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Senate Bill Seeks Action On Device Tracking

March 19, 2012
Written by: , Filed in: Diagnostic Imaging, Practice Management
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If it’s any consolation, even U.S. senators sometimes can’t get anything out of government bureaucrats.

Yeah, we didn’t think it would be much consolation. Still, senators can do something most of the rest of us can’t: they can introduce legislation designed to force agencies into action.

And so, last week, U.S. Senators Jeff Merkley (D-Oregon), Chuck Grassley (R-Iowa), Michael Bennet (D-Colorado), and Herb Kohl (D-Wisconsin) introduced the Ensuring Safe Medical Devices for Patients Act.

It appears designed, as DOTmed News reports, to prod the White House’s Office of Management and Budget (OMB) into deciding whether to approve a Food and Drug Administration rule about implementing a law requiring unique device identifiers (UDIs) for medical devices.

The bill’s supporters include not only Public Citizen, the National Research Center for Women & Families, and the Healthcare Supply Chain Association (a trade association for group purchasing organizations) but also, at least tentatively, the Advanced Medical Technology Association, or AdvaMed, a trade group for device makers.

Stephen J. Ubl, AdvaMed’s president and CEO, released a statement saying, in part:

America’s medical device manufacturers have long supported the appropriate implementation and use of a UDI system and believe it can play an important role in advancing patient safety.

Ubl said the association was reviewing the bill.

The bill would require devices to carry UDIs so the devices could be tracked through the supply chain. And it would require the FDA to issue a final rule to carry out that mandate by the end of this year.

The thing is, legislation passed in 2007 already requires UDIs, and the FDA submitted a rule on how to carry out the law back in July. The OMB has been mysteriously “reviewing” the rule for six months, although by executive order it is supposed to make a decision or request an extension within 90 days. It ignored a letter sent in February by Grassley, Kohl, and Senator Richard Blumenthal (D-Connecticut) that demanded to know what the holdup was and requested a reply by March 1.

If the OMB is already ignoring an executive order and a senatorial letter, we suspect it might ignore a law too. Still, eventually, it will give a thumbs up or thumbs down. And maybe, eventually, it will reveal why it took so long. But we wouldn’t bet on it.

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The Medicare Payment Advisory Commission confirms: Medicare diagnostic imaging did decrease in 2010. See our Facebook page for details.

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