Updated AAMI standard addresses chemical sterilization safety, compliance

Editor's Note

New guidance from The Association for the Advancement of Medical Instrumentation (AAMI) addresses regulatory and safety concerns for hospitals using ethylene oxide (EO) for medical device sterilization—a pressing concern due to EO’s effectiveness but associated health risks.

ANSI/AAMI ST58:2024, an update on chemical sterilization and high-level disinfection practices in healthcare facilities, replaces ANSI/AAMI ST58:2013/(R)2018 and ANSI/AAMI ST41, offering comprehensive guidance for sterilization processes in hospitals, labs, and similar settings, according to a November 4 announcement. The organization announced the update amid facilities facing challenges like pathogen resistance to disinfectants and more complex medical device instructions for use (IFUs). The standard aims to improve patient safety by providing healthcare professionals with best practices for using chemical sterilants, including EO, glutaraldehyde, and hydrogen peroxide, along with other modalities.

According to the announcement, T58 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