecontaminatedwithnorovirus.

• Touchingsurfacesorobjectscontaminatedwithnorovirus,andthentouchingyourmouthorotherfooditems.

Norovirusistransmittedbyhandscontaminatedthroughthefecal-oralroute,directlyfrompersontoperson,throughcontaminatedfoodorwater,orbycontactwithcontaminatedsurfaces.(83)Thenorovirusisrelativelystableintheenvironmentandcanpersistforweeksonhardsurfaces.

NoroviruseshavenotbeenlinkedtoacupunctureorrelatedAOMproceduresinthemedicalliterature.Estimatesare19-21millioncasesofnorovirusarereportedintheU.S.eachyear.(84)AsnorovirusdiseasesareoneofthemostcommoninfectionsintheU.S.,allhealthcarepractitionersneedtofollowStandardPrecautionstopreventthespreadofthishighlycontagiousorganism.

Prevention of Norovirus Thecorepreventionstrategiesinclude:(83)

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• Followhand-hygieneguidelines,andcarefullywashhandswithsoapandwateraftercontactwithpatientswithnorovirusinfection.

• Usegownsandgloveswhenincontactwith,orcaringforpatientswhoaresymptomaticwithnorovirus.

• RoutinelycleananddisinfecthightouchpatientsurfacesandequipmentwithanEnvironmentalProtectionAgency-approvedproductwithalabelclaimfornorovirus.

• Removeandwashcontaminatedclothingorlinens.• Healthcareworkerswhohavesymptomsconsistentwithnorovirusshouldbeexcluded

fromworkforatleast3daysaftersymptomsresolve.

Appropriatehandhygieneislikelythesinglemostimportantmethodtopreventnorovirusinfectionandcontroltransmission.Reducinganynoroviruspresentonhandsisbestaccomplishedbythoroughhandwashingwithrunningwaterandsoap.Alcohol-basedhandsanitizersdonotdemonstrateefficacyagainstthenorovirus.(84,85)Healthcareworkersshouldstayawayfromworkwhileillandforatleast48to72hoursfollowingresolutionofsymptoms.(83)

Clostridium difficile Clostridiumdifficileisaspore-forming,gram-positiveanaerobicbacillusthatproducestwoexotoxins:toxinAandtoxinB.Itisacommoncauseofantibiotic-associateddiarrhea(AAD).Itaccountsfor15-25%ofallepisodesofAAD.(86)

NearlyallantimicrobialshavebeenimplicatedinthedevelopmentofClostridiumdifficileassociateddisease(CDAD).PersonswithnormalhealthygastrointestinalfloraandtheabilitytomountabriskimmuneresponseareatlowerriskforCDAD.(87)

ClinicalsymptomsofClostridiumdifficileincludewaterydiarrhea,fever,lossofappetite,nausea,andabdominalpainandtenderness.

Clostridiumdifficileisshedinfeces.Anysurface,device,ormaterial(e.g.,commodes,rectalthermometers)thatbecomescontaminatedwithfecesmayserveasareservoirfortheClostridiumdifficilespores.Clostridiumdifficilesporesaretransferredtopatientsmainlyviathehandsofhealthcarepersonnelwhohavetouchedacontaminatedsurfaceoritem.(86)

ThetwoprimaryagentsusedtotreatCDADaremetronidazoleandoralvancomycin.Adjunctivetherapiesforrefractorydiseaseincludeeffortstoreplenishcolonicflorawiththeuseoforallyadministeredprobiotics,usuallyLactobacillusspeciesorSaccharomycesboulardii.(87)

Clostridiumdifficilesporesresistkillingbyusualhospitaldisinfectantsandmaysurviveonsurfacesforuptofivemonths.(88)SpecialproceduresneedtobefollowedwhencaringforpatientswithClostridiumdifficile–associateddisease.

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Prevention of Spread of Clostridium difficile CDCrecommendationstopreventtransmissionofClostridiumdifficileinpractitioners’offices:(86)

• Usegloveswhenenteringpatients’roomsandduringpatientcarewhenthepatientisaknowncarrierofClostridiumdifficile.

• Performhandhygieneafterremovinggloves.o BecausealcoholdoesnotkillClostridiumdifficilespores,useofsoapandwateris

moreefficaciousthanalcohol-basedhandsanitizers.However,earlyexperimentaldatasuggestthat,evenusingsoapandwater,theremovalofClostridiumdifficilesporesismorechallengingthantheremovalorinactivationofothercommonpathogens.

o PreventingcontaminationofthehandsviagloveuseremainsthecornerstoneforpreventingClostridiumdifficiletransmissionviathehandsofhealthcareworkers;anytheoreticalbenefitfrominstitutingsoapandwatermustbebalancedagainstthepotentialfordecreasedcomplianceresultingfromamorecomplexhandhygienemessage.

o Ifyourinstitutionorclinicexperiencesanoutbreak,considerusingonlysoapandwaterforhandhygienewhencaringforpatientswithClostridiumdifficileinfection

• Usegownswhenenteringpatients’roomsandduringpatientcarewhenthepatientisaknowncarrierofClostridiumdifficile.

• DedicateorperformcleaningofanysharedmedicalequipmentfromatreatmentroomwhenthepatientisaknowncarrierofClostridiumdifficile.

ImplementanenvironmentalcleaninganddisinfectionstrategywhenthepatientisaknowncarrierofClostridiumdifficile:

• Ensureadequatecleaninganddisinfectionofenvironmentalsurfacesandreusabledevices,especiallyitemslikelytobecontaminatedwithfecesandsurfacesthataretouchedfrequently.

• ConsiderusinganEnvironmentalProtectionAgency(EPA)-registereddisinfectantwithasporicidalclaimforenvironmentalsurfacedisinfectionaftercleaninginaccordancewithlabelinstructions.Hypochlorite-baseddisinfectantsmaybemosteffectiveinpreventingClostridiumdifficiletransmission.

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5. Summary of Prevention of Disease Transmission in Acupuncture Practice

Basic Critical Principles • FollowCleanNeedleTechniqueforacupunctureandrelatedAOMprocedures.• Useonlysingle-usesterilefiliformneedles.• Usesingle-usesteriledevicesthatentertheskin,includinglancetsandseven-star

hammers.• Cleanhandsimmediatelybeforeanyclinicalprocedure,includinginsertingneedles,

betweenpatientvisits,aftercontactwithanybodilyfluidsorOPIM.• Alwaysestablishacleanfieldensuringthecleanlinessofthepractitioner’sandpatient’s

skinandthesterilityoftheshaftoftheneedleandothermedicaldevices.• Immediatelyisolateusedneedlesandothersharpsinanappropriatesharpscontainer.• Donotneedleorotherwisetreatareasoftheskinwithactivelesions.

Preventing Patient to Patient Cross Infections – Critical Recommendations • Usesingle-usesterileneedlesandotherdevicesthatentertheskin,including

acupunctureneedles,lancets,andseven-starhammers.• Utilizeproperhandwashingtechniquesbetweenpatientvisits.• Instituteandfollowproceduresforpropercleaningofthetreatmenttableand

treatmentroom.• Casualcontactsbetweenpatientsorbetweenpatientsandthepractitionersuchas

contactwithclothingetc.arenotcauseforconcern.However,itisstronglyrecommendedthatpoliciesbeputinplacetolimitthecontactbetweenpatientsifapatientisdisplayingsymptomsofactiveacuteinfections.

Preventing Patient to Practitioner Cross Infections • Avoidtouchingtheshaftortipofausedneedleorotherusedhealthcaresharp.• Alwaysimmediatelyisolateusedsharpsinpropercontainers.• Useadrycottonballorgauzetoclosethepoint.Neverusethebarefingertocoverthe

skinwhereaneedlehasbeenremoved.• Keepallskinbreaksonthepractitioner’shandscovered.• ConsidervaccinationagainstHepatitisB.

Preventing Practitioner to Patient Cross Infections • Handwashingiscritical.• Avoidtouchingtheshaftofaneedlethatwillpenetratethepatient’sskinpriorto

insertion.

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• Avoidallpatientcontactifyouhaveanovertclinicalinfection.Donottreatpatientsifyouhaveafeverand/orproductivecough.

• Keepallopencuts,woundsorotherlesionsonyourskincovered.• HaveayearlyphysicalwithappropriatetestingasdescribedbyOSHA/CDC.

Review Whileitisimpossibletoavoidallinfectionsinahealthcareworkplace,thereareanumberofcriticalfactorsinlimitinginfectionstotherareoccurrencestheyhavebeenshowntobeinprospectivestudies.Thesepracticesare:

• Ensuringthehandsofthepractitionerarecleanthroughhandwashing.• Properpreparationoftheneedlingsites,includingavoidingneedlingskinwithactive

lesionsandproperskinpreparation.• Utilizingsterileneedlesandotherdevicesthatentertheskin,andtheirproperstorage.• CleanNeedleTechnique.• Carefulmanagementanddisposalofusedneedlesandotherequipment.• Acleanworkingenvironment.

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51.HsiehRL,HuangCH,UenWC.Necrotizingfasciitisafteracupunctureinapatientwithaplasticanemia.JAlternComplementMed.2011Sep;17(9):871-4.doi:10.1089/acm.2010.0617.

52.SeeleyEJ,ChambersHF.DiabeticketoacidosisprecipitatedbyStaphylococcusaureusabscessandbacteremiaduetoacupuncture:casereportandreviewoftheliterature.ClinInfectDis.2006Jul1;43(1):e6-8.Epub2006May23.

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55.SafdarN,MakiDG.Thecommonalityofriskfactorsfornosocomialcolonizationandinfectionwithantimicrobial-resistantStaphylococcusaureus,enterococcus,gram-negativebacilli,Clostridiumdifficile,andCandida.AnnInternMed.2002Jun4;136(11):834-44.

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58.WooPC,LauSK,YuenKY.Firstreportofmethicillin-resistantStaphylococcusaureussepticarthritiscomplicatingacupuncture:simpleprocedureresultinginmostdevastatingoutcome.DiagnMicrobiolInfectDis.2009Jan;63(1):92-5.doi:10.1016/j.diagmicrobio.2008.08.023.Epub2008Nov5.

59.MurrayRJ,etal.Outbreakofinvasivemethicillin-resistantStaphylococcusaureusinfectionassociatedwithacupunctureandjointinjection.InfectControlHospEpidemiol.2008Sep;29(9):859-65.doi:10.1086/590260.

60.CentersforDiseaseControlandPrevention.GroupAStreptococcal(GAS)Disease,GASFrequentlyAskedQuestions.http://www.cdc.gov/groupastrep/about/faqs.html.ReviewedMay1,2014.AccessedFebruary2015.

61.WooPCY,LinAWC,LauSKP,YuenKY.AcupuncturetransmittedinfectionsBMJ2010;340:c1268

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65.Grange,J.M.(2007).Environmentalmycobacteria.InGreenwood,David;Slack,Richard;Peitherer,John;&Barer,Mike(Eds.),MedicalMicrobiology(17thed.),pp.221-227.Elsevier

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74.LiaoSJ,LiaoTA.Acupuncturetreatmentforherpessimplexinfections.Aclinicalcasereport.AcupunctElectrotherRes.1991;16(3-4):135-42.

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76.Pray,W.Steven,PhD,DPhPreventingandTreatingColdSores.http://www.medscape.com/viewarticle/557162.USPharmacist.2007;32(4):16-23.AccessedFebruary2015.

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78.CentersforDiseaseControlandPrevention.PreventionStrategiesforSeasonalInfluenzainHealthcareSettings.http://www.cdc.gov/flu/professionals/infectioncontrol/healthcaresettings.htm.ReviewedJanuary9,2013.AccessedJanuary2013.

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80.TanD.Treatmentoffeverduetoexopathicwind-coldbyrapidacupuncture.JTraditChinMed.1992Dec;12(4):267-71.

81.LouBDetal.[Impactsonrepeatedcommoncoldfortheadultswithdifferentconstitutionstreatedbyacupointapplicationinthedogdaysandthethreenine-dayperiodsafterthewintersolstice]ZhongguoZhenJiu.2012Nov;32(11):966-70.

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87.GouldCarolynandLCliffordMcDonald.Bench-to-bedsidereview:Clostridiumdifficilecolitis.CriticalCare2008,12:203,http://ccforum.com/content/12/1/203.AccessedMarch2013

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Part V: Personnel Health, Cleanliness and Safety Practices

Thissectionaddressesthepracticestoreducetransmissionofdiseasesthroughhygienicmethods.Sincetherearenostudiesofhandwashing,skinpreparation,andgloveusespecificallyinacupuncturepractices,generalhealthcarestandards(CDC,WHO)aretheprimaryresourcesforrecommendationsinthissection.

1. Handwashing Themostcommonmodeofhealthcare-associatedinfectiontransmissionisviathehands!

Pleasenote:boththeCDCandWorldHealthOrganizationhavepublishedextensiveinformationabouthandwashingtechniquesandbestpractices.Whatispresentedhereisjustanoverview.Forthoseinterestedinreadingmoresee:

• http://www.cdc.gov/handhygiene/download/hand_hygiene_core.pdf• http://whqlibdoc.who.int/publications/2009/9789241597906_eng.pdf• http://www.jointcommission.org/assets/1/18/hh_monograph.pdf• http://www.cdc.gov/mmwr/preview/mmwrhtml/rr5116a1.htm

Itisstronglyrecommendedthatacupuncturistsalwayswashtheirhands:

1. Immediatelybeforeacupunctureorotherclinicalprocedures.2. Aftercontactwithbloodorbodyfluidsorobviousenvironmentalcontaminants.3. Attheendofatreatment.

AHistoryofHandwashingforHealthcareWorkers(HCWs):

LouisPasteurdemonstratedinthe1860sthatmicrobescauseddiseases.Inthemid-1800s,IgnazSemmelweisinVienna,Austria,andOliverWendellHolmesinBoston,U.S.,establishedthathospital-acquireddiseasesweretransmittedviathehandsofHCWs.(1)ThefirstU.S.nationalhandhygieneguidelineswerepublishedinthe1980s.In1995and1996,theCDC/HealthcareInfectionControlPracticesAdvisoryCommittee(HICPAC)intheU.S.recommendedthateithersoapandwaterorawaterlessantisepticagentbeusedforcleansinghandsuponleavingtheroomsofpatients.

ImportanceofHandwashing:

Thehandsofhealthcareworkers(HCWs)arethemainsourceofhospitalinfection,andthereforehandwashingisthemostimportantprocedureforpreventingnosocomialinfections.

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Cleanhandsarethesinglemostimportantfactorinpreventingthespreadofpathogensandantibioticresistanceinhealthcaresettings.(2)Goodhandhygienereducestheincidenceofhealthcare-associatedinfections.

Healthcarespecialistsgenerallycitehandwashingasthesinglemosteffectivewaytopreventthetransmissionofdisease.(3)HygienichandcleaningbyhospitalpersonneltoremovethetransientbacteriawhichcontaminatesthehandsandskinofHCWsiscriticalforinfectioncontrolinallhealthcaresettings.(4-6)

Despiteevidencefortheimportanceofhandwashinginthepreventionofnosocomialinfection,studieshavedemonstratedthatcompliancewiththerecommendationthatHCWswashtheirhandsbetweeneachandeverypatientvisitremainslowinpatientcaresettings.(7)

Effective Handwashing Technique Handwashingwithsoapandrunningwateristhemosteffectiveformofhandwashing.However,whenthereisnosinkavailable,practitionersmayuseanalcohol-basedhandsanitizer.Analcohol-basedhandsanitizercanenhancekillingoftransienthandflorawithouttheuseofrunningwater,soap,andhanddrying,butcannotreplacehandwashingforremovingallhandcontaminants.

Duration-SoapandWater:

Althoughthereisnoacceptedoptimallengthoftimeforhandwashing,anumberofstudieshavelookedat15-secondprotocolsforhandcleansing.(8-14)Unfortunately,mostHCWsgenerallywashtheirhandsformuchshorterdurations,sotheeffectivenessofhandwashingasactuallypracticedhasnotreallybeenstudied.

Soapsaredetergent-basedproductswhosecleaningactivitycanbeattributedtotheirdetergentproperties,whichresultinremovalofdirt,soil,andvariousorganicsubstances,includingpathogens,fromthehands.Plainsoapshaveminimal,ifany,directantimicrobialactivity.(1)Handwashingwithplainsoapcananddoesremovelooselyadherenttransientflora.However,inseveralstudies,handwashingwithplainsoapfailedtoremovepathogensfromthehandsofhospitalpersonnel.(14,15)HandwashingwithplainsoapandwaterdoesdecreasethetransmissionofHAI.Therefore,whilethebestpracticeinhandwashingremainsunclearwhatisclearisthatsoapandwatershouldbeutilizedasindicatedbyStandardPractices.

Hand Hygiene Technique: Soap and Water Whenwashinghandswithsoapandwater:(16,17)

• Removealljewelryandrollupthesleevesofyourshirt,ifnecessary.• Wethandsfirstwithcooltowarmwater.

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• Applyanamountofsoaprecommendedbythemanufacturertohands.• Rubhandstogethervigorouslyfor10-15seconds,coveringallsurfacesofthehandsand

fingers.• Rinsehandswellwithrunningwater.• Drythoroughlywithaclean,disposabletowel.• Usetoweltoturnoffthefaucetusingthedisposabletowel,notyourcleanhands.

Avoidusinghotwater,becauserepeatedexposuretohotwatermayincreasetheriskofdermatitis.(18,19)

Hand Drying Becausewethandscanmorereadilyacquireandspreadmicroorganisms,theproperdryingofhandsisanintegralpartofroutinehandwashing.Carefulhanddryingisacriticalfactordeterminingthelevelofbacterialtransferassociatedwithtouchcontactafterhandcleansing.Reusingorsharingtowelsshouldbeavoidedbecauseoftheriskofcross-infection.Reusableclothtowelsorroll-typetowelsarenotrecommendedforuseinhealthcaresettings.Instead,alwaysusepapertowelsforhanddrying.(20,21)Inacomparisonofmethodstotesttheefficiencyofhanddryingfortheremovalofbacteriafromwashedhands,warmairdryingperformedworsethandryingwithpapertowels.(22)Whencleanordisposabletowelsareused,itisimportanttopattheskinratherthanrubit,toavoidskincracking.Skinexcoriationmayleadtobacteriacolonizingtheskinandpossiblespreadofbloodbornevirusesaswellasothermicroorganisms.(23)Usepapertowelstoturnofffaucetsandtoopendoorsbetweenthehandwashingstationandthepatientcareroom.

Hand Hygiene Technique - Alcohol-Based Sanitizers Whendecontaminatinghandswithanalcohol-basedhandsanitizer,applyproducttopalmofonehandandrubhandstogether,coveringallsurfacesofhandsandfingers,untilhandsaredry.(24,25)Followthemanufacturer’srecommendationsregardingthevolumeofproducttouse.Inhealthcarepractices,alwaysusedapprovedproductsforhandcleansing;“homeremedies”suchasvariouscombinationsofessentialoilsandlotionsmaynotreducetransientbacterialloadsignificantly.

Handwashing - Antiseptic Towelettes Antimicrobial-impregnatedwipes(i.e.,towelettes)maybeconsideredasanalternativetowashinghandswithsoapandwaterevenwhenthehandsarevisiblysoiled.(12)However,theuseofsoapandwaterisstillconsideredthebestmethodforcleaninghandsthathavebeensoiledwithbloodandOPIM,afterremovalofgloves,afterusingtherestroomandbeforeandaftereating.

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Hand Flora Therearetwotypesofinfectiousagentsontheskin:residentandtransient.In1938,Price(26)establishedthatbacteriarecoveredfromthehandscouldbedividedintothesetwocategories.

ResidentHandFlora:Theresidentfloraoftheskinconsistsofmicroorganismsresidingunderthesuperficialcellsofthestratumcorneumandcanalsobefoundonthesurfaceoftheskin.(27,28)Staphylococcusepidermidisisthedominantspecies.(29)OtherresidentbacteriaincludeS.hominisandotherstaphylococci,followedbycoryneformbacteriaandotherbacteria.(30)Residentflorahastwomainprotectivefunctions:itpreventscolonizationoftheskinbypathogenicorganismsandcompeteswithanyorganismsfornutrients,thuspreventingpermanentassociationwiththoseorganisms.(31)Ingeneral,residentfloraislesslikelytobeassociatedwithhealthcareassociatedinfections,butmaycauseinfectionsinsterilebodycavities,theeyes,oronnon-intactskin.(32)

Transientskinflora:Transientortemporaryskinflorareferstothemicroorganismsthattransientlycolonizetheskin.Thisincludesbacteria,fungiandviruses,whichreachthehands,forexample,bydirectskin-to-skincontactorindirectlyviatouchingsurfacesofdesks,lightswitches,utensils,andotherobjects.Handwashingisaimedatreducingoreliminatingtransientpathogenicskinflora.(33)

Rings/Jewelry Severalstudieshavedemonstratedthatskinunderneathringsismoreheavilycolonizedthancomparableareasofskinonfingerswithoutrings.Onestudyfoundthat40%ofnursesharboredgram-negativebacilli(e.g.,E.cloacae,Klebsiella,andAcinetobacter)onskinunderringsandthatcertainnursescarriedthesameorganismundertheirringsforseveralmonths.(34-36)

Healthcare workers and Actual Handwashing Practices Unfortunately,manyHCWsdonotwashtheirhandsasoftenasisrecommendedforbeinginahealthcarepractice.(37)Studieshaveconsistentlydemonstratedratesofhandwashingcompliancearelessthan50%inmanyhospitals.

Necessity of Handwashing Thenecessityofhandwashingbetweenpatients/patientvisitsandtheuseofStandardPrecautionsreflectstheimportanceoftreatingallpatientsasiftheywerecarriersofhepatitisorHIV.Beyondthis,theneedtowashthehandsisbasedonwhetherthehandsbecomecontaminatedduringthecourseoftreatment.Practitionersmustwashtheirhandsbetweenpatients,beforeandafterinsertingneedles,andaftercontactwithpotentiallyinfectiousbodyfluids.

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Sourcesofcontaminationincludebodyfluidssuchasbloodandsaliva,vaginalsecretions,andfecalcontamination,andfluidsfromopenlesions.BodyfluidsmaycontainbacteriasuchasStaphylococcusspecies,andvirusesassociatedwithhepatitisandHIV/AIDS.Itisabsolutelyimperativethatpotentiallyinfectiousfluidsnotbetransferredfromonepersontoanotherthroughtheacupunctureprovider’shands,orfromthepatienttothepractitionerand/orothermembersoftheclinicstaff.Thisismosteffectivelydonebycarefullywashinghandswheneverneeded.Handwashingshouldalsotakeplacebeforeandafteransweringthephone,wheneverthepractitionertoucheshisorherfaceorhair,eats,orengagesinanyothernon-clinicalactivity.

What is the right way to wash your hands? • Removealljewelryandrollupthesleevesofyourshirt,ifnecessary.• Wethandsfirstwithcooltowarmwater.• Applyanamountofsoaprecommendedbythemanufacturertohands.• Rubhandstogethervigorouslyfor10-15seconds,coveringallsurfacesofthehandsand

fingers.• Rinsehandswellwithrunningwater.• Drythoroughlywithaclean,disposabletowel.• Useadisposabletoweltoturnoffthefaucet,notyourcleanhands

TheCDCrecommendsspecifictypesofhandwashingunderthefollowingcircumstances:(2)

1. Whenhandsarevisiblydirtyorarevisiblysoiledwithbloodorotherbodyfluids,washhandswithsoapandwater.

2. Ifhandsarenotvisiblysoiled,practitionersmayuseeitheranalcohol-basedhandsanitizer,orsoapandwaterforroutinelydecontaminatinghandsinclinicalsituations.

3. Decontaminatehandsbeforehavingdirectcontactwithpatients.4. Decontaminatehandsaftercontactwithapatient'sintactskin(e.g.,whentakingapulse

orbloodpressure,orpalpatingpoints).5. Decontaminatehandsaftercontactwithbodyfluidsorexcretions,mucousmembranes,

nonintactskin,andwounddressingsevenifhandsarenotvisiblysoiled.6. Decontaminatehandsifmovingfromacontaminated-bodysitetoaclean-bodysite

duringpatientcare.7. Decontaminatehandsafterremovinggloveswithsoapandwater.8. Beforeeatingandafterusingarestroom,washhandswithsoapandwater.9. Antimicrobial-impregnatedwipes(i.e.,towelettes)maybeconsideredasanalternative

towashinghandswithsoapandwater.

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Handwashingwithsoapandrunningwateristhemosteffectiveformofhandwashing.However,whenthereisnosinkavailable,practitionersmayuseanalcohol-basedhandsanitizer.Analcohol-basedhandsanitizercande-germhandsinlessthan30secondsandenhancekillingoftransienthandflorawithouttheuseofrunningwater,soap,andhanddrying.

Studieshaveshownthatcliniciansfindalcohol-basedhandsanitizersconvenient,accessible,andlessirritatingtotheskin.(38)TheCDChasalsoacceptedtheuseofantiseptichandcleansersortowelettesexceptwhencircumstancesrequiretheuseofsoapandwater.(39)

ThenecessityofhandwashingbetweenpatientsandtheuseofStandardPrecautionsreflectstheimportanceoftreatingallpatientsasiftheywerecarriersofhepatitisorHIV.Beyondthis,theneedtowashthehandsisbasedonwhetherthehandsbecomecontaminatedduringthecourseoftreatment.Practitionersmustwashtheirhandsbetweenpatients,beforeandafterinsertingneedles,beforeandafterotherclinicalprocedures,andaftercontactwithpotentiallyinfectiousbodyfluids.

