The FDA has added one new and three revised AAMI sterilization documents, including guidance on ethylene oxide, to its list of Recognized Consensus Standards.
The US Food and Drug Administration (FDA) has amended its database of Recognized Consensus Standards, adding multiple Association for the Advancement of Medical Instrumentation (AAMI) documents in the agency’s latest round of updates in March.
This includes one new addition and three revised versions of sterility assurance and sterilization documents previously recognized by the FDA in December of 2024.
The new entry to the FDA’s database of Recognized Consensus Standards is AAMI TIR106:2024: Microbiological methods—Understanding and use of product bioburden data.
Three of AAMI’s most notable sterilization guidance documents were also superseded by newer versions that were recently revised and updated by AAMI. These documents are:
- ANSI/AAMI ST58:2024, Chemical sterilization and high-level disinfection in health care facilities
- 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
- AAMI TIR17:2024, Compatibility of materials subject to sterilization
“FDA had previously included prior editions of AAMI ST58, ST24, and TIR17 in its database of Recognized Consensus Standards, but the recognition of the recently updated documents and the new recognition of TIR106 is a welcome validation of AAMI’s efforts to promote patient well-being through the production of regulatory-ready sterilization and sterility assurance standards and technical documents,” says AAMI vice president of sterilization Amanda Benedict says in a release.
The most recent edition of ANSI/AAMI ST58 was revised and reorganized in 2024. The document now includes information on new technologies and chemical sterilization modalities, including ethylene oxide. Prior to 2024, ST24 had not been updated in more than two decades, and the most recent edition features FDA-cleared ethylene oxide sterilization systems not included in the prior edition. Finally, the new edition of TIR17 includes completely overhauled materials compatibility tables per modality.
All four guidance documents can be found on AAMI ARRAY.
