Is reprocessing SUDs safe and legal?
According to the FDA, SterilMed is considered the manufacturer of reprocessed devices. As such, we are as accountable as any manufacturer (including Original Equipment Manufacturers (OEMs)) for product safety, effectiveness, labeling claims, liability and warranty. The FDA oversees and regulates the practice of reprocessing with significant oversight from Congress. Reprocessors must submit 510(k)s and receive clearance from the FDA. The FDA requires that devices are clean and sterile as well as safe and effective (substantially equivalent) for their intended use as the devices were when new. The FDA conducts inspections of reprocessors twice as frequently as device manufacturers. In other words, not only are the reprocessors considered to be the manufacturer of the device when they reprocess it, they must adhere to even stricter standards than the OEMs.
