Reprocessing Advisory

Consistent with the Association’s mission to provide cost-effective, quality healthcare, AHRMM supports the regulated reprocessing of selected medical devices originally labeled for “single use” by the original equipment manufacturer. The types of “single-use” devices (SUDs) eligible for reprocessing include opened-but-unused devices, devices whose expiration date has passed, and previously used devices. However, the reprocessing of opened-but-unused devices is not currently subject to regulation by the Food and Drug Administration (FDA).

AHRMM supports reprocessing because it allows hospitals to provide quality patient care while containing costs and reducing medical waste. AHRMM believes that only those products that have been deemed reusable or single-use devices identified as safe to reprocess under FDA guidelines should be reprocessed. AHRMM also believes that the oversight of medical device reprocessing by the FDA provides assurances that medical devices that are reprocessed in accordance with FDA requirements are safe and appropriate for use by hospitals. AHRMM is aware that FDA’s goal is to regulate all reprocessors (original equipment manufacturer (OEM), hospital, and third-party) of “single use” medical devices as OEMs, subjecting them to uniform regulatory requirements including registration and listing, medical device reporting, tracking, corrections and removals, quality system regulation, labeling, and pre-market submission requirements.

The significant regulatory burden imposed by the FDA also has made in-hospital reprocessing more complex and costly for most hospitals. AHRMM, therefore, does not encourage or endorse hospital reprocessing of 'single use' devices for facilities that are unable to meet the stringent guidelines established by the FDA. 

However, to contain costs, reduce waste, and promote quality patient care, AHRMM encourages hospitals to reprocess by outsourcing to third-party reprocessors. If selecting a third-party reprocessor, AHRMM recommends that hospitals only choose firms which are registered and in good standing with the FDA. The FDA has developed suggestions for selecting a third-party reprocessor including:

• Talk with other hospitals to determine their experiences with third-party reprocessors.
• Take a tour of the reprocessor’s facility to inspect and review standard operating procedures.
• Request a copy of the facility’s establishment inspection report that lists the findings of the FDA when last inspected; and review the findings of that inspection to see how the firm has complied with the Quality System Regulation.
• For each device your hospital wishes to reprocess, ensure that the reprocessor has received approval from the FDA for any necessary pre-market requirements as well as with pre-production validation data on each non-exempt device for cleaning, function testing, and sterilization (as required by law in the Medical Device User Fee and Modernization Act of 2002).
• Ask about the reprocessor’s validated systems and study protocols for processes such as cleaning, packaging, and sterilization; and verify the integrity of the third-party lab used to oversee lab results.
• Ask if the reprocessor has set limits for the number of times a device may be reprocessed and what mechanisms the reprocessor has put in place to track devices and ensure that a facility only receives its own devices.

To learn more about single-use devices, visit the American Society for Healthcare Central Service Professionals (ASHCSP) website.