Recommendations • Critical:Washhandsbetweeneverypatientvisit.• Critical:Washhandsimmediatelypriortoinsertingacupunctureneedlesorperforming

otherproceduresthatbreaktheskin.• Critical:Washhandsafterenteringtheclinicandbeforestartinganypatientcare.• Critical:Washhandsbeforeandaftereating.• Critical:Washhandswithsoapandwaterafterusingtherestroom.• Critical:Washhandsafterremovinggloves.• StronglyRecommended:Washhandsbeforeperforminganyclinicalprocedure,

includingthosethatdonotbreaktheskin(e.g.,cupping).• StronglyRecommended:Washhandsaftertakingapatient’spulseandafterpalpating

points.• Recommended:Washhandsafterdecontaminatingreusableequipment.

2. Patient Skin Preparation TherearenoprospectivestudiesdemonstratingeithertheneedfororlackofneedforskinpreparationbeforeacupunctureandotherAOMpractices.Thebestevidenceisthathavingthepatient’sskinbecleanandhavingthepractitionershandsbecleanthroughproperhandwashingaremostimportant.

Therearenostudieswhichcompareskinpreparationpriortoacupunctureneedleinsertionwithnoskinpreparation.Theclosestinformationavailablepertainstoskinpreparationpriortoinjections,(40),suchasinsulininjectionsfordiabeticsandvaccinations.Researchconductedas

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earlyasthe1960sbyDann(41)andKoivisto&Felig(42)withdiabeticpatientsindicatedthatalthoughskinpreparationwithalcoholpriortoinjectionmarkedlyreducedskinbacterialcounts,suchtreatmentisnotnecessarytopreventatinjectionsites.(43)In1999somestandardsforimmunizationsandothersubcutaneousinjectionswerere-writtensuchthatskinpreparationwasnotabsolutelynecessary.(44)

Healthcareresearchhasreinforcedtheimportanceofensuringthattheskinofthepatientisphysicallycleanandthathealthcareprovidersmaintainhighstandardsofhandhygienepriortoinstitutinganyprocedurethatincludesabreakintheskin.(45)

TheWorldHealthOrganizationnolongerrecommendsswabbingcleanskinwithanantisepticsolutionbeforegivingintradermalorsubcutaneousneedleinjections,althoughintramuscularinjectionsdorequireskinpreparationwith60-70%alcohol.(46)TheCDCstatesthatalcohol,soapandwaterorchemicalagentsarenotneededforpreparationoftheskinpriortovaccination,unlesstheskinisgrosslycontaminatedordirty.(47)InordertobeconsistentwithWHOandCDCguidelines,skincleansingshouldbecarriedoutwheneverthepractitionerexpectstoneedlebelowthesubcutaneouslayer;inotherwordsintothemusclelayerorbelow.

Otherresearchershaverecommendedthecleaningoftheinjectionsiteinordertominimizetheriskofinfection.(48-50)Manypractitionersbelieveitfollowsbestpracticeguidelinestocleantheskinpriortoinjectiontoreducetheriskofcontaminationfromthepatient’stransientskinflora.

Thereisonecasereportofapatientwhoreportedlyhadsepticemiaafteracupunctureduringwhichtheskinwasnotswabbed.ThecasewasreportedfromScotlandinwhicha69-year-oldmandiedfromaninfectionafteracupuncturetreatmentatthethigh.Thepatientwaslaterfoundtohaveapreexistingpancytopenia(i.e.,lowtotalbloodcellcount,includingleukocytes),resultinginanincreasedsusceptibilitytoinfection.Thecasereportauthor,whoisalsothepractitioner,admittedthatthepatient’sskinattheacupuncturepointwasnotcleanedbeforetheneedleinsertionandlaterfoundlocalmuscleinfectionwhichledtosepticemia.(51)

Themostcommonandconvenientprocedureforcleaningapatient’sskinistheuseofanalcoholswab.Analcoholpumpdispenserandcottonballsmayalsobeusedinatreatmentsettingaslongasthecottonballsarediscardedwhendryorcontaminatedandthepumpdispenseriscleanedwithanapproveddisinfectantonadailybasis(aswithanyothersurfaceinthetreatmentroom).

SincemanypatientscometotheAOMtreatmentlocationfromwork,attheendoftheday,afterexercising,andingenerallessfrequentlyimmediatelyaftershowering,itislikelythattheacupuncturepointlocationsarenotcompletelyclean.Hands,feet,andthefacearecommonly

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usedareasforacupunctureandareregularlyexposedtotransientorganismsduringthecourseofregularhomeandworkactivities.

AccordingtoaJuly2013letterfromtheCDC,(52)“TheproceduresoutlinedintheCNTManualarereasonable”regardingskinpreparation.

Doesthismeanthatskinmustbecleanedwithalcoholswabspriortoneedleinsertion?Whatisclearisthattheskinmustbeclean,andthattheskintobetreatedshouldbefreefromovertinfectionsorlesions.Howindividualpractitionerschoosetomakesuretheskiniscleanandfreeoflesionsisaclinicaldecisioneachpractitionermustmake,basedontheprinciplesandsafetymanualsinuseintheclinicalsettinginwhichtheypractice.

Somestatesmandatetheuseofanantisepticswabbeforeinsertionofanacupunctureneedleintheirpracticeactsand/orrules.Thismanualshouldnotbeinterpretedasadvisingagainstapracticeoutlinedinstatelaw.Practitionershaveadutytoinvestigateandcomplywithstateregulation.

Alcohol Swab Method Whendesired,preparedalcoholswabsareusedtocleanallsitesexpectedtobeneedledaftersettingupthecleanfieldandbeforeneedling.Allowthesitetodry.Alternatively,applya60–70%alcohol-basedsolution(isopropylalcoholorethanol)onasingle-useswaborcotton-woolball.Donotusemethanolormethyl-alcoholasthesearenotsafeforhumanuse.(46)

Swabbingtheacupunctureinsertionsitewithasaturated60-70%alcoholswabandallowingtheskintodryisagoodpracticetoreducebothdirtandthenumberofpathogensatanacupuncturesite.Allowingthesitetodrypreventsstingingwhichmayoccurifalcoholistakenintothetissuesuponneedleentry.(50)

Options for Skin Preparation Optionsforcleaningtheskinbeforeacupuncturebesides70%alcoholincluderequiringpatientstowashallskinsurfacestobetreatedwithsoapandwater;orapplyingadisinfectingsolutioncontainingchlorhexidinegluconate.(53)(Note:Fortopicalapplicationasaskindisinfectingsolution,chlorhexidineismarketedundermanybrandnames,includingSpectrum-4,Hibistat,CalgonVesta,Betasept,Dyna-Hex,andHibiclens.)

Useofpovidoneiodineantisepticointmentorbacitracin/gramicidin/polymyxinBointmentisnotrecommendedasiodinemaybeabsorbedandmaycreatechangesinthyroidfunction,(54)andoveruseofbacitracinandotherantibioticointmentsmayleadtobacterialresistancetotheseproducts.

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NoAOMprocedureshouldbeconductedwherethereareactivelesionsontheskin.Alllocationsshouldbecleansedbeforeproceedingwithacupunctureorotherprocedures.Useof70%alcoholswabsorcottonsoakedin70%alcoholisaconvenientandcost-effectivemethodtoimproveskincleanliness.Skincanbecleanedwithsoapandwaterorothermethodsthatensurecleanliness.

Ifalcoholisbeingused,swabthepointsandallowthealcoholontheskintodry.Thesameswabmaybeusedforseveralpointsaslongastheswabitselfisnotdryandhasonlytouchedintactskin.Anewswabshouldbeusediftheswabbeginstochangecolor,becomesvisiblydirty,becomesdry,orhascomeintocontactwithanyskinbreak,lesion,inflammationorinfection.Thealcoholshouldbeallowedtodrytoreducethepotentialfordiscomfortduringneedling.Aseparateswabshouldbeusedforareasofhighbacterialfloraload,suchastheaxillaorgroin.

Recommendations • Critical:Avoidacupunctureinareasofactiveskinlesions.• Critical:PerformAOMproceduresonlyinareasofcleanskin.• Critical:Ensurethepatient’sskiniscleanbeforeinsertingneedlesorlancets.• Critical:Whenusingalcoholswabs,useanewalcoholswabforeachpatientandanew

swabiftheswabbeginstochangecolor,becomesvisiblydirty,becomesdry,orhascomeintocontactwithanyskinbreak,lesion,inflammationorinfection.

• StronglyRecommended:Swabeverypointwith70%alcoholorothercleansingagentpriorto“wet”cupping,useoflancetsor7-starhammers.

• StronglyRecommended:Useaseparateswabforareasofhighbacterialfloraload,suchasaxillaorgroin.

• Recommended:Havepatientscleanhandsandfacewithsoapandwaterpriortoacupunctureintheseareas.

• Recommended:Investigateandfollowlocalandstateregulationconcerningskinpreparation.

3. Recommendations for Practitioner Health and Hygiene Review:Handwashingiscritical.Themostcommonmodeofhealthcare-associatedinfectiontransmissionisviathehands!Intheacupuncturist’spracticelocationsourcesofhandcontaminationincludebodyfluidssuchasbloodandsaliva,andfluidsfromopenlesions.BodyfluidsmaycontainbacteriasuchasStaphylococcusspecies,andvirusesassociatedwithhepatitisandHIV/AIDS.Itisabsolutelyimperativethatpotentiallyinfectiousfluidsnotbetransferredfromonepersontoanotherthroughtheacupunctureprovider’shands,orfromthepatienttothepractitionerand/orothermembersoftheclinicstaff.Thisismosteffectivelydonebycarefullywashinghandswheneverneeded.Handwashingshouldalsotakeplacebefore

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andafteransweringthephone,afterusingacomputer,wheneverthepractitionertoucheshisorherfaceorhair,eats,orengagesinanyothernon-clinicalactivity.

Yearly Physical Itisrecommendedthathealthcareprofessionals,includingacupuncturists,haveayearlyphysicalthatincludestestingfortuberculosis.NotethatTSTandPPDtestingaresimilar.Theterm“tuberculinskintests”(TSTs)isusedinsteadofpurifiedproteinderivative(PPD)inmostup-to-dateCDCinformation.(55)

Clothing Itisrecommendedthatacupuncturistswearclean,washable,ordisposableprotectiveclothingwhileperformingtreatments.Thefabricshouldbechosentoavoidtrappingandsheddingcontaminatingparticlesorinfectiousagentsinthecleanfield.Looseorlargejewelry,clothing,andhairstylesthattouchthepatientorbreakthecleanfieldshouldbeavoided.Open-toedshoesshouldnotbeworn,astheyposeariskofneedlestickintheeventthataneedleisdropped.Clothingshouldcoverthepractitioner’slegsandfeettopreventtheriskofaneedlestickaccidentintheeventthataneedleisdropped.

Hand Care Acupuncturistsmusttakegreatcaretomaintainthecleanlinessoftheirhands,keepingthenailsshort.HandcleanlinessisapartofCleanNeedleTechnique.Itisstronglyrecommendedthatallcutsandwoundsonthepractitioner’shandsbewashedanddressedimmediatelyfortheprotectionofbothpatientandpractitioner.Allcuts,wounds,abrasions,chappedhands,hangnails,torncuticles,etc.mustbecoveredbywearingafinger-cotornon-sterilenon-latexgloves.

Personal Health Anacupuncturistwhoissufferingfromaninfectiousdiseasecantransmitthediseasetohisorherpatientinvariousways.Appropriatemedicalattentionshouldbesoughtforinfectiousdiseases.Generallyspeaking,patientcarepersonnelhavingovertclinicalinfection,suchasstreptococcalpharyngitis(strepthroat),activeinfluenza,orastaphylococcalfuruncle(boil),shouldrestrictthemselvesfrompatientcontact.PersonnelwithminorinfectionsoftheskinandminorviralinfectionsoftheupperrespiratorytractmayworksolongastheyarescrupulousintheirpracticeofpersonalhygieneandStandardPrecautionsarefollowed.(56)TheCDCrecommendsthatHCWsbe“excludedfromworkuntilatleast24hoursaftertheynolongerhaveafever(withouttheuseoffever-reducingmedicinessuchasacetaminophen).Thosewithongoingrespiratorysymptomsshouldbeconsideredforevaluationbyoccupationalhealthtodetermineappropriatenessofcontactwithpatients.”(57)

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• StronglyRecommended:Thatacupuncturistsrefrainfromtreatingpatientswhentheyareactivelyill.

• Recommended:Thatacupuncturistscancelpatientcareuntilatleast24hoursaftertheynolongerhaveafeverforanyacuteinfection.

Testing for TB, HBV, HCV and HIV

TB testing Inadditiontoayearlyphysical,theCDCsuggeststhatpractitionerswhoworkinhighTBincidenceinnercityclinics,orthosewhoworkwithAIDSpatientsordrugaddicts,obtainabaselineTBtest,either2-stepTSTorachestradiographonhire.EducationregardingthesymptomsofTBshouldbeprovidedbyappropriatelytrainedpersonnel,andhealthcareworkersshouldbescreenedforsymptomsannually.Settingswherethereisahighriskofinfectionshouldbeevaluatedforenvironmentalinfectioncontrol,suchasairhandling.ThetransmissionofTBisarecognizedriskinsomehealthcaresettings.IntheCDC's2005Recommendations for Preventing TB Transmission in Healthcare Settings,adetailedriskstratificationisgivenforlowrisksettings,mediumrisksettings,andpotentialongoingtransmissionsettings.Thislastclassificationshouldalwaysbetemporary,correctivestepstaken,andthereturntomediumriskmadewithinoneyear.

EffectiveTBinfectioncontrolprogramsshouldbeimplementedinhealthcarefacilitiesandotherinstitutionalsettings(e.g.,sheltersforhomelesspersonsandcorrectionalfacilities).(55)ItisrecommendedthathealthcareprovidershaveannualTBskintestsorQuantiFERON©testing.IntheeventthatthepractitionerisfromapartoftheworldwhereTBisendemic,orhasbeenvaccinatedwithBacillusCalmette-Guerin(BCG),heorsheshouldhaveabaselinechestx-rayandanannualphysicalfromaqualifiedprovider.

AlongwiththeirTBstatus,healthcareworkerswhoperformexposure-proneproceduresshouldknowtheirHBVorHIVantibodystatus.

HBV testing VarioustestsforHBVcandetecteitherthepresenceofthevirusitselforantibodiestothevirus.TestingforevidenceofhepatitisBinfectionshouldberoutineforhealthcareproviders,especiallythosewithoccupationalexposurepotential.HospitalsandbloodbanksarerequiredtotestforHBVwithaverysensitivetestthatidentifiesHBVantigenmarkers.

HCV testing Generally,theinitiallaboratorytestthatisdoneforHCVistodetermineifthepersonhasantibodiestothevirus.Ifthetestispositive,itmeansthatthepersonhasbeenexposedtothe

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virusandmayormaynothaveactivehepatitisC.Additionaltestingwillneedtobedonetodetermineifthepersonisacarrier,haschronichepatitis,orisimmune.

HIV testing Generally,theinitiallaboratorytestthatisdoneforHIVistodetermineifthepersonhasantibodiestothevirus.Thistestcanhelpdetermineifthepersonhasbeeninfectedwiththevirusbutcannotdeterminethestageofdisease.TherearerapidHIVteststhatcanprovideresultswithin20minutesoftesting.ApositivetestshouldbeconfirmedwithawesternblotorIFA(immunoflourescentassay)test.(58)

HealthcareworkerswhoareinfectedwithHIVorHBVshouldnotperformexposure-proneproceduresunlesstheyhavereceivedcounselingfromanexpertreviewpanelregardingthecircumstancesunderwhichtheymaycontinuetoperformtheseprocedures.Thereviewpanelshouldincludeexpertswhorepresentabalancedperspectiveandmayincludeallofthefollowing:

1. Thehealthcareworker’spersonalphysician.2. AninfectiousdiseasespecialistwithexpertiseintheepidemiologyofHIVandHBV

transmission.3. Ahealthprofessionalwithexpertiseintheproceduresperformedbythehealthcare

worker.4. Stateorlocalpublichealthofficials.

Ifthehealthcareworkerisinstitution-based,thepanelcouldincludethehospitalepidemiologistorotherinfectioncontrolstaff.Healthcareworkersbasedoutsidethehospital/institutionalsettingshouldseekadvicefromappropriatestateandlocalpublichealthofficialsregardingthereviewprocess.(59)

Itgoeswithoutsayingthatsuchpanelswouldberequiredtoobservetheconfidentialityandprivacyrightsofinfectedhealthcareworkers.Infectedhealthcareworkersshouldnotifyprospectivepatientsoftheirseropositivestatusbeforeundertakingexposure-proneinvasiveprocedures.Acupunctureisnotconsideredanexposure-proneinvasiveprocedure.MandatorytestingofhealthcareworkersforHIVantibodies,HBsAg,orHBeAgisnotrecommended.Theriskisnotsufficienttojustifythecostssuchmandatorytestingprogramswouldincur.Education,training,andappropriateconfidentialitysafeguardsarethebestmeanstoinsurehealthcareworkercompliancebyhealthcareworkerswithrecommendedpreventionprocedures.

4. Personal Protective Equipment (PPE)Seealso:http://www.cdc.gov/HAI/prevent/ppe.html

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StandardPrecautionsisanoutgrowthofUniversalPrecautions.UniversalPrecautionswerefirstrecommendedbytheCDCin1987topreventthetransmissionofbloodbornepathogenstohealthcarepersonnel.In1996,theapplicationoftheconceptwasexpandedandrenamedStandardPrecautions.StandardPrecautionsareintendedtopreventthetransmissionofcommoninfectiousagentstohealthcarepersonnel,patientsandvisitorsinanyhealthcaresetting.Duringcareforanypatient,oneshouldassumethataninfectiousagentcouldbepresentinthepatient’sbloodorbodyfluids,includingallsecretionsandexcretionsexcepttearsandsweat.Thereforeappropriateprecautions,includinguseofPPE,mustbetaken.WhetherPPEisneeded,andifso,whichtype,isdeterminedbythetypeofclinicalinteractionwiththepatientandthedegreeofbloodandbodyfluidcontactthatcanbereasonablyanticipatedandbywhetherthepatienthasbeenplacedonisolationprecautionssuchasContactorDropletPrecautionsorAirborneInfectionIsolation.(60)

Personalprotectiveequipment,orPPE,asdefinedbytheOccupationalSafetyandHealthAdministration,orOSHA,is“specializedclothingorequipment,wornbyanemployeeforprotectionagainstinfectiousmaterials.”(61)

OSHAissuesregulationsforworkplacehealthandsafety.TheseregulationsrequireuseofPPEinhealthcaresettingstoprotecthealthcarepersonnelfromexposuretobloodbornepathogensandMycobacteriumtuberculosis.However,underOSHA’sGeneralDutyClausePPEisrequiredforanypotentialinfectiousdiseaseexposure.EmployersmustprovidetheiremployeeswithappropriatePPEandensurethatPPEisdisposedor,ifreusable,thatitisproperlycleanedorlaundered,repairedandstoredafteruse.TheemployermustcoverthepurchaseandcleaningcostsforthePPEforallpersonnel.

TheCentersforDiseaseControlandPrevention(CDC)issuesrecommendationsforwhenandwhatPPEshouldbeusedtopreventexposuretoinfectiousdiseases.

OSHAissuesworkplacehealthandsafetyregulations.RegardingPPE,employersmust:

• ProvideappropriatePPEforemployeesatnocosttotheemployees.• EnsurethatPPEisdisposedofproperly;or,ifreusable,theemployerensuresthatthe

PPEiscleaned,laundered,repaired,andstoredafteruse.

OSHAalsospecifiescircumstancesforwhichPPEisindicated.TheCDCrecommendswhen,what,andhowtousePPEforHCWs.

TypesofPPEUsedinHealthCareSettings:(62)

§ Gloves–protecthands§ Gowns/aprons/labcoats–protectskinand/orclothing

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§ Masksandrespirators–protectmouth/nosefrominfectioussubstances§ Goggles–protecteyes§ Faceshields–protectface,mouth,nose,andeyes

GlovesarethemostcommontypeofPPEusedinhealthcaresettings.Mostpatientcareactivitiesthatinvolvemucusmembranes,blood,orOPIMrequiretheuseofasinglepairofnonsterileglovesmadeofeithernitrileorvinyl.AvoidtheuseoflatexglovesduetopatientandHCWallergies.Glovesshouldfittheuser’shandscomfortably–theyshouldnotbetoolooseortootight.Theyalsoshouldnottearordamageeasily.GlovesprotecttheHCWagainstcontactwithinfectiousmaterials.However,oncecontaminated,glovescanbecomeameansforspreadinginfectiousmaterialstoyou,otherpatientsorenvironmentalsurfaces.Glovesdonotpreventneedlestickinjuries.

UnderStandardPrecautions,glovesshouldbeusedwhentouchingblood,bodyfluids,secretions,excretions,orcontaminateditemsandfortouchingmucousmembranesandnon-intactskin.(62)

Are gloves needed for acupuncture needle insertion? Glovesgenerallydonotneedtobeusedtoinsertanacupunctureneedle.Glovesneedtobeused,however,whenbloodorOPIMisexpectedtobepresentduringahealthcareprocedureandwhenperformingproceduresonareasofmucusmembranes.(63,64)OccupationalSafetyandHealthAdministration(OSHA)regulationsdonotrequireglovestobewornwhenadministeringvaccinesunlessthepersonadministeringthevaccineislikelytocomeintocontactwithpotentiallyinfectiousbodyfluidsorhasopenlesionsonthehands.(65)AccordingtotheWorldHealthOrganization(WHO),routineintradermal,subcutaneous,andintramuscularinjectionadministrationdoesnotrequiretheuseofglovesifthehealthworker’sskinisintact.(46)Acupunctureneedleinsertionissimilartoasubcutaneousorintramuscularneedleinsertion.Sincebleedingoccursonlyextremelyrarelyduringneedleinsertion,glovesarenotneededforacupunctureneedleinsertion.

ThisinterpretationwasechoedinaletterfromOSHAtoaninquiryofMay11,2005,fromtheDirectoroftheDepartmentofVeteransAffairsregardingtheuseofglovesforacupuncture:

AccordingtotheWHO,theneedlepenetrationusedforacupunctureisdescribedtobesimilartoasubcutaneousorintramuscularinjection.Ingeneral,OSHAdoesnotconsideritnecessarytousegloveswhengivingsubcutaneousorintramuscularinjectionsaslongasbleedingthatcouldresultinhandcontactwithbloodorOPIMisnotanticipated.Thesamewouldbetruewithacupunctureproceduresaslongascontactwithbloodisnotanticipated.(66)

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Averyfewpointlocationsdorequiregloveuseduringneedlingduetotheirlocationonornearmucousmembranes.TheseincludeRen1(Huiyin),Du1(Changqian),Du27(Duiduan),Du28(Yinjiao),JinjinandYuye(M-HN-20).

Are gloves needed for acupuncture needle removal? Ingeneral,thereisnoneedtousegloveswhenremovinganacupunctureneedle.Theriskofbleedingduringmostacupunctureneedleremovalislessthan4%.(67)Thereisgenerallynoneedforglovesduringneedleremoval.However,sometypesofneedlingofthescalporearsmayincreasetheriskforbleeding.Further,OSHAstatesthat“Ifanemployeeisrequiredtocleananddresstheacupuncturesitesfollowingtheextractionoftheneedlesandanybleedingisanticipated,thenglovesmustbewornwhendoingso.”(66)

Pleasenotethatlikeneedleinsertion,removingneedlesfrompointslocatedinornearmucousmembranesdoesrequiretheuseofgloves.

UnderOSHABBPstandard29CFR1910.1030,acupuncturistsmustfollowemployerpoliciesandproceduresaboutwhenglovesneedtobeused.AccordingtoOSHA,“anemployermustestablishpoliciestoimplementthisprovision(29CFR1910.1030(c)).Theindividualemployeeperformingacupuncturedoesnotmakethedeterminationwhetherglovesaretobeworn.”(68)Ifanacupuncturistisself-employed,heorsheshouldhaveasetofguidelinestofollowregardingtheuseofglovesforallprocedures.

AdditionalCDCguidelinesforwearinggloves(60)include:

• Weargloveswithfitanddurabilityappropriatetothetask.• Weardisposablemedicalexaminationglovesfordirectpatientcare.• Removeglovesaftercontactwiththepatientand/ormedicalequipmentorthe

environment(roomsurfaces).• Donotwearthesameglovesforthecareofmorethanonepatient.• Removeglovesusingpropertechniquetopreventhandcontamination.

Notethathandwashingisrequiredafterremovalofgloves.Itiscriticalthatproperhandhygieneispracticedalongwithgloveusetobestprotecthealthcarepersonnel.(61)

Goggles:

Gogglesprovidebarrierprotectionfortheeyes;personalprescriptionlensesdonotprovideoptimaleyeprotectionandinmostcircumstancesshouldnotbeusedasasubstituteforgoggles.Gogglesshouldfitsnuglyoverandaroundtheeyes.GogglespreventthesplashingofbloodorOPIMintotheeyes.Theyalsokeephandsthatmaybecontaminatedfromhealthcarepracticesfromtouchingtheeyes.

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Gogglesorafaceshieldshouldbeusedduringpatientcareactivitiesthatarelikelytogeneratesplashesandspraysofblood,bodyfluids,secretions,orexcretions.ExamplesinAOMincludebleedingtechniques,includingwetcupping.

