Summary: AAMI has updated its ethylene oxide (EO) sterilization standard, ANSI/AAMI ST24:2024, addressing new technologies and industry challenges after two decades. This standard is crucial for medical device manufacturers and healthcare facilities.

Key Takeaways:

  • The updated standard includes new EO sterilization systems and addresses comprehensive safety and performance requirements.
  • It reflects current EO sterilization practices, moving away from outdated systems used in 1999.

The Association for the Advancement of Medical Instrumentation (AAMI) has announced an update to its standard on ethylene oxide (EO) sterilization for healthcare facilities, incorporating new technologies and addressing industry challenges.

Key Details of the Updated Standard

The fourth edition of ANSI/AAMI ST24:2024, titled “General-purpose ethylene oxide sterilizers with automated process control and ethylene oxide sterilant sources intended for use in health care facilities,” marks the first update in two decades. This standard addresses labeling, safety, performance, and testing requirements for EO sterilizers used in healthcare settings.

Relevance to Industry Stakeholders

ANSI/AAMI ST24 is immediately relevant to medical device manufacturers and sterile processing departments in hospitals, clinics, and labs, especially in light of the Environmental Protection Agency’s new Final Rule concerning EO.

The updated standard outlines:

  • Labeling, performance, safety, and installation requirements for EO emission control systems.
  • Sterilizer construction, components, and accessories.
  • Sterilizer safety, including worker safety, thermal hazards, air filtration, and exposure monitoring.
  • Requirements for registration, labeling, container safety, shipping, and emissions related to sources of EO.
  • Test methods and procedures to demonstrate conformance with the standard.

Development and Impact of the Updated Standard

Developed by AAMI’s Hospital EO Sterilizers Working Group, which includes experts from hospitals, medical device manufacturers, and regulators, this standard serves as a critical resource for manufacturers and healthcare delivery organizations using EO sterilization.

“It has been over twenty years since the third edition of ANSI/AAMI ST24 was published. During this period, the use of ethylene oxide in health care facilities has changed significantly,” said Ted May, CEO at Anderson Sterilizers, and working group co-chair. The revised edition includes EO sterilization systems cleared by the FDA since the last edition and moves away from the large EO tank and mixture-based systems common in 1999 but no longer in use today.

ANSI/AAMI ST24:2024 is available for access or purchase via AAMI ARRAY.