EtO Sterilization Standard Updated

The Association for the Advancement of Medical Instrumentation (AAMI) has updated its standard on ethylene oxide (EtO) sterilization use in healthcare facilities to incorporate new technologies and address challenges faced by the industry. 

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 is the fourth edition of the AAMI standard that was last updated 20 years ago.  
 
The updated standard addresses the labeling, safety, performance, and testing requirements for ethylene oxide sterilizers that are intended for general-purpose use in healthcare facilities and that have automatic controls. ANSI/AAMI ST24 is immediately relevant to medical device manufacturers and sterile processing departments in hospitals, clinics and labs, as the medical device industry faces supply concerns and a regulatory landscape transformed by the U.S. Environmental Protection Agency’s new Final Rule on EtO. 
 
As such, the updated standard addresses:  

• Labeling, performance, safety, and installation requirements for EtO 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 EtO.
• Test methods and procedures that can be used to demonstrate conformance with the standard. 

This edition of ANSI/AAMI ST24 was updated and produced by AAMI’s Hospital EO Sterilizers Working Group, comprised of experts from hospitals, medical device manufacturers, and regulators. Working group co-chair Ted May, CEO at Anderson Sterilizers, said the updated ANSI/AAMI ST24 is a vital resource.  
 
“It has been over 20 years since the third edition of ANSI/AAMI ST24 was published. During this period, the use of ethylene oxide in healthcare facilities has changed significantly,” May noted. “The fourth edition of ANSI/AAMI ST24 has been revised to include EtO sterilization systems that have been cleared by the FDA since the last edition was published and were not adequately described in the previous edition. This edition also de-emphasizes the large EtO tank and mixture-based systems, which were the standard for healthcare EtO sterilization in 1999 but are no longer in use. This fourth edition of ANSI/AAMI ST24 better reflects current practice of EtO healthcare sterilization.”  
 
The updated standard will serve as a critical resource for manufacturers and healthcare delivery organizations that use ethylene oxide sterilization in-house, May concluded. 
 
ANSI/AAMI ST24:2024 can be accessed via AAMI ARRAY.

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