LabCoats:Labcoatsarepersonalprotectiveequipmentandshouldbeworninthelabwhenworkingwithchemicalsandbiologicalstoprotecttheskinandclothingfromsplatterandspills.Appropriatelabcoatsshouldbefullybuttonedwithsleevesrolleddown.Inordertopreventthespreadofcontaminantsdonotwearlabcoatsinpublicplaces,suchasoffices,lunchrooms,loungeareas,orelsewhereastheycantransferhazardousmaterialsandcontaminatetheseareas.Donotbringlabcoatshomebecauseyoumaycontaminateothersinthehousehold.Donotlaunderlabcoatsathomeorwithotherclothing.LabcoatsusedforPPEshouldbelaunderedbyamedicalorlaboratorylaundryservice.(61)

InadditiontowearingPPE,youshouldalsousesafeworkpractices.AvoidcontaminatingyourselfbykeepingyourhandsawayfromyourfaceandnottouchingoradjustingPPE.Also,removeyourglovesiftheybecometornandperformhandhygiene(washhands)beforeputtingonanewpairofgloves.Youshouldalsoavoidspreadingcontaminationbylimitingsurfacesanditemstouchedwithcontaminatedgloves.

5. Needlestick Information(http://www.cdc.gov/niosh/docs/2000-108/)(69)

IfyouexperienceaneedlestickorsharpsinjuryorareexposedtothebloodorOPIMofa

patient,followthesesteps:

• Washneedlesticklocationsandcutswithsoapandwater.• Flushsplashestothenose,mouth,orskinwithwater.• Irrigateeyeswithcleanwater,saline,orsterileirrigants.• Seekmedicaladvicefromalicensedphysicianassoonaspossible.Notethatinsome

statessuchasNewYork,itisrecommendedthatsomeonewithaneedlestickinjurybe evaluatedwithinthefirst2hoursaftersuchanincident.(70,71)

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38.Boyce,J.M.,etal.,Proceedingsofthe9thAnnualSocietyforHealthCareEpidemiologyofAmericaMeeting,April18-20,1999,SanFrancisco,CA

39.29CFR1910.1030(d)(2)(iv),whichspecifiesthat“whenprovisionofhandwashingfacilitiesisnotfeasible,theemployershallprovideeitheranappropriateantiseptichandcleanserinconjunctionwithcleancloth/papertowelsorantiseptictowelettes.Whenantiseptichandcleansersortowelettesareused,handsshallbewashedwithsoapandrunningwaterassoonasfeasible.”

40.KhawajaR,SikandarR,QureshiR,JarenoR.RoutineSkinPreparationwith70%IsopropylAlcoholSwab:IsitNecessarybeforeanInjection?QuasiStudy.JLiaquatUMedHealthSciences(JLUMHS).2013;12(2)(May-Aug):109-14.

41.DannTC.Routineskinpreparationbeforeinjection:anunnecessaryprocedure.Lancet1969;2:96-7.

42.KoivistoJA,FeligP.Isskinpreparationnecessarybeforeinsulininjection?Lancet1978;1:1072-1073.

43.McCarthyJA,CovarrubisB,SinkP.Isthetraditionalalcoholwipenecessarybeforeaninsulininjection?DiabetesCare1993;16(1);402.

44.WorkmanB.Safeinjectiontechniques.NursingStandard1999;13(39):47-53.45.RotterM.Handwashingandhanddisinfection.MayhallCG.EdHospitalepidemiologyand

infectioncontrol,2ndEdition.Philadelphia.Lippincott,1999.46.WorldHealthOrganization.WHObestpracticesforinjectionsandrelatedprocedures

toolkit.http://whqlibdoc.who.int/publications/2010/9789241599252_eng.pdf.WHOLibraryCataloguing-in-PublicationData.2010.AccessedDecember2012.

47.Modlin,JohnF.,etal.Vaccinia(Smallpox)VaccineRecommendationsoftheAdvisoryCommitteeonImmunizationPractices(ACIP),2001.MMWRJune200150(RR10):1-25.

48.MallettJ,BaileyC.TheRoyalMarsdenNHSTrustManualofClinicalProcedures(5thed.)BlackwellScience:London1996.

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49.LawrenceJC.Theuseofalcoholicwipesfordisinfectionofinjectionsites.JournalofWoundCare1994;3(1):1-14.

50.DedgeonJA.Immunisation:PrinciplesandPractice.London.Chapman&Hall,1991.51.Simmons,R..Acupuncturewithsignificantinfection,ina‘well’patient.Acupuncturein

Medicine2006;24(1):37.52.Hageman,JeffreyMHS,DeputyChief,DivisionofHealthcareQuality,CDCAltantaGAto

DavidSale,ExecutiveDirectorCCAOM(copyonfileatCCAOMNationalOffice).2013.Letter.

53.CentersforDiseaseControlandPrevention.GuidelinesforthePreventionofIntravascularCatheter-RelatedInfections.http://www.cdc.gov/hicpac/BSI/05-bsi-background-info-2011.html.ReviewedApril1,2011.AccessedDecember2012.

54.BroganTV,BrattonSL,LynnAM.Thyroidfunctionininfantsfollowingcardiacsurgery:comparativeeffectsofiodinatedandnoniodinatedtopicalantiseptics.CritCareMed.1997Sep;25(9):1583-7.

55.CentersforDiseaseControlandPrevention.GuidelinesforPreventingtheTransmissionofMycobacteriumtuberculosisinHealth-CareSettings,2005.http://www.cdc.gov/mmwr/PDF/rr/rr5417.pdfMMWR2005;54(No.RR-17).AccessedApril2013.

56.OSHA.1910.1030Bloodbornepathogens.https://www.osha.gov/pls/oshaweb/owadisp.show_document?p_table=STANDARDS&p_id=10051.AccessedDecember2012

57.CentersforDiseaseControlandPrevention.PreventionStrategiesforSeasonalInfluenzainHealthcareSettings.CentersforDiseaseControl.http://www.cdc.gov/flu/professionals/infectioncontrol/healthcaresettings.htm.ReviewedJanuary9,2013.AccessedJanuary2013.

58.IppolitoG,PuroV,CarliG.TheRiskofOccupationalHumanImmunodeficiencyVirusInfectioninHealthCareWorkers:ItalianMulticenterStudy.ArchInternMed.1993;153(12):1451-1458.doi:10.1001/archinte.1993.00410120035005.

59.HICPACImmunizationofHealth-Careworkers:RecommendationsoftheAdvisoryCommitteeonImmunizationPractices(ACIP)andtheHospitalInfectionControlPracticesAdvisoryCommittee(HICPAC),MMR1997;46(No.RR18).

60.CentersforDiseaseControlandPrevention.GuidancefortheSelectionandUseofPersonalProtectiveEquipment(PPE)inHealthcareSettings.http://www.cdc.gov/hai/pdfs/ppe/ppeslides6-29-04.pdf.AccessedDecember2012.

61.OSHAFactSheet:PersonalProtectiveEquipment(PPE)ReducesExposuretoBloodbornePathogens.https://www.osha.gov/OshDoc/data_BloodborneFacts/bbfact03.pdf.2011.AccessedDecember2012.

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62.OSHAFactSheet:PersonalProtectiveEquipment.2003.http://www.osha.gov/Publications/osha3151.html.AccessedDecember2012.

63.CentersforDiseaseControlandPrevention.HealthcareInfectionControlPracticesAdvisoryCommittee(HICPAC).GuidelineforIsolationPrecautions:PrecautionstoPreventTransmissionofInfectiousAgentsinGuidelineforIsolationPrecautions2007.http://www.cdc.gov/hicpac/2007ip/2007ip_part3.html.ReviewedDecember29,2009.AccessedNovember2012.

64.CentersforDiseaseControlandPrevention.Guidelinesforenvironmentalinfectioncontrolinhealth-carefacilities:recommendationsofCDCandtheHealthcareInfectionControlPracticesAdvisoryCommittee(HICPAC).http://www.cdc.gov/hicpac/pdf/guidelines/eic_in_hcf_03.pdf.MMWR2003;52(No.RR-10):1–48.AccessedDecember2012.

65.CentersforDiseaseControlandPrevention.EpidemiologyandPreventionofVaccine-PreventableDiseases.AtkinsonW,WolfeS,HamborskyJ,eds.12thed.,secondprinting.WashingtonDC:PublicHealthFoundation,2012.PageD-4.http://www.cdc.gov/vaccines/pubs/pinkbook/downloads/appendices/appdx-full-d.pdf.AccessedFebruary2015.

66.Fairfax,RichardE,Director,OSHADirectorateofEnforcementPrograms,toJohnA.Hancock,Director,DepartmentofVeteransAffairs(copyonfileatCCAOMNationalOffice).ThisletterwasOSHA’sinterpretationof29C.F.R.1910.1030(d)(3)(ix).2005.Letter.

67.Park,Ji-EunLee,MyeongSoo;Choi,Jun-Yong;Kim,Bo-Young;Choi,Sun-Mi.Adverseeventsassociatedwithacupuncture:aprospectivestudy.JAlternComplementMed;Volume:16,Issue:9,Date:2010Sep,Pages:959-63.2010.

68.Kalinowski,DouglasJ.,Director,OSHADirectorateofCooperativeandStatePrograms,toDavidM.Sale,ExecutiveDirector,CCAOM(copyonfileatCCAOMNationalOffice)March8,2013.Letter.

69.CentersforDiseaseControlandPrevention.PreventingNeedlestickinjuriesintheHealthcareSettings.http://www..gov/niosh/docs/2000-108/pdfs/2000-108.pdf.DHHSNationalInstituteforOccupationalSafetyandHealth.(NIOSH)PublicationNo.2000-108.November1999.AccessedNovember2012.

70.Young,T.,Arens,F.J.,Kennedy,G.E.,Laurie,J.W.,&Rutherford,G.W.(2007).Antiretroviralpost-exposureprophylaxis(PEP)foroccupationalHIVexposure.InT.Young(Ed.),CochraneDatabaseofSystematicReviews.Chichester,UK:JohnWiley&Sons,Ltd.https://doi.org/10.1002/14651858.CD002835.pub3

71.PEPforOccupational|ExposuretoHIVGuideline-AIDSInstituteClinicalGuidelines.(n.d.).RetrievedJune19,2017,fromhttps://www.hivguidelines.org/pep-for-hiv-prevention/occupational/#tab_4.

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Part VI: Cleaning and Pathogen Reduction Techniques in Healthcare and AOM Practice Locations

TheWHO,CDCandOHSAstandardsforcleaninganddisinfectionapplytoalltypesofhealthcarepractices.Thesepracticesarenotspecifictoacupuncturepractices.Acupunctureschoolsandclinicsoffertraininginthepracticalapplicationsoftheseregulationsfortheacupuncturepractitioner.

Anacupuncturist’streatmentlocationshouldbekeptcleanandsanitary.OSHArequiresthattheworkplacebemaintainedinacleanandsanitaryconditionandthatthereisanappropriatewrittenscheduleforcleaninganddecontamination.Thecleanlinessofthegeneralenvironmentalsohasadirectimpactonthepractitioner’sabilitytocreateacleanfield.Ifacustodialcontractorisresponsibleforclinicmaintenance,thecontractormustbeinstructedregardingmaintenanceandthepresenceofbiohazardousmaterials.Theclinicmanagermustprovidewrittennotificationtocleaningcontractorsregardingthepresenceofcontaminatedsharpsandthepotentialforbloodbornecontamination.Asinkwithhotandcoldrunningwatermustbelocatedinornearthetreatmentrooms.Liquidhandsoapandpapertowelsmustbeavailableathandwashingstations.Alcohol-basedhandsanitizersmayalsobeavailable.

Single-use,disposabletowelsshouldbeusedtodrythehands.Cleanpapertowelsareappropriate.Anypaperorotherdisposablematerialusedasacoveringonachair,seat,couch,ortreatmenttable,andanytowel,cloth,sheet,gown,orotherarticlethatcontactsthepatient’sskinshouldbeclean,andshouldnotpreviouslyhavebeenusedinconnectionwithanyotherpatientunlesslaunderedbeforereuse.

Thetreatmentroomtabletops,shelvesandotherworkingsurfacesshouldhaveasmooth,impervioussurface,beingoodrepair,andbecleanedwithasuitabledisinfectantatleastonceadayandwhenevervisiblycontaminatedorwheneverapatientmayhavecontaminatedthesurfacebycomingincontactwiththesurfacedirectly.HepatitisBviruscansurviveonsurfacesforatleastoneweekatroomtemperature.(1)Treatmenttablesandchairsusedfortreatmentsneedtobedisinfectedbetweeneachpatientvisit.

1. Disinfectants Disinfectantsarerecommendedforofficesurfacesandequipment.Disinfectantsdonotkillallgermsorspores,buttheywillreducethedangerofinfection.EPA-registereddisinfectantsforclinicalsettingsneutralizemostviruses,includinghepatitisB.Thesesolutionslosestrengthovertimeandmustberemadeatspecifiedintervals,asperthemanufacturer’slabelinstructionsforthetypesofsurfacesbeingdisinfected.

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EPA-registereddisinfectantsforroomsurfacesandFDA-cleareddisinfectantsforreusablemedicaldevicesneedtobemixedasperpackagedirectionsforclinicalpracticesettings.Checkwiththemanufacturerfordilutionprotocolsandexpirationtimesoncommercialdisinfectants.Themanufacturer’sdirectionsmustbestrictlyfollowed.Disinfectantsmustbelabeledifnotintheoriginalbottle.Thelabelshouldstatewhatthesolutionis,whenitwasmixed,andtheconcentration.Useddisinfectantsmustbecarefullydiscardedaccordingtothemanufacturer’sinstructions.

Classifications of Disinfectants Chemicalgermicidesareclassifiedbyseveraldifferentsystems.TheEnvironmentalProtectionAgency(EPA)classifiesthemaccordingtoclaimsbythemanufacturer,buttheEPAdoesnotperformindependenttestsofefficacy.Itisimportant,therefore,tounderstandthemanufacturer’slabeltointerprettheusefulnessofaproductforitsstatedpurpose.PotentialconfusioninreadinglabelsisshowninthediscussionbelowcomparingCDCandEPAclassifications.

“Sterilant”isthetermusedtodescribeagermicidethatisusedinsuchawaythatitcanactuallysterilize.Thesamesubstance,calledasporicidebytheEPA,mightfunctionaseitherasterilantorahigh-leveldisinfectant,dependingonconcentration,contacttime,andthetemperatureatwhichitisused.Thesechemicalsarequitetoxicandarenotusedforofficecleaning/disinfecting.

TheCDCclassificationsystemestablishesthreecategoriesofitemsrequiringsterilizationanddisinfection:critical,semi-critical,andnon-critical.Theclassificationsrelatetowhatpartofapatienttheitemswillcontact.Criticalobjectsenterthevascularsystemoranysterileinternalpartofthebody.TheCDCclassifiesprocessesormethodstoachievetheselevelstobesterilants.Semi-criticalitemstouchmucusmembranesandnon-intactskin,andnon-criticalitemstouchintactskin.

Disinfectantsmaybeclassifiedashigh-leveldisinfectants,intermediate-leveldisinfectants,andlow-leveldisinfectants.“Sanitizers”(anEPAclassificationfrequentlyusedindiscussion)correspondtotheCDC’slow-leveldisinfectants.Productlabelsoftendescribethelevelofgermicidalactionintermsoftheinfectiousagentstheychallenge.

Types of Disinfectants

Chlorine and Chlorine Compounds ThemostprevalentchlorineproductsintheUnitedStatesareaqueoussolutionsof5.25%–6.15%sodiumhypochlorite.Theseproductshaveabroadspectrumofantimicrobialactivity,donotleavetoxicresidues,areunaffectedbywaterhardness,areinexpensiveandfastacting,and

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havealowincidenceofserioustoxicity.(2)Sodiumhypochloriteattheconcentrationusedinhouseholdbleach(5.25-6.15%)canproduceocularirritationororopharyngeal,esophageal,andgastricburns.(3)Otherdisadvantagesofhypochloritesincludecorrosivenesstometalsinhighconcentrations(>500ppm),inactivationbyorganicmatter,discoloringor"bleaching"offabrics,andreleaseoftoxicchlorinegaswhenmixedwithammoniaoracid(e.g.,householdcleaningagents).(4)Afterreviewingenvironmentalfateandecologicdata,EPAhasdeterminedthecurrentlyregisteredusesofhypochloriteswillnotresultinunreasonableadverseeventstotheenvironment.(5)Commercial,EPA-approveddilutionsofsodiumhypochloriteshouldbepreparedaccordingtomanufacturerinstructionsbutmayneedtobeusedwithin24hoursofpreparation.Followmanufacturerdirectionsforuseonbothsmooth,impervioussurfacesandporoussurfacesororganicmaterial.Practitionersneedtofollowlabeldirectionsfortheappropriateconcentrationsfornon-criticalandsemi-criticalreusabledevicesaswellasforcleaningofcommonsurfaceswithhypochloritesolutions.

TheCDCnolongeracceptshouseholdbleachasasuitableinstrumentdisinfectingsolutioninthehealthcaresetting.

Microbiocidal Activity Hypochloriteconcentrationsapprovedforuseonnon-criticalitemsandcommonsurfaceshaveabiocidaleffectonmycoplasmaandbacteriainseconds.(6)HigherconcentrationsarerequiredtokillM.tuberculosis,Clostridiumdifficilespores,andotherHAI.(7)Onestudyreportedthat25differentviruseswereinactivatedin10minuteswithhighconcentrationhypochloritesolution.(8)SeveralstudieshavedemonstratedtheeffectivenessofdilutedsodiumhypochloriteandotherdisinfectantstoinactivateHIV.(9)

Glutaraldehyde Glutaraldehydeisasaturateddialdehydethathasgainedwideacceptanceasahigh-leveldisinfectantandchemical.(2)Aqueoussolutionsofglutaraldehydeareacidicandgenerallyinthisstatearenotsporicidal.Onlywhenthesolutionis"activated"(madealkaline)byuseofalkalinizingagentstopH7.5–8.5doesthesolutionbecomesporicidal.Onceactivated,thesesolutionshaveashelf-lifeofminimally14days.(2)Glutaraldehydegivesoffvaporsthatarerespiratoryirritantsandcausecontactdermatitis.Ithaslimitationsinitsmycobacteriocidalactivityandcoagulatesbloodandtissuetosurfaces.(10)

Glutaraldehydeisusedmostcommonlyasahigh-leveldisinfectantformedicalequipmentsuchasendoscopes,dialyzers,transducers,anesthesiaandrespiratorytherapyequipment,andothermedicaldevicesthatenterthebody.Glutaraldehydeshouldnotbeusedforcleaningnoncriticalsurfacesbecausetheyaretootoxicandexpensive.

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Hydrogen peroxide Stabilizedhydrogenperoxidein6%to25%concentrationsisalsocapableofhigh-leveldisinfection.Thesubstanceisnottoxicanddoesnotneedhoodventilationforuse.Thehydrogenperoxidesoldover-the-counterinpharmaciesis3%andisoftenold,resultinginlesseffectivenessthanthatprovidedbyafresh3%peroxidesolution.Over-the-counterhydrogenperoxidesolutionswillnotsterilizeeffectively.(2)FDA-clearedhydrogenperoxidesolutionsareavailableundernumerousbrandnames,includingSporox.

Iodophors Iodinesolutionsortinctureshavebeenusedbyhealthprofessionalsprimarilyasantisepticsonskinortissue.Iodophors,ontheotherhand,havebeenusedbothasantisepticsanddisinfectants.FDAhasnotclearedanyliquidchemicalhigh-leveldisinfectantswithiodophorsasthemainactiveingredient.(2)

Phenol PhenolhasoccupiedaprominentplaceinthefieldofhospitaldisinfectionsinceitsinitialuseasagermicidebyListerinhispioneeringworkonantisepticsurgery.ManyphenolicgermicidesareEPA-registeredaslow-leveldisinfectantsforuseonenvironmentalsurfaces(e.g.,bedsidetables,bedrails,andlaboratorysurfaces)andnoncriticalmedicaldevices.PhenolicsarenotFDA-clearedashigh-leveldisinfectantsforusewithsemicriticalitems.(2)

EPA and FDA Approval of Disinfectants IntheUnitedStates,chemicalgermicidesformulatedassanitizers,disinfectants,orsterilantsareregulatedininterstatecommercebytheAntimicrobialsDivision,OfficeofPesticidesProgram,EPA,undertheauthorityoftheFederalInsecticide,Fungicide,andRodenticideAct(FIFRA)of1947.(11)UnderFIFRA,anysubstanceormixtureofsubstancesintendedtoprevent,destroy,repel,ormitigateanypest(includingmicroorganismsbutexcludingthoseinoronlivinghumansoranimals)mustberegisteredbeforesaleordistribution.

AlistofproductsregisteredwithEPAandlabeledforuseassterilantsortuberculocidesoragainstHIVand/orHBVisavailablethroughEPA'swebsiteat:http://www.epa.gov/oppad001/chemregindex.htm

AlistofFDAapprovedhigh-leveldisinfectantscanbefoundhere:http://www.fda.gov/medicaldevices/deviceregulationandguidance/reprocessingofreusablemedicaldevices/ucm437347.htm

Monitoring and Labeling of Disinfectants Alldisinfectantsshouldbehandledaccordingtothemanufacturer’sinstructions.Hypochloritesolutionsshouldbemadefreshdailyaccordingtotheuseforwhichthesolutionisintended.

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OSHAregulationsrequirethatcontainersofdisinfectantmustbelabeledifnotintheiroriginalbottle.Thelabelmustincludewhatthesolutionis,whenitwasmixed,anditsconcentration.AnMSDS(ManufactureSafetyDataSheet)shouldalwaysbeavailableincaseofaccidents.

2. Indications for Sterilization, High-Level Disinfection, and Low-Level Disinfection AccordingtotheCDC:(2)

• Sterilizationisrequiredforinstrumentsthatenternormallysteriletissueorthevascularsystem.

• Highleveldisinfectionisrequiredforequipmentthattoucheseithermucousmembranesornonintactskin.Afterhigh-leveldisinfection,rinseallitems.Usesterilewater,distilledorfilteredwater.Afterrinsing,dryandstoreinamannerthatpreventsrecontamination.

• Low-leveldisinfectionisrequiredfornoncriticalpatient-caresurfaces(treatmenttables,equipmenttrays)andequipment(e.g.,bloodpressurecuff)thattouchintactskin.Ensurethat,ataminimum,noncriticalpatientcaresurfacesaredisinfectedwhenvisiblysoiledandonaregularbasis(suchasafteruseoneachpatientoroncedailydependingonthetypeofsurfaceandthefrequencyofuse).

ReusablemedicalandAOMequipmentmustbedisinfectedbetweenuseonpatients.ThetablebelowhasguidelinesfordisinfectingasdescribedinCDCmaterials.(http://www.cdc.gov/HAI/prevent/sd_medicalDevices.html)

3. Cleaning Equipment

Reuse of Single-Use Medical Devices Thereuseofsingle-usemedicaldevicesdoesnotfollowbestpracticesforanAOMpracticefordevicesthatbreaktheskin.Beforethelate1970smostmedicaldevices(includingacupunctureneedles)wereconsideredreusable.However,theAIDSepidemicandthegrowingawarenessofHBVinfectionassociatedwithreusingmedicalsharpsrenderedsuchuseunacceptableintheU.S.Reuseofsingle-usedevicesinvolvesregulatory,ethical,medical,legalandeconomicissues.(12)Noacupuncturistshouldreuseneedlesorotherequipmentthatbreakstheskin.

Pre-cleaning of Reusable Medical Equipment Cleaningistheremovalofforeignmaterial(e.g.,soilandorganicmaterial)fromobjectsandisnormallyaccomplishedusingwaterwithdetergentsorenzymaticproducts.Thoroughcleaningisrequiredbeforelow-,intermediate-,orhigh-leveldisinfectionandsterilizationbecauseinorganicandorganicmaterialsthatremainonthesurfacesofinstrumentsinterferewiththe

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effectivenessoftheseprocesses.Also,ifsoiledmaterialsdryontotheinstruments,thedisinfectionorsterilizationprocessisineffective.

Instrument Cleaning ReusablemedicalandAOMequipmentmustbedisinfectedbetweenuseonpatients.SeeSafetyGuidelinesforDisinfectingReusableMedicalEquipmentasdescribedinCDCmaterialsabove.(http://www.cdc.gov/HAI/prevent/sd_medicalDevices.html)

Safety Guidelines for Disinfecting Reusable Medical Equipment SterilityCategoryofEquipment:

AcupuncturePracticeExamples

DisinfectantLevelRequiredbeforeReuse

DisinfectingProcedure

Non-Critical

BPcuff,Stethoscope,e-stimclips.

Loworintermediatedisinfectingagentsacceptable.

Fabricequipment(BPcuffs)maybedisinfectedwithisopropylalcoholEPAapprovedsolutionsfornon-criticalitems.Smoothsurfacescanbedisinfectedthrough2steps:soapandwatercleansingfollowedbywipingwithaloworintermediatedisinfectingagent.

Cupsorguashatoolsusedoverintactskin.

Intermediatedisinfectingagentsrequired.

Step1Removalofallbiologicalandforeignmaterial(e.g.,soil,organicmaterial,skincells,lubricants)fromobjectsusingsoapandwater.Step2SoakinappropriateFDA-cleareddisinfectantforthetimeindicatedforreusableequipment.Followlabeldirectionsforuseasanintermediatedisinfectingagent.

Semi-Critical

Allcupsusedforwetcupping;cupsandguashaspoonsusedonnon-intactskin.

Sterilizebeforereuse;orhigh-leveldisinfectantrequired.

Step1Removalofallbiologicalandforeignmaterial(e.g.,soil,organicmaterial,skincells,lubricants)fromobjectsusingsoapandwater.Step2Option1:Autoclave.Option2:Soakinhigh-leveldisinfectant(e.g.,Sporox,Sterrad,Acecide,Endospore,Peract)asperproductlabelinstructions.

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SterilityCategoryofEquipment:

AcupuncturePracticeExamples

DisinfectantLevelRequiredbeforeReuse

DisinfectingProcedure

ReusableCritical

Equipmentthatbreakstheskinorentersthevascularsystem;NoAOMequipmentfallsinthiscategory.

Mustbesterilized.

Example:autoclave.

SterilityCritical;non-reusable

Needles,7-starhammers,lancets,presstacks,earseeds.

