What is the Food and Drug Administration (FDA) opinion or view of reprocessed single use medical devices?
The Food and Drug Administration (FDA) has issued enforcement priorities governing reprocessing, and the safe reuse of devices labeled “single-use only”. The FDA considers reprocessed devices “substantially equivalent” to (original) manufactured devices and subjects third party reprocessors to the same applicable regulatory guidelines as the original device manufacturer (OEM). The FDA has stated that certain specific single-use medical devices may be reprocessed and are “substantially equivalent” to the OEM device. The General Accounting Office (GAO) and Centers for Disease Control (CDC) have stated there is no evidence reprocessed devices have harmed ANY patients. Further, there has never been an adverse claim on a non-critical or semi critical reprocessed device.
