SELF-STUDY SERIES
typical temperature at which these sterilizers operate. An addition to the standard were performance requirements for Type 3 and 4 indicators for vaporized hydrogen peroxide sterilization processes. The 2005 version of the document only provided test and performance requirements for Class 1 process indicators for this method of sterilization.
What to expect Chemical indicator manufacturers will begin transitioning their products’ standard compli- ance claims and labeling from satisfying the 2005 to the 2014 version of the ANSI/AAMI/ ISO 11140 standard. For those types of chemical indicators having new performance require- ments and/or test methods, the first step will be to test products to substantiate compliance with the new requirements. The next step will be updating graphics on the actual devices, IFU, packaging and labeling to reflect the new term ‘type.’ Products that are sold globally often have multi-lingual packaging and label- ing which will add complexity and time to this relabeling step. Later this year, sterile processing person- nel may begin to receive chemical indicators labeled as ‘Type X,’ rather than as ‘Class X.’ These CIs may also be marked with the letter ‘e,’ ‘s,’ or ‘i’ to signify the product’s intended use. This new labeling will indicate that the product satisfies the performance requirements speci- fied in the current version of ANSI/AAMI/ ISO 11140-1.
In the future we can also expect to see the terminology from this new ISO 11140-1:2014 standard incorporated into applicable health- care user documents, for example in ANSI/ AAMI ST79, as those documents are updated.
Summary
Chemical indicator categories are designed to enable the user to understand the performance parameters and tolerances of various types (for- merly known as classes) of chemical indicators. The appropriate chemical indicator can then be selected and used to obtain the informa- tion needed to determine the effectiveness of the sterilization process. ISO has revised the international document detailing the general requirements for performance of chemical indi- cators. The revised document adopted the new term “type” rather than “class” of indicator in order to emphasize that the six categories of chemical indicators are not hierarchical. AAMI and Association of PeriOperative Registered Nurses (AORN) guidance docu- ments on the use and application of chemical indicators have not changed. At this time, their recommended practices have not yet incorpo- rated use of the new term “type” of chemical indicators. What does this mean to you? Dur- ing the transition phase, sterile processing personnel will observe some chemical indica- tors labeled by the new categorization term, “type” while AAMI and AORN recommended
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practices continue to reference the older term, “class.” Don’t be alarmed! Continue to choose the chemical indicator type (a.k.a. “class”) based on the information you need about a particular sterilization process. The industry will get through this transition together! HPN
References 1. Association for the Advancement of Medical Instrumentation. Ster- ilization of health care products - Chemical indicators - Part 1: General
requirements. ANSI/AAMI/ISO 11140-1:2014.
2. Association for the Advancement of Medical Instrumentation. Compre- hensive guide to steam sterilization and sterility assurance in health care facilities. ANSI/AAMI ST79: 2010 and A1:2010 and A2:2011 and A3:2012 and A4:2013 (Consolidated Text).
Susan Flynn BESc, C.S.P.D.T. is a Technical Service Special- ist with 3M Infection Prevention Division. She is routinely involved in troubleshooting and addressing questions about sterilization processes.
Continuing eduCation test • august 2015
What’s your type? Changes in chemical indicator categorization
Circle the one correct answer:
1. The current chemical indicator (CI) standard that defines the performance requirements for CIs is ANSI/AAMI/ISO 11140-1:2014 Sterilization of healthcare products-Chemical Indicators-Part 1: General requirements.
A. True B. False
2. The performance of chemical indicators is char- acterized by the manufacturer in a resistometer, a specialized test vessel capable of reproducible cycles.
A. True B. False
3. The current standard uses the term “type,” rather than the term “class” of chemical indica- tor.
A. True B. False
4. Sterile processing personnel should select the type of chemical indicator to use based on the information needed about a particular steriliza- tion process.
A. True B. False
5. The performance of Type 5 integrating indicators are equivalent to or exceed the performance requirements for biological indicators.
A. True B. False
6. AAMI ST79 has been revised to reflect the new term “type” of chemical indicators.
A. True B. False
7. Type 5 steam integrating indicators are required to be tested at three stated values.
A. True B. False
8. Type 1 ‘exposure’ or process indicators allow differentiation between processed and unpro- cessed items.
A. True B. False
9. Internal indicators, signified by the optional prefix ‘i’ are placed inside individual load items to assess the attainment of the critical process variable(s) at the point of placement.
A. True B. False
10. If a chemical indicator reaches its endpoint, the user can be confident the sterilization process achieved an acceptable sterility assurance level.
A. True B. False
The approval number for this lesson is HPN 150207.
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