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LearningObjectives1. Understand the role that eachsterility assurance product plays

2. Identify the areas wherehealthcare professionals have achoice in monitoring products

3. Relate where the Class 6emulating indicator fits on thesterility assurance monitoring team

March 2008The self-study lesson on this central service topicwas developed by STERIS. The lessons are adminis-tered by KSR.

Earn CEUsThe series can assist readers in maintaining their CScertification. After careful study of the lesson, com-

plete the examination at the end of this section.Mail the complete examination and scoring fee to

Healthcare Purchasing News for grading. We willnotify you if you have a passing score of 70 percentor higher, and you will receive a certificate ofcompletion within 30 days. Previous lessons are avail-able on the Internet at www.hpnonline.com.

Certification

The CBSPD (Certification Board for Sterile Process-ing and Distribution) has pre-approved this in-ser-

vice for one (1) contact hour for a period of five (5)years from the date of original publication. Success-ful completion of the lesson and post test must bedocumented by facility management and those

records maintained by the individual until re-certifi-cation is required. DO NOT SEND LESSON OR TEST

TO CBSPD. For additional information regarding cer-tification contact CBSPD - 2 Industrial Park Road,Suite 3, Alpha, NJ 08865

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ELF-STUD

YSERIE

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Any good coach will tell you thattheir teams success comes fromeach member doing what he or

she does best. A running back is not ex-pected to be good at charging the quarter-back and a quarterback would not beexpected to kick the football through thegoal every time. All members have specificfunctions that, when combined, make a

winning team.Sterile processing department (SPD)

managers are playing to win a much moreserious victory the successful sterilizationof critical surgical instruments. In thismust-win game, sterility assurance moni-toring tools are among the key players fora winning team. From the process indica-tor tape to the biological indicator, eachteam member has specific goals and expec-tations. The latest members to be added tothe team roster are the Class 6 emulatingindicators. Though this technology is newin the United States, it has been used in ster-

ile processing departments throughout theworld for several years.

Lets see how each sterility assurancemonitoring member works to make a greatteam, and where the emulating indicatorfits in the program.

The goalThe goal of sterility assurance monitoringis to ensure that medical devices are sterilewhen they arrive in the operating room.Each sterility assurance tool performs acritical function on the way to achieving

this objective.PreparationIts critically important to start the gameby properly preparing every dirty or con-taminated medical device that comes intothe SPD for reprocessing. The device mustbe clean, properly assembled and correctlypackaged for the sterilization process be-ing used. The monitoring goal at this pointin the process is to oversee the devicepreparation activities and assure that theyare correctly done.

The SPD professional is the first line of

defense to ensure proper pre-cleaning andto visually inspect cleaned devices for any

residual debris and moisture. To monitorthe cleaning process, SPD staff can usewashing indicators, which are designed tovalidate specific washing processes. Wash-ing indicators are used to ensure that anautomated washer is functioning properlyand that an appropriate amount and con-centration of detergent is used.

After being cleaned, the devices are pack-

aged for sterilization using trays, contain-ers or peel pouches. Many sterilizationprocesses have specific recommendationsregarding the materials that should be usedto encase, package or pouch the devices.The SPD professional is also the guardianof the packaging process, ensuring thatcleaned devices are packaged according tothe device and sterilizer manufacturersinstructions. To assist with identification,the packaging is labeled to identify loadcontents, and an appropriate external pro-cess chemical indicator is also attached orincluded (e.g., chemical indicator tape, in-

dicators on peel pouches, or rigid steriliza-tion container locks or data cards).

Process chemical indicators are definedas Class 1 indicators in the globally rec-ognized ANSI/AAMI/ISO 11140 stan-dard (See Table 1). Process indicators servethe important role of a segregator, identi-fying processed and unprocessed packsand indicating the sterilization processthat is required. This basic role requiressimple performance requirements forthese indicators.

Sterilizer performanceverificationSterilization occurs when sterilant contactsall device surfaces and causes the death ofmicrobes. This is accomplished using apreprogrammed sterilizer. The monitoringgoal during sterilization is to track the per-formance of the sterilizer and to monitorthe achievement of sterilization conditionsinside each pack in the load.

A sterilizers performance is confirmedin a variety of ways. The first validationoccurs when the unit is first installed inthe SPD, if it is relocated, or if it under-

goes any major repairs. The second typeof validation occurs periodically during

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SELF-STUDY SERIES

Self-TestAnswers:1.B,2.C,3.D,4.B,5.A,6.E,7.D,8.B,9.C,10.A

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normal sterilizer operation. The third con-firmation occurs when each load of itemsis sterilized.

