AAMI STERILIZATION STANDARDS MEETING UPDATE

By Emily Mitzel, MS

On March 20-23, 2017, I attended the Association for the Advancement of Medical Instrumentation (AAMI) semi-annual Sterilization Standards Committee Meeting. These Association meetings, and the standards discussed during them, have a major impact on medical device manufacturers, testing facilities, HCF managers, and FDA.  It is important for industry experts to participate in these meetings to ensure the standards and technical informational reports reflect current industry changes and trends, and to make sure the standards are written scientifically.

In addition to the satisfaction of positively impacting global health, participating on these committees allows me to stay up to date with the standards and understand what is trending in the industry. The clients I work with benefit because I can make sure they are meeting current and future regulatory requirements.

Highlights from the meetings include:

  • Working Group 93. TIR 30: 2011. This document needs to be updated to reflect current standards and published documents. A task committee, which included me, was established to determine the updates.
  • Working Group 40. ST79. This group finished reviewing all comments. It was noted that the document has been placed on AAMI public review but still needs to be placed on ANSI public review, and this could drive public review comments that will need to be discussed.
  • Working Group 13. ISO 15883 series. I provided an update from the February 6-8, 2017 interim meeting of ISO/TC 198/WG 13. Comments are still being resolved on ISO/DIS 15883-4, Washer-disinfectors – Part 4: Requirements and tests for washer -disinfectors employing chemical disinfection for thermolabile endoscopes, and that work will continue in April. The majority of this group’s time was spent on ISO 15883-5, Washer-disinfectors – Part 5: Performance requirements and test method criteria for demonstrating cleaning efficacy. Substantial changes and additions were made to the document during the February meetings that required discussion. ISO/CD 15883-5 is out for ballot and comment until April 2017. It was also reported that there will be a major revision to ISO 15883-1, Washer-disinfectors – Part 1: General requirements, terms and definitions and tests to begin soon.

In April, I will be attending the ISO meetings as a U.S. delegate. The standards that will be discussed at this meeting are ISO 17664, ISO 15883-1, ISO 15883-4, and ISO 15883-5.

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