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Objective 1: Explain the Difference between Product Validation and Verification

Product testing is of two types: validationis done by the manufacturer to establishevidence with a high degree of assurancethat a product complies with a regulation,specificationorconditionsthatwereimposedat the start of the products developmentphase. Inotherwords, validation isdone toconfirm that the product is functioning asit was designed to function and complieswiththeFDA510(k)submissionrequirement.Note:A510(k)isapremarket(before-market)submission fromamanufacturer to theU.S.FoodandDrugAdministration.Itspurposeistodemonstratethatadevicetobemarketedisatleastassafeandeffectiveas(substantiallyequivalentto)alegallymarketeddevicethatis not subject to premarket approval formanufacture.

The manufacturers validation covers allphases of the product handling process,includingcleaning,testingandsterilization.Italsoincludessterilizationtestingutilizinghalf-cycles,confirmingasterilityassurancelevelof10-6sterilantconcentration,andmeticulouslydocumentingallphasesofthetestingprocess.In almost all healthcare facilities, complyingwiththesetestingparametersis,atbest,verydifficultandprobablyimpossible.

Incontrasttovalidationbythemanufacturer,verification is a hospital-based processof establishing evidence that provides a

high degree of assurance that a productaccomplishes its intended requirements atthespecificfacility.Itspurposeistoensurethevendor-documented results canbeobtainedinthatCSSD.Forexample,canaspecifictrayvalidatedbythemanufacturertobesterilizedin the four-minutecyclebesterilized in thatcyclewiththefacilityssterilizers?

Objective 2: Determine When Product Testing is Necessary

The need for product testing should bestrongly considered when evaluating newtypes of instrumentation if they differsignificantly from those currently beingprocessed. Testing should be done duringproductevaluationpriortopurchasetoavoidobtainingaproductthatcannotbeeffectivelycleanedandsterilizedwithinthefacility.

Testing should be done periodically onroutinely-processed reusable sets. Testingshould also be performed when changingpackaging materials, and new containersystemsmostcertainlyshouldbethoroughlytested prior to purchase. When changingtypes of flat wrappers or peel packagingproducts, it is important to retest thesterilization process to confirm that theresultsarethesameasthosethatoccurwiththepreviouslyusedproducts.

Manufacturers changes from the FDA-approved InstructionsforUse (IFU)mayalsotrigger product testing, depending on thetypes of changes made, such as changes

Yesterdays Central Sterile Supply Department (CSSD) technicians spent much of their time cutting and rolling bandages, and cleaning and sterilizing gloves, bedpans and reusable needles and syringes. Their counterparts today process laparoscopes, robotic instrumentation, neurological cages, and complex loaner instruments used in all surgical specialties. In addition to the ever-increasing complexity of instrumentation, many types of microorganisms are becoming more resistant and difficult to kill. These and other trends have brought the priority of product testing to the forefront of our profession.

As with all CSSD processes, the need to correctly perform product testing is extremely important. This lesson reviews basic protocols that should be incorporated in the product testing procedures used by all healthcare facilities.

Product Testing

LEARNING OBJECTIVES:

1. Explainthedifferencebetweenproductvalidationandverification

2. Tellwhenproducttestingisnecessary

3. Discusshowtocreateproductfamilies

4. Reviewprocedurestotestthecleaningprocess

5. Reviewprocedurestotestthesterilizationprocess

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This series of self-study lessons on CSSD topics was developed by the International Association of Healthcare Central Service Materiel Management (IAHCSMM). Purdue Universitys Extended Campus and IAHCSMM both offer grading opportunities for Extended Campus points.

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Each 20 question, online quiz with a passing score of 70% or higher is worth two points (2 contact hours) toward your CRCST re-certification (12 points).

By mail or online. From January 1 to June 30 each year, Purdue Extended Campus offers an annual mail-in or online, self-study lesson subscription for $75 (6 specific lessons worth 2 points each). Call (800) 830-0269 for details. For grading of individual lessons, send completed 20-question quiz and $15 to: PEC Business Office, Purdue University, Stewart Center Room 110, 128 Memorial Mall, West Lafayette, IN 47907-2034.