When a unit is installed, relocated or re-paired, it is tested before it is released fornormal operation to ensure it is function-

ing properly. For this purpose, some ster-ilizers require a microbial challenge pack,which contains a biological indicator andis constructed of materials that are difficultfor a particular sterilant to penetrate. Thebiological indicator contains viable bacte-rial spores that have the greatest kill resis-tance for a particular sterilization process.The typical number of spores ranges from100,000 to 1,000,000 on each indicator. Somesterilizers, like the STERIS SYSTEM 1 Ster-ile Processing System, a low-temperatureliquid process, do not require a challengepack and use a biological indicator as their

challenge.Some sterilizers have critical processing

steps that are verified at the time of instal-lation. These include things like steamquality or air removal in steam sterilizers.Other systems may include verification ofthe electrical or water supply. Some eveninclude verification of air supplies. All ofthese are confirmed at installation andwhenever a major repair would affect thesefunctions. Monitoring products used toevaluate these functions fall under theAAMI Class 2 classification of Indicators

for Specific Tests. Currently, only one typeof indicator is recognized under this cat-egory: the Daily Air Removal Test, alsoknown as the Bowie-Dick Test.

Following initial qualification, SPD staffis responsible for periodic verification ofthe units performance.This verification con-sists of both microbialtests (using a combina-tion of biological indica-tor products andchemical indicatorproducts) and checks of

key performance pa-rameters. Periodic test-ing catches performancechanges in the sterilizerover time. The sametests used to qualify thesterilizer are repeated ata frequency recom-mended by thesterilizers manufac-turer. For example,some recommendationsinclude weekly (or pref-erably daily) microbial

challenges of steam or low-temperature liq-uid sterilizer systems.

In addition to the manufacturers recom-mendations for periodic monitoring, manystandards organizations also provide rec-ommendations for this type of verification.

It is important to know that an organ-izations stated frequency preferences mayor may not align with what a manufacturerhas recommended. It is the SPD managerscall to decide and document what thepolicy should be for periodic monitoringin their particular department.

Load sterilization performanceverificationA sterilizers function is also evaluatedduring the sterilization cycle itself. Eachtype of load requires a specific sterilizationcycle with specific sterilization parameters

(length of exposure time, temperature set-ting, and steam quality or sterilant concen-tration, for example). The goal of loadmonitoring is to ensure that the steriliza-tion parameters for a specific cycle wereachieved.

Standards organizations, manufacturersof sterilizers and manufacturers of loadmonitoring products all provide recom-mendations for load monitoring. The rec-ommended practices will be differentdepending on the sterilization process be-ing used. For example, AAMI recommends

that every ethylene oxide load be moni-tored, while a steam sterilizer only has tobe monitored when loads contain implant-able devices. Monitoring device manufac-turers may recommend somethingdifferent for these situations. However, all

manufacturers and standards organiza-tions agree that, prior to release of the load,the parameters must be met per the cycleprintout, all process indicators in the loadmust pass and any load monitoring prod-ucts used must pass. Each healthcare facil-

ity must review the recommendations thatrelate to their sterilization processes anddecide which is most appropriate for them.

Load monitoring tools vary in perfor-mance and the types of loads they verify.The oldest player on this team is the previ-ously mentioned microbial challenge pack.The microbial challenge pack consists of abiological indicator placed within a barrierto the sterilization process. This is typicallya commercially available challenge pack,but SPD staff can also construct their ownchallenge pack following industry recom-mended practices. The same microbial

challenge packs used for qualification andverification of sterilizer performance areoften used as a load monitoring device. Themain difference between the system veri-fication testing and load testing is the cycleused. With verification testing, the cyclewith the shortest time frame is used, whilein load testing, all time frames are moni-tored, both short and long, using the sametype of challenge pack. A biological chal-lenge pack can be used across all steriliza-tion processes to release all loads and allitems in a load.

The second type of load monitoring de-vice is the Class 5 integrating indicator.This chemical indicator mimics the behav-ior of a biological indicator when exposedto the sterilization process. It can be placed

Table 1: Listing of ANSI/AAMI/ISO 11140 chemical indicator classificationsClassification Description Examples of Sterility Assurance

