Summary: The Association for the Advancement of Medical Instrumentation (AAMI) has officially adopted ANSI/AAMI/ISO 13004:2022, a guidance standard for radiation sterilization of medical devices. This new American standard, aligned with ISO guidelines, enhances methods for sterilization dose substantiation and auditing, ensuring a sterility assurance level of 10-6.

Key Takeaways:

  • ANSI/AAMI/ISO 13004:2022 establishes rigorous methods for selecting and verifying sterilization doses in medical device radiation sterilization.
  • The standard integrates with ISO 11137-1 and updates previous ISO guidance, improving language consistency and expanding guidelines on re-substantiation.

The Association for the Advancement of Medical Instrumentation (AAMI) officially adopted a key international guidance document related to radiation sterilization.

About the Radiation Sterilization Guidance Document

The guidance document, ANSI/AAMI/ISO 13004:2022; Sterilization Of Health Care Products—Radiation—Substantiation Of Selected Sterilization Dose: Method VDmaxSD, is an American version of a pre-existing standard produced by the International Standards Organization (ISO).

Application and Impact

ANSI/AAMI/ISO 13004:2022 applies to sterility assurance, a key part of the sterilization of medical devices. The document’s guidance directly applies to industrial sterilizers. The standard establishes a method for ensuring that a sterilization dose selection results in a sterility assurance level of 10-6 or less for radiation sterilization used on medical devices. It also specifies a method of sterilization dose audit that can show the effectiveness of the verified sterilization doses.

Integration and Updates to Existing Standards

The newly adopted guidance is meant to be used with ISO 11137-1 Sterilization of health care products, and makes several major changes to existing guidance.

Key Changes in the New Standard:

  • Cancels and replaces ISO/TS 13004:2013.
  • Determines sample item portions for materials like powders, liquids, and gels.
  • Has been reworded to match language in ISO 11137-2.
  • Adds additional guidance on when to re-substantiate sterilization dose based on bioburden shift.

Contributors to the Adoption

AAMI’s Radiation Sterilization Working Group helped make this ISO adoption a reality. The group has produced many of AAMI’s radiation sterilization guidance documents, and is co-chaired by Elaine Daniell of EDan-SA LLC Consulting and Niki Fidopiastis, director of microbiology at Medtronic’s Global Laboratory Services.