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.
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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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.
Related Articles on Medical Devices:
HSCA Agrees With GAO Reporting Finding Lack of Transparency Raises Medical Device Prices
Proposed Legislation Would Allow for Direct Approval of Medical Devices
12 Critical Concepts to Know About ASC Supplies and Contracts