Study: Harmful medical devices get OK to easily

CHICAGO – Most medical devices recalled in recent years because of deaths or life-threatening problems were cleared for approval under less stringent regulations that don’t require human testing, an analysis found.

The report comes as the Food and Drug Administration is reviewing sweeping proposals to revise the medical device approval process. The studied devices fell under rules for products similar to ones on the market, not regulations for brand new ones, which call for more extensive testing.

Thousands of deaths or serious medical problems occurred in patients with the recalled devices, which included external heart defibrillators, brain shunts and implanted pumps that deliver cancer drugs, the researchers said.

Device makers say the new data are flawed and conflict with previous reports.

For their analysis, the researchers looked at the FDA’s list of high-risk devices that were recalled from 2005 through 2009.

Of the 113 highest-risk recalled devices, 71 percent, or 80 devices, had been approved through the less stringent regulation. Only 19 percent, or 21 devices, were approved under a stricter process for brand new products that involves inspections and human testing. Eight were registered with the FDA but exempt from regulation.

“Because so many medical devices are not being held to a higher safety standard, people are dying who wouldn’t otherwise die and who don’t have to die, and people are being harmed who don’t have to be harmed,” said study co-author Diana Zuckerman, president of the National Research Center for Women & Families, a Washington-based health advocacy group.

FDA spokeswoman Karen Riley said the study’s findings aren’t new and noted that the recalls it highlighted represent a small portion of the more than 19,000 devices cleared through the less strict standard during those years.

The report appears in Monday’s Archives of Internal Medicine. An editorial says millions may be at risk from high-risk devices “that were cleared by FDA without any supporting clinical trial data.”