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Unique identifying codes
could make it
easier to track
down device recalls.

Hospital groups, GPOs, call for unique device codes

by Brendon Nafziger , DOTmed News Associate Editor
A group of hospitals, medical societies and group purchasing organizations expressed their impatience to the U.S. Food and Drug Administration with the lack of progress on adopting unique codes to better track medical devices.

In a letter to FDA Commissioner Margaret Hamburg, the Advancing Patient Safety Coalition, a lobby that includes the American Hospital Association, American Nurses Association and Premier Inc., urged the agency to push forward with establishing a unique device identification system, as required by an act of Congress three years ago.

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The UDI would essentially be a coded system, like a bar code, that would let hospitals and other health care providers know the exact model and manufacturer of a product, as with the Universal Product Code found on, say, a box of cereal.

"A regulated, mandatory UDI system that is globally harmonized will ultimately improve patient safety, reduce medical errors, facilitate device recalls, improve device adverse event reporting and recognize the full potential of [electronic health records] and delivery system reforms," the coalition said in its July 7 letter to the FDA chief.

A UDI would have both patient safety and health care cost benefits, the group said. It would make it easier to prevent dangerous device interactions, such as those found between certain pacemakers and MRI scanners, the group said on its website.

It could also make it easier to track down recalls, of which there were more than 700 in 2008, 100 of which were Class 1 recalls - the most serious, the group said.

A unique identifying code could also cut billions of dollars in processing costs for health care centers, the coalition said. An update to the 1996 Efficient Healthcare Consumer Response study by Arizona state researchers estimated such a system, combined with electronic tracking measures, could cut $16 billion from supply chain costs every year, the group noted in its letter.

"These savings were tied to the adoption of a health care identifier, universal product number, identification standards and electronic data interchange and bar coding," the group said.

Currently, there's no universal system in place for devices, although most manufacturers use unique product numbers, or UPN, the FDA said on its website, but without a comprehensive central database.

On Sept. 27, 2007, the Food and Drug Administration Amendments Act of 2007 was signed into law, requiring the FDA to create a UDI system. The FDA had been considering UDIs for several years before the law passed, according to documents on FDA's website. The FDA has required bar code identification for drug labeling since 2004.

When contacted by DOTmed News, the FDA declined to comment on the UDI rule because it is under development.

"It's a priority of the center, and we hope to get it out before the end of this year," an FDA spokesman said.

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