New Study Seriously Questions Ability of FDA to Ensure U.S. Medical Device Safety

A new study by researchers at the National Research Center for Women & Families in Washington, DC and the prestigious Department of Cardiovascular Medicine at the Cleveland Clinic in Cleveland, Ohio has found that most recalled medical devices were not approved by the Food & Drug Administration as the result of rigorous pre-market testing and review but, instead, were “cleared” for marketing by FDA through a much more lenient regulatory scheme know as the “510k” process.

Writing in the February 14, 2011 issue of the Archives of Internal Medicine, cardiologist Steven E. Nissen, M.D. and his colleagues determined that from 2005 through 2009, 21 of 133 (71%) devices that were the subject of “high-risk recalls that could cause serious health problems or death.”

Many people assume that medical devices, like prescription drugs, are “approved” by FDA following a showing by device manufacturers that their products are “safe and effective.” In fact, the vast majority of devices on the market were not required to undergo pre-marketing approval. Rather, manufacturers have benefited in an enormous loophole contained in a 1976 federal law ostensibly designed to augment FDA’s authority to regulate medical devices. The loophole allows manufacturers to market their devices after a showing that they are “substantially equivalent” to similar devices already on the market.

About 31 percent of the recalled products reviewed in the study were heart devices, including automated external defibrillators used in public places such as airports to revive cardiac arrest victims. The FDA has reported hundreds of cases where AEDs failed and might have contributed to deaths and is looking for ways to avoid future problems with AEDs.

“These findings demonstrate systematic problems in the implementation of existing medical device regulations that have exposed patients to serious harm,” the researchers wrote. Their conclusions echo those reached by the Government Accountability Office (GAO) in a 2009 report on the 510(k) process.

These studies point to the need for regulatory reform, as well as the importance of a robust civil justice system in which consumers injured by defective and recalled devices can be justly compensated.