New Study Shows that Most Medical Devices Recalled for Life-Threatening Problems Were Not Tested on Patients

MONDAY, FEBRUARY 14, 2011

Media Advisory:  To contact Diana M. Zuckerman, Ph.D, call Brandel France de Bravo at 202-223-4000 or e-mail bfb@center4research.org

A new study released today 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 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,” write the study’s authors, all of whom have testified before the FDA regarding the safety and effectiveness of medical products.

Cardiovascular devices represented the largest category (31%) of recalled medical products and included commonly used devices such as automatic external defibrillators (AEDs), currently widely employed in public places to allow resuscitation of victims of cardiac arrest. Failure of AEDs has resulted in reports of hundreds of patient deaths.

The study authors express concern that too many medical devices intended for life-preserving indications are cleared by the FDA using the 510(k) provision. “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,” points out Dr. Zuckerman.  “Our study shows that as a result, many devices fail and more than 112 million products were recalled in just 5 years,” she adds.

“The excessive use of the abbreviated approval process has allowed too many devices intended for life-preserving indications to reach the market without adequate clinical testing,” Dr. Nissen comments.

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.

About the Authors

The National Research Center for Women & Families 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.

Editor’s Note: This study was funded by individual donations to the National Research Center for Women & Families, which does not accept contributions from medical device companies. Please see the article for additional information, including other authors, author contributions and affiliations, financial disclosures, funding and support, etc.

To read the abstract of this article, click here. To read the full text of this article in The Archives of Internal Medicine, click here.