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AAMI

After three years, a widely used standard in health care and industry has undergone an important update. The Association for Advancement of Medical Instrumentation (AAMI) has released four amendments to ANSI/AAMI ST79 “Comprehensive Guide to Steam Sterilization and Sterility Assurance in Health Care Facilities,” offering users new clarity and fresh guidance to stay in compliance with accrediting bodies.

“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.”

ANSI/AAMI ST79 is a particularly important standard because it provides comprehensive guidance to health care personnel who use steam for sterilization, regardless of the size of the sterilizer or the type of facility. This includes hospitals, ambulatory surgery facilities, physician offices, cardiac catheterization laboratories, endoscopy suites, radiology departments and dental offices. It remains a go-to document for The Joint Commission.

In 2017, the standard was revised from its 2010 version to provide flexible guidance for this wide variety of users while also providing new strategies for assuring the safety of sterilization professionals.

The AAMI Standards working group responsible for the 2017 update anticipated questions and comments to follow these initial changes. Since then, the AAMI working group ST-WG 40 has heard from manufacturers, health care facilities and even biologists. The group typically meets twice a year in conjunction with AAMI Sterilization Standards meetings and, according to the group’s co-chairs, participants are not shy about sharing their thoughts and questions.

“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.”

After three years of collecting feedback, the working group’s efforts have culminated in ANSI/AAMI ST79:2017’s 2020 amendments. Recommendations and clarifications were added for maintaining the integrity of the sterile processing area. This includes even “common sense” additions, such as stipulating that there should be no food or drink in the area. Other amendments were made to best practices, such as how often sterilizers in health care facilities should be cleaned. The group also built upon recommendations for the instrument inspection process, recognizing that relatively new technologies, such as borescopes and Adenosine Triphosphate (ATP) monitoring, enable more thorough inspections and record keeping.

“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.”

How to Get the Amendments

The amended document is available through AAMI at aami.org/ST79. ANSI/AAMI ST79:2017. It 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.

For those who do not yet have the current edition of the standard, ST79:2017, it is available for purchase from the AAMI Store with the amendments included.

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