Revised sterilization standards demand urgent attention from perioperative leaders

Editor's Note

New and revised sterilization and reprocessing standards are reshaping the landscape for sterile processing departments, placing greater emphasis on chemical modalities, device-specific protocols, and system-wide quality management, according to the Healthcare Purchasing News May 27 update on compliance and standards.

Among the most significant developments is the overhaul of ANSI/AAMI ST58:2024, which now consolidates guidance for all chemical sterilization and high-level disinfection (HLD) modalities—such as ethylene oxide and vaporized hydrogen peroxide—into a single, comprehensive resource. The update replaces the 2013 version and is especially valuable for facilities that rely on sterilization methods beyond steam.

Also highlighted is AAMI TIR99:2024, a new technical report addressing the reprocessing of devices like dilators and ultrasound probes, often handled outside central sterile processing. Experts note the need for tailored guidance, given that many of these items are processed by clinical teams lacking formal sterile processing training.

The article also previews AAMI TIR119, now in development to support implementation of the water quality standard ST108:2023, especially in smaller or resource-limited healthcare sites. Meanwhile, the widely used ANSI/AAMI ST79, covering steam sterilization and sterility assurance, is slated for full revision starting in late 2025. Leaders expect a sweeping update across areas such as packaging, training, and facility design, as the current edition is nearly a decade old.

Internationally, ISO has released new guidance, including ISO 22441 for vaporized hydrogen peroxide sterilization and a revised ISO 17665 for moist heat. Still under development are ISO 25224, which will guide sampling and culturing of flexible endoscopes, and ISO/AWI TS 20327, focused on safe handling and transport of sterile medical devices. US standards are aligning closely, as seen in AAMI TIR109:2025, which addresses external transport of reusable devices.

Another emerging focus is UV disinfection. The article reports that AAMI TIR118, now in development, will help facilities evaluate the safe and effective use of UV technologies within sterile processing departments.

Finally, the article revisits ANSI/AAMI ST90:2017, a framework for quality management systems in healthcare device processing. Experts recommend it as a tool to translate complex technical standards like ST79 and ST108 into actionable quality assurance programs tailored to each facility's needs.