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Dangerous Medical Device Loophole Puts Patients At Risk
Date:5/21/2012

WASHINGTON, May 21, 2012 /PRNewswire-USNewswire/ -- Consumers Union, the policy and advocacy arm of Consumer Reports, is calling attention to a dangerous medical device loophole that puts patients at risk in a full-page print ad in Politico today. The ad is running as the Senate prepares to vote on a bill this week to reauthorize the statute governing medical device oversight.

The ad notes that the FDA does not have the power under current law to require device makers to prove they have fixed design flaws when they want to sell a new device based on one that has been recalled by manufacturers for safety problems. Consumers Union has urged lawmakers to give the FDA the authority to require device makers to demonstrate that the safety flaws have been corrected in the new device.

"It's time to close this absurd loophole and give the FDA the power it needs to protect patients," said 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. 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."

The medical device industry claims that the FDA has the authority it needs to address this problem. However, Dr. Jeffrey Shuren, director of FDA's Center for Devices and Radiological Health, has confirmed in media interviews that the agency does not have the power it needs to prevent device makers from repeating safety flaws when new devices are cleared based on their similarity to ones recalled by manufacturers. While the Senate and House bills being considered this month include some important reforms, both bills are mi
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SOURCE Consumers Union
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