Cannotbereused.

Example:ethyleneoxidegas.

Instrumentsusedinperforminginvasiveproceduresshouldbeappropriatelysterilizedpriortouse.AllinstrumentsthatentertheskinforAOMproceduresshouldbesingle-usepre-sterilizedequipment.

Equipmentanddevicesthatdonottouchthepatientorthatonlytouchintactskinofthepatientneedonlybecleanedwithalow-leveldisinfectantordetergent.

Equipmentanddevicessuchascupsandguashatoolsthathavetouchedintactskin,butwherethatskinhasbeensubjectedtocompressionshouldbecleanedwithatleastintermediateleveldisinfectants.Contaminatedequipmentthatisreusableshouldbecleanedofvisibleorganicmaterialbywashingandscrubbingwithsoapandwater,andthendisinfectedusinganintermediate-leveldisinfectingsolution(suchasCaviCide,Sterilox,Spor-Klenz,DisCide,orSuperSani-Cloth).Wheneverthetoolswillbeplacedovernonintactskin(suchasincuppingafterneedlingorwetcupping),theyneedtobetreatedassemi-criticalreusabledevices.Inthesecases,theequipmentneedstobecleanedwithsoapandwatertoremovethelubricant(ifused)andbiologicalmaterialbeforedisinfectingwithanFDA-clearedhigh-leveldisinfectingsolution(e.g.,Sporox,Sterrad,Acecide,Endospore,orPeract),orautoclaved.

Thecurrentcontroversyisabouthowoftentheskinbarrieriscompromisedwhenusingequipmentsuchascupsandguashatools.Ina2014articleNielsenetal.maintains,“GuashaandBaguan[cupping]instrumentshavebeenmistakenasnon-criticalinstrumentsbecausetheyappeartocontact‘intact’skin.However,thecontactisnotincidentalbutinvolvesenoughrepeatedorsustainedpressureasto(intentionally)causeextravasationofbloodandfluidsthatcanseeporbeletfromtheskinevenifnotimmediatelyvisible.”(13)Morestudiesneedtobe

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performedtodeterminehowfrequentlytheintactskinisdisruptedincuppingproceduresnotassociatedwithbleedingandguashatechniques.Takingintoconsiderationthepotentialrisktopatients,itistheeditor’sopinionthatisprudenttoconsiderhigh-leveldisinfectionofallcupsandguashainstrumentsuntiladditionalstudiesarecompletedtodemonstratethedegreetowhichcuppingandguashacompromisetheskinbarrier.Havingonemethodofdisinfectionincreasesthepracticalconsiderationsthatthepractitionerwillalwayshavepreparedandbeusingdevicesthathavebeenproperlydisinfected.

Wrappingorpackaginghelpstoidentifythatproperdisinfectionhasbeencompletedandpreventscontactcontaminationthatmayoccurbydirectlyplacingthedeviceinatravelkitoronacounter.

4. Clean Use of Lubricants Lubricantsinopen-mouthjarscanbecomecontaminatedbythetransientbacteriafromthepractitioner’shands.Topreventthis,eitherusepumporsqueezebottlesoflubricantsforusewithcuppingorguasha,ordecantatreatment-sizedportionoflubricantintoasmalldisposablecuporothercleandisposablecontainerusingacleantonguedepressororothercleandisposabledevicepriortostartingtheprocedure.Disposeofleftoverlubricantwithoutreturninganylubricanttotheprimarycontainer.Thispreventscontaminationoftheprimarylubricantcontaineranditscontents.

5. Cleaning and Disinfecting Environmental Surfaces in Healthcare Facilities

• Cleanhousekeepingsurfaces(e.g.,floors,tabletops)onaregularbasis(e.g.,daily,oratleastthreetimesperweek),whenspillsoccur,andwhenthesesurfacesarevisiblysoiled.

• Followmanufacturers'instructionsforproperuseofdisinfectingproducts—suchasrecommendeduse-dilution,materialcompatibility,storage,shelf-life,andsafeuseanddisposal.

• Cleanwalls,blinds,andwindowcurtainsinpatient-careareaswhenthesesurfacesarevisiblycontaminatedorsoiled.

• Decontaminatemopheadsandcleaningclothsregularlytopreventcontamination(e.g.,launderanddryatleastdaily).

• Detergentandwaterareadequateforcleaningsurfacesinnonpatient-careareas(e.g.,administrativeoffices).

• Donotusehigh-leveldisinfectants/liquidchemicalsterilantsfordisinfectionofnon-criticalsurfaces.

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• DisinfectnoncriticalsurfaceswithanEPA-registeredhospitaldisinfectantaccordingtothelabel'ssafetyprecautionsandusedirections.

• Promptlycleananddecontaminatespillsofbloodandotherpotentiallyinfectiousmaterials(OPIM).Discardblood-contaminateditemsinthebiohazardcontainersaspercompliancewithfederalregulations.

Use of Disinfectants for Surface Cleaning Theeffectiveuseofdisinfectantsispartofanyhealthcaresettingstrategytopreventhealth-care–associatedinfections(HAI).Surfacessuchasfloorsanddoorhandlesareconsiderednoncriticalitemsbecausetheycontactintactskin.Contactwithnoncriticalsurfacescarriesonlyaminorriskofcausinganinfectioninpatientsorstaff,(14)primarilyHAIsuchasinfluenza.Medicalequipmentsurfaces(e.g.,bloodpressurecuffsandstethoscopes)canbecomecontaminatedwithinfectiousagentsandmaycontributetothespreadofhealth-care–associatedinfections.Forthisreason,noncriticalmedicalequipmentsurfacesshouldbedisinfectedwithanEPA-registered(forsurfaces)/FDA-cleared(formedicaldevices)low-orintermediate-leveldisinfectant(e.g.CaviCide,Sani-Dex,DisCide,orSterilox)betweeneachpatientuse.

6. Blood or Body Fluid Spills TheCDCrecommendsdecontaminationofspillsofbloodorotherpotentiallyinfectiousmaterials(OPIM),usingthefollowingprocedures:(2)

• UseprotectiveglovesandotherPPE(e.g.,whensharpsareinvolvedusehemostatstopickupsharps,anddiscardtheseitemsinapuncture-resistantcontainer)appropriateforthistask.

• Washtheareawithsoapandwaterfirst.

• Disinfectareascontaminatedwithblood/OPIMspillsusinganEPA-registeredcommercialhypochloritesolution.Followmanufacturer’slabeldirectionsforspillsbasedonthetypeofsurface(porousornon-porous)andtheamountofbloodpresent.

• Ifthespillcontainslargeamountsofbloodorbodyfluids,cleanthevisiblematterwithdisposableabsorbentmaterial,anddiscardthecontaminatedmaterialsinappropriate,labeledbiohazardouswastecontainer.

Cleaningaccidentalspillsofbloodorbodyfluid(orOPIM)requiresathree-stepprocedure:(1)Usingrubbergloves,pickupthevisiblematterwithdisposableabsorbentmaterial;then(2)cleantheareawithadetergentsoapandwater;then(3)cleantheareaofthespillwithanapproveddisinfectingsolutionappropriatetothetypeofsurfacebeingdisinfected.Useagownorimperviousapronifthereisariskofcontaminatingyourclothingduringtheclean-up.Where

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theremaybeariskofsplashingoraverylargespill,safetyglassesandadisposableorsterilizableclothingprotectorshouldbeworn.Whendisinfectinganextensiveareawithdisinfectingsolution,disposableglovesmaynotbeadequateandmayfailduringthedisinfectingprocess.Heavierglovesshouldbewornifthisisapossibility.Alldisposablematerialsusedinthecleanupjobshouldbediscardedindoublewrappinginbiohazardbagsorcontainers;andhandsshouldbewashedattheendofthecleanup.

Whencleaningaccidentalspillsofneedlescontaminatedwithblood,pickuptheneedlesusingglovesandhemostatsfirstanddiscardtheseintoanappropriatesharpscontainer,thenfollowthedirectionsabovetodealwiththebloodorOPIMspill.

7. Laundering Sheets, Towels or Other Linens Alllinens,gowns,etc.,mustbechangedbetweenpatienttreatments/visits.Thisincludesthesheetsonatreatmenttable,evenifprotectedbyalayeroftablepaper.Unlessapatientisfullyclothedinstreetclothesduringthetreatment,alllinensoranyothermaterialsuchasMylar“space”blankets,thatareusedoverthepatientfordrapingorwarmthmustalsobechangedbetweenpatients.

Clothgowns,sheets,etc.aresafeforreuseafterlaunderingwithhotwaterandsoapordetergent.Addinghypochlorite(bleach)solutiontothewashprovidesanextramarginofsafety.

Acupuncturepracticelocationsthatuseahighvolumeoflinensmaywanttoconsidertheuseofacommerciallaundryfacilityforwashingtowelsandlinens.Commerciallaundryfacilitiesoftenusewatertemperaturesofatleast160°Fand50-150ppmofchlorinebleachtoremovesignificantquantitiesofmicroorganismsfromgrosslycontaminatedlinen.Inthehome,normalwashinganddryingcycles,includinghotorcoldcycles,areadequatetoensurepatientsafety.Instructionsofthemanufacturersofthemachineandthedetergentorwashadditiveshouldbefollowedclosely.(15)

Commercialdrycleaningoffabricssoiledwithbloodalsorenderstheseitemsfreeoftheriskofpathogentransmission.

8. Sharps and Non-Sharps Biohazard Equipment and Disposal (Seealsohttp://www.cdc.gov/niosh/docs/97-111/andOccupationalSafetyandHealthActof1970[OSHAAct]ortherequirementsof29CFR1910.1030,OccupationalExposuretoBloodbornePathogens.)

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Sharpscontainersmusteitherbelabeledwiththeuniversalbiohazardsymbolandtheword"biohazard"orbecolor-codedred.Sharpscontainersmustbemaintaineduprightthroughoutuse,replacedroutinely,andnotbeallowedtooverfill.Also,thecontainersmustbe:

• Closedimmediatelypriortoremovalorreplacementtopreventspillageorprotrusionofcontentsduringhandling,storage,transport,orshipping.

• Placedinasecondarycontainerifleakageispossible.Thesecondcontainermustbe:o Closable.o Constructedtocontainallcontentsandpreventtoleakageduringhandling,

storage,transport,orshipping.• Labeledorcolor-codedaccordingtothestandard.• Reusablecontainersmustnotbeopened,emptied,cleanedmanually,orusedinany

othermannerthatwouldexposeemployeestotheriskofpercutaneousinjury.• Uponclosure,ducttapemaybeusedtosecurethelidofasharpscontainer,aslongas

thetapedoesnotserveastheliditself.

Sharpscontainersmustbeeasilyaccessibletoemployeesandlocatedascloseasfeasibletotheimmediateareawheresharpsareused(e.g.,patientcareareas).

Moststateshaveregulationregardingthetypesofsharpscontainersthatmaybeusedandtheappropriatedisposalofthesharpscontainers.Contactyourlocalhealthdepartmentforhelpunderstandingtheregulations,checkthewebsitehttp://www.safeneedledisposal.org/,orcontactyourstate’sOSHAofficeforstate-specificdetails.

9. Regulated Waste TheBloodbornePathogensStandardusestheterm"regulatedwaste"torefertothefollowingcategoriesofwastewhichrequirespecialhandling:(1)liquidorsemi-liquidbloodorOPIM;(2)itemscontaminatedwithbloodorOPIMandwhichwouldreleasethesesubstancesinaliquidorsemi-liquidstateifcompressed;(3)itemsthatarecakedwithdriedbloodorOPIMandarecapableofreleasingthesematerialsduringhandling;(4)contaminatedsharps;and(5)pathologicalandmicrobiologicalwastescontainingbloodorOPIM.

Inthetypicalacupuncturepractice,thereisrarelyanyregulatedwastebesidesthatwhichgoesinthesharpscontainer.(Itemstobedisposedinthesharpscontainerincludetheacupunctureneedles,lancetsandplumblossomhammers.)Insometypesofpractice,thebloodfromwetcuppingwouldneedtobedisposedofinabiohazardbag,ratherthanthesharpscontainer.Also,anybloodspills,vomitorotherOPIMwouldbedisposedofinabiohazardbag.

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Disposal Disposalofallregulatedwastemustbeinaccordancewithapplicablestateregulations.Theserulesaretypicallypublishedbystateenvironmentalagenciesand/orstatedepartmentsofhealth.Inadditiontostaterulesfordisposingofregulatedwaste,therearebasicOSHArequirementsthatprotectworkers.TheOSHArulesstatethatregulatedwastemustbeplacedincontainerswhichare:

• Closable.• Constructedtocontainallcontentsandpreventleakageoffluidsduringhandling,

storage,transportorshipping.• Labeledorcolor-codedinaccordancewiththestandard.• Closedpriortoremovaltopreventspillageorprotrusionofcontentsduringhandling,

storage,transport,orshipping.• Ifoutsidecontaminationoftheregulatedwastecontaineroccurs,itmustbeplacedina

secondcontainermeetingtheabovestandards.

Contaminated Laundry Contaminatedlaundrymeanslaundrywhichhasbeensoiledwithbloodorotherpotentiallyinfectiousmaterialsormaycontainsharps.

Contaminatedlaundrymustbehandledaslittleaspossiblewithaminimumofagitation;itmustbebaggedorcontainerizedatthelocationwhereitwasusedandmustnotbesortedorrinsedinthelocationofuse.OtherrequirementsoftheBBPstandard1910.1030(d)(2)include:(16)

• Contaminatedlaundrymustbeplacedandtransportedinbagsorcontainerslabeledandcolor-codedinaccordancewiththebloodbornepathogensstandard.

• Whenevercontaminatedlaundryiswetandpresentsareasonablelikelihoodofsoak-throughorleakagefromthebagorcontainer,thelaundryshallbeplacedandtransportedinbagsorcontainerswhichpreventsoak-throughand/orleakageoffluidstotheexterior.

• Theemployermustensurethatemployeeswhohavecontactwithcontaminatedlaundrywearprotectiveglovesandotherappropriatepersonalprotectiveequipment.

• Whenafacilityshipscontaminatedlaundryoff-sitetoasecondfacilitywhichdoesnotutilizeStandardPrecautionsinthehandlingofalllaundry,thefacilitygeneratingthecontaminatedlaundrymustplacesuchlaundryinbagsorcontainerswhicharelabeledorcolor-codedinaccordancewiththestandard.

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• Employeesarenotpermittedtotaketheirprotectiveequipmenthomeandlaunderit.Itistheresponsibilityoftheemployertoprovide,launder,clean,repair,replace,anddisposeofpersonalprotectiveequipment.

Summary of Recommendations – Part VI • Critical:Allinstrumentsthatbreaktheskinshouldbesingle-usepre-sterilized

equipment.• Critical:Neverreusesingle-usemedicaldevices.• Critical:Ifacustodialcontractorisresponsibleforclinicmaintenance,thecontractor

mustbeinstructedregardingmaintenanceandthepresenceofbiohazardousmaterials.• Critical:Asinkwithhotandcoldrunningwatermustbelocatedinornearthetreatment

rooms.• Critical:DisinfectsurfacesonlywithproductsregisteredwithEPAandlabeledforusein

thehealthcareoffice.• Critical:Cleanhousekeepingsurfaces(e.g.,floors,doorhandlesandlightswitches)

immediatelywhenspillsoccur,andwhenthesesurfacesarevisiblysoiled.• Critical:Promptlycleananddecontaminatespillsofbloodandotherpotentially

infectiousmaterials(OPIM).Discardblood-contaminateditemsinthebiohazardcontainersincompliancewithfederalregulations.

• Critical:Cupsandguashaequipmentthathavebeencontaminatedandarereusableshouldbecleanedofvisibleorganicmaterial,thendisinfectedusingappropriateintermediate-orhigh-leveldisinfectingsolution,thenrinsedanddriedbeforebeingreused.

• Critical:Tablepaperanddrapingmustbechangedbetweeneachpatientvisit.• Critical:Sharpscontainersmusteitherbelabeledwiththeuniversalbiohazardsymbol

andtheword"biohazard"orbecolor-codedred.• Critical:Sharpscontainersmustbemaintaineduprightthroughoutuse,replaced

routinely,andnotbeallowedtooverfill.• StronglyRecommended:Noncriticalmedicalequipmentsurfaces(e.g.,bloodpressure

cuffs,treatmenttables)shouldbedisinfectedwithanEPA-registeredlow-orintermediate-leveldisinfectantbetweeneachpatientuse,followinglabeldirections.

• StronglyRecommended:Theclinicalworkplacemustbemaintainedinacleanandsanitaryconditionandtheremustbeanappropriatewrittenscheduleforcleaninganddecontamination.

• StronglyRecommended:Thetreatmenttabletops,shelvesandotherworkingsurfacesshouldbecleanedwithasuitabledisinfectantatleastonceadayandwhenevervisiblycontaminatedorwheneverapatientmayhavecontaminatedthesurfacebycomingincontactwiththesurfacedirectly.

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• StronglyRecommended:Alllinens,gowns,etc.,mustbechangedbetweenpatienttreatments/visits.

• Recommended:Thetreatmenttabletops,shelvesandotherworkingsurfacesshouldhaveasmooth,impervioussurfaceandbeingoodrepair.

• Recommended:Low-leveldisinfectantsshouldbeusedforcleaningofficesurfaces,notjustdetergents.

References 1.USCoastguard.BloodbornePathogens.http://www.coastusd.org/wordpress/wp-

content/uploads/bloodborne-pathogens1.pdf.AccessedJanuary2013.2.CentersforDiseaseControl.HealthcareInfectionControlPracticesAdvisoryCommittee

(HICPAC).GuidelineforDisinfectionandSterilizationinHealthcareFacilities,2008.http://www.cdc.gov/hicpac/Disinfection_Sterilization/3_4surfaceDisinfection.html.AccessedJanuary2013

3.WeberDJ,RutalaWA.Occupationalrisksassociatedwiththeuseofselecteddisinfectantsandsterilants.In:RutalaWA,ed.Disinfection,sterilization,andantisepsisinhealthcare.Champlain,NewYork:PolysciencePublications,1998:211-26.

4.MrvosR,DeanBS,KrenzelokEP.Homeexposurestochlorine/chloraminegas:reviewof216cases.South.Med.J.1993;86:654-7.

5.R.E.D.Factssodiumandcalciumhypochloritesalts.EnvironmentalProtectionAgency.1991.http://www.epa.gov/oppsrrd1/REDs/factsheets/0029fact.pdf.AccessedJanuary2013.

6.DychdalaGR.Chlorineandchlorinecompounds.In:BlockSS,ed.Disinfection,sterilization,andpreservation.Philadelphia:LippincottWilliams&Wilkins,2001:135-157.

7.PerezJ,SpringthorpeS,SattarSA.ActivityofselectedoxidizingmicrobicidesagainstsporesofClostridiumdifficile:Relevancetoenvironmentalcontrol.Am.J.Infect.Control2005;33:320-5

8.KleinM,DeForestA.Theinactivationofvirusesbygermicides.Chem.SpecialistsManuf.Assoc.Proc.1963;49:116-8

9.SattarSA,SpringthorpeVS.Survivalanddisinfectantinactivationofthehumanimmunodeficiencyvirus:acriticalreview.Rev.Infect.Dis.1991

10.Rutala,William,DisinfectionandSterilizationinHealthCareSettings:WhatCliniciansNeedtoKnow,CID2004:39,HealthCareEpidemiology.http://www.hpci.ch/files/documents/guidelines/hh_gl_disinf-sterili-cid.pdf.AccessedJanuary2013.

11.SandersFT,MorrowMS.TheEPA'sroleintheregulationofantimicrobialpesticidesintheUnitedStates.In:RutalaWA,ed.Disinfection,sterilizationandantisepsis:Principles,practices,challenges,andnewresearch.Washington,DC:AssociationforProfessionalsinInfectionControlandEpidemiology,2004:29-41.

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12.GreeneVW.Reuseofdisposabledevices.In:MayhallCG,ed.Infect.ControlandHosp.Epidemiol.Philadelphia:LippincottWilliams&Wilkins,1999:1201-8

13.NielsenA,KliglerB,KollBS.Safetyprotocolsforguasha(press-stroking)andbaguan(cupping).ComplementTherMed.2012;20(5)(October):340-344.

14.CentersforDiseaseControlandPrevention.GuidancefortheSelectionandUseofPersonalProtectiveEquipment(PPE)inHealthcareSettings.http://www.cdc.gov/hai/pdfs/ppe/ppeslides6-29-04.pdf.AccessedDecember2012.

15.CentersForDiseaseControlandPreventionHealthcare-associatedInfections(HAIs).Laundry:WashingInfectedMaterial.CentersforDiseaseControl.http://www.cdc.gov/HAI/prevent/laundry.htmlReviewedJanuary27,2011.AccessedFebruary2015.

16.OccupationalHealthandSafetyAdministration(OSHA).NeedlestickSafetyandPreventionAct.FrequentlyAskedQuestions.http://www.osha.gov/needlesticks/needlefaq.html.AccessedApril2013

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Part VII: Office Procedures for Risk Reduction

Thissectionaddressesfederalandotherlegalstandardsrequiredforambulatoryhealthcareoffices.Thisinformationisnotmeanttoreplaceschooltraininginpracticemanagement,buttoofferaresourceforpractitionerstolocatesourcesandexamplesforfederalstandardsfromOSHA,CDCandothersources.

Pleaseusethewebsitesreferencedhereinasneededtoidentifylegalstandardsandpracticesthatapplytoyourofficeorclinic.

Stateandlocalrulesandregulationsvary.Practitionersneedtokeepabreastofchangesinthelegallandscapeofhealthcarepracticeregulation.

Riskreductionisatermusedtodescribeavarietyoftechniquesemployedtoreducethelikelihoodandconsequencesofanunintendedevent,namelyanaccidentthatmayresultinrisktoorinjuryofpractitioners,otherclinicemployees,orthepublic.Thesetechniques,policies,andproceduresmayberecommended,ormandatedbystatuteorrule.Regardlessoforigin,riskreductionisaprocessofreducingtheprobabilityofanunintendedeventcausinginjury,loss,orlegalactionthatbringsharmtotheproviderorotherindividuals.Riskreductiontechniquesareforthemostpartcommonsense,whetherornottheyarerequiredbystatuteorrule,orarerecommended.ExamplesofriskreductiontechniquesincludetheuseofCNTandStandardPrecautionswitheverypatient.However,inadditiontocomplyingwiththespecificrequirementsofacupuncturepracticeacts,practitionersmustcomplywithlocal,state,andfederalstatutesregardinggeneralmedicalpracticesuchasinformedconsent,recordkeeping,patientconfidentiality,reportingofcommunicabledisease,andmaintenanceofanExposureControlPlan.Additionally,theprovidermustcomplywithothersafetyrequirements,suchas:

• HazardCommunicationStandardwithrespecttotoxicchemicalssuchasdisinfectantsandotherchemicalssuchasisopropanolintheworkplace.

• Firedepartmentregulationswithrespecttofireprotectionandelectricalsafety.

• Buildingandsafetycodeswhenmodifyingaclinicorofficespace.

• Stateandfederalstandardswithrespecttodocumentingsafety-relatedpoliciesandprocedures.

• Theproperdocumentationofaccidentsleadingtopropertyloss,injury,ordeath.

• Safeandlegalinteractionwithpatientswhomaybeadangertothemselvesorothers.

• Thepreventionofworkplaceviolence.

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• Completionofallmandatedreportingwithregardtosafety-relatedincidents.

Abroaddiscussionofthetopicofriskreductionisbeyondthescopeofthismanual.Thereaderisreferredtoanappropriateriskreductiontextformoreinformation.Practitionersmustalsocomplywithallrequirementsmandatedbystatestatutesthatallownon-physicianacupuncturiststopracticeacupunctureinthatstate.Theserulesincludecompliancewithstateorfederallawpertainingtoinformedconsent,recordkeeping,andpatientconfidentiality.ThisalsoincludestheHealthInsurancePortabilityandAccountabilityActof1996(HIPAA).Ethically,practitionersshouldpracticeinaccordancewiththesegeneralmedicalguidelines;nottodosomaycausepractitionerstobevulnerabletocivilandcriminalpenalties.

Includedinthismanualisasummaryofsomeoftheprinciplesofriskmanagement,especiallywheretheseideasaregermanetothepracticeofacupuncture.ThistextisnotintendedtoreplacecomprehensivetraininginanAOMprograminacupuncturerecognizedbytheAccreditationCommissiononAcupunctureandOrientalMedicine.

1. Federal Standards and Guidelines

OSHA: Bloodborne Pathogens Standard OSHAhasdevelopedprocedurestohelphealthcareworkersprotectthemselvesfromavarietyofpossibleinfections,includingHBVandHIV.Ingeneral,theseprecautionsincludetheuseofanappropriatebarrier(gloves,gowns,masks,goggles,etc.)topreventcontactwithinfectedbodyfluids.Additionally,standardsterilizationanddisinfectionmeasuresaswellasinfectiouswastedisposalproceduresmustbefollowed.

Thesepracticesareespeciallyimportantforallhealthcareprofessionalswhoparticipateininvasiveprocedures.Inadditiontogowns,gloves,andsurgicalmasks,protectiveeyewearorfaceshieldsshouldbewornwherethegenerationofdropletsorthesplashingofbodyfluidsispossible.Iftheprotectivebarrierbecomestorn,itshouldbereplacedimmediatelyorassoonaspatientsafetypermits.Intheeventofinjurytothehealthcarepractitioner,thebarriershouldberemovedandthewoundtreatedpromptly.Anysuchinjuryshouldalsobefollowedupwithanincidentreport.

SincemedicalhistoryandexaminationcannotreliablyidentifyallpatientsinfectedwithHBV/HIVorotherbloodbornepathogens,infectionpreventionmethodsshouldbeusedconsistentlyforallpatients.

