Healthcare Purchasing News Q&A on Reprocessed single use devices, by Ray Taurasi (August 2010):
Q We have been utilizing an outside third party source to reprocess some of our single use devices (SUDs).While I have been keeping a log of all devices that we send out for reprocessing to date we have not been notifying our patients that a single use medical device may be used on them. Should patients be informed when a SUD is used on them? Doesn’t using a new device on some patients and a reprocessed SUD on another constitute a double standard of care?
A The reprocessing of single use devices is classified as a manufacturing activity and the process is regulated by the US Food and Drug Administration (FDA). Any source that reprocesses SUDs in the eyes of the legal system is deemed to be the manufacturer of that device. Manufacturers of medical devices including “third party reprocessors” or hospitals that choose to do this practice must comply with very rigid FDA manufacturing standards and regulations. To be certain that the SUDs you are having reprocessed meet the FDA’s strict requirements it is critical that you contract with a reprocessing company that is registered and regulated by the FDA with the appropriate clearances to reprocess the devices you are sending to them.
Assuming that you are indeed utilizing the services of a reprocessing company regulated by FDA and the devices being reprocessed have been cleared by FDA there is no need to inform patients that reprocessed devices are being used on them, nor is it considered a dual standard of care to use a new device versus an FDA cleared reprocessed device on patients. To obtain FDA clearance the reprocessor must demonstrate and prove that the reprocessed device is equivalent in performance, safety and quality as it was when originally manufactured by the OEM (original equipment manufacturer). The reprocessor must validate amongst other things the device’s effective functionality, cleaning, and sterilization. Once the FDA has cleared a reprocessed SUD it means that the device has proven to be equivalent in all regards to the original or new device. In such, there is no considerable difference between the two products and thus no dual standard exists.