A range of patient advocacy groups is urging the Office of Management and Budget to release a final Unique Device Identification (UDI) rule as soon as possible.
In a letter to OMB Director Sylvia Mathews Burwell earlier this month, 18 groups noted that owners of recalled cars have more information than patients with dangerously defective pacemakers. Those groups include Consumers Union, Public Citizen and the National Women's Health Network.
Similar correspondence from the Advancing Patient Safety Coalition echoed a letter sent to the U.S. Food and Drug Administration in 2008. That group includes American Hospital Association, Federation of American Hospitals and American Association of Medical Colleges.
Six years ago, Congress asked the FDA to develop regulations for a medical device tracking system. Frustrated by the FDA's slow pace, Congress last year passed a law mandating that it be done by this June 19, a deadline that has come and gone. The FDA's proposed rule has been under review with the OMB for nearly a full year, the groups note.
The groups also are pressing to ensure the UDI markings appear not only on the box, but on the device itself, since packaging material generally is thrown away. They also want the UDI information scanned into the patient's medical record.
A 2011 report by the Government Accountability Office found that when devices are recalled, manufacturers are able to locate fewer than half the defective devices. In 2012, the FDA recalled 50 medical devices that were either defective or a risk to health, the coalition notes.
A database of adverse events will help determine whether a problem is more likely due to a design flaw or to manufacturing problems on particular days or weeks.
The coalition also argues that the seven-year implementation framework in the proposed regulation is far too long. It advocates phased implementation beginning one year from release of the final rule.