AAMI Updates Sterilization Standards Collections


The Association for the Advancement of Medical Instrumentation (AAMI) has released two major editions of its sterilization collections that contain important new and updated standards and guidance documents.

A new 2010 edition of Sterilization, Part 1: Sterilization in Health Care Facilities is now available in the AAMI Marketplace, while Sterilization Part 2: Sterilization Equipment Design and Use, 2010 Edition will be available later this month.

Sterilization Part 1, which is designed to help hospitals, contains 11 AAMI standards and guidance documents, including a new amendment to AAMI’s comprehensive standard ST79, Comprehensive guide to steam sterilization and sterility assurance.

Sterilization Part 2, which is designed for manufacturers and purchasers of sterilization equipment, includes 23 standards and guidance documents including two new standards— a new edition of ANSI/AAMI ST15883-1:2009, Washer-disinfectors, Part 1: General requirements, terms and definitions and tests, and the 2009 edition of ANSI/AAMI/ISO 14161:2009, Sterilization of health care products — Biological Indicators — Guidance for the selection, use and interpretation of results, 2nd edition.

The sterilization books are available individually in print or as a collection either in print or on CD. The collection also includes the 2009 edition of Sterilization, Part 3: Industrial Process Control.

A significant addition to Sterilization, Part 1 is a new amendment to ST79, clarifying and updating information in the standard.

The ST79 amendment also provides new guidance, including how to deal with a sterilization process failure. The amendment includes a decision tree that “goes through the steps that should be taken if there is any sort of apparent sterilization failure,” says Judy Veale, the AAMI standards coordinator who participated in the development of the amendment. “For example, if a chemical indicator is found to be nonresponsive, then the recommendation is to quarantine the remainder of the load, remove the sterilizer from service, and try to determine the cause of the failure.”

The new amendment also includes a checklist of all the possible causes of sterilization failure, such as operator error or poor steam quality. “A lot of people really don’t go to these documents until they have a problem,” says Cynthia Spry, an independent clinical consultant and co-chair of AAMI’s Steam Sterilization Hospital Practices Working Group, which developed ST79. “This will help people walk through what they should investigate when it comes to a sterilization failure.”

The amendment also contains new requirements for mechanical cleaning equipment such as ultrasonic cleaners used on difficult-to-clean devices and instruments. “Cleaning is important. Mechanical equipment should be tested similar to testing the sterilizer,” Spry says. “You should test the efficacy of your cleaning equipment. That should be done weekly, but daily testing is preferred.”

Other additions to Sterilization, Part 1 include an errata to ANSI/AAMI ST41: 2008, Ethylene oxide sterilization in healthcare facilities: Safety and effectiveness regarding the type of a biological indicator test pack to be used for sterilizer qualification testing after malfunctions and major repairs to a sterilizer, and a clarification that the load used for the qualification testing should be similar to the load that exhibited the sterilization failure.

For more information, visit www.aami.org


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