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AAMI Standards

Revised Standard Addresses Sterility Challenge for Manufacturers

A revised standard published by the Association for the Advancement of Medical Instrumentation (AAMI) could make it easier for manufacturers to use a less-restrictive sterility assurance level (SAL) for medical devices that are sensitive to 10-6 sterilization processes, ...More
August 9, 2011
Posted in News, Disinfection & Sterilization
MicroCool Surgical Gown Meets AAMI Level 4 Requirements

Kimberly-Clark Health Care announces that it has been cleared by the Food and Drug Administration (FDA) to market its MicroCool* Breathable High Performance Surgical Gown as meeting the Association for the Advancement of Medical Instrumentation (AAMI) Level 4 Standard for ...More
May 16, 2011
Posted in News, PPE & Standard Precautions
AAMI Encourages More Government Participation in Standards

The Association for the Advancement of Medical Instrumentation (AAMI) says it wants more federal agencies to take part in standards development as a way to create better standards. "Other agencies could provide different perspectives, and therefore increase the level of ...More
February 8, 2011
Posted in News
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 ...More
May 12, 2010
Posted in News, Disinfection & Sterilization
Spend the System 1 Transition Time Wisely, Experts Advise

For an update on the System 1 situation since this article went to press in the May issue of ICT, CLICK HERE.Hospitals are scrambling to transition away from the STERIS System 1 processor (SS1) to legally marketed alternatives, as mandated by the Food and Drug ...More
April 26, 2010
Posted in Articles, Disinfection & Sterilization
OR and SP Riding the Wave in the Perfect Storm

Sterile processing (SP) and operating room (OR) staff once “lived” in separate worlds, rarely working or communicating. They were on two different islands. However, there is a tidal wave of issues causing “the perfect storm” that is requiring these ...More
February 24, 2010
Posted in Articles, Disinfection & Sterilization
Loaner Instrumentation: How to Turn a Horror Story Into a Happy Ending

Growing up, I became quite the horror movie buff. I recall Lon Chaney as the Wolfman, roaming the moors in search of his next victim, and Bela Lugosi’s Count Dracula who would strike fear in the hearts of Transylvanians – and moviegoers alike. And who can forget ...More
February 22, 2010
Posted in Articles, Disinfection & Sterilization
3M Sterilization Assurance Announces Addition to the Comply Line of Chemical Indicators

3M Sterilization Assurance announced today the availability in the United States of the 3M™ Comply™ 6600 Emulating Indicator for pack monitoring for sterilization departments. With the addition of its Class 6 steam emulating indicator, 3M adds to its expansive ...More
January 11, 2010
Posted in News, Disinfection & Sterilization
Product Quality Assurance Testing: One Hospital's Experience

Testing of routinely sterilized products should be part of a healthcare facility’s quality control program, and ANSI/AAMI ST79:2006, Comprehensive Guide to Steam Sterilization and Sterility Assurance in Health Care Facilities, recommends that quality assurance testing ...More
November 30, 2009
Posted in Articles, Disinfection & Sterilization
Revised AAMI Standard Addresses Risk Analysis, Other Hot Topics in Sterilization

As of press time in August, the Association for the Advancement of Medical Instrumentation (AAMI) was poised to release a major update of its steam sterilization standard, ST79, to incorporate new information on risk analysis and chemical indicators, among other topics. The ...More
August 26, 2009
Posted in Articles, Disinfection & Sterilization

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