A recent New York Times article reported that a new study indicated that in recent years the Food and Drug Administration (FDA) has not rigorously studied or tested many of its approved medical devices before clearing them for sale. The study specifically assessed many medical devices which have been the subject of major recalls over the past few years, such as mechanical ventilators, hospital infusion pumps, and external heart defibrillators.
Diana Zuckerman and Paul Brown, both with The National Research Center for Women and Families, headed up the study along with cardiologist Steven Nissen, M.D. of the Cleveland Clinic. The study, published in The Archives of Internal Medicine, focused on those medical devices that have since been labeled as high risk for recalls between 2005 and 2009. It found that most, if not all, of the medical devices were cleared for public use by the FDA without being first being tested. The FDA and a trade group representing medical device manufacturers called The Archives of Internal Medicine study flawed.
Dr. Nissen has long been interested in the reasons behind the widespread drug and medical device recalls in the past decade; he was among the first physicians to raise concerns about the drug Vioxx, which was associated with heart attacks. Dr. Nissen had said that he was concerned that the government had not been more aggressive in tightening the regulation of medical devices. Over the past several years, thousands of individuals have been injured or died as a result of failed medical devices that had been cleared for sale by the FDA.
The study outlined the two different pathways the FDA typically uses when reviewing medical devices. One is most often applied to devices that sustain life, such as heart defibrillators, require the medical device manufacturers to run a clinical trial which demonstrates that the products are safe and effective.
However, the FDA has also used a process called 510(k), which only requires a medical device manufacturer to demonstrate that the new product is equivalent to a device that is already being used in the marketplace. Therefore, if a manufacturer is attempting to get its artificial hip device approved for public use, then all it has to do is demonstrate how its artificial hip is similar or equivalent to a product that has already received FDA approval.
The Archives of Internal Medicine study specifically focused on these 510(k)-approved devices, including artificial knee, artificial hips, external defibrillators, and infusion pumps. The study showed that between 2005 and 2009, over 70% of the medical devices recalled were cleared through the 510(k) process. Likewise, the majority of the medical devices the FDA approved in those years were approved through the 510(k) process. Given the nature of these results, it is expected that more investigation into this review process will be done.
Kreisman Law Offices has been handling Chicago medical device liability lawsuits and Cook County wrongful death cases for more than 35 years, in areas in and around Cook County, including Downers Grove, Richton Park, Forest Park, and Hillside.
Barry Meier. “Recalled Devices Mostly Untested, New Study Says.” The New York Times. February 14, 2011.
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