Reprocessed Single-Use Semicritical and Critical Medical Devices

Key Messages

What Is the Issue?

• Reprocessing a medical device includes cleaning, reconditioning, testing, and disinfection to ensure the device can safely be reused. In contrast to reusable medical devices, manufacturers are not required to provide instructions for properly cleaning and sterilizing single-use medical devices (SUMDs).
• Health Canada regulates third-party device reprocessors and requires they meet the same requirements as new device manufacturers. Health Canada does not provide oversight for hospital onsite reprocessing, deferring to the oversight provided at the provincial and territorial levels. Given the potential economic and environmental benefits of using reprocessed SUMDs, there is a growing interest in determining the clinical safety of reprocessed SUMDs.
• Current standards for reprocessing medical devices use definitions for sterilization and disinfection based on measurement of bioburden, but not necessarily clinical outcomes such as infection.

What Did We Do?

• To inform decisions about the appropriate use of reprocessed critical and semicritical SUMDs, CADTH sought to identify and summarize literature evaluating the clinical safety of reprocessed SUMDs, defined as infections, mortality, or other adverse events, compared with nonreprocessed (new) SUMDs. Microbiological outcomes, such as bacterial colony counts, were not included. An information specialist searched for peer-reviewed and grey literature sources.
• This report does not provide a comprehensive list of device reprocessors in Canada or recommend any specific methods of reprocessing medical devices.

What Did We Find?

• We identified 8 studies, including one study based in Canada, that evaluated the use of reprocessed SUMDs compared with new SUMDs; most did not report statistically significant differences in patient outcomes between groups.
• Most of the included studies were of very low to moderate quality, which limits confidence in the observed outcomes resulting from the reuse of these devices. Half of the included studies were published before the year 2005, which may limit applicability given potential improvements and changes over time in reprocessing standards, surgical approaches, device specifications, and patient care protocols.
• Most of the studies evaluated a different type of reprocessed single-use medical device for different surgical populations, so there is very limited evidence for the use of a specific device in a specific population or intervention of interest. All included studies evaluated SUMDs classified as critical, and all were conducted in surgical settings; however, it is unclear whether patient risk levels would be different for semicritical devices or in nonsurgical settings.

What Does it Mean?

• Given various devices, clinical applications, and reprocessing methods, it is difficult to draw broad conclusions about the appropriateness of reprocessing SUMDs.
• While the evidence base in this review was insufficient to conclude whether reprocessed critical SUMDs in surgical settings affect patient outcomes, Canadian standards and other resources exist to help inform decisions around medical device reprocessing based on infection risk.
• To ensure patient safety, any reprocessing of SUMDs should meet standards for safety, effectiveness, and labelling that follow Health Canada regulations.