Our new study finds that most medical devices recalled during the last five years for “serious health problems or death” were originally cleared (approved) by the Food and Drug Administration (FDA) using a less stringent process that does not require testing in patients. The study, released on-line on February 14 prior to publication in the Archives of Internal Medicine, was co-authored by Dr. Diana Zuckerman and Paul Brown of the National Research Center for Women & Families and Dr. Steven Nissen, Chairman of the Department of Cardiovascular Medicine at the Cleveland Clinic.
The study analyzed all recalls of medical devices that the FDA deemed had defects that were potentially life threatening or could cause serious permanent harm from 2005 to 2009. Only 19% of the 113 recalls were initially approved using the FDA’s rigorous pre-market approval (PMA) process. The majority, 71%, of recalled devices were cleared using the FDA’s 510(k) provision that only requires the medical device be similar to an already marketed product. Clinical trials are not required, and the manufacturing facilities are not inspected to assure sterility or quality manufacturing practices. Another 7% of recalled devices were deemed so low risk that they were considered exempt from any FDA regulation. The few remaining devices were counterfeit or for other reasons had not undergone any FDA 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. The FDA is now using the 510(k) process for 98% of the medical devices that they review, including heart valves, glucose meters, and artificial hips and knees. We think patients will be shocked to learn how often new medical products, using different materials, made by a different manufacturer, are not scientifically tested in humans to see how well they work. Our study shows that as a result, many devices fail and more than 112 million products were recalled in the five years we studied.
The article was accompanied by an editorial by Dr. Rita Redberg, editor-in-chief of the Archives of Internal Medicine, a JAMA publication, agreeing that the findings indicate the urgent need to strengthen patient safeguards regarding medical devices. The online release of both the article and editorial predates the journal publication by several months. To read the article in its entirety, click here. To read the accompanying editorial, click here.
About the Authors
The National Research Center for Health Research is an independent nonprofit organization dedicated to improving the health and safety of adults and children. Its president, Dr. Diana Zuckerman, is the author of five books and dozens of research articles on health issues, and she and Public Policy Manager, Paul Brown are nationally recognized experts on patient and consumer safety issues. Dr. Steven Nissen has published hundreds of articles in medical journals, has testified before Congress and the FDA about the safety of medical products. and is Chairman of the Department of Cardiovascular Medicine at the Cleveland Clinic, a not-for-profit multispecialty academic medical center that U.S. News & World Report consistently names as one of the nation’s best hospitals in its annual “America’s Best Hospitals” survey.