Originally published August 8 2010
FDA calls for stricter rules to approve medical devices
by Ethan A. Huff, staff writer
(NaturalNews) The U.S. Food and Drug Administration (FDA), the federal agency responsible for approving medical devices, is calling for stricter rules for medical device approval. The new rules, which would specifically apply to redesigned medical devices, may require that medical device manufacturers seek new approval every time they update or redesign a device.
The proposed changes are a response to growing pressure from the public over possible harm being caused by redesigned devices. Current FDA provisions allow medical device manufacturers to release updated versions of medical devices if they are only slightly different than previous models. But that determination is made entirely by manufacturers in "good faith", and they can bypass the formal approval process and market any supposed medical device under the pretense that it is a redesign of a former model.
This practice has led to numerous lawsuits filed by patients who say that various devices have caused them permanent injury. And manufacturers are not even informing patients that these devices, which are often implanted directly into the body, are not the FDA-approved versions.
Antonitsa Vlahoulis, a woman who says her heart was permanently damaged by a redesigned heart valve ring, is one of many who has sued the manufacturer of that device for failing to inform her about the change.
"I want to make sure that anything (surgeons) implant has FDA approval and is done with the patient's consent and knowledge," she explained to the Chicago Tribune.
Concealing the truth about redesigned medical devices is highly unethical, but technically legal because FDA guidelines in the matter are vague and open-ended. Because of the widespread damage this loophole is causing, many in the medical field are questioning whether or not the FDA has the ability to properly handle medical device approval, which has spurred the agency to initiate changes.
Sources for this story include:
http://articles.chicagotribune.com/2010-08-0...
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