Adding Up the Numbers behind UDI

Achieving unique device identification (UDI) will be tough during a down economy. But that’s what FDA is hoping you will do.


Evidenced by the regulatory hints that FDA’s senior adviser for patient safety Jay Crowley gave at the February 12 UDI workshop, the agency is urging the medical device industry to step up to fight sluggish recalls, which endanger patients. (For more details on the two-part coding system FDA is considering for medical devices, see the Bar Code Supplement beginning on page 58 or visit


Workshop panelists and attendees all acknowledged the need for a better way of identifying recalled medical devices. But the sticky issue of the down economy just couldn’t be ignored. Jean Sargent, supply-chain director for the University of Kentucky’s two-hospital system, explained that she has “C-Suite” support for better product identification. “Our pharmacy and clinical lab are moving toward bedside scanning,” she reported. “Our CFO is happy, and our CTO [pointed out that by] standardizing processes and nomenclature, we could reduce unnecesary variation.” But “we have to keep it simple—various standards would not work.”


Later, during an open discussion, Sargent pointed out that “we don’t need UDI on syringes or ‘doodads,’ ” getting a chuckle. There are “economic issues—we don’t need to increase a 5 cent item to an 8 cent item.”


Separately, Corwin Hee from Covidien suggested a “risk-based approach” to UDI as well as a “phased-in approach,” adding that “there is a finite limit on our resources so [let’s] use the most cost-efficient system.”


And costs could even be measured in terms of effort spent. Added Tom Werthwine from Johnson & Johnson: “We don’t need broadsweeping rules and then have exclusions—that’s a burden on manufacturers and on the agency.”


FDA has yet to release draft guidances or rules on UDI. Crowley explained the workshop was industry’s chance to speak up about UDI. Written comments were accepted through February 27.
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