Tags: FDA | Companies | Fix | Issues | Heart | Devices

FDA: Companies Must Fix Issues With Heart Devices

Monday, 15 Nov 2010 01:54 PM

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 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 and others -- have failed to fix problems that have led to the recall of hundreds of thousands of devices.

"Many of the types of problems we have identified are preventable, correctable, and impact patient safety," the FDA said in a statement Monday.

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, 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 also plans a public meeting on the issue next month among government, industry and academic scientists.

Previous announcements from the agency have focused on the safety of implantable defibrillators, which are surgically installed beneath the skin, similar to pacemakers.

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. Douglas Zipes, who helped invent the implantable defibrillator, said he is such a believer in the value of the devices that he had one 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.

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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 led to injuries and death. The Food and Drug Administration said Monday that the devices...
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2010-54-15
Monday, 15 Nov 2010 01:54 PM
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