The FDA has begun to require compliance with specifications designed to ensure that reprocessed single-use medical devices are as safe and effective as new ones. In the first stage of the program, the agency is requiring that the highest-risk (class III) devices–such as PTCA catheters—that are reprocessed by hospitals and firms for reuse receive FDA premarket approval based on data showing safety and effectiveness. The only exceptions are cardiac ablation catheters reprocessed by four firms that have received an extension to complete clinical studies. Any other unapproved products may be reused only as investigational devices with the approval of the institutional review board and the patient's informed consent.
Schwetz BA. Reprocessing of Single-Use Devices. JAMA. 2001;286(13):1569. doi:10.1001/jama.286.13.1569-JFD10009-3-1