Itisafactthatexposuretobloodbornepathogensposesasignificantrisktohealthcareworkersandtheirpatients.Thisexposurecanbeeliminatedorgreatlyreducedthroughworkpracticehabits,personalprotection,training,vaccination,labeling,andmedicalsurveillance.(1)Therefore,twofederalagencieshaveestablishedstandardsthatapplytoallmedical

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practitioners,includinglicensedacupuncturists.TheCDChasestablishedproceduresthataretobefollowedwithregardtooccupationalexposuretobloodbornepathogensinhealthcaresettingsintheUnitedStates.TheseproceduresareknownasStandardPrecautions.OSHAhascodifiedtheCDCstandardsintorecommendationsthatapplytoallhealthcareproviders.TheapplicationofStandardPrecautionsandtheotherprotocolsthatconstitutethebestpracticesforacupuncturistsintheUnitedStatesisreferredtoasCleanNeedleTechnique(CNT).ItisimportanttorememberthattheapplicationofCNTinaclinicalsettingisathoughtfulprocessbasedonanunderstandingofprinciplesratherthanaroteapplicationofmemorizedguidelines.

Standard Precautions StandardPrecautionsinclude:1)handhygiene,2)useofpersonalprotectiveequipment(e.g.,gloves,gowns,masks),3)safeinjectionpractices,4)safehandlingofpotentiallycontaminatedequipmentorsurfacesinthepatientenvironment,and5)respiratoryhygiene/coughetiquette.

(Seehttp://www.cdc.gov/HAI/settings/outpatient/outpatient-care-gl-standared-precautions.html(2)formoredetails.)AllhealthcareworkersshouldadheretoStandardPrecautions,includingtheappropriateuseofhandwashing,protectivebarriers,andcareintheuseanddisposalofneedlesandothersharpinstruments.Handsshouldbewashedbeforeandafterpatientcontact,andimmediatelyifhandsbecomecontaminatedwithbloodorotherbodyfluids.Handsshouldalsobewashedafterremovinggloves.Healthcareworkersshouldcomplywithcurrentguidelinesforhandwashingtoreducepossibletransientpathogenicorganismsfrombeingpassedbetweenpatients.Instrumentsandotherreusableequipmentusedinperforminginvasiveproceduresshouldbeappropriatelydisinfectedandsterilized.Glovesshouldbewornwheneverthereisapossibilityofcontactwithbodyfluids.(Bodyfluidstowhichstandard/universalprecautionsapply:blood,serum/plasma,semen,vaginalsecretions,cerebrospinalfluid,vitreousfluid,synovialfluid,pleuralfluid,pericardialfluid,peritonealfluid,amnioticfluid,andwoundexudates.)Healthcareworkerswhohaveexudativelesionsorweepingdermatitisshouldrefrainfromalldirectpatientcareandfromhandlingpatient-careequipmentanddevicesusedinperforminginvasiveprocedures.Sharpobjectsrepresentthegreatestriskforexposures.Contaminatedneedlesshouldneverbebent,clipped,orrecapped.Immediatelyafteruse,contaminatedsharpobjectsshouldbediscardedintoapuncture-resistantbiohazardcontainerdesignedforthispurpose.Needlecontainersshouldneverbeoverfilled;containersshouldbesealedanddiscardedwhentwo-thirdstothree-quartersfull.

NSPA TheNeedlestickSafetyandPreventionAct(NSPA)of2000givespractitionersandemployeesinhealthcarefacilitiesthepowertoparticipateinselectingandevaluatingdevicesthatwouldbemosteffectivefortheirownandtheirpatients’safety.Besidesrequiringtheuseofsafety-

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engineeredneedlesandsharpsdevicesintheworkplace,NSPArequiresemployerstodevelopandupdateexposure-controlplansannually.

BBPstandard1910.1030(d)(2)incorporatestheNSPAasan“amplification”ofOSHAstandards:[CPL2-2.69]“Whereexposurestobloodandotherpotentiallyinfectiousmaterials(OPIM)arereasonablyanticipatedandengineeringcontrolswillreduceemployeeexposureeitherbyremoving,eliminating,orisolatingthehazard,theymustbeused...Ifyouhavenotalreadyevaluatedandimplementedappropriateandavailableengineeringcontrols(safermedicaldevices),youmustdosoimmediately...and...theevaluation,implementation,anduse...mustbedocumentedintheemployer'sExposureControlPlan.”(3)

Thoseusingtherapeuticneedlingtechniques,bleedingtechniquesandothertypesofsharpinstrumentsinhealthcaresettingsmustevaluatetheircurrentuseofthesedevices.Employersandemployeesinhealthcaresettingsneedtoevaluateiftheycanshiftfromconventionaltosafety-engineereddevices(suchasauto-lancetsforbleeding)baseduponbestpractices.

Seehttp://www.osha.gov/needlesticks/needlefaq.htmlformoreinformationaboutNSPA.

OSHA: Exposure Control Plan Employersofhealthcareworkersareencouragedtoparticipateinthetaskofcontrollingrisksintheworkplace,includingthespreadofblood-bornepathogenssuchasHBV/HIV,bydisseminatingpreventiveinformationintheworkplacethroughadetailedexposurecontrolplan(ECP).Eachemployerhavinganemployee(s)withoccupationalexposuremustdevelopsuchaplandesignedtoeliminateorminimizetheincidenceofemployeeexposuretoworkplacerisks.

Practitionerswhohaveemployees,whethertheybeareceptionistoracustodian,whomaybeexposedtobloodbornepathogensbypullingneedles,emptyingthetrash,assistingpatientsindressingandundressing,shouldhaveanECP.ThisECPmustincludeinformationaboutpreventingthespreadofBBP,includingavailabilityofHBVvaccination,forallworkersinanacupuncturist’semploywhomaycomeincontactwithbloodorOPIM.Practitionerswhoshareofficespacewithotherpractitioners,includingatreatmentroomorstorageareaforbiohazardouswaste,mustalsodevelopanECP.

Allhealthcarepracticesmustcreate,maintain,updateandtrainallpersonnel(includingtheowner/acupuncturist)onpossibleexposurestoinfectiousagentsandotherhazards.Trainingmusttakeplacebeforepersonnelmaybeexposedtohazardsandagainannually.AllhealthcarefacilitiesmustmaintainanExposureControlPlanforBloodbornePathogens(BBP)aswellasaHazardousCommunicationPlanforchemicalexposures.(4)

Anexposurecontrolplan(ECP)forBBPconsistsof:

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1. WRITTENPOLICIES(Includingtheplan)2. PROGRAMADMINISTRATION(Nameofresponsibleofficerforpolicies,training,and

reports)3. EMPLOYEEEXPOSUREDETERMINATION(Listofemployeetitlesofthosethatmay

becomeexposed;includesanyonewhotreatspatientsorentersatreatmentroomwhereinalooseneedlemaybefound.)

a. Alistofjobclassificationswhereallemployeeshaveoccupationalexposure.b. Alistofjobclassificationswheresomeemployeeshaveoccupationalexposure.c. Alistofalltasksandprocedures(orcloselyrelatedgroupsofactivities)inwhich

occupationalexposureoccurs.4. METHODSOFIMPLEMENTATIONANDCONTROL

a. ExposureControlPlan.b. EngineeringControlsandWorkPractices:Includesrequirementsfor

handwashingfacilities,sharpscontainment,maintenanceanduseofworkareas,proceduresinvolvingbloodorpotentiallyinfectiousmaterials,andhandlingofequipmentthatmaybecomecontaminated.

c. PersonalProtectiveEquipment(PPE):Coverstheprovisionanduseofitemssuchasgloves,gowns,masks,andotherpiecesofclothingorequipmentwhenoccupationalexposureispossible.Latex-freeglovesmustbeprovidedifanemployeeisallergictolatex.

5. REGULATEDWASTEa. Housekeeping:Includesrequirementsformaintainingtheworksiteinacleanand

sanitarycondition.b. Sharpscontainmentanddisposal.c. Laundry:policiesandproceduresforcleaningalllaundryandpoliciesfor

handlingcontaminatedlaundry.d. Labels:forallcontainerswhichmayhavecontaminatedwasteorsharps.e. Disposalofbiohazardmaterialsandcontaminatedwaste.

6. HEPATITISBVACCINATION7. POST-EXPOSUREEVALUATIONANDFOLLOW-UP

a. Administrationofpost-exposureevaluationandfollow-up.b. Proceduresforevaluatingthecircumstancessurroundinganexposureincident.

8. EMPLOYEECOMMUNICATION:Includesstandardsforlabelsandsignssuchasbiohazardlabelsandwarningsigns,containers,andbags.

9. EMPLOYEETRAININGa. NewemployeesmustbeofferedahepatitisBvaccineandreceivebloodborne

pathogeneducationbeforehavingcontactwithbloodorbodyfluids.b. AllemployeesmustreceiveannualtrainingregardingtheOSHABBPstandard.

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10. RECORDKEEPINGa. Employeetraining(maintainforatleast3yearsafterthedurationof

employment).b. Medicalrecordsofthoseexposed(maintainforthedurationofemployment

PLUS30years).c. OSHARecordkeeping,includingmaintainingcontractsandreceiptsfor

biohazardouswastedisposal(maintainforaminimum5years).d. SharpsInjuryLog(logisreviewedaspartoftheannualprogramevaluationand

maintainedforatleastfiveyearsfollowingtheendofthecalendaryearcovered).

11. HEPATITISBVACCINEDECLINATIONSTATEMENT/POLICY(maintainforthedurationofemploymentPLUS5years)

TheECPshouldalsoprovideascheduleandmethodsforimplementingprecautionprocedures,andproceduresforevaluatingexposureincidents.Acopyoftheplanmustbemadeavailabletoallemployees.Theplanmustbereviewedandupdatedannually,orwheneverneworrevisedtasksorproceduresareaddedtothepractice,orifnewpositionsarecreatedthatmayhaveexposurepotential.

SampleECPsforBBPcanbefoundhere:

• http://www.osha.gov/Publications/osha3186.pdf(pdfversion)• http://www.osha.gov/Publications/osha3186.html(htmlversion)• http://www.osha.gov/OshDoc/Directive_pdf/CPL_2-2_69_APPD.pdf(specificsmall

businessplanversion)

OSHAdocumentsrelatingtoECPsinclude:

• http://www.osha.gov/pls/oshaweb/owadisp.show_document?p_id=1574&p_table=DIRECTIVES

• http://www.osha.gov/pls/oshaweb/owadisp.show_document?p_table=standards&p_id=10051

AmodelBBPECPandamodelHazardousCommunicationdocumentcanbothbefoundinthefollowingOSHApublication:

• http://www.osha.gov/Publications/osha3186.pdf

AdditionalinformationforthoseworkinginCaliforniacanbefoundhere:

• http://www.dir.ca.gov/dosh/dosh_publications/expplan2.pdf

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AsampleECPforTBcanbefoundhere:

• http://www.osha.gov/SLTC/etools/hospital/hazards/tb/sampleexposurecontrolplan.html

OSHA: Hazardous Communication

http://www.osha.gov/dsg/hazcom/index.html(5)

Inordertoensurechemicalsafetyintheworkplace,informationabouttheidentitiesandhazardsofthechemicalsmustbeavailableandunderstandabletoemployees.OSHA'sHazardCommunicationStandard(HCS)requiresthedevelopmentanddisseminationofsuchinformation.Allemployerswithhazardouschemicalsintheirworkplacesmusthavelabelsandsafetydatasheetsfortheirexposedworkers,andtrainthemtohandlethechemicalsappropriately.Thisincludesallhealthcare/acupuncturepracticesettingssinceallthedisinfectingandcleaningproductsusedtotreatcups,guashadevices,treatmenttablesandcountertopsfallintothisstandard.

AHazardousCommunicationPlanconsistsof:

1. CompanyPoliciesregardingchemicalexposures–writtenrecords2. ContainerLabeling–Listsoflabelsandplansforlabelingofchemicalsafterbeingputin

newcontainersorchanges3. ChemicalList–Listofallhazardouschemicalsfoundatthepracticelocation.Thiswill

includecleaningsolutions,alcoholforswabbing,andhandcleaningsolutions4. MaterialSafetyDataSheets(MSDSs)5. EmployeeTrainingandInformation6. HazardousNon-RoutineTasks(list)7. PoliciesregardingInformingOtherEmployers/Contractorswhomayenterthepremises

(e.g.,outsidecleaningagencies)8. Howtheemployerhastrainedandmadethispolicyandprogramavailabletoemployees

AsampleHazardousCommunicationpolicycanbefoundhere:http://www.osha.gov/Publications/osha3186.html

Anexcellentchecklistandmorereadableexplanationoftherequirementscanbefoundhere:

http://www.lni.wa.gov/IPUB/413-012-000.pdf

WhiletheabovechecklistisfromtheWashingtonStateoffices,theinformationcanbeusedforallacupuncturistslookingtocomplywiththeHazardousCommunicationStandard.

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OSHA: Other Hazards Duetotheuseofmoxa,standardsregardingindoorairqualityandfiresafetyapplytomostAOMpracticelocations.Arecentstudyontheaircontaminationrelatedtomoxapointstotheneedforsufficientventilationinacupuncturesettings.(13)Alistofthestandardsandtheirapplicationsshouldbereviewedbythepractice’ssafetyofficerannually.OSHAstandardscanbefoundhere:

Fire:• http://www.osha.gov/SLTC/firesafety/index.html• http://www.osha.gov/SLTC/etools/hospital/hazards/fire/fire.html• http://www.osha.gov/Publications/laboratory/OSHA3403laboratory-safety-

guidance.pdf

Indoorairquality:http://www.osha.gov/dts/osta/otm/otm_iii/otm_iii_2.html#5

Theuseofelectricalequipmentisregulatedbyvariousstateandfederalstandards.Thoseutilizingheatlamps,electroacupuncture,andanyelectricalequipment(computers,faxmachines,etc.)needtohavesomepoliciesinplaceformeetingthesestandards.Alistofthestandardsandtheirapplicationsshouldbereviewedbythepractice’ssafetyofficerannually.OSHAstandardscanbefoundhere:

• http://www.osha.gov/SLTC/electrical/index.html• https://www.osha.gov/pls/oshaweb/owadisp.show_document?p_table=FEDERAL_REGI

STER&p_id=19269PractitionersshouldcontacttheirlocalhealthdepartmenttoobtainfurtherinformationregardingOSHAtrainingandstate-ortown-specificrequirementsforhealthcareoffices.Notethatonceyouhaveidentifiedtheexistingandpotentialhazardsinyourtreatmentlocation,yourstateOSHAConsultationProgramcanhelpyouimplementthesystemsthatpreventorcontrolthosehazards.Thestateconsultationprogramisfreeforallemployersandhavingthestateinspectyourpracticesettingwillnotresultinafine,evenifallstandardshavenotbeenmet.Usually,youwillhave90daysafterreceivingareportfromyourstateconsultationtocreateaplantoaddressalldeficiencies.Utilizingthisserviceisagreatwaytopreventproblemsinthefuture.

OSHA: Disposing of Biohazardous Waste Whendiscussingbiohazardouswaste,thefollowingtermsareapplicable:

Biohazardouswaste:Anysolidwasteorliquidwastethatmaypresentathreatofinfectiontohumans(includingnon-liquidhumantissueandbodyparts),laboratorydisease-causingagents,discardedsharps,humanblood,orclinicwastesuchastablepaperorcottonballsthatcontain

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humanblood,humanbloodproducts,orbodyfluids.(Note:OSHAhasdeterminedthatacottonballcontainingenoughbloodthatitcanbewrungoutmustbeclassifiedasmedical,orbiohazard,waste;lessthanthatamountonacottonballmeansthatitshouldbeconsideredtrash.OSHAreferstobiohazardouswasteas“regulatedwaste.”)(5)

Biohazardouswastegenerator:Afacilityorpersonthatproducesorgeneratesbiohazardouswasteincludingawiderangeoffacilitiesfromhospitalstomedicaloffices,fromveterinaryclinicstofuneralhomes.(6)Licensedacupuncturistsareincludedinthiscategory.

OSHAhasenactedspecificrulesconcerningthehandlinganddisposalofbiohazardousorinfectiouswasteinordertoeliminatetheexposureofemployees,patients,andthepublictodisease-causingagents.Theserulesrequire:

1. Wastegeneratorsmustprepare,maintain,andimplementawrittenplantoidentifyandhandlesuchwaste.Anyemployeewhoworksinanareawherebiohazardouswasteiskeptmustbeprovidedwithanemployeetrainingprogramthatexplainsproceduresforon-siteseparation,handling,labeling,storage,andtreatmentofbiohazardousmaterials.

2. Biohazardouswaste,exceptsharps(devicescapableofpuncturing,lacerating,orpenetratingtheskin),mustbepackagedinimpermeable,red,polyethyleneorpolypropylenebags(“redbags”),andsealed.

3. Discardedsharpsmustbeseparatedfromallotherwasteandplacedinleak-resistant,rigid,puncture-resistantbiohazardcontainers.Allcontainersmustbelabeledproperly,especiallyifthetreatmentanddisposalaretotakeplaceoff-site.

4. Instoringthepackagedwaste,caremustbetakentoplaceitinadesignatedareaawayfromgeneraltrafficflowandaccessibleonlytoauthorizedpersonnel.Oneoptionistostorebiohazardouswasteawaitingpickupinalockedclosetnotusedforstorageofcleanitemsorfood.

Allwasteshouldbedisposedofbyremovalbyamedicalwastedisposalcompany.Donotthrowmedicalwasteintothetrashforremoval.Thisisespeciallytrueforsharpswhichposeahazardtocustodialandwasteremovalpersonnel.OSHAregulationscontainminimumstandardsestablishedbythefederalgovernment.However,stateandlocalregulationsarepermittedtobe,andoftenare,morestringent,regardingthedisposalofhazardouswaste.(7,8)Thesewastelawsdiffergreatlyfromstatetostateandmayvaryatthecountyandevenmunicipallevel.Forexample,somecity,county,orstategovernmentsrequireapermitandinspectionforallofficesthatgeneratehazardouswaste.Othersrequirethatusedneedlesandothercontaminatedwastebepickedupbyalicensedcontaminateddisposalservice(andmayrequireproofsuchasavalidcontractandreceiptsofpickupanddisposalheldbyanacupuncturist).Stillothersrequireapermittotransportcontaminatedwastewhichmaypreventapractitionerfromcarryingasharpscontainerinatravelkitunlessaspecialpermitisacquired.(9)Itisimportant

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tobethoroughlyfamiliarwiththeregulationsinyourlocality.Thestateorcountypollutioncontrolagencyand/orhealthdepartmentisthebestsourceforinformationandrecommendations.Wheneverpossible,itisadvisabletohavehazardouswastetransportedbyanapprovedcarrier.

Discarding gloves, cotton balls and other material contaminated with blood OSHAdefinesregulatedwasteas:liquidorsemi-liquidbloodorotherpotentiallyinfectiousmaterials(OPIM);contaminateditemsthatwouldreleasebloodorOPIMinaliquidorsemi-liquidstateifcompressed;itemsthatarecakedwithdriedbloodorotherpotentiallyinfectiousmaterialsandarecapableofreleasingthesematerialsduringhandling;contaminatedsharps;andpathologicalandmicrobiologicalwastescontainingbloodorotherpotentiallyinfectiousmaterials.(10)

Gauze,cottonballs,gloves,etc.thatareusedduringthepatientvisit,butarenotsaturatedorsoakedwithbloodorOPIM,canbediscardedinregularwaste.AnyoftheseitemsthataresaturatedwithbloodsuchthattheywouldreleasebloodorOPIMduringroutinehandlingofthetrashmustbediscardedinredbiohazardouswastebags.

What should patients do with press tacks or other imbedded devices that they need to remove at home? Safesharpsdisposalisimportantwhetheryouareathome,atwork,atschool,traveling,orinotherpublicplaces.Asof2004,theFDA/CDCnolongerallowssimpletrashdisposalofbiohazardsharpsathome(includinglancetsfordiabetics).Allsharpsmustbedisposedofthroughapropersharpscontainerormail-backprogram.Whenusingpresstacks/intradermalneedles,eitherhavethepatientwiththeintradermalneedlesandpresstacksstillimbeddedreturntothepractitionerforproperremovalanddisposal;(7)orthepatientcanbegivenasharpscontainertotakehome,useitforintradermalneedleswhenremovedathome,andthenthesharpscontainerwouldneedtobereturnedtothepractitionerforproperdisposal.(6)Seethewebsiteslistedbelowformoreinformation:

http://www.fda.gov/downloads/MedicalDevices/ProductsandMedicalProcedures/HomeHealthandConsumer/ConsumerProducts/Sharps/UCM278775.pdf

http://www.cdc.gov/niosh/topics/bbp/disposal.html

http://www.hercenter.org/osha.cfm

Thebestpractice(safestoption)whensendingapatienthomewithpresstacksorothersharpsistoprovidethemwithasmallsharpscontainer.Oncethepatientremovesthepresstacks,heorsheshoulddiscardtheminthesharpscontainerandthenbringthecontainerbacktothepracticelocationathisorhernextvisit.

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2. Safety Considerations Regarding the Practice Environment Acupuncturistsmustconducttheirpracticeinsuchawayastoensure,sofarasisreasonablypossible,thatpersonswhomayenterthepracticeenvironmentarenotexposedtoriskstotheirhealthorsafety.Thisdutyextendstobothpatientsandemployees.ItisbyfollowingrecognizedstandardsestablishedbyOSHAthatthisdutycanbefulfilled.Inparticular,attentionshouldbefocusedonthefollowing:

1. Allfloors,passages,andstairsshallbeofsoundconstruction,properlymaintained,andshouldbekeptfreefromobstructionandfromanysubstancelikelytocausepersonstoslip.

2. Asubstantialhandrailandadequatelightingshouldbeprovidedforeverystaircase.3. Adequatelightingmustbeprovidedandmaintainedinallofficespaces.4. Allstructuresandequipmentshouldbesubjectedtoregularinspectionand

preventativemaintenance.5. Allelectricalinstallationsshouldbeinaccordancewithlocalcodes.6. Everychair,seat,orcouchonthepremisesshouldbekeptcleanandmaintainedin

properrepair.7. Floorsshouldbeeasilycleaned.Carpetinginareaswherebiohazardouswasteis

generatedorstoredisnotrecommendedsinceitisdifficulttocleanupspilledneedlesorfluids.

8. Allmodificationstotheclinicshouldbedoneinsuchamannerthatallconstruction,plumbing,andwiringmeetlocalconstructioncodesandaredoneinacompetentandsafemanner.

9. Allfireextinguishers,firesprinklersystems,andotherfiresafetyequipmentshouldbemaintainedaccordingtothemanufacturer’sinstructionsandlocalfireregulations.

10. Thelocationofhandwashingfacilities,sharpscontainers,biohazardcontainers,andtheavailabilityofsafetyequipmentshouldbesuchthatthesematerialsarereadilyavailabletotheacupuncturistintheworkplace.

11. Allprovidersandotherclinicpersonnelshouldknowwherematerialsafetydatasheetsandsafetymanualsarelocatedandhaveaccesstothemonademandbasis.

PractitionersshouldalsoconsultOSHArequirements,Section3(EngineeringControlsandWorkPracticeControlsRegulations,Standards–29CRF,1910.1030d2)forprovisionsregardingmaintenanceanduseofworkareasandsigns.Othersourcesofinformationregardingaproperofficeenvironmentforthepracticeofacupunctureshouldalsobeconsulted.

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3. Recordkeeping

Charting

General Charting Considerations Patientrecordsshouldbekeptofallpatientvisitsandtreatmentsperformed.Thetreatmentrecordshouldbeacomplete,accurate,up-to-datereportofthemedicalhistory,condition,andtreatmentofeachpatient.

Treatmentrecordsaremaintainedprimarilytoprovideaccurateandcompleteinformationaboutthecareandtreatmentofpatients.Theyaretheprincipalmeansofcommunicationbetweenhealthpractitionersinmattersrelatingtopatientcareandserveasabasisforplanningthecourseoftreatment.Theyarealsothepractitioner’srecordofwhatoccurredifthereisacomplaintorlawsuit.Legislationandregulationsconcerningmedicalrecordsvaryfromstatetostate.Manystatesrequiremedicalrecordstobekeptforaspecificlengthoftimeaftertreatment.Somestatesdetailtheinformationrequiredconcerningthepatient’streatment.Otherssimplydeclarethatthemedicalrecordshouldbeadequate,accurate,orcomplete.Allpatientrecordsshouldbecompletedinblackink,becompletewithrespecttothedatafromthepatientcontact,andnotbeerasedorotherwiserenderedillegibleafterthepatientcontact.Intheeventthepractitionerwishestomakeachangeintherecordduringatreatment,suchasdecidingnottouseaspecificpoint,ifthepractitionerutilizespaperrecords,theacupuncturistshoulddrawonelinethroughthetextinquestion,initialthechange,andthenrecordtheupdatedinformation.Donotscratchoutorrenderillegibleanyinformationrecordedinachartnote.

Patientrecordsmustbeprotectedagainsttheft,fireorwaterdamage.Eachofficeshouldsetpoliciesandimplementproceduresthatwillpreventthelossofpatientrecords,whetherelectronicorpaper-based.

Thereareninecriticalpartsofanychart.Theseare:

1. Patientinformation2. Pastmedicalhistory3. Allergiesandadversereactions4. Familyhistory5. Datedandsignedrecordsofeveryvisit6. Flowsheetsfororganizationofhealthmaintenance,chronicconditions,well-

carevisits,etc.7. Narrativenotesdescribingconversationswithpatientsregardingtreatments

(acceptedandrefused)andpreventativetesting

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8. Consentdocumentation9. Flowsheetsornarrativesindicatingthatunresolvedproblemsfromprevious

officevisitsareaddressedinsubsequentvisits

Treatmentrecordsarelegaldocumentsandarethereforerequiredtomeetcertainstandards.Somebasicstandardsforchartinginclude:

• Dateofthevisitshouldbeincludedonallentriesintotherecord.Thedatemustappearimmediatelyabovethefirstentryforeachvisitorprocedure.Also,thedatemustbeoneverypageofachartforanyoneday’sinformation,includingfrontandbackofthesamepage,sothatifrecordsneedtobecopied,allpagesareclearlyidentified.

