FDA Proposal for Worldwide, Uniform Medical Device Code Stuck in Office of Management and Budget

In 2007, Congress voted for the FDA to create a uniform device identification system for medical devices using simple bar code technology, but the initiative has yet to be implemented, according to a Politico report.

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The system would make tracking medical devices — including faulty hip replacement and pacemakers — easier and speed up the process of recalls. Amanda Forster, a senior communications director at Premier, a hospital alliance advocating for fast implementation of the system, told Politico, “We can recall tainted dog food faster than a pacemaker.”

The FDA submitted its proposal to the Office of Management and Budget for review in July 2011, where it currently sits. No action can be taken until the OMB releases the proposed rule.

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