Contents

Overview Objectives

A Guide to Sterility Assurance isa practical handbook for health-care workers who are respmlsiblefor an organizations decontam-ination and sterilization processes.The Guide presents a comprehensive quality control programfor handling contaminated medicaldevices and equipment, andprocessing them with appropriatechecks and monitors to provideoptimum conditions for sterility

Steam and ethylene oxidesterilization are discussed aswell as packaging, labeling,and the difl~rent kinds ofmonitors, biological and chemicalindicators. Sample flow chartst~r identifying step by stepprocedures, and forms forrecording quality control dataare provided so that centralprocessing services can adoptthese tools as appropriate.

Upon completion of this Guide,the healthcare worker shouldbe able to:

1. Discuss the purpose ofdeveloping a sterility assuranceand quality control program.

2. List the recommended steps inthe transportation, decontam-ination, sterilization, inspection,packaging, and labeling ofmedical devices and equipment.

3. Explain how to select cyclesfor steam and ethylene oxidesterilizers.

4. Identify the application ofvarious sterilization processcontrols inclucfmg mechanical,chemical, and biologic monitors.

5. Develop sterility assuranceflow charts and quality controllorms for your work settingbased o]1 the examples provided.

Introduction ToSterility Assurance

A fundamental value forhealtficare workers today ispro,Ading safe workingconditions and equipment inthe patient care process andprotecting themselves andothers from exposure topathogens, l-his requires thatthe healthcare worker beknowledgeable about OSHAregulations and safe practicesfor their setting. It also requiresexquisite attention to all phasesof quality control.

Quality control processesstandardize the acti~ities andsteps necessary to produce aconsistently sterile productand safe, optimum functioninginstruments and equipment.Sterility, assurance is a level ofconfidence that each productwill meet the predeterminedstandards. The person usingthe product is assured or isconfident that the product issterile (i.e., free from allforms of microbial life), freeof harmful residues, and ifapplicable, nonpyrogenic.This is the standard of qualitythat each patient should receive.Sterility assurance is moreinclusive than just monitoringthe sterilization process. Itencompasses all of the activitiesthat healthcare workers dothat are necessary to produce asterile device.

There is no feasible way todirectly determine that aparticular item is sterile priorto use. We rely on secondary orindirect means to veri[) sterilit)~The more variables we cancontrol, the greater tfie probabilitTthat the system will produce asterile device. A comprehensivesystem (i.e., several points ofmeasurement) provides a higherlevel of confidence than a singlepoint system. A sequence ofrepeatable conditions that havebeen proven to effectivelypromote device sterilizationmust be implemented in allphases of the sterilizationprocess, from handling andcontainment at point of use tosterile storage. When there isverification and documentationthat all the physical parametersof the processing system havebeen consistently met, thenprocessed de,Aces may be releasedfor use with a high level ofconfidence that they are sterile.Sterility assurance or qualitycontrol is ongoing testing,monitoring, and calibration ofmstmments and equipment priorto use in the delivery of patientcare. It also requires that evaluation of infom~ation in a mannerthat can be acted upon to attainthe highest probability thatdevices are safe for patient use.

In This Book:A Program for SterilityAssurance

A method of assuring sterilityis a critical element of theprocessing activity: Controlsand monitors must be built intothe system to assure the userthat the processed device willbe acceptable and COl~Sistent inqualitT¢ Processing activitiesshould be performed correctlyeach time. This can be doneby developing specific detailedprocedures, giving employeeseducation, training, and pragmatic tools for them to know ifthe task was completed correctl}~This method of quality controlshould be built into every taskof the processing system. It isthe foundation of any qualitycontrol program.

This sterility assurance programmodel is presented as a guidethat may be used by any servicein a healthcare organizationwhere devices and equipmentmust be decontaminated andsterilized. It can be modifiedor condensed to fit particularprocessing situations. Thepurpose of the model is todemonstrate the interrelationships among all phases of theprocess. All monitoring controls,methods, and examples usedin this sterility assurance modelare in alignment with nationallyaccepted standards andrecommendations.

The first step in developing asterility assurance program isto list each step in the process,beginning at point of use andending in sterile storage. (Seethe flowchart "A Typical SterilityAssurance Process" in theAppendix.) Next, proceduresmust be collaborativelydeveloped tfiat define theexpected outcome in measurableor quantifiable terms for eachstep of the process. Once theprocedures have been developed,they should be reviewed by thecentral processing department,the user department, and theinfection control practitioners,to ensure they will achieve theoutcome in an effi’ctive andefficient manner. It must berecognized that the necessary-resources, including time forprogram development andeducational preparation of allemployees, must be allocated ifthe system is to succeed.

Finally, control checkpointsare assigned. Sterility must beassured at a reasonable cost.Control checks (CC) need to selected where they will do themost good at the least cost. (Seethe flowchart "A Typical SterilityAssurance Process with ControlChecks" in the Appendix.) Eachpoint requires an assessment asto whether the desired resultwas obtained. These assess-ments are designed to cover anobservable or measurable

outcome. The sample sizeand frequency should bedeterngmed by the intectioncontrol committee.

Sample lorms for suggestedcontrol checks are providedfor each step in this SterilityAssurance program. In addition,this program provides a seriesof six flowcharts that facilitateclassroom instruction and in-service activities. These flow-charts can also be reproduced asposters for on-site reinforcementof your Sterility Assuranceprocedures.

