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New Study Questions FDA Medical Device Review Process

February 2011

According to a new study in the Archives of Internal Medicine, most medical devices recalled for life-threatening or very serious hazards were originally cleared for market using the U.S. Food and Drug Administration’s (FDA) less stringent 510(k) process or were considered so low risk that they were exempt from review. In the 501(k) process, a manufacturer only needs to show a new product is comparable to one already on the market.

The study, posted on the journal’s website, found 113 recalls from 2005 through 2009 of devices the FDA felt could cause serious health problems or death – which totals 78 percent of the FDA’s recalls during that time. The devices included external heart defibrillators, hospital infusion pumps and mechanical ventilators. Cardiovascular devices comprised the largest recall category, with 35 of the high-risk recalls (31%). Two-thirds were cleared by the 510(k) process (66%).

According to the study, most of the recalled cardiovascular devices were automated external defibrillators (AEDs). Researchers have reported that more than 20 percent of the almost 1 million AEDs in circulation were recalled by the FDA, and hundreds of people died due to AED malfunctions, according to the study.

Steven E. Nissen, M.D., M.A.C.C., one of the study authors, told the New York Times he was concerned that the administration had failed to take a more aggressive posture toward tightening the regulation of medical devices. In recent years, thousands of patients have been injured and some patients have died because of failed medical devices that were cleared for sale with little testing. He said the FDA has failed the public in this area.

One reason that the FDA has relied heavily on the 510(k) process is because it is less expensive and enables the relatively small Center for Devices and Radiological Health (CDRH) to review thousands of devices each year, according to the study.

In the same New York Times article, the FDA called the study’s findings unoriginal and a trade group representing medical device makers called the research flawed. In a statement, the FDA said that the data was not new and reflected a similar analysis that had been presented last year at a public meeting held at the Institute of Medicine.

View the full text of the study.