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UDI Rule for Medical Devices Finally Issued

Cheryl Clark, for HealthLeaders Media, September 23, 2013

"People call things by different names," she says. Some may say Medtronic pacemaker or some may say Medtronic PM…and lots of hospitals in the absence of a UDI system come up with their own numbering system."

Because labels are not automated, staff must spend hours combing patient medical records, sometimes going back years, to find patients who may be walking with implanted devices.

The manual process will inevitably introduce errors, she says. "Because it's not automated, things get missed. Or someone can write down a 7 instead of a 1."

Lack of a UDI system today can be expensive and labor-intensive.

According to last October's McKinsey & Company report, "the typical recall of a medical device can take up to about 2 man-days of effort in the hospital (involving various departments: procurement, logistics, medical physics), and in some cases more time, especially for implanted devices, where substantial effort is required to contact affected patients."

The FDA indicated it received nearly 300 comments to last year's proposed rule, most of them favoring most parts of the rule. However, the Medical Device Manufacturer's Association requested numerous changes, such as two-year delays for any implementation and restrictions on the FDA launching any investigations based solely on UDI information.

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