AMSCO: A Leading Resource

Over i00 years of leadershipin sterilizer technology haspositioned AMSCO as a leadingresource in the techniques ofsterility assurance. This Guideto Ste~’ili~y Assura~c¢ is intendedto provide you with a benefit ofthat experience--to impart theknowledge we’ve gained inworking with the needs of tensof thousands of customers, aswell as working to perfect ourown equipment. We hope youwill find this Guide useful.Please feel free to cot~tact uswith any questions and problemsin developing and maintainingthe Sterility Assurance programthat’s right for your institution.You can reach your AMSCOrepresentative at (800) 846-2727.

Instructions to ReceiveContinuing Education Credit

This is a self-paced independentcontinuing education activit)~The nurse or central processinghealthcare worker may chooseto complete this course in onesitting or during a few concen-trated efforts. Since the unit isrelatively short and can be com-pleted in a couple of hours, it issuggested that learners completethe unit in one or two sittings.

To use this unit of instruction inan optimal manner, learnersshould complete activities in thefollowing sequence:

I. Read the unit objectives anddetemline whether this subject is pertinent and useful toyour professional setting.

2. Review the test questions tofurther assist you in focus-ing in on key areas and ter-minology

3. Study the content of die Guide.

4. Answer the self assessmenttest questions.

5. Evaluate your performanceusing the answer ke~

6. Follow the steps under ’Con-tinuing Education Credit" toreceive formal credit for com-pleting this unit.

Nurses Accreditation/Credit Hours

This offering for 2 contact hoursis sponsored by EducationDesign, which is accredited bythe American Nurses Creden-timing Center Commission onAccreditation (ANCC). Coursessponsored by an ANCC accred-ited agency will meet relicensurerequirements in the followingmandatoW states; Colorado,Kentucky, Massachusetts, NewHampshire, New Mexico, Ohio,and Texas. in addition, Educa-tion Design is a State Boardapproved provider of NursingCE in the following states:

Alabama: ABNPO141Calilbrnia: 06647Florida: 2711166 (2504)Iowa: 272Kansas: LT 0119-1116

Obtaining full credit lot thisoffering depends upon atten-dance, regardless of circum-stances, bom beginning to end.Attendance will be monitoredand the number of contacthours reduced for participantswho fail to attend any portion ofthe program. Licensees in thestates of California, Florida,Kansas and Iowa must, accord-ing to law, provide their licensenumbers for record keeping pur-poses.

To receive formal nursing continuing education credit aftercompleting this unit:

1. Respond to the evaluation andself assessment/test questions.

2, Complete the registration form.

3. Write a check for $i0.00 pay-able to "Education Design."

4. Send the registration form,self-assessment/test questions,evaluation, and $10.00 l~e to:

Education DesignPO. Box 22275Denver, CO 80222

Any questions, please call1-303-692-9758.

Upon receipt of these docu-ments, Education Design willsend you a certificate of coursecompletion indicating the credits earned.

Education Design will alsomaintain a record of your con-tinuing education credit andprovide verification if necessaryfor seven years.

This CNE activity was plannedand produced in accordance withthe ANCC. This material wasoriginally produced in September1993 and can no longer be usedafter September 1996 withoutbeing updated. Therefore, CNEcredit will not be issued afterSeptember 1996.

Disclaimer

Central Service ProfessionalAccreditation

Approved by the NICHSPDPfor 2.0 contact hours whenentire booklet is completedalong with flow charts. Individ-uals certified through theN1CHSPDP are not required tosubmit the $10 fee or form toany agencT¢ CEU credit will begiven upon successful comple-tion of this self-study program(including passing of post-test ).Certificates of completionshould be provided by theDepartment Head indicating theTitle of the Program, date pro-vided and Department Head’ssignature.

About the Author

Marimargaret Reichert, RN, MA,well-known author and lecturer,has over 25 years’ experience inthe healthcare field including17 years in clinical management.She has worked in hospitalsranging from 50 to 2500 beds,holding such positions as headnurse, Division Head of VascularServices, Staff DevelopmentCoordinator and Clinical NurseCoordinator in PerioperativeNursing, and Director of CentralSterile Reprocessing. Ms. Reichertis recognized [or her innovativeapproach in the development ofmanagement and organizationalsystems that improve the qualityof patient care while increasingrevenue or reducing operatingcosts. Throughout her career,

she has promoted new technologywith a focus on its implementationin an economically responsiblemanner. She has been involvedwith the Sterilization StandardsCommittee of the Associationfor the Advancement of MedicalInstrumentation (AAMI) since1980, and holds membershipsin the Association of OperatingRoom Nurses (AORN), Associa-tion of Practitioners in InfectionControl (APIC), American Society of Heahhcare Central Ser-vice Personnel (ASHCSP), theSociety of GastroenterologyNurses and Associates (SGNA),and the International Associa-tion of Healthcare Central Ser-vice Material Management(IAHCSMM).

About the Photography

Our thanks to the staff of St.Vincent Hospital, Indianapolis,IN, for making their ti~cilitiesavailable to our photographer.Busy schedule notwithstanding,they provided the materials andlocations that enabled us tobring this Sterility AssuranceGuide to completion.

