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A new analysis is raising questions about how good a job the Food and Drug Administration is doing at protecting Americans from faulty medical devices....   >>>

A new analysis is raising questions about how good a job the Food and Drug Administration is doing at protecting Americans from faulty medical devices.



In a new analysis released Monday by the Archives of Internal Medicine, researchers examined 113 devices that the FDA recalled between 2005 and 2009 because they posed serious health risks. Most of the devices--71 percent--had been approved using a process designed to get products on the market as soon as possible by forgoing a requirement that they undergo testing in people, the researchers found. That's because they were deemed to be similar to another product already on the market. Only 19 percent underwent more stringent review.



"Our findings reveal critical flaws in the current FDA device review system and its implementation that will require either congressional action or major changes in regulatory policy," wrote the researchers, Diana M. Zuckerman of the National Research Center for Women & Families in Washington and Steven E. Nissen of the Cleveland Clinic in Cleveland.



One-third of the recalled devices were for heart disease, including automatic external defibrillators or AEDs. Those are the gadgets that have been increasingly showing up in airports, office buildings and other public places to shock the hearts of people who suffer sudden cardiac arrest. Defective AEDs reportedly have resulted in hundreds of patient deaths, the researchers said.



The findings indicate the agency is allowing too many medical devices onto the market using the less stringent approval process, the researchers said.



**The excerpt above is taken from the Washington Post's article, "FDA oversight of medical devices questioned," written by Rob Stein which is linked below. Do click through to read more about this troubling phenomenon.**