• Aperson'sfullnameandotheridentifiers(i.e.,medicalrecordnumber,dateofbirth)shouldbeincludedonallrecords.Theseidentifiersmustbeoneverypageofachart,includingfrontandbackofthesamepage,sothatifrecordsneedtobecopied,allpagesareclearlyidentified.

• Continuedrecordsshouldbemarkedclearly(i.e.,ifanoteiscontinuedonthereversesideofapage).

• Eachpageofdocumentationshouldbeinitialed(includingbothsidesofarecord)withafullsignatureonthelastpageoftherecord;andeachprogressnotemustbesigned.

• Blueorblacknon-erasableinkshouldbeusedonhandwrittenrecords.• Recordsshouldbemaintainedinchronologicalorder.• Disposalorobliterationofanyrecordsorportionsofrecordsshouldbeprevented.This

includestakingreasonableprecautionstohaverecordsprotectedfromfireandwaterdamage,aswellastheft.

• Documentationerrorsandcorrectionsshouldbenotedclearly,i.e.,bydrawingonelinethroughtheerrorandnotingthepresenceofanerror,andtheninitialingthearea.Allsuchcorrectionsshouldbemadesothatareadercanvisiblyseewhatwaschanged,whochangedit,andwhenthecorrectionwasmade.WhenutilizingElectronicHealthRecords(EHR)thesystemshouldbeonethatsimilarlyidentifieschanges(andclearlymarkswhenthechartwaschangedandbywhom).

• Excessemptyspaceonthepageshouldbeavoided.Ifapaperchartisbeingutilized,alineshouldbedrawnthroughanyunusedspaceandinitialedwiththetimeanddateincluded.

• Alleventsinvolvinganindividualshouldbedescribedasobjectivelyaspossible,i.e.,describeapatient’sdemeanorbysimplystatingthefactssuchaswhatthepersonsaidordidandsurroundingcircumstancesorresponseofstaff,withoutusingderogatoryorjudgmentallanguage.

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• Anyoccurrencethatmightaffectthepersonshouldbedocumented.Documentedinformationisconsideredcredibleincourt.Undocumentedinformationisconsideredquestionablesincethereisnowrittenrecordofitsoccurrence.

• Ifanoteisaddedafterthecompletionofavisit,itshouldbelabeledasanaddendumandinsertedincorrectchronologicalorderratherthantryingtoinserttheinformationonthedateoftheactualoccurrence.

• Actualstatementsofpeopleshouldberecordedinquotes.• Thechartshouldnotbeleftinanunprotectedenvironmentwhereunauthorized

individualsmayreadoralterthecontents.

ItisrecommendedthatacupuncturistsfollowstandardmedicalchartingproceduressuchastheSOAPnotes:

1. Subjective(informationreportedbythepatient).2. Objective(informationgatheredbythepractitioner,i.e.,tongue,pulse,palpation).3. Assessment(ofthepatient’sconditionandtreatmentprogress).4. Plan(treatmentrecordfortheday,includingpoints,herbs,dietaryandlifestyle

recommendations,newdiagnosisandreferral,ifany).

Standard Requirements for AOM charting A. Subjective:

1. Recordpersonalprofileinformationsuchasdemographics,self-careknowledge,skillsandattitudes.

2. Recordcurrentandpastsupplements(herbalandvitamins),prescriptionsandOTCmedications.

3. Collectionofhealthhistorydataincludingsomeorallofthe“10questions”a. EnergyandSleepb. Head,Eyes&Earsc. Chest&Abdomend. Stool&Urinee. Thirst,Appetite&TastePreferencesf. Mensesg. Pain(OPPQRST)h. Hot&ColdPreferencei. Perspirationj. EmotionalIssues/Stressors

4. RecordrecentconsultationswithotherhealthcareprovidersB. Objective:Performaclinicalevaluationwhichincludes:

1. BP,pulserate2. TCMPulsedx

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3. Tongue4. Palpationsofareasofpain/dysfunction5. Mayalsoadd:

i. pointpalpation,Mupointpalpation,jointROM,reflexesii. informationrelatedtothelisteningandsmellingexamsiii. constitutionassessment/eyediagnosis/facialdiagnosis,skin,hair,nail

diagnosisiv. abdominaldiagnosisv. organ-specificfindingsvi. neuromuscularexamfindingsvii. otherbiomedicalexamfindings

Example:BP110/76,P68,R12.Tonguelong,wide,redwithathinwhitecoatanddistendedsublingualveins.Pulse:regularrateandrhythm,full,thinandwiry.ShoulderROMdecreasedinabductionto110degreesontheright;175degreesontheleft.SpecificpointtendernessnotedatGB21,SJ14,15ontherightonly.

C. Assessment:1. AnalyzeandinterpretallassessmentdatatoevaluatefindingsfromaTCM

perspective.2. Dependingonthelocalandstateacupuncturestatutes,thismayalsoincludea

biomedicaldifferentialdiagnosis(ICDcodingasappropriate).3. DeterminewhetherpatientneedscanbeimprovedthroughthedeliveryofAOM

modalities.

Example:QiandBloodstagnationintheGBandSJchannels.Shoulderpainpreviouslydiagnosedasarotatorcuffstrain/sprain(ICD9840.4).Improvementfromacombinationofacupuncture/moxibustionandcuppinglikelyafter4-6treatments.

D. Plan:Planningistheestablishmentofgoalsandoutcomesbasedonpatientneeds,expectations,values,historicaltexts,currentscientificevidenceandothersourcesofevidence.Treatmentrecordshouldincludethespecificpointsstimulated,modalitiesappliedtopoints(needle,moxa,guasha,electricalstimulation,cupping,etc.),dietaryandlifestylerecommendations,andanyneedforreferralorconsultations.Itmayincludeinformationabouthomecare/self-care.Itmayincludeprognosisortreatmentplanningforaseriesofthesameorsimilartreatment.Ifbillinginsurance,includeCPTcodes.

Dailytreatmentrecordsshouldincludethetreatmentprinciple(s),pointsandtreatmentproceduresforeachvisit,forexample:RelievestagnationofqiintheGBandSJchannelsoftherightshoulder.NeedleandindirectpolemoxaonGB21,34;electricalstimulationSJ14-15(bilaterally).CPTCodes:99212,97813.

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Implementation:ReviewandimplementtheAOMplanwiththepatient.Modifytheplanasnecessaryandobtainwrittenconsent.Confirmtheplanforcontinuingcare.

Example:Treatmenttoberepeatedweeklyfor4weeksthenreassessandreevaluateprogressbeforeadditionaltreatmentsoffered.

Daily Appointment Schedules Treatmentrecordsmustbemaintainedasperstatelaw.Inaninvestigationofanoutbreak,particularlyofhealthcareassociateddiseasessuchasHBV,nothingismoreimportantthankeepinganaccuraterecordofnamesandaddressesofallpatientsanddatesoftreatments.SincehepatitisBhasalongandvariedincubationperiod,lackofrecordedinformationaboutapatient’streatmentatrelevanttimesmaypreventtheproperinvestigationofanycross-infectionrelatedtoHBV.

4. Patient Confidentiality Practitionersshouldbeawarethatasageneralruletheymaynotreleaseinformationregardingapatient,eitherverballyorinwriting,withoutthepatient’sconsent.Practitionersmay,however,discusscaseswithotherhealthcareprofessionalssolongasthereisnoidentifyinginformationprovided.Inadditiontostateconfidentiallystatutes,mostacupuncturistsmustnowcomplywiththeHealthInsurancePortabilityandAccountabilityAct(HIPAA).Thereaderisreferredtothisactformoredetails;seeinformationbelow.

HIPAA Health Information HIPAAinformationcanbelocatedat:http://www.hhs.gov/ocr/privacy/

HIPAAincludestheconfidentialityprovisionswhichapplytomanyhealthproviders.TheHIPAASecurityRuleestablishesnationalstandardstoprotectapatient’spersonallyidentifiableinformation.“TheSecurityRulespecifiesaseriesofadministrative,physical,andtechnicalsafeguardsforcoveredentitiestousetoassuretheconfidentiality,integrity,andavailabilityofelectronicprotectedhealthinformation.”

ManyacupuncturistsarecoveredbyHIPAA.Youarea“coveredentity”ifyouconductcertainbusinesselectronically,suchassendingemailstootherhealthpractitioners,electronicallybillinghealthinsurancecompanies,orfaxinginformationtootherswhoarecoveredbyHIPAA.

TofindoutifyouareaHIPAA“coveredentity”refertohttp://www.cms.gov/Regulations-and-Guidance/HIPAA-Administrative-Simplification/HIPAAGenInfo/AreYouaCoveredEntity.html.

AsummaryoftheHIPAAprivacyrulesthatapplycanbefoundhere:http://www.hhs.gov/ocr/privacy/hipaa/understanding/summary/privacysummary.pdf.

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Additionalcomplianceinformationcanbeaccessedatthefollowingsites:

HIPAAandYou:BuildingaCultureofCompliancehttp://www.medscape.org/viewarticle/762170.

HHSInformation:http://www.hhs.gov/ocr/privacy/.

And:http://www.wedi.org/workgroups/security-privacy.

ProtectedHealthInformation.TheHIPAAPrivacyRule(http://www.hhs.gov/ocr/privacy/hipaa/understanding/summary/)protectsall"individuallyidentifiablehealthinformation"heldortransmittedbyapractitioneroritsbusinessassociate,inanyformormedia,whetherelectronic,paper,ororal.ThePrivacyRulecallsthisinformation"protectedhealthinformation(PHI)."Protectedinformationincludes:theinformationhealthcareprovidersputinamedicalrecord;conversationsaboutpatientcareortreatmentwithotherhealthprofessionals;specifichealthinsurerinformation;andpersonalbillinginformation.

ThePrivacyRuleprovidesthatanindividualhasarighttoadequatenoticeofhowapractitionermayuseanddiscloseprotectedhealthinformationabouttheindividual,aswellashisorherrightsandthepractitioner’sobligationswithrespecttothatinformation.Mostclinicalpractitionersmustdevelopandprovideindividualswiththisnoticeoftheirprivacypractices(NOPP).

ContentofaNOPP:Practitionersarerequiredtoprovideanoticeinplainlanguagethatdescribes:

• Howthepractitionermayuseanddiscloseprotectedhealthinformationaboutanindividual.

• Theindividual’srightswithrespecttotheinformationandhowtheindividualmayexercisetheserights,includinghowtheindividualmaycomplaintothepractitioner.

• Thepractitioner’slegaldutieswithrespecttotheinformation,includingastatementthatthepractitionerisrequiredbylawtomaintaintheprivacyofprotectedhealthinformation.

• Whomindividualscancontactforfurtherinformationaboutthepractitioner’sprivacypolicies.

• Thenoticemustincludeaneffectivedate.See45CFR164.520(b)forthespecificrequirementsfordevelopingthecontentofthenotice.

http://www.hhs.gov/ocr/privacy/hipaa/understanding/coveredentities/notice.html

SomesampleNOPPsmaybefoundatthefollowingsites:

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http://www.hhs.gov/hipaa/for-professionals/privacy/guidance/model-notices-privacy-practices/index.html

http://www.hhs.gov/sites/default/files/ocr/privacy/hipaa/npp_fullpage_hc_provider.pdf

http://www.hhs.gov/sites/default/files/ocr/privacy/hipaa/npp-layered-provider-spanish.pdf

Reporting of Communicable Disease and Abuse Statelawsvarywithregardtorequirementsforhealthcareproviderstoreportknownorsuspectedcommunicablediseases,orchildorelderabuse.Youshouldbeawareofthelawinyourstate.Checkwithyourlocalpublichealthofficeabouttherequirementsaboutrequirementsregardingreportingspecificdiseasesforyourpracticelocation.

5. Informed Consent Itisgenerallyrecognizedthattherelationshipbetweenaclinicianandhisorherpatientcomesintobeingbecauseofthepatient’sneedandtrustintheskill,learning,andexperienceoftheclinician.Theclinicianmaynot,underordinarycircumstances,imposeservicesuponanotherwithoutthatperson’sconsent.

Afulllegalexplanationofinformedconsentisbeyondthescopeofthismanual.However,ingeneral,thecourtshaveruledthateveryadulthasarighttodeterminewhatistobedonewithhisorherownbody(referredtoas“autonomy”).Manystateshavespecificinformedconsentstatutes.Generally,alldiagnosticandmedicalproceduresrequiretheconsentofthepatientorinthecaseofachildorsomeonewhohascertainmentalillnessesorcommunicationlimitations,hisorherlegalrepresentative.

Informedconsentisauthorizationbythepatientorapersonauthorizedbylawtoconsentonthepatient’sbehalf.Thisauthorizationchangesatreatmentfromnonconsensualtoconsensual.Althoughmostconsentcasesinvolvephysicians,theprinciplesoflawconcerningthenatureofconsentareequallyapplicabletoacupuncturists.

Anacupuncturistmaybeheldliableformalpracticeif,inrenderingtreatmenttoapatient,heorshedoesnotmakeaproperdisclosuretothepatientoftherisksinvolvedintheprocedure.

RequiredElements:therearefivebasicelementsthatmustbedisclosedtopatientsinlanguagethatalayindividualreasonablycanbeexpectedtounderstand:

1. Thediagnosis,includingthedisclosureofanyreservationstheproviderhasconcerningthediagnosis.

2. Thenatureandpurposeoftheproposedprocedureortreatment.

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3. Theprobablerisksandconsequencesoftheproposedprocedureortreatment.Thisincludesonlythoserisksandconsequencesofwhichtheproviderhas,orreasonablyshouldhave,knowledge.Itisnotnecessarytodiscloseeverypotentialminorriskorsideeffect.Usually,itisappropriatetodisclosethoseriskswhichoccurmorethan1%ofthetimeforagivenprocedure.

4. Reasonabletreatmentalternatives.Thisincludesothertreatmentmodalitiesthatareconsideredtobeappropriateforthesituation,eventhoughtheymaynotbethepersonalpreferenceofthedisclosingprovider.

5. Prognosiswithouttreatment.Thepatientmustbeinformedofthepotentialconsequences,ifheorsheelectsnottohavetherecommendedprocedure.

Writtenconsentprovidesmaterialproofofconsent.Avalid,writtenconsentmustincludethefollowingelements:

1. Itmustbesigned.2. Itmustshowthattheprocedurewastheoneconsentedto.3. Itmustaddressthenatureoftheprocedure,alternatives,therisksinvolved,the

probableconsequences,anddemonstratethatthepatientunderstoodtheseconcerns.4. Thepatientmustfillinthedateonwhichtheformwassigned.

Oralconsent,ifproven,isjustasbindingaswrittenconsent.However,oralconsentmaybedifficulttoproveincourt.

Informedconsentisparticularlyimportantwhenusingtechniquesthatmightbeinterpretedascausingdamagetothebody;thisincludesacupunctureaswellasdirectmoxibustion,andcuppingorguasha,whichmayleavepetechiae/bruises.

6. High-Risk Patients AllpatientsshouldbetreatedthesamebyfollowingStandardPrecautions.

7. Other Important Safety Practices

Preventing Trips and Falls AccordingtoOSHA:“Slips,trips,andfallsconstitutethemajorityofgeneralindustryaccidents.Theycause15%ofallaccidentaldeaths,andaresecondonlytomotorvehiclesasacauseoffatalities.TheOSHAstandardsforwalking/workingsurfacesapplytoallpermanentplacesofemployment,exceptwhereonlydomestic,mining,oragriculturalworkisperformed.”(12)

Slips:Slipsoccurwherethereistoolittlefrictionortractionbetweenthefootwearandthewalkingsurface.Thesearecommonlyrelatedtowetoroilysurfaces,weatherhazards,looseor

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unanchoredrugsormats,andflooringorotherwalkingsurfacesthatdonothavesamedegreeoftractioninallareas.

Trips:Tripsoccurwhenyourfootcollides(strikes,hits)anobjectcausingyoutoloseyourbalanceandfall.Commoncausesoftrippingincludepoorlighting,clutter,wrinkledcarpeting,uncoveredcables,andunevenwalkingsurfaces.

How to Prevent Falls Due to Slips and Trips Bothslipsandtripsresultfromsomeakindofunintendedorunexpectedchangeinthecontactbetweenthefeetandthegroundorwalkingsurface.Thisshowsthatgoodhousekeeping,qualityofwalkingsurfaces(flooring),selectionofproperfootwear,andappropriatepaceofwalkingarecriticalforpreventingfallaccidents.

Inhealthcarepracticesettings,slips,trips,andfallsmayberelatedtoanyoftheabove,plusthehazardsofwalkingwithoutshoestoandfromtreatmenttables.Considercreatinghousekeepingandpatientcarepoliciesthatminimizetherisksofslips,trips,andfalls.

Aguidetosmallbusinessandsafetycanbefoundhere:

http://www.osha.gov/Publications/smallbusiness/small-business.pdf

Response to a Bodily Fluid Spill ForaspillofasignificantamountofbloodorOPIM,usethefollowingguidelines:

• Evacuatepersonnelfromtheimmediatearea,includingpatients.• Blockoffareasonounauthorizedpersonmayenterthearea.• Don2setsofutilitygloves.• Surroundspillwithpapertowels.• Putabsorbentmaterialonthespill.• Ifglassisinvolvedremovetheglasswithforcepsand/ortweezers,oruseabroomand

dustpantopickupanybiohazardousspillwithglassimbeddedinit.• Disposeofabsorbentmaterialinhazardwastetrash.Doublebag.• Changeglovesifcontaminated.• Cleanareawithdetergentandwater.• DisinfectareawithanEPA-approveddisinfectantappropriateforuseonthesurface

beingcleaned,followingmanufacturer’sguidelinesfortheclean-upifaspill.• Washhandsafterremovinggloves.

First Aid Acupuncturepractitionersshouldbepreparedtodealwithbothminorandmajorhealthissuesinanytreatmentsetting.ItisstronglyrecommendedthatallpractitionersmaintainactiveCPR

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certification.ItisrecommendedthatofficeshaveaccesstoanAEDiffinanciallypossible.Inaddition,practitionersshouldhavepoliciesinplaceandtrainingfordealingwith:

• Minorcuts• Bleeding,bruising• Allergicreactions• Firstandseconddegreeburns

ItisstronglyrecommendedthateveryAOMpracticelocationhaveasimplefirstaidkitavailableforemployeeuse.Furthermore,itisstronglyrecommendedthateverypractitionermaintainalistofemergencynumbersforfire,ambulance,andpoisoncontroldirectlynexttothephone.

Mental Health Issues/Suicide Practitionersmayalsowanttoevaluateotherhealthcaresituationsforwhichtheywanttobeprepared.Thismayincludementalhealthissuesincludingsuicidalideationandsuicidedeclarations.Therearelegalreportingrequirementsinsomestatesregardingtheseissues.Ifapatientthreatensharmagainsthimorherself,therecanbeethicalandlegaljustificationfordisclosingthatinformationtoathirdparty(e.g.,aspouseorparent)ifthatdisclosurewillhelppreventthatharm.Whilethismayfeellikeyouareviolatingtheruleofconfidentiality,havingaplanandpolicyinplacewillhelpyoudealwiththesecircumstances.Seethefollowingformoreinformation

• http://www.dhcs.ca.gov/services/MH/Pages/SuicidePrevention.aspx• http://healthinformatics.uic.edu/resources/articles/confidentiality-privacy-and-security-

of-health-information-balancing-interests/• http://www.who.int/mental_health/media/en/59.pdf

8. Summary of Recommendations – Part VII • Critical:EveryAOMofficemusthaveawrittenBloodbornePathogensExposureControl

Plan.• Critical:EveryAOMofficemusthaveawrittenHazardousCommunicationdocument.• Critical:AllAOMofficepersonnelmustfollowStandardPrecautions.Standard

Precautionsinclude:1)handhygiene,2)useofpersonalprotectiveequipment(e.g.,gloves,gowns,masks),3)safeinjectionpractices,4)safehandlingofpotentiallycontaminatedequipmentorsurfacesinthepatientenvironment,and5)respiratoryhygiene/coughetiquette.

• Critical:EveryAOMofficemustcomplywithfiredepartmentregulationswithrespecttofireprotectionandelectricalsafety.

• Critical:EveryAOMofficemustcomplywithBuildingandSafetycodes.

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• Critical:EveryAOMofficemustcomplywithStateandFederalstandardswithrespecttodocumentingsafety-relatedpoliciesandprocedures.

• Critical:AllAOMofficesmustcreate,maintain,updateandtrainallpersonnel(includingtheowner/acupuncturist)onpossibleexposurestoinfectiousagentsandotherhazardsannually.

• Critical:AllAOMofficesmustprepare,maintain,andimplementawrittenplantoidentifyandhandlebiohazardouswaste.

• Critical:Allbiohazardouswastemustbedisposedofbyremovalbyamedicalwastedisposalcompany.Practitionersmustnotthrowmedicalwasteintothetrashforremoval.

• Critical:Patientrecordsshouldbekeptofallpatientvisitsandtreatmentsperformed.Themedicalrecordshouldbeacomplete,accurate,up-to-datereportofthemedicalhistory,condition,andtreatmentofeachpatient.

• Critical:Practitionersmustnot,underordinarycircumstances,imposeservicesuponanotherwithoutthatperson’sconsent.

• StronglyRecommended:Practitionersshouldrequirewrittenconsentbeforeinstitutinganyclinicalprocedures.

• StronglyRecommended:EveryAOMofficeshouldhaveasimplefirstaidkitavailableforemployeeuse.

• StronglyRecommended:EveryAOMofficeshouldpostalistofemergencynumbersforfire,ambulance,poisoncontrol,andotheremergencypersonnelinaprominentplacesuchasdirectlynexttotheofficephone.

• StronglyRecommended:Acupuncturepractitionersshouldhavewrittenpoliciesinplaceregardingthereleaseofpatientinformation;andasageneralruletheymaynotreleaseinformationregardingapatient,eitherverballyorinwriting,withoutthepatient’sconsent.

• StronglyRecommended:AllacupuncturepractitionersshouldmaintainactiveCPRcertification.

• Recommended:AcupuncturistsshouldfollowstandardmedicalchartingproceduressuchastheSOAPnotes.

• Recommended:Acupuncturepractitionersshouldrepeattherequestforconsenteitherverballyorinwrittenformbeforeperformingproceduresthatleavemarksonthebody(guasha,cupping),orthatmaycauseburns(moxa,heatlamps).

• Recommended:AOMofficesshouldhaveaccesstoanAED.

References 1.OccupationalHealthandSafetyAdministration(OSHA).Regulations(Standards29CFR);

Standardsforalloccupations.

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http://www.osha.gov/pls/oshaweb/owasrch.search_form?p_doc_type=STANDARDS&p_toc_level=1&p_keyvalue=1910.AccessedDecember2012.

2.GuidetoInfectionPreventionforOutpatientSettings:MinimumExpectationsforSafeCare.CentersforDiseaseControlandPrevention,NationalCenterforEmergingandZoonoticInfectiousDiseases(NCEZID).2011.http://www.cdc.gov/hai/settings/outpatient/outpatient-care-guidelines.html.AccessedNovember2012.

3.OccupationalHealthandSafetyAdministration(OSHA).NeedlestickSafetyandPreventionAct.FrequentlyAskedQuestions.http://www.osha.gov/needlesticks/needlefaq.html.AccessedApril2013

4.OccupationalHealthandSafetyAdministration(OSHA).Bloodbornepathogens.1910.1030.http://www.osha.gov/pls/oshaweb/owadisp.show_document?p_table=standards&p_id=10051.AccessedDecember2012.

5.HazardCommunication.OccupationalHealthandSafetyAdministration(OSHA).http://www.osha.gov/dsg/hazcom/index.html.AccessedDecember2012.

6.OSHAStandardsforBloodbornePathogens.HealthcareEnvironmentalResourceCenter.http://www.hercenter.org/rmw/osha-BPS.cfm.AssessedDecember2012.

7.OccupationalSafetyandHealthResourceLocator.HealthcareEnvironmentalResourceCenter.(StatespecificOSHAinformation)http://www.hercenter.org/osha.cfm.AccessedJanuary2013.

8.HealthcareEnvironmentalResourceCenter.RegulatedMedicalWaste–Overview.http://www.hercenter.org/rmw/rmwoverview.cfm.AccessedSeptember2013

9.SafeNeedleDisposalSolutionsbyStatehttp://www.safeneedledisposal.org/.AccessedSeptember2013

10.OccupationalSafetyandHealthStandards.1910.1030Bloodbornepathogens.http://www.osha.gov/pls/oshaweb/owadisp.show_document?p_table=STANDARDS&p_id=10051

11.Guidelinesforenvironmentalinfectioncontrolinhealth-carefacilities:recommendationsofCDCandtheHealthcareInfectionControlPracticesAdvisoryCommittee(HICPAC).MMWR2003;52(No.RR-10):1–48.http://www.cdc.gov/hicpac/pdf/guidelines/eic_in_hcf_03.pdfAccessedDecember2012.

12.Walking/WorkingSurfaces,2007.OccupationalHealthandSafetyAdministration(OSHA).http://www.osha.gov/SLTC/walkingworkingsurfaces/index.html.AccessedJanuary2013.

13.LuC-Y,KangS-Y,LiuS-H,MaiC-W,TsengC-H.ControllingIndoorAirPollutionfromMoxibustion.TchourwouPB,ed.InternationalJournalofEnvironmentalResearchandPublicHealth.2016;13(6):612.

