Texas Medical Device LawyerJuly 19, 2012 — As part of a new overhaul legislation aimed at  defective medical devices, medical device companies will be required to place a Unique Device Identifier (UDI) code on all high-risk medical devices. This will help the FDA track the performance, safety, and defects with high-risk medical devices after they are implanted. The U.S. currently has no system for monitoring medical devices after they are implanted, which has inhibited recalls when potential safety concerns are identified. The regulatory deficiency has been problematic in cases such as transvaginal mesh, metal-on-metal hip implants, heart-defibrillator wires, and more.


The UDI requirement was first proposed in legislation in 2007, but the law was never passed. Five years later, it has become a part of a major piece of legislation that has recently passed through the House and Senate — one of the few major laws to garner broad bipartisan support that was passed in 2012. President Obama is expected to sign it into law.

At least 18,000 deaths have been attributed to malfunctioning medical devices in the last five years. Unfortunately, it is difficult for the FDA to determine whether specific devices are prone to failure or defective, because they cannot effectively determine the rate of failure.

With the surveillance system in place, it will be much easier for FDA employees to look at hospital and/or insurance records to evaluate whether certain models are more likely to fail than previously expected, or they have an unexpected defect. Advocates of the program hope that faster recalls will mean fewer people are injured by defective medical devices.

Heart defibrillator wires should have a UDI as early as 2014. The devices have come under scrutiny in recent years in the wake of several recalls. Some defibrillator leads can fracture, wear through their insulation, or malfunction, causing the device to shock unnecessarily or fail to shock during an emergency. After these devices were recalled, thousands of people had to go additional surgery to replace the defective wires.

The surveillance program will cost an estimated $65 million per year, and the cost will likely be shouldered by the medical device industry in new legislation. The medical device and pharmaceutical industries enthusiastically sponsored the legislation, which will increase the user-fees paid by companies in exchange for faster FDA approval.

Still, some are concerned that the surveillance program does not go far enough. Doctors still are not required to report defects with medical devices, which means that the voluntary reporting system will likely under-estimate the actual numbers of medical device side effects. This could potentially delay emergency recalls.

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