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For Immediate Release:
December 15, 2008

Contact: Robert King
Phone:
  703-525-4890 ext. 242
Email: rking@aami.org


AAMI Hospital Sterilization Collection Revised for 2009


 
ORDERING INFORMATION
 

AAMI Hospital Sterilization Collection, 2008-2009 Edition

Sterilization, Part 1: Sterilization in Health Care Facilities, 2008-2009 Edition (Book version)

  • LIST PRICE: $450
  • MEMBER PRICE: $250
  • ORDER CODE: STBK08-1

AAMI Standards on CD—Sterilization Edition

  • LIST PRICE: $690
  • MEMBER PRICE: $440
  • ORDER CODE: STBKCD

Sterilization Three-Book Set (Current edition of all three sterilization collections, including the new Sterilization, Part 1 book)

  • LIST PRICE: $875
  • MEMBER PRICE: $565
  • ORDER CODE: STBK06-S

SOURCE CODE: HA

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

The Association for the Advancement of Medical Instrumentation (AAMI) has updated its flagship reference for hospital sterilization to include revisions to major standards, as well as a new guidance document addressing water for the reprocessing of medical devices.

In all, Sterilization, Part 1: Sterilization in Health Care Facilities, 2008-2009 Edition, includes 15 current hospital sterilization standards (click here for full list), recommended practices, and technical information reports (TIRs), and is available in book and CD-ROM formats.

The collection now includes ANSI/AAMI ST79:2006 and A1:2008, Comprehensive guide to steam sterilization and sterility assurance in health care facilities (Consolidated text of ST79 and Amendment 1); the newly revised ANSI/ AAMI ST41:2008, Ethylene oxide sterilization in health care facilities: Safety and effectiveness; and AAMI TIR34:2007, Water for the reprocessing of medical devices.
Sterilization, Part 1, is AAMI’s most popular standards collection for healthcare professionals.

Revised Steam Sterilization Guidance

According to Cynthia Spry, co-chair of AAMI’s Steam Sterilization Hospital Practices Working Group, which developed ST79 and its recent update, the primary updates to ST79 include:

  • Two new tests to assess efficacy of washer-disinfectors
  • New guidelines intended to reduce incidence of a postoperative eye infection called toxic anterior segment syndrome (TASS)
  • New guidelines to assess the efficacy of sterilizers

“Users will find two simple additional washer-disinfector tests listed in Table D.2 of the update,” says Spry. “In the last several years there has been an increased focus on cleaning and a growing appreciation for the significance of proper cleaning in ensuring successful sterilization. The two tests added to the table will give users additional tools to evaluate cleaning.”
                                             
Updated Guidance on Ethylene Oxide Sterilization
           
To help facilities prevent infections by effectively reprocessing and sterilizing medical devices by using ethylene oxide (EO), AAMI’s Ethylene Oxide Sterilization Hospital Practices Working Group published a combined revision of three existing documents, titled ANSI/AAMI ST41:2008, Ethylene oxide sterilization in health care facilities: Safety and effectiveness.

The guidelines of the new ST41 are intended to promote sterility assurance and to assist healthcare personnel in the proper use of processing equipment. The guidelines are also intended to help ensure the safe use of EO by defining equipment and procedures, including ventilation recommendations and other controls to minimize personnel exposure to EO or its residuals.

“EO should only be used for items that cannot be steam sterilized,” because of its the toxicity, flammability, and explosiveness, notes Phil Schneider, co-chair of the Ethylene Oxide Sterilization Hospital Practices Working Group.

Because healthcare facilities differ in their physical design and equipment, and in the training level of personnel with regard to sterilization processing, the revised ST41 sets forth guidelines for facility design and work practices to assist healthcare personnel in developing procedures to achieve and maintain the sterility assurance level (SAL) of devices sterilized by EO.

New Guidance on Water Quality

TIR34: 2007 — Water for the Reprocessing of Medical Devices is the first-ever TIR to address this issue. Developed by AAMI’s Water Quality for Medical Devices Reprocessing Group under the auspices of the AAMI Sterilization Standards Committee, the document is an ideal guide for professionals involved in either water quality or device reprocessing — including infection control practitioners, central sterile personnel, and physical plant/maintenance professionals.

According to Steve Goldstine, PhD, a sterilization consultant and co-chair of the working group, “because there are so many different types of equipment available for sterilizing water, this document can be very helpful as an aid in making purchasing decisions.”

Ensuring adequate water quality for device reprocessing requires collaboration between the personnel who reprocess medical devices and those who establish and maintain the water treatment system. TIR34 describes how to assess, generate, monitor, and maintain water to meet requirements.

Also included in Sterilization, Part 1, is ANSI/AAMI/ISO TIR11139, Sterilization of health care products — Vocabulary, which provides a useful baseline in sterilization terminology for the field.


The Sterilization, Part 1,collection includes the following documents:

  • ST79: Comprehensive guide to steam sterilization and sterility assurance in health care facilities, 1st edition (incorporates Amendment 1)
  • ST40: Table-top dry heat sterilization and sterility assurance in health care facilities, 2nd edition
  • 14161: Sterilization of health care products—Biological indicators—Guidance for the selection, use, and interpretation of results, 2nd edition
  • 15882: Chemical indicators — Guidance for the selection, use, and interpretation of results, 3rd edition
  • TIR34: Water for the reprocessing of medical devices
  • TIR31: Process challenge devices/test packs for use in health care facilities, 1st edition
  • ST41: Ethylene oxide sterilization in health care facilities: Safety and effectiveness, 4th edition
  • ST58: Chemical sterilization and high-level disinfection in health care facilities health care facilities, 2nd edition
  • ST81: Information to be provided by the manufacturer for the processing of resterilizable medical devices, 1st edition
  • TIR12: Designing, testing, and labeling reusable medical devices for reprocessing in health care facilities: A guide for device manufacturers, 2nd edition
  • TIR30: A compendium of processes, materials, test methods, and acceptance criteria for cleaning reusable medical devices, 1st edition
  • ST65: Processing of reusable surgical textiles for use in health care facilities, 1st edition
  • PB70: Liquid barrier performance and classification of protective apparel and drapes in health care facilities, 1st edition
  • TIR11: Selection of surgical gowns and drapes in health care facilities, 2nd edition
  • TIR11139: Sterilization of health care products — Vocabulary, 2nd edition

Founded in 1967, AAMI is the world's leading organization dedicated to advancing the safe and effective development and use of medical technology. AAMI's annual conference attracts healthcare professionals from hospitals, universities, consulting firms, independent service organizations, and manufacturing companies around the world.