Outbreaks of multidrug-resistant organisms and other infections linked to contaminated duodenoscopes and other reusable medical devices have been well-documented. These outbreaks likely represent just a fraction of the total infections resulting from contaminated reusable medical instruments and devices.
A new document provides comprehensive guidance to help healthcare facilities use reusable devices safely. The Society for Healthcare Epidemiology of America, in collaboration with eight partner organizations, published "Multisociety Guidance for Sterilization and High-level Disinfection" in Infection Control & Hospital Epidemiology in April 2025.
"Reusable devices are prolific in healthcare," says Erica S. Shenoy, MD, PhD, co-chair of the guideline panel and chief of Infection Control at Mass General Brigham. "They're used in hundreds of thousands of procedures every year, so it's critical to have evidence to support the types of cleaning and sterilization or disinfection that's required to prevent transmission of infections from one patient to the next."
An Important Distinction
Clinicians tend to use the terms "sterilization" and "disinfection" interchangeably, Dr. Shenoy points out. In fact, the two processes are not the same — and which process is required for an instrument depends on how the instrument is classified.
Instruments or devices that come into contact with sterile tissue or the vascular system (e.g., surgical instruments) are categorized as "critical" and must be sterilized because any microbial contamination has a high risk of leading to infection. Sterilization is designed to destroy all microorganisms, including highly resistant microbes and bacterial spores. Common agents used in healthcare settings include steam or dry heat, hydrogen peroxide vapor, and immersion in liquid chemical sterilants.
Instruments that come into contact with mucous membranes or non-intact skin (e.g., laryngoscope blades) should not have any microorganisms. These devices are categorized as "semi-critical" and require, at a minimum, high-level disinfection (HLD). HLD is designed to destroy all microorganisms except for small numbers of bacterial spores. (A small number of bacterial spores is permitted because mucous membranes are generally resistant to spores.) Methods of HLD include pasteurization and liquid immersion in chemical high-level disinfectants such as hydrogen peroxide.
Not addressed in this guideline, but the subject of a forthcoming guideline that Dr. Shenoy is co-chairing, are "non-critical" medical devices that come into contact with intact skin but not mucous membranes. Examples include blood pressure cuffs and surface ultrasounds. These devices require low-level disinfection.
The type of processing (sterilization or HLD) and the technology used are determined by the device's manufacturer. Imprecise manufacturer instructions, shortcomings in a healthcare facility's physical infrastructure to support the complex steps of sterilization and HLD, and personnel without the necessary expertise are all factors that could compromise sterilization or HLD. So, too, is the design of certain devices.
"Many devices have complex designs that challenge even the most experienced programs. Duodenoscopes are a prime example and have been implicated in multiple outbreaks," Dr. Shenoy says. "There are real challenges in removing all or a majority of those pathogens before the device is used in the next patient."
Recent innovations in the design of duodenoscopes, including disposable components, have been shown to reduce contamination. These components do not eliminate risk but do reduce it.
The new document aims to help healthcare facilities navigate any potential pitfalls associated with sterilization or HLD by providing evidence-based, practical recommendations that reflect the current science.
MIFUs, 3D Printing, and Augmentative Strategies
Work on the guideline began in 2018 and was delayed by the COVID-19 pandemic. The document builds on the most recent guideline, from 2008, summarizing the literature along with the major changes and questions that have emerged in the interim.
Among the highlights:
- Manufacturers' instructions for use (MIFUs): The document outlines steps that facilities can take to adhere to ambiguous or confusing MIFUs. "MIFUs have become increasingly complex, so much so that some facilities are unable to implement them," Dr. Shenoy says. "In the guideline, we've tried to explain how to approach a situation where the MIFU is ambiguous, lacks sufficient detail, or cannot be implemented due to complexity or some other reason. An example is when an MIFU requires using a product that is not available."
- 3D printing: Clinicians have begun to experiment with creating reusable devices using 3D printers. As noted in the document, individuals must be aware that devices manufactured in healthcare facilities are regulated by the FDA. "This is going to be a very challenging space because most facilities don't have the expertise to validate an HLD or sterilization process," Dr. Shenoy says.
- Augments and alternatives to HLD: The document presents steps that facilities faced with continued challenges in reducing risk associated with failures in HLD can take. These include prioritizing sterilization (when possible) and using single-use components. "For many devices, there are disposable options that may make sense depending on factors like your volume and available resources," Dr. Shenoy says. Environmental impacts and cost considerations, however, were beyond the scope of the guideline.
Reusable medical devices are a standard part of the workday for many physicians, nurses, and other healthcare professionals. However, Dr. Shenoy observes, clinicians may not appreciate the complexities, expertise, and resources required to minimize patient risk when using the devices.
"There's a science behind the processing of devices, and the implementation is complex," she says. "Facilities need to have the dedicated resources and expertise to do it safely and effectively."
