FDA Recognizes AAMI Ethylene Oxide Standards

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AAMI is pleased to announce that the U.S. Food and Drug Administration (FDA) has added four AAMI sterilization guidance documents to its Recognized Consensus Standards Database.

The standards and TIRs added to the database apply to both industrial and clinical sterilization topics. Several of the documents include novel guidance or data on the use of ethylene oxide (EO). The four guidance documents are: 

• ANSI/AAMI ST24:2024; General-purpose ethylene oxide sterilizers with automated process control and ethylene oxide sterilant sources intended for use in health care facilities
• ANSI/AAMI ST58:2024; Chemical sterilization and high-level disinfection in health care facilities
• AAMI TIR17:2024; Compatibility of materials subject to sterilization
• AAMI TIR106:2024; Microbiological methods—Understanding and use of product bioburden data

AAMI’s Amanda Benedict, Vice President, Sterilization, reacted to the news, saying, “We are immensely pleased about the addition of these four guidance documents to FDA’s Recognized Consensus Standards Database. These recognitions come at a key moment, as the sterilization and microbiological quality community navigates issues like the use of ethylene oxide and expanded information on topics like materials compatibility.

This action by FDA proves the utility of AAMI’s consensus-based method of producing standards and guidance suitable for use by regulators, industry, and clinicians. We look forward to the publication and future FDA recognition of additional regulatory-ready documents for the industrial and clinical sterilization communities.”

While the four documents apply to different subject areas within industrial and clinical sterilization, they are all oriented toward advancing the theory and practice of medical device sterilization and promoting optimal patient care outcomes. 

With their inclusion in the FDA database, the agency will now accept Declarations of Conformity that align with the documents. This means that ST24, ST58, TIR17, and TIR106 are more relevant than ever to sterile processing professionals, industrial sterilizers, and medical device manufacturers.

FDA also included several ISO documents relevant to AAMI’s overall standards program. These were developed under the ISO/TC 150/SC 2 and ISO/TC 121/SC 2 committees. They are:

• ISO 25539-4, Cardiovascular implants — Endovascular devices — Part 4: Application of ISO 17327-1 for coated endovascular devices
• ISO 5910:2024 Cardiovascular implants and extracorporeal systems — Cardiac valve repair devices
• ISO 12417-1:2024, Cardiovascular implants and extracorporeal systems - Vascular device-drug combination products - Part 1: General requirements
•  ISO 5632:2024, Anaesthetic and respiratory equipment - Anaesthetic reservoir bags

Those interested in accessing the AAMI sterilization guidance documents can find them for purchase at the links above, on AAMI ARRAY, or as part of an AAMI e-Subscription.