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7. ANSI/AAMI/ISO 17665: 2005. Sterilization of healthcare products - Moist heat - Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices. As- sociation for the Advancement of Medical Instrumentation, Arlington, VA.
8. ANSI/AAMI/ISO 11135: 2014. Sterilization of healthcare products — Ethylene oxide — Requirements for development, validation and routine control of a sterilization process for medical devices. Associa- tion for the Advancement of Medical Instrumentation, Arlington, VA.
9. ANSI/AAMI/ISO 11137:2006. Sterilization of healthcare products — Radiation — Part 1: Requirements for development, validation and
SELF-STUDY SERIES
routine control of a sterilization process for medical devices. Associa- tion for the Advancement of Medical Instrumentation, Arlington, VA.
Craig Wallace is a Senior Technical Special- ist in the 3M Infection Prevention Division laboratory. Craig is the Convener of the ISO Biological Indicator Working Group (TC 198, Working Group 4), the international committee
responsible for biological indicator performance standards. He is also the Co-Chair of the United States (AAMI) Biological Indicator Working Group. Craig leads the 3M Sterilization Techni- cal Service and Education Team, and has given lectures on a wide range of sterilization-related topics in North America, South America, Eu- rope, and Asia.
CONTINUING EDUCATION TEST • APRIL 2018 The science of speed
Today’s rapid readout biological indicators Circle the one correct answer:
1. Biological indicators utilize bacterial spores because spores are difficult to kill and present a significant challenge to the sterilization process. A. True
B. False
2. Biological indicators with rapid readout technology rely on a biological signal from germinating and replicating spores. A. True
B. False
3. The reference incubation time for a conventional biological indicator is seven days, but rapid readout technology has enabled biological indica- tors with incubation times of less than 30 minutes. A. True
B. False
4. The most effective quality control system for healthcare sterilization uses a combination of physical, chemical, and biological monitoring. A. True
B. False
5. Sterilizer printouts from the electronic sensors in the chamber can prove that a sterilization cycle was effective A. True
B. False
6. Chemical indicators on the outside of packages are used to test all the sterilization process parameters and prove that the process was effective. A. True
B. False
7. Chemical indicators can provide a direct measurement of the lethality of the sterilization process. A. True
B. False
8. Biological indicator manufacturers’ IFUs are the best reference for where biological indicators and PCDs should be placed in the sterilizer chamber. A. True
B. False
9. Rapid readout biological indicators can make it easier to quarantine implantable devices until the BI test is complete. A. True
B. False
10. For biological monitoring of steam sterilization, AAMI ST79 recommends weekly, but preferably daily testing, as well as use of biological indicator PCDs with all implant loads. A. True
B. False
The approval number for this lesson is 3M-HPN 180903.
Request for Scoring o I have enclosed t he scoring fee of $10 f or EACH test taken — Payable to KSR Publishing, Inc. We regret that no refunds can be given. (It is not neccess ary to submit multiple tests separately.)
Detach exam and return to: Continuing Education Division KSR Publishing, Inc.
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hpnonline.com • HEALTHCARE PURCHASING NEWS • April 2018 43 Presented by
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