Study rips recalled medical device reviews

Most medical devices recalled for posing life-threatening risks to patients were initially approved by federal regulators through an expedited process or were exempt from review, according to an analysis released Monday.

Further, an array of medical devices have had to be recalled in recent years because people's lives were either endangered, or they died when the products failed, the study found.

Reporting in The Archives of Internal Medicine's online edition, researchers with the National Research Center for Women and Families found that automatic external defibrillators designed to send an electric shock to the heart of someone in cardiac arrest haven't responded when urgently needed. More than a dozen models were recalled last year.

Other notable failures include flawed glucose test strips that led to erroneous blood-sugar readings and warmers developed for tiny hospitalized newborns that in one case caught fire, injuring a baby.

But a Long Island foundation instrumental in promoting the use of defibrillators in schools and other public venues criticized the research, as did the U.S. Food and Drug Administration and AdvaMed, a trade group that represents medical-device manufacturers.

The analysis was authored by the research center and Dr. Steven Nissen, the Cleveland Clinic physician who first highlighted dangers associated with the painkiller Vioxx, which was pulled from the market by its maker in 2004 and was the subject of numerous lawsuits.

The study examined device recalls between 2005 and 2009. "Most medical devices are not tested on humans," said Diana Zuckerman, who heads the research center.

The FDA's standards for approval of medical devices is relaxed compared with the rigorous testing required of new prescription drugs. Devices can be automatically approved when a similar product is already on the market, Zuckerman said. That standard is intended for devices that are supposed to pose low to moderate risk, but she said the defective infant warmer also went that route.

Zuckerman's research took particular aim at defibrillators because of unanswered questions, including whether a person who isn't trained can use them and how long after purchase the devices will function properly.

A major FDA recall last year targeted 14 models after the devices were found to be unable to deliver a lifesaving shock.

In a statement Monday, the FDA downplayed the research, saying it was nearly identical to findings released last year by the Institute of Medicine.

Karen Acompora, co-founder of the Louis J. Acompora Foundation in Northport, said it's shortsighted to take aim at defibrillators. "I do believe they're safe, and there is solid science behind them," said Acompora, who lobbied more than a decade ago to have the devices placed in schools in the wake of her 14-year-old son's death during a lacrosse match."All technology has glitches, but these devices are saving lives, and we have 52 documented cases in New York public schools," she said. "So they are doing their jobs."