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As the aphorism goes, the only constant is change, and the field of sterile processing is certainly no exception. This self-study article is written to provide the reader with a heads-up about a change in the name of the categories used to describe chemical indicators. The International Standards Organization published a revised version of ISO-11140-1, Sterilization of health care products - Chemical indicatorsPart 1: General requirements in late 2014. This document was subsequently adopted by the Association for the Advancement of Medical Instrumentation (AAMI) and approved as an American National Standard, ANSI/ AAMI/ ISO 11140-1:2014/ replacing ANSI/AAMI ISO 11140-1:2005. Chemical indicator manufacturers wishing to sell product complying with the performance, testing, and labeling requirements specified in this revised standard will begin to offer "types," rather than "classes" of chemical indicators. End-user guidance on the use and application of chemical indicators has not changed.
Background
Sterile Processing staff understand they play a critical role in their facility's infection prevention program by ensuring the sterility of reprocessed medical devices. A variety of monitoring tools, including chemical, physical, and biological indicators, are used as part of an effective quality assurance program to determine whether to release a sterilized load. This article focuses on one of these tools, chemical indicators (CIs). ANSI/AAMI ST79 defines CIs as "devices used to monitor the presence or attainment of one or more of the parameters required for a satisfactory sterilization process, or are used in specific tests of sterilization equipment."2 End-users rely on CIs for three main applications: special tests; exposure indicators; and internal indicators. Special test chemical indicators are designed for use in specific tests and/or procedures, such as the Bowie-lDick test. Exposure chemical indicators allow staff to distinguish between processed and unprocessed items at a glance. Internal chemical indicators verify sterilant has penetrated to the point of placement inside containers, wrapped packs or peel pouches. ANSI/AAMI/ISO 11140-1:2014 specifies the requirements and test methods "for indicators that show exposure to sterilization processes by means of physical and/or chemical change of substances, and which are used to monitor the attainment of one or more of the process parameter(s) specified for a sterilization process."1 The standard reminds the reader that, "Attainment of the chemical indicator's end point should not be regarded as an indication...