Heart devices have glitches

FDA discusses better oversight of safety of defibrillators

September 17, 2005|By Jonathan D. Rockoff | Jonathan D. Rockoff,SUN NATIONAL STAFF

WASHINGTON - A federal study released yesterday has found that certain heart devices are malfunctioning at significant, and increasing, rates. The authors of the study said that better government monitoring of the performance of the implanted defibrillators is needed.

The report was presented at a meeting of heart specialists by the Food and Drug Administration, which said it is already taking steps to improve oversight of device safety and considering several additional ones.

The FDA said the increasing rate of malfunctions, while significant, shouldn't cause alarm, considering the numbers of patients benefiting.

"We are concerned obviously," said Julie Zawisza, an agency spokeswoman. "But there's a lot of good and a lot of value these devices bring to people's lives."

The FDA and manufacturers have endured months of criticism over the safety of drugs and medical devices. The Guidant Corp., in particular, has been assailed for delays in informing doctors about an electrical problem with some of its defibrillators. The Indianapolis-based company has recalled thousands of the devices.

Defibrillators emit an electrical jolt to return the heart to a safe rhythm. In 2002, more than 267,000 were implanted.

The study was based on a review of malfunction reports filed by manufacturers from 1990 to 2002. In that time, there were 31 deaths, but most of the nearly 8,500 malfunctions didn't lead to death or serious injury.

The study found that defibrillator malfunctions increased at a rate more than four times higher than the rate for pacemakers. The rates began increasing in the latter half of the 1990s. More than half of the malfunctions took place during the last three years studied.

In addition, the study looked at pacemaker malfunction rates, which it found were decreasing.

The cause of the defibrillator malfunctions is unclear, possibly the result of doctors reporting more often or the effect of increasing miniaturization, said Zawisza.

Experts attending the meeting of the Heart Rhythm Society, where the study results were presented, discussed possible preventive measures and improvements in the FDA's system of warning doctors of problems, Zawisza said.

The FDA is considering ways of bolstering its notification system, while making sure not to issue a warning prematurely or create a panic, Zawisza said. It is also considering how to make sure that companies file clear reports about devices and problems. And it is discussing asking companies to provide more safety data before a device is approved, and after approval.

The FDA is developing a system for staff to quickly review and assess malfunction reports and is running a pilot program for hospitals to report device failures and other adverse events.

Some congressmen and outside reviewers have proposed that the FDA be given more authority to study devices after they hit the market.

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