Have there ever been any law suits involving medical devices reprocessed by SterilMed?
SterilMed has never been involved in any lawsuit arising out of a patient injury or allegation of improper or negligent reprocessing of a medical product or device. A recent analysis of FDA’s MAUDE database concludes there is no evidence to suggest that reprocessed devices fail more often than original equipment. The Association of Medical Device Reprocessors (AMDR) analyzed data from 2000-2006 for the most-frequently reprocessed single-use devices, reprocessed devices have a 99.9997% adverse event free rate. For many products listed (i.e., cardiac stabilization devices, compression sleeves, burrs, blood pressure cuffs, pulse oximetry sensors, drill bits, external fixation devices, saw blades, etc.), the entire reprocessing industry has zero MDRs, as compared to dozens or even hundreds of events associated with OEM devices.
