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 (design inputs) differ? I mean, if the design engineer is developing a single-use device, one would think he or she wouldn’t have to follow the same protocols as they would for a reprocessed device.
• Does this guidance mean developers of single-use devices have to test their device for multi-use and reprocessing?
• Are there limitations on this guidance? Are there certain types of single-use devices that the guidance does not permit to be reprocessed?
• If a patient is harmed by a reprocessed device, who is liable? The device maker, the regulatory agency, or the reprocessor?
• Does this guidance reflect a need for a new definition of single-use?

Listen to this episode and see what you think of the European Commission issuing these guidelines. If you’d like to share thoughts, ask questions, or have a suggestion for a future topic for us to cover, please reach out to me at [email protected] and we’ll see if we want to address your ideas/inquiries/suggestions in a future episode.

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