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.