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Loophole in medical device governing statute puts patients at risk

Consumer Reports News: May 21, 2012 04:38 PM

As the Senate prepares to vote on a bill this week to reauthorize the statute governing medical device oversight, Consumers Union, the advocacy arm of Consumer Reports called attention to a loophole that puts patients at risk.

The Food and Drug Administration does not currently have the power to require medical device makers to prove they have fixed design flaws when they want to sell a new device based on one that has previously been recalled by manufacturers for safety issues. Consumers Union has urged lawmakers to give the FDA such authority.

The medical device industry claims that the FDA does have this authority, but according to Consumers Union, the director of the FDA's Center for Devices and Radiological Health, Dr. Jeffrey Shuren, has confirmed in media interviews that the agency does not have the power to prevent device makers from repeating safety flaws when new devices are cleared based on their similarity to ones recalled by manufacturers.

"It's time to close this absurd loophole and give the FDA the power it needs to protect patients," says Lisa McGiffert, director of Consumers Union's Safe Patient Project. "But so far, the politically powerful medical device lobby has blocked this common sense reform."

According to our investigation, many implanted devices, including artificial joints and surgical mesh, are never clinically tested on humans before being put on the market. Tens of millions of Americans live with medical device implants, including artificial joints, heart defibrillators and surgical mesh, among others.

"Medical device makers should have no objection to proving they have fixed safety flaws in order to sell products based on ones that are dangerous to patients," says McGiffert.

Consumers Union ran an ad in Politico today, and its Safe Patient Project debunks the medical device industry's misleading arguments to Congress.

Senate OKs weak Safety And Innovation Act for medical devices
CR poll: Americans want safer medical devices

Dangerous Medical Device Loophole Puts Patients At Risk [Consumers Union]

Maggie Shader

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