Recalled (Medical) Devices Mostly Untested, New Study Says (FDA Says Study Is Flawed Or Not New)

[HuckleB]

http://www.nytimes.com/2011/02/15/business/15device.html?partner=rss&emc=rss

"Most medical devices recalled in recent years by the Food and Drug Administration because they posed a high risk to patients were not rigorously studied before being cleared for sale, according to a study in a medical journal released Monday.

The study, which was posted on the Web site of The Archives of Internal Medicine, found that most medical devices that were the subject of high-risk recalls from 2005 to 2009 had been cleared through a regulatory pathway that requires little, if any, testing. The devices included external heart defibrillators, hospital infusion pumps and mechanical ventilators.

...

The study was written by Diana M. Zuckerman and Paul Brown, two officials from the consumer group the National Research Center for Women and Families, and Dr. Steven E. Nissen, a cardiologist at the Cleveland Clinic, who was among the first physicians to raise questions about the drug Vioxx.

In a telephone interview, Dr. Nissen said that he was concerned that the administration had failed to take a more aggressive posture toward tightening the regulation of medical devices. In recent years, thousands of patients have been injured and some have died because of failed medical devices that were cleared for sale with little testing.

..."

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While the study may be flawed (or it may not be flawed), and/or the data may not be new, the FDA's "cover all bases" (even if they're seemingly contradictory) response is a bit odd, IMO.

[xchrom]

1. recommend -- my guess would be that this study and action

is going to garner some interesting information as people chime in on this.

interesting to watch as time goes on.

[HuckleB]

2. Indeed. I do hope oversight improves, and dramatically. -eom-