Monitoring Products

Examples of Per formance Criteria for a 250 F,

30-Minute Steam Sterilization Cycle

Class 1 Process Indicator Indicator Tape PASS at 10.0 min. 5sec. at 250 F

FAIL at 3.0 min. 5sec. at 250 F

Class 2 Indicators for

Specific Tests

Daily Air Removal Test Not applicable

Class 3 Single VariableIndicators

Internal Indicator Strips PASS at 250 F FAIL at 246.4 F

Class 4 Multi-variable

Indicators

Internal Indicator Strips PASS at 4.0 min. at 250 F

FAIL at 3.0 min. at 246.4 F

Class 5 Integrating

Indicators

Internal Indicator Strips

Integrator Challenge Packs

PASS at 16.5 min. at 250 F

FAIL at 10.5 min at 250 F

Correlation to biological indicator kill

FAIL when exposed to dry heat for 30 minutes

at 278.6 F

Class 6 Emulating

Indicators

Internal Indicator Strips

Emulating Indicator

Challenge Packs

PASS at 30.0 min. at 250 F

FAIL at 28.2 min. at 248.2 F

Correlation to biological indicator kill

FAIL when exposed to dry heat for 30 minutes

at 278.6 F

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within a challenge pack just like a biologi-cal indicator. However, at this time onlysteam and ethylene oxide processes haveClass 5 indicators to verify their cycles.

The standards organizations have dif-

ferent recommended practices for Class 5indicators as well. However, manufactur-ers of integrating indicators agree thatwhatever the sterilization process, inte-grating indicators within challenge packsmay be used to monitor and release loadsthat do not require a biological challengepack. They also recommend using an in-tegrating indicator within a biologicalchallenge pack for those times when loadsare released prior to knowing the biologi-cal indicators results.

The third load monitoring device is theClass 6 emulating indicator challenge

pack, the newest addition to the team. Thischemical indicator is designed to emulatethe sterilization cycle. Like the integrat-ing indicator, the emulatingindicators performance mustcorrelate to a biological indi-cator. It must also monitor thesterilization parameters thatshould be achieved by thesterilizer. For example, if acycle requires three minutes ofsteam contact, then the emulating indica-tor will need to be able to show a changeafter three minutes. If a different cycle re-quires the same temperature with 10 min-utes of steam contact, then a differentemulating indicator designed to validate10-minute cycles is used. The emulatingindicator differs from the integrating in-dicator because it is cycle-specific.

The emulating indicator is placedwithin a sterilization barrier, just like abiological indicator. Not every steriliza-tion process has a Class 6 emulating indi-cator available at this time, and since thisclassification is so new, there are no rec-ommendations available as of yet from the

various standards organizations. Cur-rently, only one manufacturer in theUnited States and Canada supplies a Class6 emulating indicator challenge pack andit is only for steam sterilization processes.Based on the recommendations from thiscompany, the Class 6 emulating challengepack can be used to release all loads andall items in the load.

The SPD team has several choices ofload monitoring devices. They can workindividually or in combination to pro-vide a high level of confidence that thesterilizer performed as intended during

each cycle.

Internal pack monitoringSo far, all the sterility assurance devices andmonitoring activities have worked togetherto ensure that the sterilizers functioned asintended. This results in a high level ofprobability that items in the load are also

sterile. But how can SPD professionals re-ally know that sterilant made it throughthe packaging and reached the medicaldevices inside? The only way to be sure isto monitor the internal confines of everypack. Since each type of tray, container andpouch represents a different challenge tothe sterilization process, this is the mostcritical role played by sterility assurancedevices.

The sterility assurance product bestsuited for this challenge is the chemicalindicator strip. Chemical indicator stripsperform in a variety of ways. They range

from the simple Class 1 process indica-tor to the more complex Class 6 emulat-ing indicator.

Class 1 process indicator strips providethe simplest level of performance. Each

strip confirms the presence of sterilant butis not related to a biological indicatorsperformance or a sterilization cycles per-formance. The same type of Class 1 indi-cator may be used for more than one setof sterilization cycle parameters (differentexposure times, for example) as long as itmeets the minimum performance criteria,such as those in Table 1. Some process in-dicators may be used in different steril-ization processes (steam, ethylene oxide,for example). These indicators have twochemical reactions that produce a uniquecolor change for each type of sterilization

process.Class 3 single variable indicator strips

provide confirmation that at least one ofthe critical parameters of sterilization wasachieved. That parameter is either linkedto the biological indicators performanceor the sterilization cycles performance, butit monitors only one of the several criticalparameters for successful sterilization. Forexample, a single-parameter indicator mayshow the concentration of ethylene oxideto kill a biological indicator but would notdetect if the temperature, humidity or timewere wrong. The Class 3 indicator strips

can be used for multiple sterilization cycles

but must be used for one type of steriliza-tion process. For example, a steam indica-tor is for steam sterilization but not for dryheat sterilization.

Class 4 multi-variable indicator stripsprovide confirmation that two or more of

the critical parameters were achieved.Like the Class 3 indicator strips, the Class4 indicator strips do not monitor all criti-cal sterilization cycle parameters.