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Part VIII – Appendices

Appendix A: Glossary/Abbreviations Thefollowingisalistofdefinitionsoftermsandabbreviationsthatareusedinthismanual.

Acupuncture:Acupunctureistheinsertionofneedlesintotheskinwherethetherapeuticeffectisexpectedtocomeprimarilyfromtheactofinserting,manipulatingand/orretainingtheneedlesinspecificlocations.

AE:Adverseevent.

AOM:Acupunctureandorientalmedicine.

Antimicrobialagent:Anyagentthatkillsorsuppressesthegrowthofmicroorganisms.

Antiseptic:Substancethatpreventsorarreststhegrowthoractionofmicroorganismsbyinhibitingtheiractivityorbydestroyingthem.Thetermisusedespeciallyforpreparationsappliedtopicallytolivingtissue.

Aseptictechniques:Techniquesforpreventinginfectionduringinvasiveproceduressuchassurgicaloperations,dressingwounds,orsomelaboratoryprocedures.Acupunctureisnotanasepticprocedurebecauseitisnotperformedinamannerthatpreservesthesterilityoftheacupuncturist’shandsortheskinofthepatient.Acupunctureisacleanratherthansterileprocedure.Nevertheless,acupunctureneedlesmustbekeptinasterileconditionforuseinCNT.

Asepsis:Preventionofcontactwithmicroorganisms.

Bacterialcount:Methodofestimatingthenumberofbacteriaperunitsample.Thetermalsoreferstotheestimatednumberofbacteriaperunitsample,usuallyexpressedasthenumberofcolony-formingunits.

Bactericide:Agentthatkillsbacteria.

BBP:Bloodbornepathogens.

Bestpractices:Activities,disciplinesandmethodsthatareavailabletoidentify,implement,andmonitortheavailableevidenceinhealthcare,suchasthosepracticesmeanttoenhancepatientcareorlimitrisks.

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Bleach:Householdbleach(5.25%or6.00%–6.15%sodiumhypochloritedependingonmanufacturer)usuallydilutedinwaterat1:10or1:100.Approximatedilutionsare1.5cupsofbleachinagallonofwaterfora1:10dilution(~6,000ppm)and0.25cupofbleachinagallonofwaterfora1:100dilution(~600ppm).

Contacttime:Forsurfacedisinfection,thisperiodisframedfromthemomentthedisinfectantisappliedtothesurfaceuntilcompletedryinghasoccurred.

Cleanfield:Theareathathasbeenpreparedtocontaintheequipmentnecessaryforacupunctureinsuchawayastoprotectthesterilityoftheneedles.Byextension,thisincludesnotonlythecleansurfaceonwhichequipmentwillbeplaced,butalsothepatient’sskinaroundpreparedacupuncturepoints,andanythingthattouchestheskin.(Note:Acleanfieldisnotthesameasasterilefield.)

Cleantechnique:Theuseoftechniques(suchasantisepsis,disinfection,sterilization,handwashing,andisolationofsharps)designedtoreducetheriskofinfectionofpatients,practitioners,andofficepersonnelbyreducingthenumberofpathogens,therebyreducingthechancesforcontactbetweenthepathogensandthepatientsandpersonnel.

Cleaning:Theremoval,usuallywithdetergentandwaterorenzymecleanerandwater,ofadherentvisiblesoil,blood,proteinsubstances,microorganismsandotherdebrisfromthesurfacesandlumensofinstruments,devices,andequipmentbyamanualormechanicalprocessthatpreparestheitemsforsafehandlingand/orfurtherdecontamination.

Contamination:Theintroductionofcontaminatingviruses,bacteria,orotherorganismsintoorontopreviouslycleanorsterileobjects,renderingthemuncleanornon-sterile.

Cupping(baguanfa):Theapplicationofapartialvacuumtointentionallycreatetherapeuticpetechiaeandecchymosisinthedermis.

Decontamination:AccordingtoOSHA,"theuseofphysicalorchemicalmeanstoremove,inactivate,ordestroybloodbornepathogensonasurfaceoritemtothepointwheretheyarenolongercapableoftransmittinginfectiousparticlesandthesurfaceoritemisrenderedsafeforhandling,use,ordisposal."[29CFR1910.1030]Inhealth-carefacilities,thetermgenerallyreferstoallpathogenicorganisms.

Detergent:Acleaningagentthatmakesnoantimicrobialclaimsonthelabel.Suchagentscompriseahydrophiliccomponentandalipophiliccomponentandcanbedividedintofourtypes:anionic,cationic,amphoteric,andnon-ionicdetergents.

Disinfectant:Usuallyachemicalagent(butsometimesaphysicalagent)thatdestroysdisease-causingpathogensorotherharmfulmicroorganisms,butmightnotkillbacterialspores.It

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referstosubstancesappliedtoinanimateobjects.EPAgroupsdisinfectantsbyproductlabelclaimsof"limited,""general,"or"hospital"disinfection.

Disinfection:Thermalorchemicaldestructionofpathogenicandothertypesofmicroorganisms.Disinfectionislesslethalthansterilizationbecauseitdestroysmostrecognizedpathogenicmicroorganismsbutnotnecessarilyallmicrobialforms(e.g.,bacterialspores).

Dx:Diagnosis

ECP:Exposurecontrolplan

Electroacupuncture(EA):Theapplicationof0.5to6mAelectricalstimulationtoacupunctureneedles.

Efficacy/efficacious:The(possible)effectoftheapplicationofaformulationwhentestedinlaboratoryorinvivosituations.

Effectiveness/effective:Theclinicalconditionsunderwhichaproducthasbeentestedforitspotentialtoactasperclaims,e.g.,fieldtrials.

GCP:Goodclinicalpractice.

Germicide:Anagentthatdestroysmicroorganisms,especiallypathogenicorganisms.

Guasha:Ahealingtechniquewherethebodysurfaceis“press-stroked”withasmooth-edgedinstrument.

HAI:Healthcareassociatedinfections.

HCP:Healthcareprovider.

HCW:Healthcareworker.

High-leveldisinfectant:Anagentcapableofkillingwhenusedinsufficientconcentrationundersuitableconditions.Itthereforeisexpectedtokillallothermicroorganisms.

Inanimatesurface:Anonlivingsurface(e.g.,floors,walls,furniture).

Infectiousmicroorganisms:Microorganismscapableofproducingdiseaseinappropriatehosts.

Intermediate-leveldisinfectant:Anagentthatdestroysallvegetativebacteria,includingtuberclebacilli,lipidandsomenonlipidviruses,andfungi,butnotbacterialspores.

Low-leveldisinfectant:Anagentthatdestroysallvegetativebacteria(excepttuberclebacilli),lipidviruses,somenonlipidviruses,andsomefungi,butnotbacterialspores.

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Medicaldevice:Anyinstrument,apparatus,material,orotherarticle,whetherusedaloneorincombination,includingsoftwarenecessaryforitsapplication,intendedbythemanufacturertobeusedforhumanbeingsfor:

• diagnosis,prevention,monitoringtreatment,oralleviationofdisease• diagnosis,monitoring,treatment,oralleviationoforcompensationforaninjuryor

handicap• investigation,replacement,ormodificationoftheanatomyorofaphysiologicprocess• controlofconception• andthatdoesnotachieveitsprimaryintendedactioninoronthehumanbodyby

pharmacologic,immunologic,ormetabolicmeansbutmightbeassistedinitsfunctionbysuchmeans.

Microbicide:Anysubstanceormixtureofsubstancesthateffectivelykillsmicroorganisms.

Microorganisms:Animalsorplantsofmicroscopicsize.Asusedinhealthcare,generallyreferstobacteria,fungi,viruses,andbacterialspores.

Moxibustion:Theheatingofanacupuncturepointutilizingmoxa(Artemesiavulagaris)invariousforms.

Mycobacteria:Bacteriawithathick,waxycoatthatmakesthemmoreresistanttochemicalgermicidesthanothertypesofvegetativebacteria.

Nosocomialinfection:Aninfectionthatisacquiredfromhealthcare-associatedfacilitiesandprocedures,includinghospitalsandotherthanacute-carefacilities;andinfectionsacquiredthroughoutpatientcare.

OPIM:Otherpotentiallyinfectiousmaterial.OPIMincludessynovialfluid,amnioticfluid,cerebrospinalfluid,pleuralfluid,semenandvaginalsecretions,peritonealfluid,pericardialfluid,saliva(indentalproceduresonly),andanyfluidsvisiblycontaminatedwithbloodorstool.OPIMincludesallbodyfluidswhereitmaybedifficulttodifferentiatebetweencontaminatedandnon-contaminatedfluids.

Personalprotectiveequipment(PPE):Specializedclothingorequipmentwornbyanemployeeforprotectionagainstahazard.Generalworkclothes(e.g.,uniforms,pants,shirts)notintendedtofunctionasprotectionagainstahazardarenotconsideredtobePPE.

Partspermillion(ppm):Commonmeasurementforconcentrationsbyvolumeoftracecontaminantgasesintheair(orchemicalsinaliquid);1volumeofcontaminatedgasper1millionvolumesofcontaminatedairor1¢in$10,000bothequal1ppm.Partspermillion=μg/mLormg/L.

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Plumblossomneedle:Ahammer-likeobjectwithmultipleneedleprojections.

Prions:Transmissiblepathogenicagentsthatcauseavarietyofneurodegenerativediseasesofhumansandanimals,includingsheepandgoats,bovinespongiformencephalopathyincattle,andCreutzfeldt-Jakobdiseaseinhumans.Theyareunlikeanyotherinfectiouspathogensbecausetheyarecomposedofanabnormalconformationalisoformofanormalcellularprotein,theprionprotein(PrP).Prionsareextremelyresistanttoinactivationbysterilizationprocessesanddisinfectingagents.

RCT:Randomizedcontrolledtrial.

Residentflora(residentmicrobiota):Microorganismsresidingunderthesuperficialcellsofthestratumcorneumandalsofoundonthesurfaceoftheskin.

SAE:Seriousadverseevent.

Sanitizer:Anagentthatreducesthenumberofbacterialcontaminantstosafelevelsasjudgedbypublichealthrequirements,thatiscommonlyusedwithsubstancesappliedtoinanimateobjects.Accordingtotheprotocolfortheofficialsanitizertest,asanitizerisachemicalthatkills99.999%ofthespecifictestbacteriain30secondsundertheconditionsofthetest.

Shelflife:Thelengthoftimeanundilutedordilutionofaproductcanremainactiveandeffective.Italsoreferstothelengthoftimeasterilizedproduct(e.g.,sterileinstrumentset)isexpectedtoremainsterile.

SOP:Standardoperatingprocedures.

Spore:Arelativelywater-poorroundorellipticalrestingcellconsistingofcondensedcytoplasmandnucleussurroundedbyanimperviouscellwallorcoat.Sporesarerelativelyresistanttodisinfectantandsterilantactivityanddryingconditions(specificallyinthegeneraBacillusandClostridium).

Standardpractice:Oftensynonymouswith“customarypractice.”Itisalegaltermthatiscommonlydefinedaswhataminimallycompetenthealthcareproviderinthesamefieldwoulddointhesamesituation,withthesameresources.

StandardPrecautions:StandardPrecautionsareasetofbasicinfectionpreventionpracticesintendedtopreventtransmissionofinfectiousdiseasesfromonepersontoanother.Seehttp://www.cdc.gov/HAI/settings/outpatient/basic-infection-control-prevention-plan-2011/standard-precautions.html

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Sterileorsterility:Thestateofbeingfreefromalllivingmicroorganisms.Inpractice,usuallydescribedasaprobabilityfunction,e.g.,astheprobabilityofamicroorganismsurvivingsterilizationbeingoneinonemillion.

Sterilization:Avalidatedprocessusedtorenderaproductfreeofallformsofviablemicroorganisms.Inasterilizationprocess,thepresenceofmicroorganismsonanyindividualitemcanbeexpressedintermsofprobability.Althoughthisprobabilitycanbereducedtoaverylownumber,itcanneverbereducedtozero.

SterilizationforAOM:Theuseofproceduresthatdestroyallmicrobiallife,includingviruses.Thisisarigid,uncompromisingterm.Thereisnosuchthingaspartialsterility.Inacupuncture,sterilizationisrequiredforallinstrumentsthatpiercetheskin:needles,plumblossomneedles,seven-starhammers,lancets,andinsertiontubes.

Surfactant:Anagentthatreducesthesurfacetensionofwaterorthetensionattheinterfacebetweenwaterandanotherliquid;awettingagentfoundinmanysterilantsanddisinfectants.

Tabletopsteamsterilizer:Acompactgravity-displacementsteamsterilizerthathasachambervolumeofnotmorethan2cubicfeetandthatgeneratesitsownsteamwhendistilledordeionizedwaterisadded.

TCM:TraditionalChineseMedicine.

Transientflora(transientmicrobiota):Microorganismsthatcolonizethesuperficiallayersoftheskinandaremoreamenabletoremovalbyroutinehandwashing.

Tuina:AChinesesystemofmassageandmanipulationusingmanualmaneuvers,includingpushing,rolling,kneading,rubbing,andgrasping.

Use-life:thelengthoftimeadilutedproductcanremainactiveandeffective.Thestabilityofthechemicalandthestorageconditions(e.g.,temperatureandpresenceofair,light,organicmatter,ormetals)determinetheuse-lifeofantimicrobialproducts.

Vegetativebacteria:bacteriathataredevoidofsporesandusuallycanbereadilyinactivatedbymanytypesofgermicides.

Virucide:anagentthatkillsvirusestomakethemnoninfective.

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Appendix B: Where to Find More Information FederalCDC,stateOSHAoffices,andlocalhealthdepartmentsareavailabletogivepractitionersspecifichelpregardinginfectiousdiseases,toxins,orsuspiciousinjuries.Youshouldkeepyourlocalhealthdepartment’sphonenumbereasilyavailableandcontactthedepartmentwithanyquestionsaboutspecificdiseasesorregulationsregardingthepracticeofhealthcare.

World Health Organization (WHO) – Acupuncture Related Information

WHO:AdverseEventsRelatedtoAcupuncture:http://www.who.int/bulletin/volumes/88/12/10-076737/en/

GuidelinesonBasicTraininginAcupuncture:http://apps.who.int/medicinedocs/en/d/Jwhozip56e/4.html

SelectedPointsforBasicTraininginAcupuncture:http://apps.who.int/medicinedocs/en/d/Jwhozip56e/3.10.html#Jwhozip56e.3.10

SkinPreparation:http://whqlibdoc.who.int/publications/2010/9789241599252_eng.pdf.

Healthcare Associated Infections CDCGuidelines:HealthcareAssociatedInfectionshttp://www.cdc.gov/HAI/settings/outpatient/outpatient-care-gl-standared-precautions.html

NationalClinicians’Post-ExposureProphylaxisHotline:http://nccc.ucsf.edu/clinical-resources/pep-resources/pep-quick-guide/CDCNationalSTDHotlinehttp://www.usa.gov/directory/federal/cdc-national-std-hotline.shtml

• Email:cdcinfo@cdc.gov• Toll-free:1-800-232-4636

CDCNationalPreventionInformationNetwork:http://www.cdcnpin.org/

CDC/Specific Pathogens

Hepatitis • http://www.cdc.gov/hepatitis/PDFs/disease_burden.pdf• http://www.cdc.gov/hepatitis/Statistics/index.htm• http://www.cdc.gov/hepatitis/resources/professionals/pdfs/abctable.pdf• http://www.cdc.gov/vaccines/pubs/pinkbook/downloads/hepa.pdf• http://www.vaccineinformation.org/hepa/qandavax.asp

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• http://www.who.int/csr/disease/hepatitis/whocdscsrlyo20022/en/index3.html• http://www.cdc.gov/HAI/pdfs/bbp/Exp_to_Blood.pdf• http://www.cdc.gov/niosh/docs/2000-108/pdfs/2000-108.pdf• http://www.hepb.org/professionals/high-risk_groups.htm• http://www.cdc.gov/hepatitis/HBV/PDFs/HepBGeneralFactSheet.pdf• http://www.who.int/csr/disease/hepatitis/whocdscsrlyo20022/en/index1.html• http://www.osha.gov/OshDoc/data_BloodborneFacts/bbfact05.pdf• http://www.cdc.gov/hepatitis/Resources/Professionals/PDFs/ABCTable.pdf• http://www.cdc.gov/mmwr/preview/mmwrhtml/rr6103a1.htm

UpdatedCDCRecommendationsfortheManagementofHepatitisBVirus–InfectedHealth-CareProvidersandStudents

• http://www.cdc.gov/hepatitis/Statistics/2010Surveillance/Commentary.htm• http://www.cdc.gov/hepatitis/C/cFAQ.htm• http://www.cdc.gov/hepatitis/PDFs/disease_burden.pdf• http://www.cdc.gov/hepatitis/HDV/index.htm• http://wwwnc.cdc.gov/travel/yellowbook/2012/chapter-3-infectious-diseases-related-

to-travel/hepatitis-e.htm

HIV • http://www.cdc.gov/hiv/az.htm• http://www.cdc.gov/hiv/surveillance/resources/reports/2010report/index.htm• http://www.cdc.gov/mmwr/preview/mmwrhtml/rr5409a1.htm• http://www.cdc.gov/HAI/organisms/hiv/Surveillance-Occupationally-Acquired-HIV-

AIDS.html• http://aids.gov/federal-resources/national-hiv-aids-strategy/nhas.pdf

TB • http://www.cdc.gov/tb/publications/guidelines/infectioncontrol.htm• http://www.cdc.gov/tb/publications/factsheets/statistics/TBTrends.htm• http://www.cdc.gov/mmwr/pdf/rr/rr5417.pdf• http://www.cdc.gov/tb/publications/factsheets/statistics/TBTrends.htm• http://www.cdc.gov/HAI/organisms/tb.html

Other Diseases • http://www.cdc.gov/bloodsafety/bbp/diseases_organisms.html• http://www.cdc.gov/features/mrsainfections/• http://www2.cdc.gov/ncidod/dbmd/abcs/calc/calc_new/intro.htm

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• http://www.cdc.gov/hai/organisms/organisms.html• http://www.cdc.gov/flu/professionals/infectioncontrol/index.htm• http://www.cdc.gov/flu/professionals/infectioncontrol/healthcaresettings.htm• http://www.cdc.gov/HAI/organisms/norovirus.html

Handwashing information and details • http://www.cdc.gov/handhygiene/download/hand_hygiene_core.pdf• http://whqlibdoc.who.int/publications/2009/9789241597906_eng.pdf• http://www.jointcommission.org/assets/1/18/hh_monograph.pdf• http://www.cdc.gov/mmwr/preview/mmwrhtml/rr5116a1.htm• http://www.cdc.gov/hicpac/pdf/guidelines/eic_in_hcf_03.pdf• http://www.cdc.gov/features/handwashing/• http://www.cdc.gov/handwashing/• http://www.cdc.gov/handhygiene/index.html

Standard Precautions • http://www.cdc.gov/HAI/settings/outpatient/outpatient-care-gl-standared-

precautions.html

OSHA Documents and Training Requirements

OSHA Bloodborne Pathogen Standards • http://www.osha.gov/SLTC/bloodbornepathogens/standards.html• http://www.osha.gov/OshDoc/data_BloodborneFacts/bbfact03.pdf• http://www.osha.gov/Publications/osha3151.html

Exposure Control Plan (ECP) Samples • http://www.osha.gov/Publications/osha3186.pdf(pdfversion)• http://www.osha.gov/Publications/osha3186.html(htmlversion)• http://www.osha.gov/OshDoc/Directive_pdf/CPL_2-2_69_APPD.pdf(specificsmall

businessplanversion)

OSHA Documents Relating to ECPs • http://www.osha.gov/pls/oshaweb/owadisp.show_document?p_id=1574&p_table=DIR

ECTIVES• http://www.osha.gov/pls/oshaweb/owadisp.show_document?p_table=standards&p_id

=10051

Hazardous Communication • AsampleHazardousCommunicationpolicycanbefoundhere:

http://www.osha.gov/Publications/osha3186.html

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HIPAA TofindoutifyouareaHIPAA“coveredentity”referto:http://www.cms.gov/Regulations-and-Guidance/HIPAA-Administrative-Simplification/HIPAAGenInfo/AreYouaCoveredEntity.html

AsummaryoftheHIPAAprivacyrulesthatapplycanbefoundhere:http://www.hhs.gov/ocr/privacy/hipaa/understanding/summary/privacysummary.pdf

BasicHIPAAinformation:http://www.hhs.gov/ocr/privacy/hipaa/understanding/coveredentities/notice.html

SampleNOPP:www.nahu.org/members/hipaa/7_Sample_Employer_Notice.doc

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Appendix C: Acupuncture Points that Require Special Skill Acupuncturehastraditionallytrainedpractitionersusinganoraltradition.OnlyrelativelyrecentlyhavecomprehensivetextsonacupuncturepointsbeenproducedinEnglish.ResearchonthelimitedefficacyofacupuncturepointsforspecificconditionsortimesoflifeisnotreadilyavailableinEnglish.ThefollowingchartismeanttobringtogetherinformationfromsourcessuchastheWorldHealthOrganization,(1)ChineseAcupunctureandMoxibustion,(2)AManualofAcupuncture,(3)andsomeoraltraditionstoidentifypointsthat,insometraditions,mayrequiremorepracticeorskilltoutilizesafely.Notalltextsagreeonthesamelistofsuchacupuncturepoints.

Someofthefollowinglistedpointsarebasedonriskreductionratherthanidealcareconsiderations.Forinstance,modernacumoxapracticesintheU.S.,wherescarringmaycreateamalpracticeconcern,maycreatealongerlistofpointsrequiringspecialskillthantraditionalAsianpracticesutilizingacumoxainthesameareas.

Thereisnoconsistentcomprehensivelistofpointsthatmaybecontraindicatedforacupuncture,moxaorothertechniquesduringpregnancy.Traditionally,studentshavebeencautionedtoavoidutilizingpointsthatcanbeusedtostimulatelabor(e.g.,SP6,LI4),pointsonthesacrumwhichmaystimulatenervesthatalsoinnervatetheuterus(e.g.,BL31,32,33),orpointsonthefootthatmayhaveareflexactionontheuterus(e.g.,BL67).Baseduponanimalresearch,someresearchershavequestionedwhetherpointsthatareoftenidentifiedasbeingcontraindicatedinpregnancybytraditionaltextsororaltraditionsreallyneedtobeavoidedinmodernpractice.(4-6)Practitionersareurgedtofullyunderstandtheanatomicalchangesthattakeplaceduringpregnancywhenneedlingbetweenthepubisandtheumbilicus.Theyarealsocautionedtousegoodclinicaljudgmentwhenneedlingbladderpointsonthefootduringpregnancy(excepttouseBL67forbreachpresentations);andiftheyplantousepointsthatactstronglytocausetheqitodescendduringpregnancy.StudentsareurgedtostudystandardpointfunctiontextssuchasChineseAcupunctureandMoxibustion,(2)andAManualofAcupuncture(3)tounderstandwhichpointsareconsideredtoneedspecialskillifusedduringpregnancy.

Acupuncturepractitionersneedtostayabreastofinformationinthefieldaboutrisksassociatedwithacupuncturepractice,aswellasresearchre-assessingthosesamereportsofrisks,andmakecaredecisionsbasedonevidence-informedpracticesandclinicaljudgment.

GeneralAOMProcedureContraindications:Nodirect,scarringmoxaonthefaceorinthehairline.NouseofAOMproceduresoveractiveskinlesionsoraroundareasofacutetraumawithoutspecialtrainingorsupervision.Nodeepneedlingonthethorax;useextracautiononpointstheWHOindicateshavebeenassociatedwithpneumothorax.

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CategoriesofPoints*:

A. Duetoanatomicalconsiderations,limitneedlingofpointforcriticalcircumstanceswhenotheroptionsarenotavailable;orwhenpointfunction/useoutweighstherisks.

B. Duetoanatomicalconsiderationsoraccordingtohistoricaltexts,limituseofmoxibustiontechniquesforlimitedcircumstanceswhenfunction/useoutweighstherisks.

C. Direct,scarringmoxibustionshouldbeavoided;therisksofdamageoutweighthebenefits(e.g.,ontheface).

D. ApplyE-Stimonlywithspecialcareorforlimitedcircumstances.E. Pointisatoroveramajorvessel;usecarewhenneedling.F. PointhasbeenassociatedwithpneumothoraxbyWHOorotherauthority;limitdepth

andconsiderproperangleforneedling.

*Notethatthereisawidevarietyoftypesandstylesofacupuncture.Therefore,thereisalsoawidevarianceincultureandtraditionregardinganyrisksassociatedwithspecificpointuses.Eventheprecautionsassociatedwithanatomicallocationsmaybemoreorlesscriticaldependinguponthestyleofacupunctureormoxibustionbeingutilized.

Point: A B C D E FLU2 X LU3 X LU9 X LU10 X LU11 X LI15 X LI19 X LI20 X ST1 X X ST2,3,4,5,6,7 X ST8 X X ST9 X X ST12 X X XST13 X ST17 X X SP7 X SP11 X X HT1 X X HT2 X SI10 X SI18 X

239

Point: A B C D E FBL1 X X BL2,3,4,5,6,7,8,9,10 X X BL13 XBL51 X BL60,61 BL62 X KI11 X SJ16-23 X GB1TO19 X GB21 XLR12 X REN5 X(*) REN8 X X REN14 X X XREN15 X X XREN17,18 X REN22 X XDU4 X(**) DU6 X DU11 X DU15 X X DU16 X X X DU17 X X X DU18,19,20,21,22,23,24,25 X X DU27,28 X

*FEMALEPATIENTS(historicalreference)**MALESUNDER21only(historicalreference)

References 1.WHO,GuidelinesonBasicTrainingandSafetyinAcupuncture.WorldHealthOrganization.

http://apps.who.int/medicinedocs/en/d/Jwhozip56e/4.htmlAccessedNovember2012.Published1996.AccessedDecember2012.

