WASHINGTON — Clinicians are typically the first to have a grasp of the precise contours of an adverse event related to a drug or medical device, and FDA is rolling out two programs designed to close some of the gaps in device safety reporting systems. All the same, an FDAer told attendees at a medical society conference that patient-specific features of some devices – such as the settings programmed into cardiac electrophysiology devices – will not appear in unique device identifiers. Bill Maisel, MD, the chief science officer at the agency's device branch, said of programmable devices, "how they're programmed can certainly affect" safety, but he remarked that this dilemma is one that UDI "is not going to solve."
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