Class 5 integrating indicators monitorall the critical parameters of sterilizationand are linked to biological indicator per-formance. In simple terms, the indicatormust show passing conditions when thesame conditions would have killed a bio-logical indicator and failing conditionswhen the sterilization parameters wouldhave resulted in a living biological indi-cator. For example, if a biological indica-

tor exposed to 270F saturated steam diesin 1.5 minutes and survives at 1.0 minutes,a Class 5 indicator would need to show apass at 1.5 minutes or longer of exposureand failing at 1.0 minutes of exposure.

Class 6 emulating indicators monitor allthe critical parameters of sterilization, arecorrelated to biological indicators, andemulate a specific sterilization cycle. A dif-ferent indicator strip would be used foreach cycle exposure time. For example, a270F cycle may have a 4 minute or 15minute exposure; the goal being to deliver

either 4 minutes or 15 minutes of steam inthe pack. A 4-minute indicator stripwould be used for 4-minute cycles and a15-minute indicator used for the 15-minute cycles, which will ensure that thesterilizer delivers the steam intended.

Though there are six indicator classifi-cations, not all classifications are availablefor a given sterilization process. As newsterilization processes are developed, theyare launched with accompanying processindicators that can be used to monitorthem. As the processes become more ac-cepted, more complex indicators with

higher performance standards are devel-oped for them. In addition, regulatorybodies such as FDA require specific per-formance criteria. Today, FDA only rec-ognizes the Class 1 and Class 6 indicatorstrips (as defined by ANSI/AAMI/ISO11140-1). This means that all new indica-tor strips brought to the US must meet ei-ther the Class 1 or Class 6 performancecriteria.

Go team!In the life-saving game of sterility assur-ance, each SPD team can only succeed by

combining its people and the right moni-

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CONTINUING EDUCATION TEST MARCH 2008

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1) The only types of sterility assurancemonitors are biological indicators.

a. Trueb. False

2) What is the goal of sterility assurancemonitoring?a. Protect devices from moistureb. Kill microorganisms that cause diseasec. Ensure that devices arrive sterile to the

operating roomd. Ensure that sterilant killed the

microorganisms

3) Which sterility assurance monitoring devicesare used when preparing devices forsterilization?a. Washing indicators and the SPD

professionalb. Washing indicators and chemical indicator

stripsc. Detergent volume monitor and container

data cardsd. Washer indicators and Class 1 process

indicators

4) Which of the following checks are notrequired for a sterilizer verification?a. Microbial challenge using a biological

challenge packb. Confirmation that all process indicators are

passingc. Confirmation of electrical voltage delivered

to the sterilizerd. Confirmation of critical process steps

5) When would a sterilizer be re-qualified?a. When the sterilizer is movedb. After preventative maintenance is performedc. Whenever a new maintenance person has

repaired the sterilizerd. All of the abovee. None of the above

6) Which sterility assurance products arereviewed prior to releasing a sterilizationload?a. Process indicatorsb. Integrating indicator challenge packsc. Biological indicator challenge packsd. Emulating indicator challenge packse. All of the abovef. None of the above

7) Which products are used to monitor andrelease all loads and all items in those loads?a. Biological Indicator Challenge Packb. Integrating Indicator Challenge Packc. Emulating Indicator Challenge Packd. A and C only

8) Only integrating indicator strips may be usedas an internal pack indicator.a. Trueb. False

9) Which is the main difference between Class3, Class 4, Class 5 and Class 6 indicators?a. Each classification monitors a different

sterilization processb. Each classification is used with a specific

type of sterile packaging

c. Each classification provides a different levelof performance

10) When would an emulating indicator oremulating indicator challenge pack be used?a. To monitor all sterilization loads and as an

internal indicator stripb. To monitor some sterilization loads and as

an internal indicator stripc. To monitor all sterilization loads and as an

external process indicatord. To monitor no sterilization loads and as an

internal process indicator

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SELF-STUDY SERIESSponsored bytoring devices to assure the delivery ofsterile instruments. The Class 1-6 moni-toring tools provide the team with vary-ing levels of capabilities, and each plays acontributing role in achieving the goal.The newest players, Class 6 emulating in-

dicators, fit well on this team because theyoffer the healthcare professional an evenhigher level of performance and assurance

for monitoring packs and releasing steril-ized loads. HPN

Linda Clementis the marketing manager forthe Sterile Processing Division of STERIS Cor-

poration. Clement has worked in the sterile pro-

cessing arena for more than 28 years. She workedfor 18 years in sterile processing as a technicianand manager in the hospital environment and

for a little over 10 years in the healthcare in-dustry with STERIS Corporation.

Heide Ames is the product manager, Steril-ity Assurance, for STERIS Corporation, re-sponsible for managing the Companys entireoffering of biological and chemical indicators

and integrators. She also has years of experi-ence as a senior scientist and microbiology labo-ratory manager for STERIS.