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UDI Final Rule Still Pending

Cheryl Clark, for HealthLeaders Media, July 22, 2013

Alkire added: "In fact, of the 700 device recalls initiated a year, the Government Accountability Office estimates that half the time (53%) companies are unable to remove all the faulty devices from the market, largely because there is no uniform way to track medical devices electronically in the supply chain."

Hospitals and other healthcare organizations also want the tracking system to better control inventory.

One study from Arizona State University's Carey School of Business "estimates that the increased efficiency and accuracy of a UDI system will save manufacturers, distributors, and healthcare providers $16 billion annually," says the letter from 18 consumer groups.

The consumer groups insist that when the rule is published, it specify that unique identification must be on the devices themselves, not just on the package the device came in, which the industry might prefer because it might be less expensive.

But, the consumer groups wrote, "medical devices are often separated from their packaging before they are used by patients, and the packaging is often discarded…A UDI is essentially useless if it is only on packaging that has been lost or discarded…[and] would undermine the effectiveness of the entire UDI system."

A representative from the Medical Device Manufacturing Association could not be reached for comment.


Cheryl Clark is senior quality editor and California correspondent for HealthLeaders Media. She is a member of the Association of Health Care Journalists.
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