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Feds Crack Down On 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 Monday 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 last 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, defibrillators 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 Monday. 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.

On Monday the agency sent letters to all manufacturers of the products, requesting they meet with the government to discuss fixes and improvements to defibrillators. The agency plans a public meeting on the issue next month among government, industry and academic scientists.

The FDA is also reviewing how it approves new defibrillators. Currently, the devices are cleared through an accelerated pathway that does not require new studies if a device appears similar to those already on the market.

External defibrillators generally include two plastic pads that attach to the patient's chest and detect whether the heart is suffering an abnormal heart rhythm. If the problem can be corrected _ which is the case about one-fourth of the time _ the pads deliver an electric shock that resets the heart's pumping action.

Nearly 300,000 people in the U.S. collapse each year from cardiac arrest, according to the FDA.

Dr. John Weisfeldt of Johns Hopkins Hospital in Baltimore estimates 500 lives are saved each year in the U.S. as a result of bystanders using external defibrillators. About 1 million of the devices have been sold in the past five years.

"Research has shown that defibrillators have saved lives of countless numbers of cardiac arrest victims, and we feel strongly that defibrillation is the only effective treatment for stopping the most common abnormal heart rhythm that causes sudden cardiac arrest," said Dr. Ralph Sacco of the University of Miami and president of the American Heart Association. The group learned of the FDA's concerns over the weekend during its annual conference in Chicago.

Dr. Douglas Zipes, who helped invent the implantable defibrillator, said he is such a believer in the value of the devices that he had an external defibrillator installed in his Indianapolis subdivision several years ago.

"It's like an oversized mailbox that sits on my lawn," said Zipes, a past president of the American College of Cardiology.


AP Medical Writer Marilynn Marchione contributed to this story from Chicago.


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