Handling and Containment atPoint of UseProducing a sterde medical device is a

complex process that is dependenttlpon the successful completion of allthe steps from the time of use untilthe time for the next use. Proceduresmust be established to meet thecriteria for effective processing as well

as the requirements for employeesafety as stated ~1 the 1991 OccupationalSafety and Health Achnirtisl~afion (OSHA),Occupational Exposure to BloodbornePathogens; Final Rule, and all otherOSHA safety requirements

In the operating room, gross soil anddebris are w~ped from the surgicalinstmment~ throughout the procedure.In other areas, the person preparingthe device for return to the processingarea will remove the gross soil anddehris with a sponge moistened withwater, Disposable sharps such asdisposable knife blades and needle~must be removed at point of use anddLscarded in a puncture- and leak-proof container. Reusable textiles are

removed and placed in the appropriate

Contaminated supplies are contained

without damaging the items, The cartmust be identified as "Biohazard"when it contains contaminated

supplies. This can be accomplisixed bycovering a cart with a "Biohazard"labeled plastic cover, or by using aclosed cart with a label holdercontaining a "Biohazard" label. Somemethods of containment inclndeplacing prepared items that do notpose any risk of puncture (e.g., manual resuscitator) into a plastic bag,placing a tray of surgical instrumentsinto a rigid sterdization containersystem with solid bottoms, or placingthe tray of instntments into apnncture and leak resistant coveredcontainer designed expressly forcontainment of contaminated supplies.

The prepared items should then beplaced on a cart that has been labeled

"Biobazard" for transportation.Containers of solutions must be sealedor secured to prevent spills duringtransport.

Incorrect handling and containment

of contaminated supplies could resultin exposure for individuals who w~ilsubsequently contact the device.Eor this reason, the procedure shouldbe audited during and immediatelyfollowing the preparanon for transport,rather than after a problem has occurred.

TransportationThe contaminated supplies should betransported as quickly as possible tothe decontamination area. The methodof transport should ensure thatcontainment of the contaminants is

maintained (e.g., not leaving unlockedsoiled casecar ts unattended in publicaccess hallways).

Cleaning and Biocidal ProcessAs soon as the contamLnated suppliesarrive in the decontamination area, they

should be sorted and prepared for thedecontamination process. Devices thatare designed to be disassembled shouldbe taken apart. Pretreatment processes

such as enzymatic soaks should becompleted at this time.

The purpose of the decontaminationprocess is the removal of soft, and thereduction ni the number of potentiallyinfectious mmroorganisms. It isnecessary so that the dewce can be safelyhandled by persormd in the preparationarea who are not wearing protectiveattire. Potentially infectious, a relativeterm, is based on such variables as type,number and virulence of organiams on

a device, susceptibility of individuals todisease, and the route of transmission(e.g., niha]ation, percutaneous or

ingestion), There are many differentdevices constructed of many different

materials. For this reason, a singleuniversal decontamination processcannot be recommended. The criticalelement is to select a process that millminimize the risk to the employee

while maintaining good care andhandling of the device. (See the flow-chart "A Decision Matrkx for Selectingan Appropriate DecontamniationProcess" in the AppendLx.) This flowchart illustrates the various optioDs.

Manual CleaningAll hospitals clean some specialty andcomplex insnmments manually, Inmany hospitals, however, manualcleaning is the only method available.While manual cleaning can be a veryeffective process for the removal ofgross soil and debris and reduction ofmicroorgantsms, there is less assuranceof the efficacy nf this process because itcannot be monitored. The actualmechanics of manual cleaning w~th abrush, if not performed under water,can introduce aerosols into the air.These airborne contaminants have the

potential of transmitting some diseasesto the employee.

Automatic CleaningV/hen possible, items sbould heautomatically cleaned Automaticprocesses reduce the risk of employeeexposure when compared with themanual process. Items must be prepared properly to optimize the process.Specialty basket~ may be provided bythe manufacturer of the equipment.Automatic systems can offer a highlevel of conbdence that the outcomewas attained because tbe process can

be physically monitored

Washers

Washers clean the device with hotwater (150° F), cleaning agents and themechanical action of the jet sprayers

The items are then rinsed with hotwater at 180° F and exposed to adrying process at 240° F. Many itemsthat cannot withstand the pressureand/or temperature (270° F) of thewasher/sterilizer process can beeffectively processed in a washer.

The washing process can be chemicallyand physically monitored. Chemicalindicators (Cis) for the washingprocess are available. These CIs aredesigned to sense and record surface

temperatures. They are designed asmultiple point (160~, 170°, 180°, 19W F),no~reversible, chemmal-~hange lempera-

ture recorders

Cycle records indicating exposure timeand temperature should be reviewedat the completion of each cycle to

ensure the preset parameters havebeen atCained, and the data sbould bebled in a record-keeping system Thisinformation documenls the physicalparameters (exposure time and temperature)~ it does not document acraalmicrobial kill

Routine, periodic review should

include a comparison of cycle recordsThis comparison can pro~nde valuableinformation aboul the consistency

of machine performance It may alsohighlight shibs in operationalperformance that indicate the need

lot preventative maintenance work,thereby diminating some of Iheemergency set-vice calls due to hreakdowns. With the AMSCO Stage 3control inslalled, this data is auto-madcally recorded. With the oldermodels, one must look al tbe gaugesto see the temperature

Washer/sterilizersThe washe~/ste~lizer process can bemonitored mecbanically, chemicallyand biologically. The biologicalindicator (BI) selected must be onethat bas been designed for a wetprocess (eg., the biological indicatormust be able to sur~qve the wash cyclebefore the sterilization cycle) Some

biological monitoring systems alsocontain a chemical indicator. Thiscombination provides more comprehensive reformation. The response of

the CI promdes instant informationabout certean process parameters and,after incubation, the BI provides theassurance of microbial kill.

Immediately after the decontaminationprocess and betore the it~struments areinspected, the employee should verifythat the cyde parameters were altainedThis can be accomplished by visualobservation of the gauges and docu-mentation during the process or bychecking the printout upon completionof the cycle.

