Study of Medical Device Rules Is Attacked, Unseen, New York Times, July 27, 2011

Aug 14th, 2011 | By | Category: Media Reports

Allies of the medical device industry criticized an Institute of Medicine report, to be released July 29, that says the approval process for a wide range of medical devices such as hip implants, hospital pumps, surgical mesh and external heart defibrillators is deeply flawed, is injuring patients and causing numerous injuries, reports the New York Times.

An industry group took a pre-emptive strike even before the IOM release calling the report biased and saying it would slow innovation.

“Christine Stencel, a spokeswoman for the Institute of Medicine, which is part of the National Academy of Sciences, said the group was unaware of a previous instance in which one of its reports, sight unseen, was the target of a similar effort to invalidate it.

“Dr. Sheldon Greenfield of the University of California, Irvine, who has served on several Institute of Medicine panels, said he was surprised by the campaign’s intensity. “It is pretty audacious,” he said.”

A University of Minnesota professor of law, Ralph F. Hall, who also is a medical device industry lawyer, said the criticism is aimed at how the review has been conducted and not a way to front-run the report.  Minnesota has been a hub of much of the criticism about tightening medical device approval of late.

See the rest of the story here.


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We hope you find this a helpful resource. National News Editor, Jane Akre, began MDND with the hope of providing the latest news, information and perspective from the regulatory, industry and patient point of view, something that goes under-reported in much of the coverage of medical devices. The public is just now becoming aware that many devices do not undergo the same scrutiny as prescription drugs and are instead grandfathered in under an FDA loophole that has gone largely unchanged since the 1970s. As a result, patients become the post-market clinical trial subjects, and many suffer devastating and permanent injuries.