Summary: AAMI has updated its primary guidance on chemical sterilization with ANSI/AAMI ST58:2024. This revision, which includes new information on ethylene oxide (EO) sterilization, aims to enhance safety and regulatory compliance in healthcare facilities. The update is essential for preventing healthcare-associated infections and aligning practices with modern standards.

Key Takeaways:

  • Comprehensive Guidance: ANSI/AAMI ST58:2024 covers a range of sterilization modalities, including EO, providing healthcare professionals with a structured approach to sterilization and disinfection.
  • Enhanced Safety and Compliance: The updated standard emphasizes best practices for safety, quality control, and personnel training, crucial for patient safety and infection prevention.

The Association for the Advancement of Medical Instrumentation (AAMI) released an update to its primary guidance on chemical sterilization and high-level disinfection in healthcare facilities. The update addresses regulatory and safety concerns for hospital employees who use ethylene oxide (EO) to sterilize medical devices.

New Edition of ANSI/AAMI ST58:2024

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.

RELATED: AAMI Updates Ethylene Oxide Sterilization Standard

Adopting and implementing ST58 will be critical to preventing healthcare-associated infections, according to AAMI. With the update, it 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.

Coverage of ANSI/AAMI ST58:2024

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

Access to ANSI/AAMI ST58:2024

Interested parties are encouraged to purchase a copy of ANSI/AAMI ST58:2024 on AAMI Array.

“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,” said Alpa Patel, director of scientific improvement at Nelson Laboratories and co-chair of AAMI’s Chemical Sterilants Hospital Practices Working Group. “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.”