Art Sedrakyan

The federal government and stakeholders interested in device innovation and evaluation should support the creation of a comprehensive partnership on medical devices to monitor the products' performance after they become commercially available, a Food and Drug Administration-initiated and independent national group of experts is recommending in a report. The recommendations call for a master network of data in each clinical area where devices are used. Information on medical devices does exist — in registries, electronic health records (EHR) and claims data — but the disparate locations make it difficult for regulators, doctors and patients to understand and use it efficiently. Yet millions of patients undergo surgery each year and require some type of medical device during the procedure.

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