FDA, NIH unveil medical device database

High-risk devices, like pacemakers and heart valves, will be the first devices to receive UDIs. (Wikimedia Commons)

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The Food and Drug Administration, along with the National Institutes of Health’s National Library of Medicine, has unveiled a new site that will allow the public to search for data on certain medical devices.

Called AccessGUDID, the site lets users search and download information related to devices with unique device identifiers, or UDIs.

The site comes after FDA issued a rule in 2013 requiring device labelers — who are usually the manufacturers — to include UDIs on device labels and packages. The new system aims to create a consistent way to identify medical devices as they’re sold and used in the U.S.

Not all medical devices are in the online database right now. The program will be phased in over several years, starting with high-risk devices, like pacemakers and heart valves. That accounts for a small portion of marketed devices. Over time, a wider range of devices will need to carry UDIs.

UDIs “will let hospitals manage their inventory better; it will let hospitals and doctors and the FDA access the performance of devices in a way that they couldn’t before; and will let hospitals identify patients who might have a recalled device,” Josh Rising, director of Pew Charitable Trust’s health care program, said in a video the think tank produced last year.

In the video, Pew highlighted the efforts of Mercy, a health care system in the Midwest, to pilot a UDI program. Dr. Joseph Drozda, Mercy’s director of outcomes research, said the UDI system allowed the hospital group to incorporate information on the devices into the supply, inventory management and billing systems as well as patent clinical records.

“Just stop and think about it: When your car is recalled, they don’t have a hard time tracking you down,” he said. “But right now,” he added, “we don’t have a system like that for devices that are implanted in you.”

The UDI has two parts: a device identifier, which says who the labeler is, and a production identifier, which has information about the specific device or the batch within which the device was made.

“[W]e encourage everyone — health care systems, clinicians, patients, researchers and industry — to explore its contents, assess its functionality, and provide us with feedback,” FDA said in a release

Take a look at Pew’s video below.

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big data, data analytics, Department of Health and Human Services (HHS), Departments, Food and Drug Administration, Health data, Health IT, Tech
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