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New Guidance Document Focuses on Water Quality for Reprocessed Devices

by Barbara Kram, Editor | October 23, 2007
The Association for
the Advancement of
Medical Instrumentation
(AAMI).
Arlington, VA- The Association for the Advancement of Medical Instrumentation (AAMI) has developed a first-of-its kind guidance document addressing water quality for the reprocessing of medical devices. Now in final review, TIR34 - Water for the Reprocessing of Medical Devices - addresses the determination of water quality needs for reprocessing medical devices at various stages. It also describes how to assess, generate, monitor, and maintain water to meet those requirements.

"TIR34 will be of value to infection control practitioners, central sterile personnel, and physical plant/maintenance professionals," says Steve Goldstine, PhD, a sterilization consultant and co-chair of AAMI/ST/WG 95 - Water quality for reprocessing medical devices, which is the working group responsible for developing TIR34. "Because there are so many different types of equipment available for sterilizing water, this document can be very helpful as an aid in making equipment-purchasing decisions."

While AAMI has published other technical documents on water quality in the past, TIR34 is the first to focus on water quality specifically for reprocessing medical devices. After discussing the issue of water for reprocessing devices, AAMI's sterilization committee decided the issue was critical enough to warrant the creation of a working group. The late Lee Fischbach of Minntech, who served for many years as a developer of AAMI standards for water for dialysis, created the initial drafts of the TIR.

AAMI Releases New Chemical Indicator Standards

Three new AAMI/American National Standards on the use of chemical indicators in steam sterilization applications are now available at AAMI's online Marketplace. A chemical indicator is used to demonstrate that desired sterilization conditions have been achieved when sterilizing a medical instrument or set of instruments.

ORDER INFORMATION

ANSI/AAMI/ISO 11140-3:2007
LIST PRICE: $95
MEMBER DISCOUNT PRICE: $50
ORDER CODE: 1114003 or 1114003-PDF

ANSI/AAMI/ISO 11140-4:2007
LIST PRICE: $90
MEMBER DISCOUNT PRICE: $45
ORDER CODE: 1114004 or 1114004-PDF

ANSI/AAMI/ISO 11140-5:2007
LIST PRICE: $95
MEMBER DISCOUNT PRICE: $50
ORDER CODE: 1114005 or 1114005-PDF

To order these documents, call (877) 249-8226 or visit http://marketplace.aami.org

The new standards - available in print or PDF formats - have been adopted in full from their international (ISO) counterparts. Each standard pertains to a specific aspect of the Bowie and Dick-type test, which is designed to indicate rapid and even penetration of steam into a sterilization test pack.

Further information:
ANSI/AAMI/ISO 11140-3:2007, Sterilization of health care products-Chemical indicators-Part 3: Class 2 indicator systems for use in the Bowie and Dick-type steam penetration test is identical to ISO 11140-3:2007.

ANSI/AAMI/ISO 11140-4:2007, Sterilization of health care products-Chemical indicators-Part 4: Class 2 indicators as an alternative to the Bowie and Dick-type test for detection of steam penetration is identical to ISO 11140-4:2007.

ANSI/AAMI/ISO 11140-5:2007, Sterilization of health care products-Chemical indicators-Part 5: Class 2 indicators for Bowie and Dick-type air removal tests is identical to ISO 11140-5:2007.