FDA Prepares To Unveil Monitoring Program for Medical Device Safety

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This month, FDA is expected to unveil an improved medical device safety monitoring and reporting program aimed at identifying and removing faulty devices from the market earlier, the Wall Street Journal reports.

Background

The agency has been facing pressure from physicians to strengthen the program after a wave of faulty heart-defibrillator wires were linked to patient injuries and deaths.

Under the current program, FDA relies heavily on about 300 hospitals to alert the agency about device malfunctions. However, the program is not mandatory, creating an uncertainty about the frequency of the malfunctions and the urgency for action.

Proposal for Unique Device Identifier System

According to the Journal, one of the proposals for improving the program is to assign each medical device a unique number that FDA can link to billing and medical records to more accurately track faulty devices (Burton, Wall Street Journal, 4/9).

There currently is no uniform labeling system for medical devices, making it difficult to track down problematic equipment used by hospitals and patients.

In 2007, Congress voted to support FDA's plan to create a unique device identifier system for medical devices. A UDI system would allow FDA officials to electronically track medical tools and promptly recall any devices that could jeopardize patient safety (iHealthBeat, 3/16).

Peper Long -- associate director for external relations at FDA's medical device center -- said, "The ability of the unique device identifier number to strengthen our post-market surveillance is enormous" (Wall Street Journal, 4/9).


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