UDI Final Rule Still Pending

Cheryl Clark, July 22, 2013

Patient safety advocates are urging federal officials to issue an overdue final rule on unique device identification. In the absence of a rule, "patients are being harmed," says one.

It's been six years since Congress ordered the U.S. Food and Drug Administration to require simple unique markings like bar codes to track potentially harmful medical devices, like pacemakers, artificial hips or heart valves. And it's been more than a year since the FDA proposed one.

But there's still no final rule, though the congressionally mandated deadline passed on June 19. And there's no good reason for the delay, insist several large organizations that often disagree on healthcare policy.

The long-anticipated regulation has apparently hit a snag in the Office of Management and Budget, prompting industry leaders and consumers to wonder if the industry has been successful in delaying or weakening the effort. Contacted for comment, an OMB spokeswoman said the agency's policy is "not to comment on rules under review."

"Unfortunately, however, the UDI (unique device identification) rule has encountered delays at every step of the process," says a July 3 letter from 18 consumer groups, including Breast Cancer Action, Public Citizen, and Consumer's Union, to Sylvia Mathews Burwell, OMB director.

"We are anxious to see the UDI system up and running, and contributing to patient safety efforts as soon as possible," says another letter signed by 21 healthcare organizations, including two large healthcare group purchasing organizations, Premier Inc. and VHA Inc., as well as the Federation of American Hospitals and the Association of American Medical Colleges.


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