The Food and Drug Administration contends that universal device identifiers will enable the agency to actively monitor medical device performance and better identify patient safety concerns and recalls.
Medical devices marked with a unique code are used to track them through their distribution and use in patients. In particular, the FDA sees tremendous value in capturing universal device identifiers in electronic health record systems.
“A medical device may ultimately get approved and—as it is used in a larger population—we understand its benefits but also potential concerns and may need to pull that device from the market,” Amy Abernethy, MD, FDA’s principal deputy commissioner and acting CIO, told last week’s Interoperability Forum, held by the Office of the National Coordinator for Health IT.
Andrew Harrer/Bloomberg
“One way to do that is to have the universal device identifier available in the electronic health record and now have the universal device identifier start to be linked to patient outcomes,” said Abernethy.
The Global Unique Device Identification Database, which is publicly available, contains key device identification information submitted to the FDA about medical devices. Currently, the GUDID database contains more than 2 million device records and enables patients and healthcare providers to download information about their devices.
However, the FDA is working with ONC, the Centers for Medicare and Medicaid Services and the National Library of Medicine on improving the accuracy of device-related adverse event reporting and expediting the resolution of device-related problems, according to Abernethy.
“I believe interoperability is key to all types of processes going forward—including the interoperability from the electronic health record—and that this is a place where FDA and ONC can continue to collaborate and work together,” she added.
In the next couple of months, the FDA will release a plan to modernize the agency’s technology infrastructure, including interfaces with stakeholders, Abernethy said.
She made the case that modernized, active surveillance that utilizes real-world data is the future of medical device safety signal detection and is one of the agency’s main priorities.