Mary Ann Drosnock: New Amendments and TIR Coming for ANSI/AAMI ST79

As we all know, the typical standards revision cycle for updating documents can take quite a long time. One very well-known standard, ANSI/AAMI ST79: Comprehensive Guide to Steam Sterilization and Sterility Assurance in Health Care Facilities, was last revised and published in 2017 after years of review and major revision. After publishing, however, the working group found several areas that warranted updating sooner than the typical cycle would allow. Therefore, four new amendments were written and have been finalized by the working group.

As of the writing of this blog post, the amendments have gone through their 15-day review period and are awaiting publication. After publication, these four amendments will be distributed to those who already own AAMI ST79:2017 edition as amendments to that document.

As a preview, let’s look at a high-level overview of the content of the new amendments:

  • A.1: Amendment for Environmental Services/Fans/Food and Drink. This amendment provides more explicit recommendations for the environmental cleaning of sterile processing departments. Environmental cleaning procedures should be established by a multidisciplinary team and should be based on a risk assessment for each processing area. Additionally, it recommends against the use of either fixed or portable fans in any area of sterile processing. Also, it stipulates that food and drink are strictly prohibited in device processing areas.
  • A.2: Amendment for Inspection of Insulated Instruments. This amendment adds two new subsections, 8.2 and 8.21, to the document. It now includes more concrete recommendations for the inspection of insulated instruments during processing. This includes assessing the cleanliness and integrity of the device using enhanced inspection tools, such as lighted magnification and borescopes. Electrosurgical devices needing additional testing are identified as well as appropriate inspection steps, including testing for electrical integrity, insulation integrity, and other physical damage.
  • A.3: Amendment for Modification of Content Pertaining to Frequency of Cleaning for Routine Care of Sterilizers for Sterile Processing Areas in Health Care Facilities. This amendment removes the recommendation for the daily cleaning of sterilizers from section 12.4. The text was revised to recommend following the IFU of the sterilizer manufacturer for the frequency of cleaning. It also recommends performing a daily visual inspection step.
  • Amendment A.4: Amendment for Content Addressing Recording BI Lot Numbers in Sterilizer Records for Sterile Processing in Health Care Facilities. This amendment revises section 13.3.3 to clearly state that the lot number of the biological indicator (BI) being used (including the control) should be documented/recorded.

Another endeavor that’s been started by this working group is the creation of a new technical information report, TIR109, for External Transport of Medical Devices Processed by Health Care Facilities. Because of the perceived need in the Health Care Industry and the existing gap in the standards on the topic, the group has decided to address it with this new TIR. There will be a kickoff web meeting for members of the AAMI ST-WG 40 (Steam sterilization hospital practices) task group working on drafting TIR109 on Oct. 26. Again, we know it can take a while to complete this process, but an exciting new endeavor and important topic this new TIR will address! Stay tuned for more information.

Mary Ann Drosnock is director of clinical affairs at Healthmark Industries in Fraser, MI, and co-chair of AAMI ST/WG 84, the working group responsible for endoscope processing. This working group is currently revising ST91, the national standard for processing flexible and semi-rigid endoscopes in Healthcare facilities, and is newly creating TIR99 – Dilators, transesophageal, and ultrasound probes processing in Healthcare facilities.

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