Inspection for CleanlinessTbe fi~s[ step i. the preparationprocess is the inspection for cleanli-ness Any device with visible soft, orsuspected retained soil in areas tlutcannot be visually observed, should bereturned to the decontaminatmn areafor further processing.

neassemblyBefore a devi~e ¢~n he i~spected ~orfunctionali~, it must first be assembled,Step-by-step instructions should beprovided by the device manufacturer.

Inspection for Fnnctionality

PreparationSteam Sterilization

¯ Textile packs should not exceed the

size, weight and density as recom-

mended by the texule manufacturer

For 100% cotton or cottotv’polyesterblends, the size of the pack should be

no greater than 12" x 12" x 20" with

a weight of 12 lbs (or less), and

density of no more than 7.2 Ibs./cu t~(Illuslration 1 ) The chemical in&cator

should be placed in the center of the

pack between layers of goods, not

between stacks of items.

¯ Basin sets should be prepared so that

all basins are placed in the samedirection. Graduated nested basins

should ditter in diameter by at least

one inch. Position items so that

when placed on the sterilizer cart,

they are standing on edge tilted for

drainage Place absorbent surgical

towels between each nested item sothat the lowel Iouches the inner

surfaces of each basin (Illustration 2)

¯ Instrument sets should be preparedin ~ire mesh or perforated-botlom

trays The weight of the instrument

set should be based on the designand density of the individual

inst~ ument., comprising the set

distribution of mass v*~t bin the set,and the ability of the employee to

use good body mecbanics in

transferring the set to and from the

sterilizer cart and to and from storageafter sterilization (Illustration 3)

The judicious use of absorbent

cotton surgical towels when

preparing instrument sets will mini-

mize the occurrence of wet packs

caused b) inadequate condensate

drainage or inadequate revaporiza-

tion. A towel should be used to line

the inner bottom of the instrument

tray. Addil~onal towels may be

needed between the tray and thewrapper (if wrappers are used ralher

than rigid containers) and around

heavy metal insumments.

Illustration 1:Textile pack preparedfor sterilization.

Basin set preparedfor sterilization.

illustration 3:instrument set preparation.Oissection instruments in onebasket, retractors in another.

Preparation must be perlormed in anarea vdth connolled relative humidity.It is recommended lhat the relativehumidity be maintained within 35% to

70% throughout tl~e processing depart-ment (Associauon for the Advancementof Mcdical Instrumentation [A&MI] 1992)

Although humidity is essential forsterilization with EO, excessivemoisture (i.e, water droplets) forms barrier to sterilization and t:acilitatesthe formation of toxic EO by productsGuidelines lor preparing supplies forEO sterilizalion include:

¯ All products and packaging mustbe preconditioned (eg, held tor minimum of 2 horns m a contxolled

of 35% to 70%) Adequate h~~lmtion

removed betore preparing the itemfor sterilization. The water droplets

~e probabfliW of tom~adon of ethylene

glycol, a liqmd which cannot be removed

heated torced air. Although the

¯ Some devices may require specialpreconditioning procedures The

mended should be asked if an}" ~pecial

Packaging

healthca~e facility. These includetextile ~rappel~,, nonwoven (disposable)

and pouch packaging The type of

and the needs of the end user (eg.,

whether asep6c presentation is required).For example, an acceptable packagingmaterial for steam would incorporatethe follov~ng attributes:

¯ Be able to vAthstand pressurechanges.

¯ Be able to tolerate moist conditioos.¯ Be able to tolerate high temperatures¯ Allow the removal of air.¯ Allow the penetration of the

sterilant.¯ Allow drainage of condensate and

removal of steam.¯ Provide a barrier to microorganisms

after processing.

Acceptable packaging materials forEO would incorporate the followingattributes:

¯ Allow the penetration of thestefilant.

¯ Allow the removal of fi~e steri/ant.¯ Allow removal of EO during the

aeration process.¯ Will not react with EO or other

chemicals.¯ Provide barrier to microorganisms

after processing.

Labeling - Product and ProcessIdentificationEach package should be Labeled toidentify the contents and process lotcontrol information, Generally, the lotcontrol number should designate:

¯ the date of sterilization.¯ the sterilizer identification number

¯ the cycle number.¯ the operator’s initials

Placement of Supplieson the Sterilizer Cart

Illustration 4:Textile packs pieced on cart withfolds of contents perpendicularto shelf and spaced te allow forremoval end steam penetration.

¯ Like items should be processedtogether (eg, either textile packs,

inst~ment set& or utensil sets).Standardizing the number andplacement of products controls someof the process variables. A higherLevel of assurance is attained whenvariables are controlled (Illustrations4, 5, and 6)

¯ When different items must beprocessed together, textile packsshould always be placed aboveinstrument sets and utensils.This dirainates the potentialcondensate from the instrumentsdripping onto the textile packs(Illustration 7)

EOThe load configuration should beestablished to ensure contact with thesterilant, adequate aeration andemployee safety. Genm’al recom~nendations include:

¯ Items should be placed loosely, wellwithin the comqnes of the cart, shelf

or basket. If the items are to be transferred from a steril~zarion chamber toa separate aeration chamber, the load

should be cotffigalred so that it ~511not be necessary to touch individualpackag~ during the t~a~sfer process.Car/s and baskets should be made ofnon-EO absorbent materiaL.

¯ ltem_s in peel pouch packaging shouldbe placed in a vertical positron

¯ hems should not touch the chmnber

Illustration 5:8asins placed on carl with allsurfaces of the contents of eachset positioned to allow removal ofair, steam contact, and drainageof condensate. This requiresstandardization in preparing thesets, since the contents are notvisible once wrapped.

