July 19, 2012 — In the wake of thousands of lawsuits over defective medical devices, the U.S. Food and Drug Administration (FDA) has proposed a new plan to track all high-risk medical devices. The U.S. currently has no system to track the performance, safety, or effectiveness of medical devices after they are implanted. This makes it very difficult to determine the safety of an implant. This has been especially problematic in the wake of defective hip implants, heart-defibrillator wires, transvaginal mesh, and more.
The plan will require a high-risk medical devices to carry a unique device identifier (UDI). This proposal was originally part of a 2007 federal law, but it was never enacted. It was included in a new plan that has been passed by the House and Senate, and is expected to be signed into law by President Obama.
In the last five years, nearly 18,000 deaths have been attributed to medical devices. However, without a way to track medical device injuries and deaths, the FDA has no way to determine how often devices fail. With a UDI in place, the FDA will be able to quickly review hospital/insurance records to determine when certain models of a device carry a higher-than-normal risk of failure.
The UDI will appear on defibrillator wires as early as 2014. There have been several high-profile instances of the devices malfunctioning — the wires can wear through their silicone insulation or fracture, causing the defibrillator to deliver unnecessary shocks or fail to shock a person during an emergency.
In many cases, recalls are delayed because manufacturers and the FDA are unable to determine how often a device has a defect. The UDI will likely help the FDA and manufacturers identify defects earlier, which could help people before they suffer serious injury or death.
The annual cost of the surveillance program is estimated to be $65 million. The additional cost will likely be levied on medical device companies. As part of a new bill, medical device and drug companies have agreed to pay higher user fees to the FDA in exchange for faster approval of new products. The bill has garnered bipartisan support and was one of the few pieces of major legislation passed through congress in 2012.
However, some are saying that the UDI is not enough. Just because a device has an identification number does not mean that doctors will automatically report defective devices. Some doctors routinely fail to report defective medical devices, which may extend the amount of time it takes for the FDA to determine a device is defective.
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