AAMI Updates Standard on Hospital use of Ethylene Oxide, Chemical Sterilization

AAMI ST58 Will Help Prevent Healthcare Associated Infections

Arlington, VA, Nov. 04, 2024 (GLOBE NEWSWIRE) — Regulatory and safety concerns are currently a pressing issue for hospital employees who use ethylene oxide (EO) to sterilize medical devices.

The Association for the Advancement of Medical Instrumentation (AAMI) today addresses these concerns with an update to its primary guidance on chemical sterilization and high-level disinfection in health care facilities.

ANSI/AAMI ST58:2024, Chemical sterilization and high-level disinfection in health care facilities, is a revision of ANSI/AAMI ST58:2013/(R)2018 and is intended to supersede ANSI/AAMI ST41. The newest edition of ST58 applies to healthcare professionals in hospitals, labs, and other facilities and includes new information on sterilization modalities such as ethylene oxide. The adoption of ST58 will be critical to preventing healthcare-associated infections. The standard is now a comprehensive document that healthcare professionals can use to protect patients and demonstrate conformance with best practices.

The update to ST58 comes at a pivotal time, as some pathogens have become resistant to high-level disinfectants and medical device instructions for use (IFUs) have become more complex. The public debate over EO sterilization and alternative modalities also increases the salience of ST58.

Alpa Patel, Director of Scientific Improvement at Nelson Laboratories and co-chair of AAMI’s Chemical Sterilants Hospital Practices Working Group said:

“ST58 will help healthcare workers comply with the current recommendations and practices needed to process medical devices to keep patients safe, as the last time the standard was revised was in 2013. Ethylene oxide (EO) sterilization was added to the document with updated text and practices that replace outdated information in ANSI/AAMI ST41 and provide comprehensive information regarding safety, monitoring, and effective use of this method.”

The standard applies to liquid chemical sterilants, high-level disinfectants, and gaseous chemical sterilizers. It includes extensive information on ethylene oxide, glutaraldehyde, hydrogen peroxide, and many other sterilization modalities. ST58 specifically addresses:

• How to select liquid chemical sterilization, high-level disinfection, and gaseous chemical sterilization systems
• Processing recommendations for facilities that clean and sterilize medical devices
• Transport and storage of sterilized and disinfected devices
• Quality control and quality process improvement
• Work area design for processing areas
• Safety considerations, including PPE, spill containment, and storage
• Personnel considerations, including education, training, and certification
  
  

Interested parties are encouraged to purchase a copy of ANSI/AAMI ST58:2024 on AAMI Array. Sample copies of the standard are available to members of the trade press.

Further, AAMI member Alpa Patel is available as a subject matter expert for journalists and writers working on stories related to EO and chemical sterilization. Members of the press who have questions about the standard can reach out to the AAMI Media Team at dvisnovsky@aami.org.