2.ChengXinnong(chiefeditor).ChineseAcupunctureandMoxibustion.ForeignLanguagesPress,Beijing;1987

3.Deadman,P.,Al-Khafaji,M.AManualofAcupuncture.JournalofChineseMedicinePublications;2001

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Clean Needle Technique 7th Edition FAQ

Shouldpressurebeappliedbeforeandduringneedleremoval?

No.Becauseapplyingpressurenexttoaneedlethatisbeingremovedincreasestheriskforinadvertentneedlestickinjuries,bestpracticetechniqueswouldbetoapplypressuretoanacupuncturepointonlyaftertheneedlehasbeencompletelyremovedfromthesite.

Doesstrongthrusting,twisting,insertingandliftingcauseanincreaseinbleedingandbruising?

Unknown/untested.Whileitmakessensethatthemoreaneedleismanipulatedthemorebruisingandbleedingwilltakeplace,therehavebeennostudiestosupportthistheory.

Doesthesizeorwidthofneedlemakeforastrongerorlessstrongneedlesensation?

Unknown/untested.Generally,practitionerexpertisehasmoretodowiththeamountofneedlesensationthandoesthesizeorwidthofanacupunctureneedle.

Inmakingsuretherearenoneedlesleftinapatientattheendofatreatment,doespalpatingthesitewhereaneedlewasinsertedfollowbestpractices?

Palpatingareaslookingforforgottenneedlesmayincreasetheriskofneedlestickinjuries.Usecountingandproperdocumentationtocheckformissingneedles.However,ifneedlecountsdonotmatch,palpationmaybenecessarybutshouldbedonewithextremecaution.

Shouldwarmwaterorwaterwithsugarbegiventopatientswhohavefaintedduringacupuncture?

Variable.Ifthepatientjustfeelsfaint,somewater,teaorotherliquidsmaybehelpful.Ifthepatienthasfainted,thendonotforceliquidsintothemouthuntilthepatientregainsconsciousnessandclarityofthought.

HowoftendoIneedtowipedownatreatmenttablewithappropriatedisinfectingsolution?

Wipedowneachtreatmentchairortablewithasolutionordisinfectantclothbetweeneverypatientvisitandattheendoftheday.Aswithhandwashing,disinfectingtreatmentsurfacesmustbedonebetweeneachpatientvisittopreventcrosscontamination.

Whenusingamulti-needlepackofsterilizedneedles,oncethepackagingisopenedforonepatientvisit,cantheunusedneedlesbeusedforanotherpatient?WhatifIamseeingthepatientsback-to-back?

No.Onceamultipackofneedleshasbeenopened,theneedlesarenolongersterile.Sinceyoumustuseneedlesthataresterileatthestartofeverytreatment,unusedmulti-packneedlesmustbediscardedinasharpscontainerattheendofeachpatientvisit.

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IfIusetablepaperoverasheetorotherclothtocoverthetreatmentsurface,canIchangethepaperonlyforeachpatientandchangethesheetattheendoftheday?

No.Tablepaperdoesnotcompletelycovertheareathatapatientmaytouch.Alltreatmentsurfacesmustbecleanedbetweeneachpatientvisit.Ifusingsheetsorotherclothcoverings,thesemustbechangedforeachandeverypatientvisit.Notethattheincidenceofmycobacteriumoutbreaksinsomecasesmayhavebeenassociatedwithpracticesofreusingtowelsandsheets.

Canpatientsleavetheclinicwiththepresstacks/intradermalneedlesstillinsertedontheskin?

Yes.Ifproperinstructionshavebeengivenregardingthecareoftheskinaroundtheintradermalneedle,thencurrentstudiessuggestthattheymayberetainedafterthepatientleavesthetreatmentoffice.Writteninstructionsforreturningtotheclinicforremovaland/orasharpscontainerandinstructionsforremovaloftheintradermalneedlesathomemustbefullyexplainedbythepractitioner.

Canpractitioners’handsbesterilized?

No.Sterilizationisdefinedas“thecompletedestructionofalllivingtissue.”Sincepractitionersareliving,breathingindividuals,theirhandscanbecleanbutnotsterile.

Mustadifferentguidetubebeusedfordifferentareasonthepatient’sbody?

No.Guidetubesmustbesterileatthestartofatreatmentbutaguidetubemaybeusedformultipleneedleinsertionsatvariousareasofthepatient’sbody.

Isthebestwaytocleanskinpriortoneedleorlancetinsertiontouse70%alcohol?

Unclear.Theliteratureisclearabouttheskinbeingcleanbuttherehavebeennocomparisonstudiesofsoapandwatervs.alcoholvs.otherproducts,suchasthosecontainingchlorhexidine.

HowdoIuseanalcoholswabtocleantheskin–onedirectiononlyorbackandforth“cleaning”?

Unclear.Thealcoholisbeingusedtobesuretheskinisclean.Sincetheneedlesdonotenterthevasculartree,specificdirectionalityofswabbinghasnotbeenstudied.

Whendoingwetcuppingshouldthecupbeleftinplaceforapproximately30secondsafter“breakingtheseal”soastoavoidanaerosoleffectofthedrawnblood?

No.Somebloodwillbereleasedduringthelossofsuctionnomatterhowlongthecupisretained.UseofproperPPEisneededtoprotectthepractitionerfrombloodandOPIM.

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Shouldanewalcoholswabbeusedfordifferentbodyregions?

No.Alcoholswabscanbeusedformultiplepointsinmultiplepartsofthebodyaslongastheswabremainsmoistandisnotvisiblydirty.Newswabsareneededwhencleaningareasthatarecoveredwithmake-uporotherproducts,orforareaswithhighbacteriacountssuchasthegroinoraxilla.

CanIusereusableneedlesfortreatments?

No.ThestandardofcareforU.S.CCAOMCNTcoursegraduatesistousesingle-usesteriledisposableneedlesonly.Reusingneedlesisnotpermittedlegallyinmanystates.Thecostsavedbyautoclavingneedlesisnegligiblewhencomparedtothecostofevenonepatientcontractingadiseasefromneedlereuse.

Whencleaningacuporguashadevice,doIdisinfectfirst,thencleanthecupordevice?

No.Youmustremoveallbiologicalmaterialforthedisinfectanttoworkproperly.Cleanthedevicewithsoapandwaterfirst,thendisinfect,thenrinsethedevice(ifitisdesiredtoremoveanyremainingdisinfectant)beforeusingonthenextpatient.

Whencleaningacuporguashadevice,doesitneedtobesterilized?

AcuporguashadeviceneedstobecleanedofanybiologicalmaterialandthendisinfectedusinganEPA-approveddisinfectingsolutionorautoclaved.Ifthecuphasorwillbeusedforwetcupping,therewillbeabreakintheskin.Inthiscase,youmustfollowtheCDCdirectivesforcleaning,disinfecting,storingandusingsemi-criticaldevices.PPEisalsorequired.Ifthecuporguashadevicehasorwillbeusedonintactskin,youmustfollowCDCdirectivesforcleaning,disinfecting,storingandusingnoncriticaldevices.TheCNTManualadviseswhenthesetoolsareusedoverintactskin,youmustuseatleastintermediate-leveldisinfectants.Becauseyoucannotalwaysanticipatethattheskinwillremainintactduringcuppingorguasha,takingtheextraprecautiontoconsiderallcupsandguashatoolsassemicriticaldevicesthatrequirehigh-leveldisinfectantsorautoclavingisstronglyrecommended.

HowdoIdecidewhethertousehigh-orintermediate-leveldisinfectionsolutionformycupsandguashatools?

Itiseasiesttouseonemethodforallcupsandguashatools.Ifyoueverusewetcupping,cuppingorguashaoverareaswheretheskinisnotintact,thebestpracticeistouseahigh-leveldisinfectingsolution(aftercleaningwithsoapandwater)followingpackagedirectionsforsemi-criticalreusablemedicalequipment.Otherwise,youhavetosegregateyourequipmentbetweenthoseusedonintactskinandthoseusedovernon-intactskin,whichisanunnecessarycomplication.

WhatoptionsdoIhaveforholdingtheshaftofaneedle,ifnecessary,duringneedleinsertion?

Theshaftoftheneedlecanbetouchedwithsterilegauze,sterilecottonorasterileglove.Anythingthattouchestheshaftoftheneedlebeforeinsertionintotheskinmustbesterile.

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Whenremovingneedles,doIneedtoremoveacupunctureneedlesoneatatime?

Unclear.Whileitmakessenseforoptimalsafetypurposestoremoveneedlesoneatatime,nostudieshavebeendonetodetermineifremovingacoupleneedleslocatedclosetogetherisriskierthansingleneedleremoval.Whatiscriticalisthatusedneedlesbeimmediatelyisolatedinanappropriatesharpscontainer.Practitionersremovingneedlesshouldneverdemonstrateorgesticulatewhileholdingusedneedlesasthisgreatlyincreasestheriskofaneedlestickincident.

Whatdoesitmean:“Immediateisolationofusedneedlesandlancets”?

Whenremovingneedles,usedlancetdevices,orotherusedsharps,theseitemsneedtobeplacedinapropersharpscontainerassoonaspossible.Practitionersneedtodeveloppracticesthatlimittheamountofmovementrequiredtomovethesharptothesharpscontainer.Walkingaroundwithusedsharps,holdingthemwhiletalkingtothepatientorothers,andmovingfromonelocationtoanotherwithusedsharpsincreasestheriskofaneedlestickinjury.

Specificallywhatfluidsareconsideredpotentiallyinfectious?

BloodandOPIM.OPIMinclude:synovialfluid,amnioticfluid,cerebrospinalfluid,pleuralfluid,semenandvaginalsecretions,peritonealfluid,pericardialfluid,saliva(indentalproceduresonly),anyfluidsvisiblycontaminatedwithblood,stool,andallbodyfluidswhereitmaybedifficulttodifferentiatebetweencontaminatedandnon-contaminatedfluids.

WhatbodilyfluidsareknowntobeasourceforHIVinfections?

Blood,anybodyfluidcontaminatedwithblood,semen,vaginalsecretions,synovialfluid,amnioticfluid,cerebrospinalfluid,andbreastmilk.SweatandurinearenotsourcesforHIVinfections.

Whatarethestandardprocedurestofollowafteranexposureincidentsuchasaneedlestick?

1. Treattheexposuresiteassoonaspossibleaftertheexposureincident.

2. UsesoapandwatertowashandcleanareasexposedtobloodorOPIMassoonaspossibleafterexposureoccurs.DONOT“milk”apuncturesitetodrawoutsomebloodfirst.

3. Flushexposedmucusmembraneswithwater.4. Flusheyeswithrunningwaterorsalinesolution.5. Donotinjectantisepticsordisinfectantsintothewound.6. Reporttheincidenttoyoursupervisor.7. Notetheincidentintheincidentlog.8. Utilizefollow-upproceduresasspecifiedintheclinic’sBBP

manual.

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IfIcanreachintothecleanfieldtopickupneedles,whyhasitbeentaughtthatIcannotreachacrossthecleanfieldwhendisposingofuncleanitems?

Unclear.Itisimportanttoavoidcontaminatingthecleanfieldwithdirtyitemsbydroppingthemonthecleanfield,brushingclothingacrossthecleanfield,ordrippinguncleanliquidsonthecleanfield.Reachingacrossthecleanfieldmaynotbeaproblemaslongaspractitionersremembernottocontaminatethecleanitems.Thehistoricalavoidanceofreachingacrossthecleanfieldhelpsremindpractitionersoftheimportanceofmaintainingcleanliness.

Whatproceduresrequireconsent?Doesconsentforacupuncturetreatmentcovercupping,bleeding,moxa,andguashaaswellasneedleinsertion?

Informedconsentrequiresthatallpatientsshouldunderstandandagreetothepotentialconsequencesoftheentiretyoftheircare.Consentmustincludeanumberoffeatures,includingthenatureandpurposeofaproposedtreatmentorprocedureandtherisksandbenefitsofproposedtreatmentorprocedures.IfyouracupunctureconsentincludesthisforALLproceduresyouperform,thenthatprobablycoversyou.Butifyourconsentformonlydiscussesacupuncture,thenyouprobablyneedtoobtainadditionalorseparateconsentforallplannedprocedures.Seehttp://www.templehealth.org/ICTOOLKIT/html/ictoolkitpage5.html

Whydoesthiseditionofthemanualofferopposingviewsforsometraditionallyrestrictedprocedures,suchaselectricalstimonsomeonewithapacemaker,orpointsthatrequirespecialskill?

Practitionersareencouragedtoreadthemanualwithacriticaleye,reviewingtheevidenceprovidedandusingtheirpersonalknowledgeandpractitionerjudgmenttominimizerisksfortheirspecificpractice.Thismanualisateachingtool.Informationaboutrisksandbenefitsofspecificprocedurescontinuestogrow.Practitionersareencouragedtocomparetheirstandardofcarewiththeevidencefromresearchstudiesandcasestudiestocreatetheirownbestpractices.

Whyarethetechniquesdescribedinthemanualcalled“cleantechnique”ratherthan“steriletechniques?”

Whiletheneedlesandlancetsusedasdescribedinthismanualaresterilebeforeuse,otherdevicesarecleanbutnotsterileandtheentirefieldbeingpreparedforpatienttreatmentsisclean,notsterile.Cleantechniqueisabetterdesignationthansteriletechniquewhichwouldrequiresurgical-levelcleanlinessandsterility.

Canyouuseofalcoholpumpdispensersinclinicsettingratherthanalcoholwipes?

Alcoholpumpdispenserscanthemselvesbesourceofcontamination.Ifsuchdispensersused,theyshouldbedisinfecteddailywithappropriateEPAapproveddisinfectingsolution.

Whyistherenoreferenceto“needleretentiontime”eventhoughtheCNTManualreferences“cuppingretentiontime?”

Noavailableresearchonneedleretentiontimesuggestsanyadverseeffectsoflongerretention.Thisisnotthesameissueascuppingascuppingcompressestheskinandhasprovenadverseeffectsfromexcessiveretention.

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TheManualpermitsremovalofmultipleneedlesatsametime,butnotclearifneedlescanbeplacedinintermediatecontainerforcountingpurposesbeforebeingputinsharpscontainer.

Ifapractitionerwishestotakeoutneedlesneareachotherbeforethose2or3needlesareputinthesharpscontainer,andcanremovethemwithoutthesharpendofanyneedlecomingbackincontactwiththepatient’sskin,thenthatispermissible.Butneedlescannotbeputinasecondarycontainer/receptaclebetweenremovalfromabodyanddisposalinthesharpscontainer.Allneedlesneedtogoimmediatelyintoasharpscontainerafterremoval.

WhyisthereinconsistencyintheManualastowhethersweatandtearsaresourcesofinfection?

Sweatandtearsarenotsourcesofbloodbornepathogens.Sweatcancarryskinbacteriasocanbeasourceofcontaminationandcrossinfectionofskininfectionsbetweenpatients,orpatientsandpractitioner.Tearsarenormallynotasourceofinfectionexceptwhenapersonhasacurrentconjunctivaldisease.Sothisisaboutcontext.Wedon’texpectthatnormalhandshakesandhugsortouchingface-to-facewillspreadbloodbornepathogens.However,peoplewithconjunctivitisorimpetigoorHSVmayspreadthoseillnessthroughsweatortears.

Doused/contaminatedcupsneedtobeisolatedafteruse?

Disinfected,notisolated.Ifbleedingoccurs,inadvertentlyorasaresultofwetcupping,thosecupsneedtobehandledcarefullyasbloodandOPIMwillbepresentontheinsideofthecup.Personalprotectiveequipment,inthiscaseprimarilygloves,shouldbeusedwhenhandlingsuchcontaminatedcups.Strictisolationproceduresarenotnecessary.Allsuchcupsmustbecleanedanddisinfectedasdefinedinthistext.Allsurfacesthatthecontaminatedcupscomeincontactwithmustbedisinfectedaswell.

Doalllabcoatsneedtobelaunderedbythehealthcarefacility?

No.IftheuseoflabcoatsisasaformofuniformratherthanforthepurposesofPPE,thenitisOKforcliniciansworkingathealthcarefacilitiestopurchasetheirownuniformsandlaunderthoseathome.

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Index

70%isopropylalcohol,35,71,84,174,175,176,241adverseevent(AE):acupuncture,3,7,9,233;

bleedingtherapy,48;cupping,31,32,33,34;electroacupuncture(EA),43,44,45;guasha,52,53;moxibustion,24,25,26;PlumBlossomneedling,57;presstacksandintradermalneedles,59;serious(SAE),3,4,10,13,31,43

aggravationofsymptoms,4,9,98AIDS,14,17,77,143,172,176,178,193alcoholswab,71,72,174,175,241alcohol-basedhandsanitizer,69,78,85,86,157,

158,169,170,189antiseptic,71,72,168,170,173,174,175,192,227aseptictechniques,xiv,1,69,126,227autogenous,16,132bacteria,79,131,132,149,151,153,169,170,171,

172,176,185,191,196,227,228,229,230,231,232,242

bacterialload,73,170bacterialspores,228,229,230biohazardtrash,36,37biohazardouswaste,86,197,207,211,212,213,

214,225bleeding,3,4,39,48,50,57,69,84,92,93,96,114,

118,119,120,123,124,127,128,181,182,183,196,207,244,245;Internal,14

bleedingdisorders,39,53,119blistering,24,102,107,116blood,31,32,33,35,36,48,49,50,52,57,69,74,

76,80,84,85,87,91,92,94,115,119,120,122,124,127,132,133,134,135,136,137,138,140,141,144,146,153,168,170,172,176,178,180,181,183,191,197,198,199,200,206,207,208,211,213,241,243

bodyfluid,69,74,80,127,133,135,136,137,144,146,168,171,172,173,176,180,181,183,197,205,206,208,212,230,243

brokenneedle,4,18,19bruising,3,4,24,34,39,49,125,127,224burns,xix,24,25,26,27,28,29,30,102,103,105,

106,108,109,111,113,114,117,124,125,191,224,225

caffeine,6

CCAOM,xv,xix,72,84,188,242CentersforDiseaseControlandPrevention(CDC),

36,49,54,74,76,91,126,127,133,136,137,138,144,145,146,156,158,168,172,173,174,175,177,178,180,182,189,190,193,194,197,204,206,213,233

chemicalgermicides,190,192,230childorelderabuse,221chlorhexidine,72,175,241cleanfield,68,70,74,75,76,77,82,83,84,86,87,

88,89,90,92,94,95,96,118,120,123,125,129,159,175,177,189,228,244

CleanNeedleTechnique(CNT),17,68,69,75,76,95,127,138,142,151,159,177,204,206,227

cleantechnique,228,244cleaningaccidentalspills,197Clostridiumdifficile,157,158,191clothing,78,92,177,197,208communicabledisease,204,221confidentiality,179,204,205,219,224contamination,9,50,70,72,76,77,86,92,98,125,

126,127,151,158,172,174,176,182,183,189,196,200,228,240

cupping,4,31,32,33,34,35,36,37,39,48,53,114,115,117,155,176,183,194,196,199,222,225,241,242,244,245

cutaneous,3,57disinfectant,17,36,54,60,74,77,95,97,118,127,

152,157,158,174,189,190,191,192,195,197,201,202,228,229,240,242

ecchymosis,31,32,39,40,52,114,124,228electricalstimulation,43,45,46,59,229engineeringcontrols,74,156,207,208,214fainting,3,4,7,43,93,127,240firedepartmentregulations,204,224forgottenneedle,4,8fungi,149,171,230gloves,17,35,36,37,50,57,69,74,76,84,92,95,

96,114,118,119,120,122,123,126,127,129,144,148,152,157,158,177,181,182,183,197,200,205,206,208,213,224

glutaraldehyde,191GroupAStreptococcus(GAS),153

247

guasha,52,53,54,124,125,194,195,196,201,222,225,242,244

handwashing,69,70,74,76,78,79,91,94,97,134,152,153,155,157,159,160,168,169,170,171,172,173,182,189,206,208,214,228,232

HazardCommunicationStandard,204,210healthcareassociatedinfections(HAI),131,149,169,

171,233hepatitis,3,4,14,25,48,77,80,91,126,131,133,

135,136,139,140,141,142,148,171,172,173,176,178,179,208,219,233;hepatitisA(HAV),134;hepatitisB(HBV),48,80,91,126,133,135,136,137,138,139,178,179,189,192,205,207,208,219;hepatitisC(HCV),25,80,91,126,139,140,141,178;hepatitisD(HDV),141;hepatitisE(HEV),142

hepatitisB(HBV),48herpessimplexvirus(HSV),34,148,154,155HIPAA,205HIV,80,91,131,133,139,140,143,144,145,146,

147,148,171,172,173,176,178,179,191,192,205,234,243

housekeeping,196,201,208,223hygiene,134,138,176,177;hand,74,126,157,158,

168,169,170,174,182,183,206,224;respiratory,156,206,224

hypochloritesolution,190,191,192,197,198,202,228

immunesystem,91,131,133,137,147impetigo,153infection,3,4,14,16,24,26,33,34,36,37,48,49,

59,60,64,67,72,73,74,76,80,88,91,102,125,126,127,131,132,133,134,135,137,138,139,140,141,144,145,147,148,149,152,153,154,155,157,158,160,168,174,177,178,179,189,197,205,211,219,227,228,230

infectiousagent,77,131,132,133,171,177,180,190

infectiousdiseases,64,127,131,132,177,180,231influenza,155,177,197informedconsent,204,205,221,222injections,126,127,129,174,181injury:bloodvessels,16;centralnervoussystem,15;

heart,13;nerveinjury,3,65;organ,13;peripheralnerves,15;tissue,15

lancet,17,31,32,35,48,49,50,68,74,76,80,95,96,114,118,119,120,123,159,176,199,207,213,232,243,244

materiamedica,2medicalwaste,74,85,88,212,225methicillin-resistantStaphylococcusaureus(MRSA),

16,79,133,152,153moxa,xix,24,25,26,27,29,68,101,102,103,104,

105,106,107,108,109,110,111,211,222,225,230,237,244

moxasmoke,25,27,102Mycobacteriaotherthantuberculosis(MOT),153,

154NCCAOM,xv,xvi,xviineedlemanipulation,6,7,15,43,95,97needlestick,8,75,76,77,80,81,92,120,136,144,

177,181,183,240,243NeedlestickSafetyandPreventionAct(NSPA),206norovirus,156,157OSHA,138,180,181,182,189,193,198,200,204,

205,206,207,210,211,212,213,214,222,235pacemaker,44,46,47,244paresthesia,3patientrecords,215,225personalprotectiveequipment(PPE),35,74,114,

118,119,126,179,180,183,200,201,206,208,224,230

petechiae,31,32,39,40,52,54,114,124,125,222,228

plumblossom/"seven-star",17,32,57,69,74,76,80,122,199,231,232

pneumothorax,4,10,12,32,79,95,237,238PPD,177publichealthsettings,91,92riskreduction,xv,204,205rubefaction,24SafetyGuidelines:AggravationofSymptoms,10;

AvoidFireCuppingBurns,35;AvoidOrganandCentralNervousSystemInjury,15;AvoidPneumothorax,12;AvoidTissueInjury,16;Bloodletting,50;BrokenNeedle,19;CupDisinfection,38;Cupping,39;DisinfectingReusableMedicalEquipment,194;DisinfectionofGuaShaTools,55;Earseeds,63;GuaSha,53;HandSanitation,69;HeatTherapies,28;IntradermalNeedles,60;MoxaBurnPrevention,

248

26;MoxaBurnTreatment,27;MoxaSmokeReaction,27;NeedleCupping,40;NeedleRemoval,9;PlumBlossomTherapy,57;PreparingandMaintainingaCleanField,70;PressTacks,60;PreventBruising,BleedingandVascularInjury,5;PreventCuppingAdverseEvents,40;PreventCupping-RelatedInfections,36;PreventFainting,7;PreventInfection,17;PreventNeedleSitePain,6;PreventingEAAdverseEvents,45;PreventingElectricalInjuryduringEA,46;PreventingExcessiveMuscleContractionduringEA,45;PreventingInterferencewithaCardiacPacemakerDuringEA,46;SkinPreparation,73;StuckNeedle,8;TuiNa,65

sharps,68,73,74,75,76,78,126,189,193,199,200,211,212,228

sharpscontainer,73,74,80,81,84,85,86,87,88,92,199,201,208,214

soapandwater,35,36,37,54,69,71,72,78,91,157,158,168,169,170,172,174,175,183,195,197

SOAPnotes,217,225spills,84,183,196,197,198,199,201StandardPrecautions,xvii,68,74,76,77,94,137,

142,144,145,146,148,155,156,171,173,177,180,181,200,204,206,222,224,231,235

Staphylococcus,4,131,132,151,152,171,172,176Staphylococcusaureus,16,34,35,152sterilant,190,191,192,196sterile,3,17,18,26,35,57,59,60,68,69,70,75,

76,77,78,79,81,82,83,84,87,89,90,91,94,95,96,102,106,118,122,127,128,129,143,159,160,171,177,190,193,227,228,231,232,240,241,242,244

sterilization,78,193,205,232Streptococcus,131,151,153stuckneedle,4,7TDPlamps,27,112treatmentrecords,215,218,219tuberculosis(TB),133,149,150,177,180,191,234universalprecautions.Seestandardprecautions,

Seestandardprecautionsvaccination,133,134,136,137,138,141,150,156,

159,174,205,207vaccine,80,135,137,139,141,142,148,181,208virus,131,133,143,149,171,172,176,178,189,

191,228,229,232workplaceviolence,204Zip-lockbags,86

Clean Needle Technique Manual, 7th edition