Each 20-question quiz with a passing score of 70% or higher is worth two points (contact hours) toward your CRCST re-certification (12 points). Two attempts to achieve a passing score are permitted per examination.

IAHCSMM provides online grading service for any of the Lesson Plan varieties. Purdue University provides grading services solely for CRCST lessons.

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CRCST Self-STudy leSSon Plan

LESSON NO. CRCST 121 (Technical Continuing Education-TCE)

Lesson AuthorPatti Koncur, CRCST, CHMMC, ACE

Corporate Director, CSPDDetroit Medical Center

Detroit, MI

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IaHCSMM CRCST Self-Study lesson Plan

in the cleaning process or the productssterilizationparameters.

Installation of new decontamination andsterilizationequipment,ormajorrepairsdonetoexistingdecontaminationandsterilizationequipment require that the equipment betestedbeforeitisplacedintoservice.

CSSD personnel should not permitreconfiguration of a manufacturersorganizedinstrumentset,suchasscrewandplatesetsororthopedicloanersets.Doingsowillrequirethatthesetberevalidatedbythemanufacturerbecause itno longermatchesthesetconfigurationsubmittedtotheFDA.

Testing should occur whenever there is anydoubtabouttheeffectivenessofthecleaningand sterilization process. The facilitysInfectionControlandPreventionCommitteeshouldbeactivelyinvolvedindeterminingtheneedforandfrequencyofproducttesting.

Objective 3: Discuss How to Create Product Families

Because it is not possible to test everyreusableitemprocessedinaCSSD,productfamilies can be created and tested. Familyitems should be similar in nature, such aslumened instrumentsororthopedic reamersandgraters.Familiescanalsobeinstrumentsetsforthesamesurgicalspecialties,suchascardiothoracic, orthopedic, neurology, andgeneral.

Afterproductfamiliesareselected,eachsetwithin each family should be evaluated forcomplexity of instrumentation and requireddecontamination and sterilization processes.The most difficult-to-clean sets should beselected for verification of the cleaningprocess.

Examples of these sets include instrumentswithsmall, long lumensandmultiple-pieceinstrumentation,suchasflexibleendoscopesand laparoscopic instrumentation thatcannot be completely disassembled.Instrumentswithsmallcrevicesorserrationsor other difficult-to-reach areas should alsobe evaluated, as should instruments thatrequiremanual cleaningwith no additionalmechanicalcleaning.

The most difficult sets to sterilize in eachtype of sterilization process should beselected for sterilization verification. Thesesets include complex instruments, such as

flexibleendoscopes, powerequipmentandmultiple-part instrumentation that cannotbecompletelydisassembled.Setscontaininginstruments with small lumens or setsrequiringextendedsterilizationcyclesshouldalsobeconsidered.

Objective 4: Review Procedures to Test the Cleaning ProcessProductverificationrequiresthatthefacilitystesting process be very carefully followed.Before the testing process begins, ensurethat there are sufficient amounts of therecommendedcleaningchemicalsthatwillbeneeded.Ameetingwithlaboratorypersonnelisessentialifsomeinstrumentationwillneedto be sent to the laboratory for culture toverifybioburdenreductionasaresultofthecleaningprocess.

ThecleaningverificationprocessrequiresthattheManufacturersIFUbecarefullyfollowedas the instruments are cleaned. CSSDpersonnelshoulddocumenteachstepinthecleaningprocess,includinguseoftherequiredchemicalsintheproperconcentrationandforthesoaktimesrequiredformanualcleaning.Ifmechanicalcleaningisdone,itisimportantto document the cycles utilized, the timesin each phase of the cycle, the chemicalsand chemical concentrations used, and thetemperaturesofeachphaseinthecycle.

