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Not-So-Simple Device Identifier Will Affect Docs

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It seems so simple to tag every medical device with a unique identifier. Just slap a bar code onto it, like the one displayed on just about every item in every store in America, right?

Well, no. The new unique device identifier (UDI) rules will potentially help radiologists, but a lot of work must be done first.

The Food and Drug Administration last week finally released proposed rules for adding a UDI to every medical device sold in the United States. The FDA is now accepting public comments about the proposals; here’s more from the agency.

Incidentally—or perhaps not so incidentally—the UDI system will work in only one direction. Users will be able to pull information about devices from an FDA database. But the FDA says no information about device users will flow the other way, toward the database. The agency’s Web site declares:

The UDI does not indicate and FDA’s database will not contain any information about who uses a device, including personal privacy information.

A 2007 law mandated UDIs. After four pilot studies, the FDA developed proposed rules in July 2011. The federal Office of Management and Budget held them up, without explanation, until last Tuesday. They are expected to go into full effect by 2015. But there are a few hurdles.

For one thing, a bar code by itself isn’t enough. Want to find out whether a patient’s pacemaker or joint implant is MRI-safe? A bar code won’t work unless you open up the patient, which would not be the first choice for either physician or patient. Implantable devices will need radio frequency identification (RFID) or some other sort of ID that’s readable through human tissue.

The UDI system will depend on a database that has not yet been created. Pulling it together won’t be simple, either. A DOTmed News report points out that “the attributes needed for the database are often kept on different systems—some clinical, some supply chain.” The final UDI database will need to include technical information from the manufacturer, recall information or safety warnings from the FDA, and maybe clinical alerts or recommendations from the American College of Radiology, for example.

And then there’s the UDI reader itself. How will it work? How big will it be? And how much will it cost?

The device industry, physicians’ and hospitals’ associations, consumer groups, and the FDA will work things out. Eventually. But not simply. Stay tuned.

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Electronic medical records: bane or boon? Our Facebook page notes two very differing perspectives.

Related seminar: Radiology Review

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