Pilot Project Aims to Ease Standards Comparisons

Abstract

A AMI is launching a pilot project to provide red line versions of standards so users can readily identify changes from the prior edition of a document. The red line version uses strikethrough to identify text deleted during the revision process. New text is clearly displayed in red and underline. This formatting makes it easy for users to quickly identify additions, deletions, and other changes between new and old editions.While it may be extremely useful, the red line document is not the official AAMI standard. Since it may be difficult to adequately depict all changes between editions of a standard, users are encouraged to consult the current edition, and prior editions as necessary.The red line version is available in PDF and is offered along with the PDF of the official standard. For convenience, and to ensure that users also receive the official document, the red line and official standard are packaged together as one PDF.With a red line document, you no longer need to compare a revised and prior standard—saving you time and eliminating the need for line-by-line comparisons.The first document offered as a red line is ANSI/AAMI/ISO 14161:2009, Sterilization of health care products—Biological indicators—Guidance for the selection, use and interpretation of results. The red line compares the 2000 and 2009 editions of 14161.The 14161 standard contains updated guidance on the application of biological indicators to validate a sterilization process.Biological indicators are used to detect any problems within a sterilization process and for various sterilization methods such as ethylene oxide and steam. “Since the purpose of sterilization is to destroy microbes, the only way to test microbial inactivation sterilization is to test it against microbes. Biological indicators are used because of their consistent resistance and population as a reproducible measure of microbial lethality,” says Gregg Mosley, president of Biotest Laboratories Inc., and co-chair of AAMI's Biological Indicators Working Group.The standard is ideally suited for users of biological indicators. “Anyone who manufactures devices or pharmaceuticals and uses biological indicators as part of routine monitoring or sterilization validation would find use in the document,” Mosley says. The standard has been updated to comply with the ANSI/AAMI/ISO 11348 series, which are a series of biological indicator standards revised in 2006.The standard also has additional information on determining the resistance of a biological indicator, including survival/kill response characteristics. “There is a time defined at which all of the indicators tested would be positive, which is a survival time, and then the kill time is the point at which all indicators are rendered inactive,” says Phil Schneider, senior consultant for LexaMed Inc. and co-chair of the AAMI Biological Indicators Working Group.