by
Brendon Nafziger, DOTmed News Associate Editor | July 05, 2012
ORIGINS WITH THE IOM
Although the latest version of the proposed rules only came out this week -- and as of this writing have not even been printed up by the Federal Register yet -- the UDI has actually been a long time coming.
According to Conway, its origins lie, ultimately, in the Institute of Medicine's influential 1999 report on medical errors, "To Err Is Human," which in turn was the catalyst for a 2006 national drug bar code rule, which improved the tracking of pharmaceutical shipments. As Conway explained, the FDA's device office realized it wanted something similar for devices, and in 2007, Congress passed a law that required the agency to implement UDIs.
But here's where things get tricky. The FDA's original proposed UDI rule was actually released in July 2011, but was then held by the Office of Management and Budget, in charge of reviewing these things, ever since. Under a standing executive order, the OMB has only 90 days to make a decision, or request another 30-day extension, on the rules it's examining. But for reasons no one outside the OMB really knows, the office exceeded its allotted time. In fact, this past February, Sens. Herb Kohl (D-Wis.), Chuck Grassley (R-Iowa) and Richard Blumenthal (D.-Conn.) wrote a letter to the OMB, urging it to hurry up.
Although it's not really known what caused the snag, on her GHX blog, Conway suggested that maybe the Obama administration was reluctant to stack one more regulation on the medical community on the heels of meaningful use, ICD-10 and the health reform changes.
"I would guess there's probably some politics involved in health care," she joked, when DOTmed News spoke with her by phone.
BETTER TRACKING, COMING SOON
For now, though, the UDI is back on track. According to language in the FDA user fee bill, within two years of final regulations being issued, implantable devices would have to bear UDIs. As the FDA released its new proposed rules this week, with an accompanying 120-day comment period, this means the UDI should be working by 2015 -- at least for riskier, implantable medical devices, like pacemakers and orthopedic implants, following the FDA's risk-based approach.
A sample UDI, courtesy of the FDA
But once the system's up and running, what kinds of benefits will the U.S. health care system see?
