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UDI Final Rule Still Pending

Cheryl Clark, for HealthLeaders Media, July 22, 2013

"We think medical devices should have these codes," Michael Carome, MD, director of Public Citizen Health Research Group says in a phone interview. "They should be device- and unit-specific, so in the post-marketing period, one can adequately enhance the tracking of these devices, so if there's a need for recall, that can be communicated to the doctors, with timely reporting of adverse events."

In the absence of this rule, he adds, "patients are being harmed."

"I believe the industry has expressed concerns about the burdens of the rule, and how they need time to implement systems in their various procedures for making devices—whether the unique identifier is going to appear directly on the device, which for many deices, particularly those implanted will be a requirement, or on the packaging or both," Carome says.

"It's like the agency got significant pushback and concern from the industry about the burdens of doing this… there may be concerns about overregulating."

Blair Childs, a vice president at Premier, which drafted the healthcare industry's letter, says that currently, "it's like a monopoly. There's only one entity that has all the information, and that's the manufacturer."

When there's a recall of a medical device, like a defibrillator or a pacemaker, it's nearly impossible to identify which patients received it, Childs says.

"If you ever talk to people in hospitals when there's a recall, no one wants to be anywhere in sight, because it's one of the more cumbersome processes that goes on in a hospital. Who knows how many are in that lot of affected products?"

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