Medtronic may tell more about heart device flaws...

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Medtronic may tell more about heart device flaws...

Post by ~guin » September 17th, 2005, 5:28 pm

Hi All;

My hubby found this for me in the New Yord Times... Thought I would share - seems Medtronic is trying....

Medtronic may tell more about heart device flaws

By Barry Meier

New York Times

WASHINGTON - A representative of the nation's biggest maker of heart devices, Medtronic, said Friday that it was considering making available to doctors and patients some of the data about product malfunctions that it regularly provides to federal regulators.

Robert Clark, a spokesman for the Minneapolis company, said in response to a question that Medtronic was examining whether to publicly release some of the device data that it reports annually to the Food and Drug Administration in regular filings.

In those reports, manufacturers of devices like defibrillators and pacemakers provide the FDA with far more details about how and why those devices are malfunctioning than they currently give to doctors.

Clark declined to elaborate further or to say if or when Medtronic would make a decision. But any action by Medtronic, because of its dominant position in the market, is likely to influence what others do.

His comments came as heart specialists, industry officials, regulators and others gathered at a meeting in Washington to discuss better ways to disclose data to doctors and patients about heart-device failures and the potential risks. The meeting followed a widely publicized episode about decisions by Guidant not to disclose electrical flaws in some of its products.

The meeting did not result in the adoption of any immediate changes, but many physicians, corporate officials and regulators involved in it said they expected that policy changes would be made.

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Post by Shelby » September 17th, 2005, 5:59 pm

Thanks for posting this Guin. Looks like Medtronic is taking a step in the right direction and putting device information where it belongs--in doctor's and patient's hands. I hope they do decide to do this and that Guidant follows suit.

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