Industry Insights

In addition to instruments in disrepair making their way to the sterile field, Joint Commission surveyors have unfortunately noted with increasing frequency, the reprocessing of single-use devices (SUDs) – items labeled by their manufacturer as “single use” or disposable. These devices often consist of lower-quality material and as a result, develop pitting and oxidation which indicates possible hazard to a surveyor. Reprocessors are regulated by the Food and Drug Administration (FDA) and are subject to all regulatory requirements currently applicable to the original device manufacturer, including premarket submission requirements. If a health care organization reprocesses a single-use device, it is dangerously allowing itself to become a manufacturer of a medical device – and thus assumes all of the manufacturer’s liability, should that device fail. In addition, it takes on the liability of possible FDA rule violation. Single-use instruments must be removed from trays and discarded or sent to an FDA-approved reprocessor of SUDs.