Feds call on companies to fix faulty defibrillators

WASHINGTON - Federal health officials are calling on manufacturers of heart-zapping defibrillators to fix long-standing problems with the emergency devices that have triggered dozens of recalls and occasionally have led to injuries and death.

The Food and Drug Administration said yesterday that the devices have been plagued by design and manufacturing flaws for years, occasionally failing to work in life-and-death situations.

In 2009, the FDA issued 17 recalls on the devices, up from nine in 2005. And more than 28,000 problems have been reported to the agency in the past five years.

Defibrillators use electric shocks to jolt the heart back to normal after patients collapse from cardiac arrest. Once considered high-tech devices for use in emergency rooms, they are now found in airports, office buildings, gyms and schools.

But the FDA says the companies that make the devices - including Philips Healthcare, Cardiac Science Corp. and others - have failed to fix problems that have led to the recall of hundreds of thousands of devices.

"The pattern of widespread safety problems we have seen with external defibrillators is unusual and it calls for a multipronged, comprehensive approach," said FDA's medical device chief, Dr. Jeffrey Shuren. "Many of the problems we've identified are preventable, correctable and have the potential to impact patients' safety."

Problems cited by the FDA include:

Faulty circuitry that can cause devices to fail.

Confusing design that makes devices difficult to use.

Sloppy manufacturing standards that can lead to device defects.

Spokesmen for Philips Healthcare and Cardiac Science would not immediately provide comment. Other makers of the devices include Defibtech and Welch Allyn.

FDA officials say manufacturers typically fix problems on a case-by-case basis, rather than addressing larger quality problems with their devices.

In one case, the FDA said, a company tracked hundreds of reports of a common defect with its defibrillators, fixing each device individually. But the company never issued an announcement to alert all owners of the devices to the problem.

The FDA also said it had uncovered a circuitry problem that caused a defibrillator to shut down automatically, which may have resulted in the patient's death.

The agency sent letters Monday to all manufacturers of the products, requesting they meet with the government to discuss fixes and improvements to defibrillators.