Recalled Devices Mostly Untested, New Study Says

Barry Meier

New York Times | February 14, 2011

Most medical devices recalled in recent years by the Food and Drug Administration because they posed a high risk to patients were not rigorously studied before being cleared for sale, according to a study in a medical journal released Monday.

The study, which was posted on the Web site of The Archives of Internal Medicine, found that most medical devices that were the subject of high-risk recalls from 2005 to 2009 had been cleared through a regulatory pathway that requires little, if any, testing. The devices included external heart defibrillators, hospital infusion pumps and mechanical ventilators.

The F.D.A. described the study’s findings as unoriginal, and a trade group representing medical device makers called the research flawed. Still, the report is coming out at a time when the Obama administration appears to be stepping back from what initially appeared to be a more aggressive approach to the regulation of medical devices.

The study was written by Diana M. Zuckerman and Paul Brown, two officials from the consumer group the National Research Center for Women and Families, and Dr. Steven E. Nissen, a cardiologist at the Cleveland Clinic, who was among the first physicians to raise questions about the drug Vioxx.

In a telephone interview, Dr. Nissen said that 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 have died because of failed medical devices that were cleared for sale with little testing.

“This is an area where the F.D.A. has failed the public,” Dr. Nissen said.

In a statement, the F.D.A. 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. Ms. Zuckerman said she was the one who presented data at that meeting.

Recently, the agency announced a series of steps that it said would “strengthen” device regulation, though it deferred decisions on some other major proposals pending recommendations later this year from the Institute of Medicine.

The F.D.A. uses two pathways to review medical devices. In one pathway, typically used for critical, life-sustaining products like implanted heart defibrillators, manufacturers must often run clinical trials to show that a product is safe and effective.

But there is a less rigorous route, known as the 510K process, through which a manufacturer need only show that a new product is equivalent to one already on the market. Some devices implanted in the body like artificial hips and knees fall into this category, as do dozens of other products, including external defibrillators and infusion pumps.

The study focused on these 510K devices. It reported that of the 113 high-priority recalls initiated by the F.D.A. from 2005 to 2009, 80 of the recalls, or 71 percent, involved devices cleared through the 510K process.

In a statement, an industry trade group, the Advanced Medical Technology Association, described the findings as misleading. Among other things, the group said that it was not surprising that 510K devices accounted for the most recalls since most devices that F.D.A. allowed for sale went through that process.