Education & Training

1 78 AUGUST 2005 MANAGING INFECTION CONTROLO bjectivesAfter completion of this self-study activity, the learnerwill be able what a biological indicator process challengedevice (BI test pack/PCD) why biological indicator process challengedevices (BI test pack/PCDs) were an appropriate biological indicator processchallenge device (BI test pack/PCD) for all steam andlow temperature sterilization a policy and procedure for the use of biologicalindicator process challenge devices (BI test pack/PCDs) for routine and qualification testing of steamand low temperature sterilization TrainingMany thanks to the team at 3M Health Care for workingwith Managing Infection Controlto provide the followinga c c redited course. IAHCSMM has awarded 1 contact point for completion of this continuing Education lesson towardIAHCSMM recertification.

2 The CBSPD has pre-approved thisinservice for 1 contact hour for a period of five (5) years fromthe date of publication. This inservice is 3M Health CareP rovider approved by the Californial Board of Registere dNurses, CEP5770 for 1 Contact form is valid up to five years from the date of publication. Instructions for submitting results are on page 92. Managing Infection Controland 3M Health Care will beworking collaboratively to provide continuing Education coursesin monthly editions of Managing Infection Control. Test Packs Used in Healthcare FacilitiesBy Martha Young, BS, MS, CSPDTB iological Indicator Process Challenge Devices79 AUGUST 2005 MANAGING INFECTION CONTROLTest QuestionsTrue indicator process challenge device (BI testpack/PCD) is the same as a challenge or test pack.

3 Indicator process challenge device (BI testpack/PCD) should create a challenge to sterilant penetrationthat is less stringent than the load contents and placed in theleast challenging area in the indicator process challenge devices (BI test pack/PCDs) are the most important part of a sterilization process-monitoring program because they tell you spores are killed. 4 .The Association for the Advancement of MedicalI n s t r u m e n t a t i o n(AAMI) developed healthcare preparedbiological indicator process challenge devices (BI test pack/PCDs) to test the ability of sterilants to penetrate the .Commercially available disposable test packs can be used if they are shown to be equivalent to the AAMI gold standard packs. same biological indicator process challenge device (BItest pack/PCD) can be used for flash and non-flash steamsterilization Training7.

4 If a steam sterilizer is designed to be used for multiple types ofcycles [gravity-displacement, dynamic air-removal (prevaccumor steam-flush pressure-pulse), flash], only one sterilizationcycle type should be tested with an appropriate biological indicator process challenge device (BI test pack/PCD) at leastw e e k l y, preferably each day the sterilizer is used. type of tray configuration ( , open surgical tray,single-wrapped surgical tray, protective organizing case,rigid sterilization container) used for flash sterilizationshould be tested with an appropriate biological indicatorprocess challenge device (BI test pack/PCD) at leastweekly, preferable each day the sterilizer is used. Association of periOperative Nurses (AORN) standardsstate that implantable medical devices should not be flash sterilized but if they are the implant must be usedimmediately after a negative biological temperature sterilization processes should be monitored every load with an appropriate biological indicator process challenge device (BI test pack/PCD) tomonitor the penetration of all critical parameters into thepackages being 2005 MANAGING INFECTION CONTROLI ntroductionYou maybe looking at the title of this inservice and asking:What is a process challenge device (PCD)?

5 APCD is the newterm for challenge or test packs. It is a term that is part of theInternational Standards Organizations (ISO) documents and isnow used in the Association for the advancement of MedicalInstrumentation (AAMI) recommended practices and standards. You will not routinely see this name as part of acommercially available challenge or test pack because it is anew term but be assured that commercially available productslabeled as challenge or test pack are PCDs. For this inservicethe term test pack/PCD will be pack/PCD is designed to simulate product to besterilized and to constitute a defined challenge to the sterilizationprocess, and used to assess the effective performance of theprocess 1. In other words the test pack/PCD creates a challengeto the sterilization process representative of load contents butpresents the worst case.

6 In addition it is placed in the sterilizerin the location that creates the worst-case or greatest challengeto sterilant penetration. For routine (daily to every load and every load that containsan implantable medical device) and qualification testing (after asterilizer is installed, relocated, after sterilizer malfunctions, or asterilization process failure and after any major repairs), a testpack/PCD contains biological indicators (BIs) and chemical indicators (CIs). CI test packs/PCDs are available for limited usetesting also, but will not be discussed in this test packs/PCDs are an important part of monitoring the sterilization process. If the BI is killed in a test pack/PCD thatrepresents the worst case or greatest challenge to the sterilizationprocess, then other items in the hospital load were probably e ffectively sterilized.

7 Let s take a journey through the history oftest packs/PCDs, review the appropriate test packs/PCDs fortesting all steam and low temperature sterilization processes, andexamine how to use test packs/PCDs for routine and qualificationtesting of steam and low temperature sterilization 2003, the Association for the Advancement of MedicalInstrumentation (AAMI) published a Technical InformationReport (TIR), AAMI TIR31, 2003 Process challenge devices/test packs for use in health care facilities, to provide technicalinformation to healthcare facilities in the selection and use ofprocess challenge devices (PCDs). TIRs are developed whenthere is an immediate need for information and when the fieldor technology is rapidly is different than a standard or recommended practice because it does not require the formal process ofcommittee approval, public review, and resolution of addition a standard or recommended practice is formallyreviewed usually every five years to reaffirm, revise or withdrawthe standard or recommended practice.

8 ATIR is approved fordistribution by a technical committee and the AAMI StandardsBoard and, after five years, a technical committee can decide ifthe TIR should be removed from circulation. In the early days of steam sterilization, practitionersconsidered proper sterilization of surgical supplies in hospi-tals an art rather than a science. 1 This was because theoutcome of the sterilization process depended on the skill ofthe individual operator in manipulating the sterilizer valvesby hand and reading the gauges of early gravity type steamsterilizers. Even at that time, it was identified that a needexisted for a dependable type of sterilizer detector that couldidentify whether an adequate temperature was reached in theload during the period of exposure to the steam. Sterilizertechnology advanced with the introduction of the recordingthermometers in the discharge pipe system ( , drain),considered the coolest part of the chamber.

9 A d d i t i o n a ltemperature monitors included temperature tubes and self-registering or lag thermometers that were placed in larg e ,dense fabric packs. These monitors were adequate until the introduction of the prevacuum steam sterilizers. At that time it became important to assess the ability of the vacuum system toremove air and allow steam to penetrate porous a b r i cpacks were thought to be the most resistant to air removal and steam penetration so in 1980 the AAMI org a n i z a t i o ndesigned a 12 x 12 x 20 inch heterogeneous challenge packwith one or more BIs and optional CIs in the geometric centerof the pack to be used in an empty chamber for testing after asterilizer is installed, relocated, after sterilization failures, and major repairs, as well as for routine testing in a fullyloaded sterilizer.

10 Because the materials in this pack were nolonger readily available, in 1988 the 16-towel challenge packwas , 2In 1985 the need for a test pack to challenge the ethyleneoxide (EO) sterilization process was that time,AAMI developed an EO challenge pack consisting of two BIsplaced inside two disposable syringes, a plastic item, and arubber item (EO absorbents) placed inside the center of fourfolded and stacked towels, wrapped and , 6 This EO challenge pack was developed to represent a greater challengeto the sterilizer than a typical load. It is used for qualificationtesting by sterilizer manufacturers and by the health care facilities for installation testing, periodic quality assurance(quarterly) testing, after major redesign, relocation, correctivemaintenance and after a sterilization process failure.