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Greg Webb
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FDA 510(k) Approval Process for Medical Devices Flawed?

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The WallStreet Journal of February 15, 2011, reports in an article by Alicia Mundy and Jon Kamp, that a recent study initiated by a Washington health-research group and the Cleveland Clinic’s Steven Nissen, published in the Archives of Internal Medicine, indicates that most medical devices which have been recalled, from 2005-2009, due to serious and/or life-threatening hazards were at least initially approved for placement on the market by FDA’s abridged approval system, dubbed “510(k)”, which did not require testing for use in patients.

Why is this important? It’s not nice to learn from an article in The Washington Post (July 28, 2005) that your defibrillator or pacemaker was one of those, which—if the special glue that held its case together melts at body temperature—the pacemaker quits! Charlotte Frederick of Broadway, Virginia, read it in the newspaper. She then received a letter from Guidant of July 18, 2005, which identified her Guidant pacemaker model number as one of the faulty pacemakers. She called her heart specialist the next hour, “What do I do now?” Her cardiac specialist replied that he would install a new pacemaker the following week for free, and all she needed to do was be present.

The manner of notification gave her pause, “Do I want another pacemaker from Guidant?” she asked. The answer was moot. Guidant was swiftly purchased by another medical device company (Boston Scientific), and Mrs. Frederick opted to wait until her pacemaker’s battery was 80% used before getting a new pacemaker two years later. She maintained that she was still surprised that an uncertain technology was allowed to be inserted in her body and she wanted to know what the failure rate was. How was she to know whether the next pacemaker would be any good? At her advanced age, she still didn’t want to be a guinea pig. She said, “It’s kind of like living with a time bomb in your body, but I guess this is what we do now.” (Source: Mrs. Frederick’s daughter, phone interview 2/23/11).

Eighty of the 113 different medical technology devices recalled during the study period of from 2005-2009 were cleared through the 510(k) abbreviated approval process by the FDA. Cardiac devices were the largest group—at 35 percent—and two-thirds of those were cleared by the abbreviated approval process.

The FDA proposed changes which would tighten its approval process of medical devices, but under pressure from the device industry and its lobby AdvaMed, they seem to have backed away from the challenge. AdvaMed represented by Stephen Ubl, have taken the position that “making radical changes to the [510(k)] program in light of "remarkably low recall rates" would "harm patient access to medical technology."

Over 3,000 medical devices are cleared for patient use by the FDA’s 510(k) process annually, including the recently recalled DePuy ASR metal on metal prosthtic hips. We hope all of these devices are are not as critical as Mrs. Frederick’s pacemaker…