Assoonasthecleaningprocessiscomplete,test the most difficult-to-clean instrumentsin thesetwith theselected testingproduct.Culture swabs should be obtained fromareasoftheinstrumentthatthecommercialproduct cannot reach, such as the centeroflonglumensorinsidethecasingofsomepowersurgicalinstrumentation.

Handlethecultureswabscarefullytopreventcross contamination. For example, ensureswabsdonottouchthesidesoftheculturetubewhileplacingtheminsidethetube.

Swabs should be immediately sent to thelaboratoryforculture.Insomeinstances,itmaynotbepossibletosafelyswabtheinstrumentswithoutpotentiallycontaminatingtheswab.Then the instruments themselvesmay needto be protectedwhile being transported tothe lab to obtain the culture swabs.Whensendinginstrumentstothelabfortesting,besuretoprotectthemfromcontaminationbyplacingtheminsideapre-sterilizedtransportcontainer,suchasaflashpan.

Some commercially-prepared test materialsmayalsorequirelabprocessingincompliancewith the manufacturers instructions.Procedures for transporting them includeprotecting the instrument in apre-sterilizedcontainerorplacingthetestproductinsideofvendor-providedtransportenvelopes.

Therearenocurrentbenchmarkstandardsforacceptablelevelsofbioburdenaftercleaning;however, the desired testing results are areductionofsoilandmicrobestolevelsthataresafetohandle.

The testing process should be repeated atleast three consecutive times with desiredresults for a successful test process. Whenrepeatingthisprocess,ensurethatthesametype of instrumentation is utilized for thetests. If thedesiredresultsarenotobtained,thecleaningandtestingprocessesshouldbereviewedand,ifnecessary,themanufacturershould be contacted for more informationandguidance.

Objective 5: Review Procedures to Test the Sterilization ProcessJust as with testing for the cleaningprocessing, the facilitys testing proceduresand the manufacturers IFU for sterilizationmustbeverycarefullyfollowed.

Before beginning the sterilization testing,ensure that there are sufficient quantitiesof biological indicators (BIs), chemicalintegrators(CIs),andsterilant,ifapplicable.Biological indicators may need to bepurchased in glassine packages, not thecustomary ampules, because the ampulescannot be placed into small areas such aslumens. Chemical integrators should beClass 3 or higher to properly monitor thesterilizationprocess.

Laboratorypersonnelshouldbeconsultedassomeinstrumentsmayneedtobeinoculatedwith cultured spores in areas where thebiologicalampuleortheglassinesporestripscannotbeplaced.

Beginthesterilizationverificationprocessafterthe instrumentshavebeenproperlycleanedandassembled.Note:Theseinstrumentsmaybethesameinstrumentsusedinthecleaningprocessortheymaybeinstrumentsthatareeasier to clean, butdifficult to sterilizeperthemanufacturersIFU.PlacetheBIsandCIsthroughoutthetrayasfollows:

Continued

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IaHCSMM CRCST Self-Study lesson Plan

Earn Continuing Education Points: You can use these lessons as an in-service with your staff, or visit www.iahcsmm.org for online grading at a nominal fee.Each lesson plan graded online with a passing score of 70% or higher is worth two points (2 contact , hours). You can use these points toward your , re-certification of CRCST (12 points).Mailed submissions to IAHCSMM will not be graded and will not be granted a point value.Purdue mail-in, self-study lesson subscription, (6 lessons/2 points each) for $75. Call (800) 830-0269. For grading of individual lessons, send completed quiz and $15 to: PEC Business Office, Purdue University, Stewart Center Room 110, 128 Memorial Mall, West Lafayette, IN 47907-2034.Each 20-question quiz with a passing score of 70% or higher is worth two points (contact hours) toward your CRCST re-certification (12 points). Two attempts to achieve a passing score are permitted per examination.