Cycle Selection

Cycle recommendations provided by

the sterilizer manufacturer are general

mendations for general line surgical

(i.e., basin sets) are supported

testing that was performed in the

1950s These test data may not be

applicabla to the complex medical

devices or newer type textile ~abrics

being processed in today’s healthcare

for providing specific sterilization

testn, g (See the chart "Typical Steam

Appendix which sumnmrizes the most

commonly used generic cycles,)

Upon completion of the stetfifizationprocess, the carts of sterilized items

should be ]emoved to a specific area

out of the flow of trathc and away horn

any ventilation ducts [or the cool

down pe~fod. This may take an hour or

more, depending upon conditions in

the cool doom area. The items should

not he handled unlil they are no longerwarm to the touch. Products could

become contaminated if handled while

still hot. As an example, if you were to

touch these packages just after removal

trom the stenhzer, the amount of vapor

present inside the package might be

sufficient to wel the v,q’apper frominstde to outside, and to canT micwo

orgamsms from your []and through

the material of the w~apper or pouch.

Also, hot metal items could cause

injury to the employee

EOFull loads should be processed The

sterilizer conu’ols are p~eset to injecta certain amount of EO imo the

chamber to establish a predetm~nined

concentration of EO Therefore, thesame amount of EO will be injected

into the chamber regardless of the size

of the load Full loads are more cost-

etfecfive They- reduce the opportunities~or operator exposure to EO and result

in fcwer cycles and, therelore, less

environmental release ot EO and any

diluent gases.

Cycle recommendations for EO

sterilization provided by the stenhzer

manufacturer are general purpose orgeneric cycles and are not product

specific. Because of the vast array of

products sterilized ~qtb EO, the

steriltzer manufacturer qualifie~ the

sterilizer by perfot3ning simulated load

testing using test packs described by

AAMI, rather than real products. The

sterilizer manufacturer demonstrates,

Illustration 6:Instrument sets [wrapped endcontainerized] with bottom oftray horizontal to shelf andheaviest sets on file bottom.

Illustration 7:Mixed load with metal oooflsbeneath other items and eachitem positioned as appropriate

to the satisfaction of the Federal DrugAdministration (FDA), Ihat the cycle(s)available on any given sterilizer arecapable of producing at least a l0-6

(one in one million) probability of nonsterile item In addition, a satetyfactor is added to the cycle time toallow for some anticipated differencein loads. These cycle parameters maynot, however, be adequate to sterilizesome devices, depending on design,l~aterials and methods of construction.For this reason, the device manulactureris responsible for providing specificsterilization recommendations for thmrdevice based on product testing. (Seethe chart "Typical EO ’Generic’ Recom-mendations" which summarizes themost commonly used generic cycles,)

Items that are sterilized with EO mustbe aerated to remove tl~e toxic residualEO. Because of the many variablesassociated ~qth the materials and the

construction of the device, appropriateaeration recommendatimls supportedby product testing should be providedby the device manufacturer

Sterilization Process ControlsThe goal of the sterilization process isthe complete destruction of all formsof microbial life on each item being

processed Because microorganismscannot be seen by the naked eye, theonly way to ascertain that the item issterile is to test it Because this is notpractical, we must rely on secondaryor indirect means to verify this out-come These indirect methods ofmeasurement include mechanicalindicators (eg,, gauges, dials andprintouts), air leak test~ for pre-vacuum methods, and chemical and

biological process monitors Com-prehensive quality- assurance forsterilization includes the collectionof data from all of these methods toindirectly verify each product is sterile.

Mechanical Monitors

The mechanical controls h,r EOsterilization directly monitor only twoof the required four parameters (timearid temperalure) Gas concent]ationand relative humidity are controlled bythe machine, with no practical meat~availahle tot monitoring. Thus, otherquality control measures take onadditim, al importance.

Additional methods of monitoring arerecommended to increase the level o[assurance hy verifying that steriliza-tion condition,s have been achieved atmultiple points within the load.

fhere are many dillerent types oil CIsthat will respond to one or more of theparameters nece_ssary for sterilizationhy steam (time, temperalure, steamsaturation) or EO (i e, time, tempera-

mr*’, relative humi&ty, and EO gasconcentration) Before a productselecnon is made, the processing

manager should know what the CI ismeasuring, and more important, whatit is not.

The CI should be placed in an areawithin the package that would be themost dithcult for the ste~ffant to reach.

exa~nples of Cl placement in suppliesbeing processed with steam.

Each CI should be examined by theindiwdual opening the package and anassessment should be made as to theacceptability of the CI response. If a CIwithin a package does not reach an

acceptabla end point response, theproduct should not be used. This

information should be given to themanager ot Ihe processing department tor further investigation Theunacceptabla end point response ofthe CI could signal items have beenincorrectly packaged or loaded, or itcould be idendl>qng an equipmentmall[unction which ~vould affect the

sterility o[ all products processed inthai load The mm~ager of the process-ing department should first considertl~e content oil the particular package

Illustration 8:Placement of Cl in an instrumentset that will be wrapped.

Illustration 9:Placement of CI in an instrumentset that will be containerized.

Illustration 1 O:Placement of CI in a basin set.

Illustration 11:Placement of CI in a specialtyinstrument set such as ostestomes,

Illustration 12:CI should be placed in the center ofthe textile pack bet~veen the layers.

Illustration 13:In-hospitalpreparedtestpackwith a daily CI sheet andcommercially prepared test pack.

single point and may not indicate the

condihons throughout lhe load.

