Flexible EndoscopyInfection Control and Best Practices

Bradley J. Catalone, Ph.D.September 18, 2007

TopicsIntroductionStandard of CareReprocessing GuidelinesReprocessing ChemicalsRinsingAERs and ConnectorsCDS IssuesNew Developments

IntroductionMore than 18 million flexible endoscopy procedures per year in the U.S.Purpose of reprocessing is to render the endoscope safe for patient reuseInfection risk is associated with instrument reuseIatrogenic transmission (via a medical instrument) of infection is rare in GI endoscopy (estimated 1 in 1.8 million cases)Cases of transmission invariably are linked to breaches in reprocessing, damaged/defective equipmentPatient notifications due to reprocessing failuresDocumented cases of patient death

Endoscope Basics

Control BodyInsertion TubeBending SectionUniversal (umbilical) cordElectrical connector

Control Body

Angulation control knobsFree/Engage leverSuction & air/water valvesSwitch unit (buttons)Instrument port

Insertion Tube

Distal End

Electrical Connector

Suction Port

S-connector Mount

Electrical Connector

Light Guide Prong Mount

Air Pipe

Standard of Care

Spaulding Classification System

Spaulding Classification System

The“standard of care” for flexible endoscope reprocessing is generally accepted as High-level Disinfection. Flexible endoscopes are generally considered “semi-critical” devices that do not break the mucosal barrier.Semi-critical devices require high-level disinfection at a minimum according to the Spaulding System

GI endoscopes

GI tractStomach – acid is microbial barrierLarge intestine heavily colonized1011 CFU/g in feces

Mouth

Liver

Pharynx

StomachLarge Intestine

Small Intestine

Esophagus

GI Guidelines

Multi-society guideline for reprocessing flexible GI endoscopes (January 2003)

Multi-society GuidelineThe position statement that provides specific guidance for reprocessing of flexible GI scopes

It was a result of the consensus opinion from Nursing, Physician, Government and Industry organizations and leaders including SGNA

It provides 34 evidence-based recommendations

BronchoscopesBronchoscopy

Patient Status• Disease or illness• Immunocompromised• By-passes host

defensesBelow larynx is virtually sterileNasopharynx heavily colonized

Bronchoscopy Guidelines

Bronch Consensus Statement

The guideline is a position statement that discusses the reprocessing of flexible bronchoscopes

Not evidence-based recommendations

The only document that provides recommendations specifically for Bronchoscopes specifically

High-level Disinfection or SterilizationIs the same standard of care appropriate for reprocessing of bronchoscopes and GI endoscopes?

Bronch Consensus Statement indicates • Minimum of high-level disinfection • AERs can be used for bronchoscopes and other

endoscopes providing that users adhere to reprocessing protocol

CAN/CSA-Z314.8 (Draft) • Bronchoscopes should be preferably sterilized if the

manufacturer’s instructions allow. If sterilization is not provided for in the instructions, the bronchoscope may be high-level disinfected. If the bronchoscope is not being used on a routine basis, it should be reprocessed prior to use.

• Note: Steam sterilizable bronchoscopes are available.

Reprocessing OverviewPrecleaning at bedside – removes gross debrisLeak testing – ensures scope is air/water tightManual cleaning – critical for removing residual organic material and bioburdenHigh-level disinfection or sterilization – kills or inactivates microorganisms to render scope safe for patient reuseStorage – maintains scope in patient-ready state and protects scope from damage

Reprocessing Chemicals

DetergentsSingle use

Typically bacteriostatic, not bacteriocidal

Misconception that “More is Better”Dilute according to manufacturer’s instructionsUsing higher than specified concentration = inadequate rinsing and residual detergentResidual detergent may interact with the LCG and

• Reduce efficacy of reprocessing• Damage materials

Liquid Chemical GermicidesA Liquid Chemical Germicide is an agent used to high-level disinfect or sterilize a flexible endoscope

