Medtech Matters

In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we discuss the guidelines issued by the European Commission on the reprocessing of devices indicated by the manufacturer as beings single-use. Liability is brought up, as well as concerns such as material compatibility with reprocessing protocols with devices not intended to be used more than once. We also discuss measures device manufacturers should take if there’s a chance of their single-use devices being reprocessed to avoid patient injury. Specifically, the following questions are addressed:If a company states a device is single-use, how is it OK for a regulatory agency to override that indication and say it is OK to reprocess the device for at least one more use?Don’t we encounter specific material or device concerns that could arise with such a blanket guidance? What reprocessing system is safe to use and won’t have material incompatibility issues?How would the quality/design control requirements