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Consumer Reports on defective medical devices

According to the President of Consumer Reports, Jim Guest, the Food and Drug Administration needs to do more to protect the American people from defective medical devices.

"This isn't science fiction. Millions of medical devices, including artificial hips, contact lens solution, heart stents, and pacemakers, are being recalled - 700 different products a year," Guest wrote. And many of these devices, he pointed out, were never properly tested.

That is because the Food, Drug and Cosmetic Act allows a faster process for some low- and moderate-risk devices. Known as Pre-market Notification, or 510(k) approval, this process has led to the approval of a number of high-risk devices that caused death or life-threatening injuries, including synthetic mesh devices (surgical mesh) and Johnson & Johnson's DePuy hip implants.

Consumer Reports is now attempting to change the approval process, which another nonprofit organization, the Institute of Medicine, supports. That organization has called the 510(k) approval process "fatally flawed."

The FDA has said it will not scrap the process, but that it could be improved. Unfortunately, the FDA does not have the authority to improve the process. What the FDA can do is change device classifications so that certain devices are not eligible for the process. Today, low- to moderate-risk devices are eligible for the 510(k) process, and it may be possible to reclassify some of those devices.

Lawmakers, on the other hand, can change the process. At least one piece of legislation is currently before the U.S. Congress: the Safety of Untested and New Devices Act of 2012 (SOUND Devices Act). That act would give the FDA more authority to reject certain devices as long as those devices are similar to other, recalled devices.

Those injured by defective medical devices can bring lawsuits against the companies that manufactured the devices. If a physician's actions contributed to the injury, they may also be able to bring a medical malpractice lawsuit.

Source: Reuters, "Consumer Reports taps ire over bad medical devices," Debra Sherman, Mar. 12, 2012.

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