High-level disinfection kills or inactivates all microbial pathogens, except high levels of endospores, when used in accordance with the manufacturer’s instructions for use

Use Life is the amount of time a chemical can be reused, typically 14 or 28 daysShelf life is typically 12 months

Liquid Chemical Germicides

CategoriesGlutaraldehydeOrthopthaldehydePeracetic AcidHydrogen Peroxide

Reusable and Single-shot

ALWAYS minimize exposure to all liquid chemical germicides

LCGsContact Time is the time a scope soaks for and has contact with a chemical, and the time it takes to achieve high level disinfection or sterilization

Time TemperatureCidex OPA 10 min 20°C*

Steris 20 12 min 50-56°C

Cidex Activated Solution

45 min 25°C

LCGsEach time the chemical is reused, water is added

Increasing the water contentReducing the concentration of the biocidal agent.

The product label recommends testing the LCG prior to each use. At levels below the Minimum Effective Concentration (MEC) or Minimum Recommended Concentration (MRC), the efficacy of the LCG is in doubtLCG should never be used

Beyond its use lifeBeyond its shelf life expirationWhen it no longer passes the MEC/MRC test

Keep a log of use life, shelf life, and MEC/MRC testing

LCG Handling CharacteristicsSome chemicals require activation, for example mixing with a powder or with a concentrate.Restrictions on use: some chemicals, especially heated chemicals. are for use only in an automated endoscope reprocessor, this is to insure even heating of the LCG and prevent “cold spots”

Operator SafetyAvoid open lids and open containersUse transfer pumps instead of pouring in chemicalsInsure Proper ventilation in the roomWear Personal Protective EquipmentMSDS easily accessibleSpill kits should be readily available

Material CompatibilityEndoscope manufacturer may provide information related to the material compatibility of the chemical with the endoscope

Chemical damage to endoscopes poses an infection control and patient safety risk

The LCG efficacy and instructions for use are the LCG manufacturer’s responsibility

Rinsing

It is important to properly rinse residual chemicals from the outside and internal channels of flexible endoscopesReprocess and RINSE every endoscope channel after each use Use the correct endoscope connector to rinse residual chemical out of the endoscope channelsImproper rinsing poses a patient safety risk and may result in adverse events, such as chemical colitis

AERs and Connectors

AERsAutomated Endoscope Reprocessors are typically used to reprocess scopes after “bedside” pre-cleaning, leak testing, and flushing/brushing in the reprocessing room.

AERs may be categorized based on chemistryre-use chemistrysingle shot chemistry

AERs do not eliminate the requirement for manual cleaning

AER Brand/ModelSteris System 1 (single-shot)Steris Reliance (single-shot)ASP Evotech (single-shot)ASP AER+ (reuse)Custom Ultrasonics System 83 (reuse)Medivators MDS (reuse)Medivators DSD (reuse)Medivators CER (reuse)

Endoscope ConnectorsAER manufacturer validates reprocessing of specific endoscope models

AER manufacturer specifies the validated connector for each endoscope model

Contact the AER manufacturer to identify the validated connector for the AER

Endoscope Connectors

Reprocess EVERY channel whether it is used or not

Inspect connectors routinely and replace if necessary

Proper brushing assists in ensuring that channels are not blocked

CDS Issues

Reprocess all scope channels whether they were used in the procedure or not.

Special Channels

Auxiliary Water ChannelMultiple patient recalls due to failure to reprocess auxiliary water channelIdentify endoscopes with an auxiliary water channelMany customers do not utilize auxiliary water function during procedureDebris can back up into empty channelCritical that auxiliary water channel is flushed as part of pre-cleaningAuxiliary water channel must be reprocessed every time even if the channel was not used

Reprocessing AccessoriesEndoscope manufacturer designs brushes to reprocess specific endoscopes and channels

Specific bristle diameter and brush length

Single-use brushesDiscard after each use

Inspect and reprocess accessories with each use

StorageStore in a well-ventilated cabinetNo valves or capsHung vertically, no loopsDistal tip not contacting bottom of cabinetEnvironmental contaminantsHow long can you store a scope?

Environmental conditionsCAN/CSA-Z314.8 (Draft) Endoscopes for gastrointestinal procedures should be reprocessed if storage exceeds 7 days

Returning Endoscopes for RepairDamaged endoscopes should be cleaned and high-level disinfected or sterilized prior to shipment to service centerDamaged but not leaking – standard procedureLeaking

Mandatory manual cleaning• Tape over any external leaks• Maintain positive pressure with leakage tester• Follow manual cleaning instructions

Mandatory high-level disinfection or sterilization• EtO is the recommended process• Perform high-level disinfection with leakage tester connected• The leakage tester may be used in conjunction with some AERs• For AERs that do not permit connection of the endoscope to the

leakage tester, perform manual high-level disinfection

Delayed ReprocessingCommon for emergency procedures at night and on weekends

Problematic for channels that do not get brushed

Delay in cleaning = dried patient material difficult to remove

Delay between cleaning and high-level disinfection = increased bioburden, and potential biofilm formation

Extended soaks in detergent or water = increased bioburden, potential biofilm formation, and endoscope damage

Equipment repairOriginal equipment manufacturer (OEM) repairs meet stringent design and functional specifications

Independent service organizations (ISO) are unable to verify repair meets OEM specifications

Non-OEM repairs may reduce performance and pose an infection control risk

Repair Quality

Correct seal of the boot to insertion tube

Repair Quality

Repair Quality

Quality Control

Visual verification

Microbiological monitoring not recommended except in cases of an outbreak investigation

EndoCheck (Healthmark Industries)

Training

Preventative Maintenance

Clostridium difficileSpore-forming, gram-positive bacteriaCauses CDAD, primarily following antibiotic useIncreasing prevalence and most frequently reported cause of nosocomial GI infection1% - 15% mortality rate15% - 53% of healthy adults are asymptomatic carriersClostridium difficile is less resistant to liquid chemical germicides than organisms recommended in AOAC testLimited data suggests that high-level disinfectants are effective against C. difficile

Fecal OdorTwo identifiable causes

Damaged endoscope harboring debrisInadequate cleaning• Failure to follow proper reprocessing procedure• Olestra

Corrective actionsLeak testExtended soak in detergent (delayed reprocessing procedure)Olestra – Dawn or EndozimeSLR

Recent Developments in Endoscope Reprocessing

Manual CleaningPCI medical – EFP250

Dual PumpSeparate connection for Elevator wire channel or Auxiliary water channel

Medivators – Scope BuddySingle PumpSingle connection

BF-Q180AC

AutoclavableBronchoscope

First autoclavableflexible endoscope

Currently available

Steris Reliance EPS

High-level disinfectionSingle-use Peracetic AcidDual scopeLimited connectors (blue boot)Washer decontamination cycleOptional washing phase augments required manually cleaning

Instructions eliminate manual cleaningAutomated leak detectionAutomated MEC testing33 minute cycle timeCIDEX® OPA Concentrate Solution (single-shot)

ASP Evotech

ASGE issued a position statement on brushless cleaning claim of EvoTech“the Technology Committee of the ASGE and representatives of the Society for Gastrointestinal Nurses and Associates (SGNA) recently met with representatives of the manufacturer. Technology Committee members also met with the FDA.”“Members are cautioned about dispensing with manual washing and brushing steps before the capabilities of the new machine are confirmed in independent studies and in clinical practice.”

STERRAD Sterilization Systems50/100S/200/NX

Gas Plasma Technology Hydrogen Peroxide Vapor

Low-temperature sterilization

Indications for Use specify restrictions for medical device sterilization

Ethylene Oxide

Market has shifted to 100% EtO

Major manufacturers include 3M and Steris

Excellent efficacy and material compatibility

Limited availability

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