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Jackie Fedeli
Jackie Fedeli
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New FDA Safety Plan involves Long Awaited UDI System

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Two weeks ago, Consumer Advocates won another battle. The Unique Device Identifier (UID) system, originally proposed in 2007 was finally passed. This system will assign a tracking number to medical devices. The tracking numbers will be stored in a publicly accessible database to allow doctors, regulators and manufacturers monitor device safety issues. The FDA will use these tracking numbers to help quantify device malfunctions.

Among the devices included in this plan are catheters, defibrillators, heart stents, and prosthetic joints.

The announcement of the new plan, coincides with the recent FDA Advisory Panel on Metal on Metal Hip Implants. Anapol Schwartz Attorney, Melissa Hague, and her client, Patricia Lorenz, were among those who spoke out against the serious side effects caused by faulty hip implants. As of last year, there were over 12,000 complaints regarding metal poisoning and high early failure rates for metal on hip implants.

The FDA’s new Patient Safety Plan, involving the UDI system will keep track of reported device problems, and may hopefully help doctors make more informed decisions when selecting a surgical implant.

This new patient safety plan will take 7 years to implement in order to allow doctors, hospitals, manufacturers and regulators to prepare for the new system, and to spread out the costs.