UDI Rule for Medical Devices Finally Issued

Cheryl Clark, for HealthLeaders Media , September 23, 2013

The 160-page rule was ordered by Congress in 2007, and hospital officials have complained about the length of time the FDA took to issue the proposed rule, which didn't come out until last November. And some don't understand why full implementation will take another six years.

"What's good news is that it's out," says Amanda Forster, vice president of public relations for Premier healthcare alliance, a group purchasing and quality improvement organization representing 2,900 hospitals. "What's bad, though, is that it's an excessively long timetable. The real risk here is for patient safety."

"I'm scratching my head, trying to understand why the timetable for implementation in the rule is as long as it is. Frankly, it's shameful."

Forster explains that "whenever there's tainted food in the grocery store— peanut butter or broccoli—the FDA can issue a notice and say these food products are tainted, and within hours grocery stores comb through shelves and pull everything off to keep it out of circulation.

"We can't do that with medical devices."

But she notes that the process by which hospitals and doctors indicate which products were used with which patients is complicated.

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