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News / February 10, 2021
On January 20, 2021 the Association for Advancement of Medical Instrumentation (AAMI) published four amendments to ANSI/AAMI ST79 Comprehensive guide to steam sterilization and sterility assurance in healthcare facilities. These four new amendments are designed to provide sterile reprocessing technicians/personnel with updated guidance to help them comply with accrediting bodies such as The Joint Commission (TJC).
“All standards are living, evolving documents,” said Sarah Friedberg, a microbiology manager at Stryker Endoscopy and co-chair of the AAMI working group that authored the amendments. “As technology advances, scientific knowledge improves, and industry practices change, there’s often a need to revisit our standards.”1
These new amendments are important to a large number of healthcare facilities and personnel. This is because nearly every healthcare facility including hospitals, surgi-centers, physician offices, cardiac catheterization laboratories, ambulatory care facilities, endoscopy suites, radiology departments and dental offices utilize some type of steam sterilization when reprocessing reusable medical devices. Accordingly, ANSI/AAMI ST79 is an important standard for all healthcare personnel who use steam for sterilization, regardless of the size of the sterilizer or the type of facility. Additionally, ANSI/AAMI ST79 continues to be the guiding document for TJC audits/inspections.
The most recent revision to the standards occurred back in 2017, at which time the standard was revised from its 2010 version. The 2017 revision was done so as to provide updated guidance for users while also providing new procedures and ideas to improve the safety of sterile reprocessing personnel.
The AAMI Standards working group (ST-WG 40) that was responsible for the updated amendments sought input from reusable medical device manufacturers, healthcare facilities and reprocessing technicians/personnel. Over 120 members of ST-WG 40 contributed their thoughts and suggestions to the amendments during the last three years. The working group’s efforts culminated in ANSI/AAMI ST79:2017’s 2020 amendments. Well over 80% of the members of the working group voted in favor of the new amendments.
“Writing a standard is really a balancing act because it’s covering such a broad swath of venues, and yet everyone also needs the right specifications,” said Susan Klacik, ST-WG 40 co-chair and clinical educator at International Association of Healthcare Central Service Materiel Management (IAHCSMM). “Through AAMI, we have this wonderful collaborative community. We can collect everybody’s views in one place and really iron out what is working versus what isn’t.”2
“These amendments weren’t made in the interest of one company or one hospital. We set our day jobs aside and that’s what made it work so well,” added Friedberg. “Even manufacturers and hospitals, despite obvious differences, want the same thing. An instrument should work perfectly each-and-every time… That kind of reliability ensures user and patient safety.”3
Where appropriate, the group reviewed existing recommendations and built upon them to enhance best practices for reusable medical devices. A key area of improvement centers on the instrument reprocessing and inspection process. The new amendments encourage the use of borescopes and Adenosine Triphosphate (ATP) monitoring so as to enable more accurate inspections as opposed to simply relying on visual inspections. The new amendments also recommend that reusable medical device manufacturers validate their Instructions for Use (IFUs) to prove that they actually work to remove organic debris during the reprocessing cycle.
How to get the new Amendments
“The amended document is available through AAMI at aami.org/ST79. ANSI/AAMI ST79:2017 Comprehensive guide to steam sterilization and sterility assurance in healthcare 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 current edition of the standard, ST79:2017, is available for purchase from the AAMI Store with the amendments included.”4
1 https://www.aami.org/detail-pages/press-release/steam-sterilization-standard-st79-receives-community-driven-update
2 Ibid “AAMI”
3 Ibid “AAMI”
4 Ibid “AAMI”