II similar packages to the one in

question from the same load are still

available, several should be opened

and the CI examined Muhiple failures

trom the same load may prompt a

decision to recall some or all items~rorn that load, depending on whether

the tauh is thought to be a packaging/

loading error, an equipmem failure, or

of unknown cause (See "Chmmcal

Indicators: A Problem-solving Flowchart" in the Appendix.)

The Bowie-Dick test pack ~nay he

prepared in the department followingthe guidelines provided by AAMI(1992). Colnmercially prepared test

packs are a~,ailable and widelyaccepted (Illustration 13.) They offer

Ihe advantages of convenience and

consistency over in hospital prepared

test packs It is recommended thai lhe

manufacturer of the test pack provide

scientific data that supports the

equivalency of their test pack lo the

AAMI Bowie Dick Test Pack

The Bowie-Dick test pack is placed

horizontally on the lower shelf of

the sterilizer over the drain in an

otherwise empty chamber If the

sterilizer is used continuously, the test

may be completed at any time duringthe 2~,-hour period. Many departments

that are operational 24 hours a day"

pertorra Ihe Bowie-Dick test just after

] 2:00 midnight If the sterilizer is

turned o[[, or il the sterilizer is not

used during the evening and/or night

shift, a shortened cycle (ie., v, ithout

the dwing phase) should be initiated

to properly heat the sterilizer hett~rethe test load is initiated. (See "The

Bowie Dick Test: A Problem-solving

Flowchart" in the Appendix)

79

individual product is sterile. Tfiebiological test pack has been designed

biological process indicators areplaced within the cenler of the pack(Illustration la,) (See "BiologicalIndicators: A Problem sol~ng Flowchart" in the Appendix )

usage today: homogenous hospitalprepared test packs (.AAMI 1992) andcommercially prepared test packs(lllustlation 15). Commercially

prepared packs vary greatly in designand content-, They offer advantages

in-hospital prepared packs Theygenerally take up less chamber

prepared test pack should providescientific data showing the pack’s

as described in AAMI (1992):

longer available in North American

process should be tested with Ihe B1test pack at least daily and fi, r any loadwhich conlains an implantable device.The BI test pack is placed fiat in thearea of tfie chamber that is leastfavorable to slerilization This area, the"cold point," varies with the sterilizerdesign, bul is normally in the fiont,

bottom section o~" the sterilizer, overthe chamber drain

There are two t)~pes of in hospitalprepared test packs used [or EOsterilizers: a challenge tesl pack whichcreates a simulated challenge for EOsterilization, and a routine test pack(Illustzation ~6) wfiich ofl[ers lessresistance to the sterifizalion processthan the challenge pack, but moreclosely simulates actual productconfigurations being routinelysterilized by EO. The biological testpack(s) is placed in a location(s)within the chamber which is mostdittlcult to sterilize. For example,stratification of the sterilant orvariation in the temperamre through-out the chamber nmy inhibit steriliza-non In general, the test pack shouldhe placed in the center of the loadunless the sterilizer manulacturerindicates that another ]ocatmn ispreferred. Commercially available testpacks are also acceptable, providmg

the manufacturer of tfie test pack can

Illustration 14:Placement of BI and Clin ehospitalpreparedchallengetestpack.

Illustration 15:In-hospital prepared challengetest pack and a commerciallyprepared gl test pack.

Illustration 16:In-hospital prepared routinetest pack and a commereialtyprepared BI test peck.

2O

IllustraUon 17:Complete sterility assurancerecord keeping system toinsure preper storage andretrieval of data.

demonstrate equivalence to eitherthe challenge pack or the routine

monitonng pack. The biological te~tpack should be retrieved abel aeration

The EO sterilization process should be

tested with a BI test pack eveN’ load.

"Biologic[ Indicators: A Problena-soh~ngFlo~vchart" illustrates a decision flow-

chart in the event the Bl test results are

unacceptable. (See the Appendix)

Product Testing

Routine biological test packs have beendesigned m create a known challenge

to the sterilLzat~on process. But the

packaging method5 and/or loadingpractices being performed x~qthin each~aci[ity may be presenting a different

and possibly greater chaflenge to the

sterilieatmn process. For thi~ reasonAAMI (1990, 1992) recolnlnends

periodic verihcation using CIs and

in routinely prepared products.

CIs and BIs are IO be placed at diflerent

places in the package at the pointsthat would be the most ditticuh to

sterilize (i.e, those most resistant tosterilant penetration) The packaged

product is then identified and placed

among other products in a routine

sterilization load At the completion

of the process, the sample packs areopened, the Cls respected tot end-

point reaction, and the BIs prepared

and incubated. If acceptable results

are attained, there is a greater level of

assurance that the packaging and

loading practices did not inhibitsterilization

Verifying that the product can be

packaged and loaded correctly before

the product is introduced into the

institution offers the greatest level ofassurance Testing should include

chemical and biological indicator

testing, and for steam sterilization, an

evalualion of the poststerilkarion

moisture content (ie, wet packs)Once acceptable results have been

achieved, a procedure should be

written that contaii~ the specihc

measurable criteria for the packaging

and loading of tbat product. This

practice minimizes work practice

variation and offers a higher level of

assurance Ihat the resufls seen during

initial evaluation will be repeated.

DocumentationDocumentation establishes account-

ability. A system should be established

that wdl: 1) collect the needed inlor-mation~ 2) be easy to understand;

3) minimize the potential for error;4) minimize the volume of paper to

be stored; 5) consolidate infonnalXon~henever pos.s~ble; and 6) be easy to

retrieve.

The sterilization activity records(Illustration 17) for each cycle shouldinclude:

¯ The assigned lot number.¯ The contents of the lot or load.¯ The exposure time and temperature

(if not provided on the stetilizerrecording chart or printout).