Scott Davis, CMRP, CRCST, CHMMC,MaterialsManager,SurgicalServicesUniversityMedicalCenterofSouthernNevadaLasVegas,NV

Susan Klacik, ACE, CHL, CRCST, FCS,CSSManagerSt.ElizabethHealthCenterYoungstown,OH

Patti Koncur, CRCST, CHMMC, ACE CorporateDirector,CSPDDetroitMedicalCenterDetroit,MI

Natalie Lind, CRCST, CHL, FCS IAHCSMMEducationalDirector,Moorhead,MN

David Narance, RN, CRCSTNurseManager,SterileReprocessingMedCentralHealthSystemMansfield,OH

Carol Petro, CNOR, CRCST, RN, BSN O.R.RoomEducatorforSurgicalServicesIUHealthNorthHospitalCarmel,IN

Technical Editor:

Carla McDermott, RN, ACE, CRCST ClinicalNurseIIISouthFloridaBaptistHospital,PlantCity,FL

Series Writer/ Editor:

Jack D. Ninemeier, Ph.D.MichiganStateUniversityEastLansing,MI

Sponsored By:

Advisory Committee And Authors For selF-study lessons

Instrumentsets(wrapped)

Inthemostdifficultareaofthesetforthesterilanttoreach

Inthedensestpartoftheinstrumentset

Atoppositeendsofthetray

Among the instruments placed onstringers

Insidelumens

Instrumentsets(containers)

Inthemostdifficultareaofthesetforthesterilanttoreach

Each corner and in the center of thecontainer

Inthedensestpartoftheinstrumentset

Among the instruments placed onstringers

In other areas recommended by thecontainersmanufacturer

Insidelumens

Instrumentsets(vendormulti-layered)

In any area determined by themanufacturer to be the greatestchallengetothesterilizationprocess

Basinsets

DonotuseBIsintheampulebecausethe ampule will increase the spacebetween the basins and permitmoresteampenetration.

Placeglassine-packagedBIsandCIsintheareaswhereairpocketscouldform

DocumentwhereeachBIandCI is locatedwithin the set. Place completed sets on asterilizationcart.Thesetsshouldbeplacedin various areas of the sterilizer carriageor chamber along with other instrumentsets in such a way that the contents arerepresentativeofanormalload.Sterilizetheloadusingthecycleprogramrecommendedbythemanufacturer.

Whenthecycleiscomplete,allowtheitemsto cool properly. Remove the test itemsfrom the sterilizers carriage or chamber. Ifthe sets contain items inoculated with acultured spore, donot open the set untilsomeoneisavailabletoswabtheinoculentfor culture to avoid contamination by theair in the roomor by personnel accidentlytouchingtheproducts.

ProcesstheBIsfollowingthemanufacturersrecommendations.BIsshouldbeincubatedtheentirerecommendedtime(24-48hours),and rapid readings that give 1- to 3-hourreadings should be used as a guide only.Glassine-packagedBIsshouldbeasepticallytransferred to the transport envelope anddeliveredtothelaboratorytobeprocessed.

Eachstepofthesterilizationprocessshouldbe documented, including the type ofsterilizer used, cycle run, length of eachcyclephase,andtypeofBIandCIused.TheCIresultsshouldbealsobedocumented.

The sterilization testing process shouldbe repeated at least three consecutivetimes utilizing the same instrumentation.

Meticulouscleaningshouldoccurbetweentests. Results are considered successfulwhen all biological indicators are negativeforgrowth.

Conclusion

With todays complex instrumentation andtheincreasingneedtoturninstrumentationaround quickly, it is important for CSSDpersonnel to know they are providingclean,sterileinstrumentstotheOperatingRooms.Producttestingisnecessaryforthisassurance. Even though testing is time-consumingandexpensive,itisnecessarytohelpensuretheconsistentlybestoutcomesforourpatients.

References

ANSI/AAMI ST79:2010 & A1:2010 Section 7.5

ANSI/AAMI ST79:2010 & A1:2010 Section 10

ANSI/AAMI ST79:2010 & A1:2010 Annex D

IAHCSMM Central Service Technical Manual. Seventh EditionChapters9,11,12,and15

Young, Martha. Verification, Validation: Whats the difference? ORManagerVol.27,No.03.March,2011.

