Reprocessed single-use devices have no independent failure-rate tracking

Third-party reprocessors refurbish devices labeled "single-use" (like electrophysiology catheters and ultrasonic scalpels) and resell them at 30-50% discounts, but adverse events from reprocessed devices are reported under the original manufacturer's device listing, making it impossible to isolate reprocessing-specific failure rates. Surgeons using a reprocessed catheter that cracks mid-procedure have no way to know whether the failure rate for reprocessed units differs from new ones, because the data is pooled. Hospitals save money but are making purchasing decisions blind to the actual risk delta. This persists because reprocessors lobbied successfully to be regulated under the original device's clearance rather than requiring separate post-market surveillance, and the FDA's MAUDE database has no mandatory field distinguishing reprocessed from original devices.