¯ The name or initials of the sterilizer

Dust covers, if used, should be appliedimmediately after cool-down has been

completed. All supplies can be placedin sterile storage until needed. Sterilityis related to events, not time. Sterilestorage should be designed to mini-mize the events that could contaminatethe supplies. Adequate space is needed

around sterile materials to allow forair circulation in the room, preventcontamination during cleaning of floors,and prevent contact between sterile

items and condensation that may formon interior surfaces of outside walls.

ConclusionAtte]mon to the processes and controlsinvolved in the decontamination andsterilization of medical devices andequipment is critical. Protection of

self, others, and patients from unneces-saD" exposure to pathogens and unsafesituations is realistic when an adequatequality control program is developedand implemented.

The costs of the resources (i,e.,adequate staff, additional inventory,

educational preparation and appropriate equipment) can be justifiedThe hidden costs associated with

product defects include: unnecessaryinventory, iostrument sets that con-tain too many insttumenls, extendedprocedure time due to instruments orequipment not working, proceduresbeing delayed or canceled, andperhaps overtime pay if the workdayis extended to complete the schedule.While these costs are absorbed by the

user department, opportunities tolower costs will force managers toscrutinize their operations. Potentialsavings for the program includereduced processing costs, reducedlabor for both the processing and theuser departments, and reduced repairand replacement costs.

the allocation of appropriate resourcesand the ability to produce the productcorrectly 100% of the time. As theresources are reduced (e.g., inadequate

staff, no time for educational preparation,inadequate levels of inventory) therate of errors, liability and associated

Monitoring and evaluating are thedy~mmic activities that improve theprocess. Assuring sterility is a criticalelement of processing activities. A welldesigned system will ensure that theoutcome or product is acceptable andconsistent for use in patient care.The professional responsible for theprocessing activities will be managingand working in a proactive, problem-avoidance system.

Resources

AAMI Good hospital practice: Steatnsteriliza0on and sterility assm ante.Association for the A&ancement oj Medical

Journal oj Nursing Qualit) Assurance,2(3):70 78 1988

Graham G 5. Decontamination: amicrobmlogtst’s perspective J heallhcaremat mgmt. 5(9):36 41, 1988.

INSTRUCTIONAL FLOW CHARTS

This section provides instructional flow charts which can be ]eproduced for

use in classroom instruction, in selwice activities, and as posters for on-sitereinforcement of your Sterility Assurance procedures.

Contents

1 ........... A Typical St erili W Assurance Process

2 ........... A T~-pical Sterility Assurance Process ~,Vith Control Checks

3 ........... A Decision Matrix for Selecting Appropriate Decontamination Processes

4 ........... Typical Steam "Generic" Recommendatimls

5 ........... Typical EO ’Generic" Recommendatim, s

6 ........... Chemical Indicators: A Problem solving Flowchart

7 ........... Biological Indicators: A Problem solving Flowcharl

8 ........ The Bowie Dick Test: A Problem-solving Flowchart

24

ATypical Sterility Assurance Process

Clean?

A Typical Sterility Assurance Process With Control Checks (CC)

Decision Matrix for Selecting an Appropriate Decontamination Process

IIII

Typical Steam "Generic" Recommendations

SELECTED CYCLEORY TIME

ACTUALCUAMBERTEMPERATURE

EXPOSURE TIMESTERILIZER TYPE ITEM TEMPERATURE

272 276 F

272 276: F

Typical EO "Generic" Recommendations

EXPOSURE RELATIRERUMIMTY m COHCEHTRATIOHEXPOSURE TIME TEMPERATURE

Chemical indicators: A Problem-solving Flowchart

Call se[qce

Run ~owie-Dick ~

L Resume processing activity J

Biological Indicators: A Problem-solving Flowchart

Bowie-Dick Test: A Problem-solving Flowchart

Ca//for set/ice

CONTROL CHECK SAMPLE FORMS

Contents

¢¢1 .......................................... Handling and Containmelat at PclJ~t ol U~e

CC2 .............................................. Transportation

1~3 ........................................ Cleaning and Biocidal Process

1~1~4 ................................... Preparation tor Automatic Cleaning

1~1~5 ...................................... Verification of the Decontmnination Process

11~6 ....................................... Verification ol Correct Preparation Practices

~7 ......................................... Sterilization Activities

1~1~8 ........................................ Verification of the Sterilization Process

32

Handling and Containmentat Point of Use

Date

Procedure

Auditor

Preparer

ACCEPTABLE UNACCEPTABLE CORRECTIVEACTION

Appropriate leak proof, puncture-proof containers are available atpoint of use for discarding sharps

3. All disposable sharps arediscarded at point of use.

4.1nstrumentsarecontainedaccording to depa~mentalprocedure

5, Contaminated supplies arecorrectly labeled (i.e.. biohazard)

6. Contained body fluids (e.g.,suction canisters) are securedto minimize nsk of spills.

Date

CHECKProcedure

T~ansportation

ACCEPTABLE UNACCEPTABLE CORRECTIVEACTION

1, All contaminated items haveremained contained duringtranspori

4, TransporL carl was not leftunattended at any time dudngt~ansport to the processingdepariment, if public corridorswere used

CHECKq

Cleaning and Biocidal Process

Date

Procedure

Auditor

Preparer

ACCEPTABLE UNACCEPTABLE CORRECTIVEACTION

1. Personnel handling and cleaningcontaminated supplies arewea~ing protective attire asprescribed by OSHA.

2, InstnJments aredisassembled correctly

3. Enzymatic pretreatment isbeing performed correctly:

¯ Right product¯ Right concentration¯ Right exposure time

4, Manual cleaning is beingcorrectly per[ormed:

¯ Scrubbing under waterlevel with brush

¯ Channels are irngated¯ Right detergent¯ Right concentration¯ Rinsing correctly

Preparation forAutomatic Cleaning

ACCEPTABLE UNACCEPTABLE CORRECTIVEACTION

~. CI is con-ectly placed

3, BI is correctly placed

Verification of theDecontamination Process

ACCEPTABLE UHACCEPTABLE CORRECTIVEACTiDN

1. Correct cycle is selected

2, Cycle parameter8 aredocumented correctly

3. The end point response ofthe CI is acceptable

4. The BI is correctly preparedand incubated

Date

Procedure

Auditor

Preparer

Verification of CorrectPreparation Fractices

Auditor

ACCEPTABLE UHACCEPTABLE CURRECTIVEACTIOH

1. Items are prepared asdescribed in the procedure.

Inst~ment sets contain thecorrect type and number ofinstruments

3. Basin sets have adequate spacebetween each basin and allitems are placed in a mannerthat will allow d~ainage of condensate a~ld complete drying

4. Multiple pare devicesare assembled correctly,if required

5. Devices that requirefunctionali~z inspectio~lsare within specifications.

Enclosures (eg., contents cardor instrument count sheet), ifadded, are correctly completed.

Items/instruments are placedin the correct arrangement inthe basket or on the tray asdescribed in the procedure

Sterilization Activities

Date

Procedure

Auditor

ACCEPTABLE UNACCEPTABLE CDRRECTIVEACTION

Con’ect exposure time andtemperature are selected.

BI Test Pack is correctlyplaced in stedizer

3. Documentation is correctlyentered into the logbook.

4, Supplies are correctly placedin basket, or on car[ or shelf.

Verification of theSterilization Process

Date

Procedure

Auditor

Preparer

ACCEPTABLE UMACCEPTABLE CDRRECTIVE ACTION

1. Correct cycle time andtemperature are verifiedon graph or printout

__ 2. BI Test Pack(s) was correctlyplaced in the sterilizer

3. Supplies were correctly placedon carL, basket or shelf

4. Supplies were correctly transferred from EO stenlizer toaerator

5. BI Test Pack(s) was correctlyretrieved, prepared and incubated

Supplies were adequatelycooled down a~er removalfrom steam sterilizer.

7. Cool down conditions werecontrolled and maintained:

¯ Away From T~a~[ic¯ NO Touching

Sterile Storage

Date

Procedure

Auditor

ACCEPTABLE CORRECTIVE ACTIOHU~ACCEPTABLE

Stedle supplies are positioned sothat packaging is not crushed,bent, conlpressed or punctured

;~. Sterile supplies are stored onshelves that are clean and

4. Sterile supplies that are criticalbut seldom used are stored inclosed cabinets if possible

A Guide to Sterility AssuranceSelf-Assessment

Instructions: Select the best answer.After completing the assessment,check your responses against theAnswer Key Review apprepriatesubject areas if necessary.

] The purpose of decontamination is:

A removal of soil

B. reduction in tile number of

microorganisms

C prevention of punctures and leaksD. AandB

2 For steam and ethylene oxide

sterilization, where should chemical

indicators be placed for opnmum

periormance information?

a. most accessible area within

the packageB most difficult to reach area

within the package

C. in the center of the sterilizer

D in the rear of the sterilizer

3 Excessive moisture or water

droplets can interfere with steriliza-tion by ethylene oxide (EO) because:

A. water droplets form a barrier

around microorganisms and

prevent exposure to EOB toxic b}-products are formed that

I~alsely change chemical indicatorsC. moisture alters the temperature

of the cycleD excess water comhines with EO

and forms another ineffective gas

4 ~ich of the following is a requiredcharacteristic for packaging material

B. tolerate treezing

5. To select a cycle k,r either steam or

ethylene oxide, what guideline should

be Iollo~ved to achieve sterilization?

a. sterilizm manufacturerB product or device manufacturer

C FDA

D AAMI

6 Which two parameters are direcl]ymonitored by the mechanical control

of an EO sterilizer?

A humidity, gas concentration

B temperamre, gas concentration

C time, temperature

D. time, humidity

7. Chemical indicators indicate:

A sterility

B microbial kill

C. air removal/vacuum

D. cycle conditions

8 XAMI recommends the use of both

chemical and biological indicators ona routine basis

True False

9 A process (procedural and decision

making steps) for sterility assurance

can be analyzed by use of a Iorm that

records acceptable or unacceptableperformance and conecuve action ~aken

True False

10. An appropriate and adequate

qualily control and sterility assuranceprogram can be both cost etteclive and

provide safety for staff anti patients

True False

Answer Key

2B 7. D

3 A 8. True

4. A 9 False

Guide to StePility AssuranceEvaluation of Continuing Education Activity

#103446

Please rate the features of this unit and provide comments

Poor Fair Avg. 6ood Ext.

7. Do you plan IO change any aspect of your practice as a result of this activity?

Yes No

8. \Vhat else do you need Io learn about this subject?

9. What other topics would you like covered in Ihis format?

10. Other comments?

53

Guide to Sterility Assurance #103446NURSINO RE61STRATION FORM

A Guide to Sterility AssurancePractical Concepts For You] Institution

Please send this registration form,self-assessment/test questions,evaluation, and $10.00 fee to:

Education Design1~O. Box 22275Denver, CO 80222

Address:

City: State: Zip:

Social Security No.:

License rio.:

Daytime Telephone No.:

Signetme: