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Identifying Dangerous Products

By Matthew T. Stone, Esquire

On June 22, 2012, the Pew Health Group published a brief summary of the Food and Drug Administration’s (“FDA”) Sentinel Initiative. The purpose of the Sentinel Initiative is to expedite the transfer of information about a medication or product’s danger or defect to the manufacturer, thus enabling the manufacturer to create a safer product. This process takes place by monitoring electronic health records and other sources of medical data, as opposed to waiting for the manufacturer to report a problem. While the program has had success with regard to medications, according to Pew it has been harder to implement in the medical device context because of the difficulty in identifying specific devices. Perhaps anticipating this problem Congress passed legislation in advance of the Sentinel Initiative to create Unique Device Identification (“UDI”), though unfortunately the timing of UDI’s implementation was never established and it had stalled in the Office of Budget and Management (“OMB”) for almost one year.

The good news is that both the House and the Senate passed legislation which has since been signed into law getting the ball rolling. Pursuant to the FDA Safety and Innovation Act, a 120-day deadline was imposed for the implementation of Unique Device Identification. What this means is that in the 120 days from the date of a proposed UDI rule, the FDA would accept comments and suggestions regarding the content of the rule. The FDA would then have six months to implement a final rule. On July 10, 2012, the FDA proposed its UDI rule which can be found HERE. The FDA must publish the final rule no later than six months after the close of the comment period, and must implement the final regulations devices no later than two years after FDA promulgates the rule. It’s a start.

To be sure, the interplay between politics and healthcare often yields undesirable results, or at least delayed progress. However, with the anticipated passage of the FDA Safety and Innovation Act it appears that lawmakers are, at least in this regard, working to make common sense improvements to patient safety.

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