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AAMI Makes Four Amendments to ANSI/AAMI ST79

By: Susan Klacik, BS, CRCST, CIS, CHL, ACE, FCS

January 20, 2021

The Association for the Advancement of Medical Instrumentation (AAMI) released four amendments to ANSI/AAMI ST79:2017 Comprehensive guide to steam sterilization and sterility assurance in health care facilities. These include:

  • Amendment 1: Additions were added to section General design considerations, Environmental Services/Fans/Food and Drink; and section Heating, ventilation, and air conditioning (HVAC) operating parameters. Both additions include new recommendations for maintaining the integrity of the Sterile Processing area.
  • Amendment 2: Section 8, Inspection of Insulated Instruments, added two new sections. New guidance in Section 8.2 addresses the general instrument inspection process and a new section – 8.2.1 -- addresses the inspection of insulated instruments intended for use with electric current (otherwise known as electrosurgical instrumentation).
  • Amendment 3: Content was modified regarding the frequency of cleaning for sterilizers in Sterile Processing areas of health care facilities. The changes can be found in section 12.4, Routine care of sterilizers.
  • Amendment 4: Content was modified regarding the recording of biological indicator lot numbers in sterilizer records for Sterile Processing in health care facilities. The changes better clarify the specific “number” to document when the biological monitor and control are recorded.

The amended document is available through AAMI at aami.org/ST79. ANSI/AAMI ST79:2017 Comprehensive guide to steam sterilization and sterility assurance in health care facilities will be automatically updated for users with an AAMI eSubscription. For those who previously purchased the printed version or own a PDF of the current edition, a PDF of the amendments will be emailed to them at no cost. The amendments will also be available for purchase in the AAMI Store.

More information about these amendments will be included in the “Inside Washington” column in the March/April 2021 issue of IAHCSMM’s PROCESS magazine.

Susan Klacik, BS, CRCST, CIS, ACE, CHL, FCS, is a Clinical Educator for IAHCSMM. For more information email sklacik@iahcsmm.org

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