IAHCSMM acknowledges the assistance of the following two CSSD professionals who reviewed this quiz:

Lisa Huber, BA, CRCST, ACE, FCS, Sterile Processing Manager, Anderson Hospital, Maryville, IL

Paula Vandiver, CRCST, CIS CS Technician, Orthopedic Specialist, Anderson Hospital, Maryville, IL

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Quiz no. CRCST 121 (CIRCLE THE CORRECT ANSWER)lesson 121 november 2011 lesson expires november 2014

Objective 1

1. Validation testing is done in a facilitys CSSD department. a. True b. False

2. When are manufacturers required to validate medical devices? a. BeforeFDAapproval b. Annually c. Everyfiveyears d. AandC

3. The purpose of a 510(k) is to demonstrate that a device to be marketed is substantially equivalent to: a. Otherinstrumentsdevelopedbythe manufacturer b. Allotherinstrumentsinthemarketplace c. Legallymarketeddevicesnotsubjectto marketapproval d. Anydevicethatcostsnomorethandevice coveredbythe510(k)

Objective 2

4. Product testing should occur a. Duringtheevaluationperiodbeforenew productpurchase b. AfterchangestoFDA-approvedInstructions forUse c. Beforeinstallingnewdecontaminationand sterilizationequipment d. Alltheabove

5. Product testing should be done _______ product evaluation. a. Before b. During c. After d. AandBabove

6. It is acceptable to reconfigure the contents of orthopedic loaner sets as long as the set has been cleared by the FDA. a. True b. False

7. Changes in the manufacturers Instructions For Use (IFU) always require product retesting. a. True b. False

Objective 3

8. Instrument sets with small lumens and complex instruments should be selected for testing. a. True b. False

9. Which is true about a product family? a. Instrumentsshouldbesimilarinnature b. Instrumentsshouldbefromthesame manufacturer c. Instrumentsshouldbethosewithwhich CSSDpersonnelhaveprocessingexperience. d. Noneoftheaboveiscorrect

10. It is not necessary to test instruments requiring extended sterilization cycles. a. True b. False

11. Which factor is not a reason for product testing? a. Complexinstruments b. Changeinpurchasinggroup c. Changeinpackagingmaterial d. Multiple-partinstruments

Objective 4

12. The cleaning product testing process should a. Complywiththemanufacturer'sInformation ForUse(IFU)document b. Beperformedbypersonstrainedbythe manufacturer c. BedoneintheOperatingRoomimmediately aftertheitemisused d. Alloftheaboveareacceptable

13. What should be done if it is not possible to safely swab instruments without potentially contaminating the swab? a. Adifferentinstrumentshouldbetested b. Amanufacturershouldbecontactedfor suggestions c.TheFDAshouldbecontacted d.Instrumentsshouldbetransportedtothelab forcultureswabs

14. Which is true about benchmark standards for acceptable levels of bioburden? a. TheyhavebeendevelopedbyFDA b. Theymustbedevelopedbythemanufacturer c. StandardsofTheJointCommissionshouldbe used d. Noneoftheabove

15. How many times should the testing process for cleaning be repeated with desired results for the test to be considered successful? a. Two b. Three c. Four d. Five

16. Documentation for cleaning process testing should include the a. Typeandconcentrationofchemicalsused b. Washercycleutilized c. Instrumentsoaktime d. Alltheabove

Objective 5

17. Product sterilization testing should include a. BIsandCIs b. ManufacturersInstructionsforUse(IFU) c. Staffin-servicesessions d. AandBabove

18. In what form should biological indicators normally be used for sterilization testing? a. Glassinepackages b. Ampoules c. Bothoftheabove d. SpecialFDApackaging

19. The instruments used for cleaning testing should not be used for sterilization testing. a. True b. False

20. BIs should be placed a. Randomlythroughoutthetray b. Outsidethesterilizationwrap c. Amongtheinstrumentsplacedonstringers d. Alloftheabove

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