par Brendon Nafziger
, DOTmed News Associate Editor | July 05, 2012
After half a decade of conferences, workshops, pilot studies, the lobbying for legislation and the passage of legislation, and even angry letters from long-serving U.S. senators against a seemingly obstructionist executive office, the unique device identifier (UDI) rule has, at last, arrived.
The Food and Drug Administration released proposed rules for tracking medical devices Tuesday, ahead of the December 31 deadline it would have been given by a clause in a new FDA user fee renewal bill, which Congress passed last month and President Obama is expected to soon sign.
Proponents of the new device identification system say it could have far-reaching effects on U.S health care by allowing easier tracking of recalled products, as well as helping hospitals better manage their inventories and keep expired items off their shelves. They also say it could improve clinical care by, for instance, letting paramedics know the kind of implant someone has before they even reach the hospital.
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But while the expense, and hassle, of implementing UDIs will now primarily affect suppliers, who will have to tweak their production processes, if they haven't already, many of the program's predicted benefits can only be realized once providers start incorporating UDIs into their workflow. And it's possible, too, that the government will not wait for providers to do this on their own.
"In an early version of the Affordable Care Act, there was language that would have required capturing UDI in electronic medical records," said Karen Conway, executive director of GHX, a supply chain automation company that has been working with the FDA to test aspects of UDI implementation. Although she said it was later struck from the law, Conway maintains that the Office of the National Coordinator and the FDA are still having conversations about the matter.
"If I were a betting person, I would say it could happen down the road," she said.
HOW THE UDI WORKS
The UDI is essentially a number that identifies a particular medical device. As Conway explains, it would be graphically represented on an item in the form of a barcode, RFID or other machine-readable identifier. The identifier in turn will point to a database that lists different attributes of the product that could have regulatory or even clinical significance, such as its size and whether it's sterile or contains latex.
The database is, in many ways, the key to the whole endeavor, but it still has to be forged. GHX, along with its partners, worked on a pilot test of a prototype database for the FDA in 2009. The problem is the distributed nature of medical device data. The attributes needed for the database are often kept on different systems -- some clinical, some supply chain -- and they have to all be pooled into one place. GHX is also currently working with the Global Data Synchronization Network, an FDA partner organization, on external User Acceptance Testing for the agency -- that is, to see if the database works as intended and meets its users needs. Later, the FDA would likely work with the Association for Healthcare Resource & Materials Management (AHRMM), the supply chain wing of the American Hospital Association, to test how hospitals and others access data from the database, Conway said.