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AAMI has released a 2009 amendment to ANSI/ AAMI ST79:2006, Comprehensive guide to steam sterilization and sterility assurance in health care facilities. Originally published in November 2006, this revision and consolidation of five documents (ST33, ST37, ST42, ST46, and ST35) has become a widely popular resource.
ST79 was the fist AAMI standard to be part of the American National Standards Institute's "continuous maintenance" classification. As such, AAMI considers requests for change more often than the regular five-year intervals for AAMI standards. A previous amendment was published in November 2008.
The 2009 amendment provides additional guidance to a number of areas of ST79, just a few of which are discussed below.
Risk Analysis
A new subsection has been added dealing with risk analysis as it relates to sterilization. In its broadest sense, the committee that developed the standard felt that sterilization risk analysis includes risk assessment, risk management, and risk communication.
* Risk assessment involves identifying the source, likelihood, and...