Medical Device Reviews Questioned

Companies that make pacemakers, stents, and other medical devices probably are going to be held to tougher standards in the future as they try to get their products approved by the government.

Food and Drug Administration officials are vowing to change the approval process after two studies were critical of the way the agency reviews heart products. That means more scrutiny for Medtronic Inc., Boston Scientific Corp., Johnson & Johnson and other device makers.

A study by California researchers published in the Journal of the American Medical Association found that heart devices get clearance from the government often based on studies that lack strong scientific evidence.

The researchers note that almost 80 heart products they characterized as "high risk" like stents were approved earlier this decade based on data from a single study (medical devices aren't required to undergo the same rigorous process imposed on drugs). Another study appearing in the American Journal of Therapeutics was sponsored by the FDA and was less critical but still pointed out flaws in the approval process.

The California researchers examined heart devices reviewed by the government between January 2000 and December 2007 and concluded that these products don't get a rigorous review. That's a problem given the increasing usage of these heart devices, they say. In 2008, there were 1.2 million heart stents, 350,000 pacemakers, and 140,000 implantable defibrillators implanted, the researchers say.

"Although there has been recent scrutiny of evidence used in the (FDA's) drug-approval process, less attention has been paid to the approval process for medical devices," the University of California, San Francisco, researchers write.