Multiorganizational Guidance Offers Updated Recommendations to Prevent Infections through Effective Sterilization and High-Level Disinfection of Reusable Medical Devices

Arlington, VA — The Society for Healthcare Epidemiology of America (SHEA), in collaboration with eight partner organizations, has released new comprehensive guidance to help healthcare facilities prevent the transmission of infections through improved practices in sterilization and high-level disinfection (HLD) of reusable medical devices.

Reusable medical devices are essential tools in modern healthcare, yet their use is not without risk. Outbreaks of multidrug-resistant organisms (MDROs) and other healthcare-associated infections remain a serious concern. Despite ongoing efforts, risks associated with device processing persist—particularly when sterilization and HLD procedures are not followed precisely or are hampered by ambiguous manufacturer instructions or limited facility resources. Many transmissions of infections due to failures in high-level disinfection of endoscopes, especially duodenoscopes, are believed to go undetected.

The Multisociety Guidance for Sterilization and High-level Disinfection provides evidence-based, practical recommendations that reflect current science, expert consensus, and real-world challenges in infection prevention.

“This guideline was developed by a multidisciplinary expert committee that completed an exhaustive review of the literature and synthesized the findings,” said Dr. Erica Shenoy, co-chair of the guidelines panel and Chief of Infection Control at Mass General Brigham. “Sterilization and HLD are some of the most challenging practices for healthcare facilities to get right due to their highly technical aspects and the dedicated resources required. This guidance provides healthcare facilities with concrete infection prevention recommendations to ensure best practices are in place to support safe patient care and reduce risk to patients.”

The guidance also highlights augmentative strategies to reduce risk when HLD may be insufficient or impractical. These include prioritizing sterilization when possible, using single-use accessories or components in endoscopes when appropriate, and reevaluating reusable device selection based on facility capabilities.

This new multisociety guidance document, developed by SHEA in partnership with the American Society for Gastrointestinal Endoscopy (ASGE), Association for Professionals in Infection Control and Epidemiology (APIC), Association for the Advancement of Medical Instrumentation (AAMI), Association of periOperative Registered Nurses (AORN), Healthcare Sterile Processing Association (HSPA), Infectious Diseases Society of America (IDSA), Society of Gastroenterology Nurses and Associates (SGNA), and The Joint Commission, provides clear and up-to-date recommendations designed to reduce risk and promote patient safety.

In recognition of rapidly evolving technologies and practices, the guidance also addresses newer developments such as sterilization or HLD of investigational devices and 3D-printed implants, providing healthcare professionals with tools to adapt their infection prevention efforts in response to innovation.

Importantly, the document provides practical directions for handling common challenges with manufacturers’ instructions for use (MIFUs)—which may be unclear, overly complex, or call for equipment not available in some healthcare settings. The recommendations aim to help healthcare personnel resolve discrepancies and implement processing protocols that are both effective and feasible.

“This guidance fills a critical need by equipping healthcare professionals with strategies to process medical devices while adapting to modern realities,” said David J. Weber, co-chair of the guidelines panel and SHEA Board of Trustees President.

The Multisociety Guidance for Sterilization and High-level Disinfection builds on the 2008 CDC Guideline for Disinfection and Sterilization in Healthcare Facilities and provides a detailed summary of recommendations provided in the supplementary material.

To access the full guidance document, visit: https://doi.org/10.1017/ice.2025.41.

Contact: Lindsay MacMurray, lmacmurray@shea-online.org