FDA: companies must fix issues with heart devices

Using an automatic external defibrillator (AED) during emergency cardiac care
By Rob Stein
Washington Post Staff Writer
Monday, November 22, 2010; 4:11 PM

Defibrillators, those devices that are supposed to shock heart failure patients back to life, are malfunctioning far too often, costing people their lives, according to a report released last week by the Food and Drug Administration.

In the past five years, the FDA's Center for Devices and Radiological Health has received more than 28,000 reports of defibrillators failing, and companies that make the devices have issued 68 recalls involving hundreds of faulty devices, the FDA said. And the problems appear to have been increasing rapidly over that period of time, the agency said.

Some of the specific examples are disturbing. In one case, a company designed a circuit that monitored the voltage in the device to draw power from the same source it was supposed to monitor. That caused a momentary drop in voltage, triggering a faulty signal to shut down the device, preventing it from delivering a shock. That may have caused a patient's death, the FDA said.

Because of the problems, the FDA announced a program aimed at helping companies develop safer, more effective defibrillators.

Nearly 300,000 Americans collapse each year when their hearts stop pumping blood. External defibrillators are designed to save their lives by diagnosing abnormal heart rhythm and restarting the heart by delivering a shock to the organ. The devices can be life-saving when used within the first few minutes after a cardiac arrest. They used to be found only in emergency rooms. But now simpler versions that anyone can use, known as automated external defibrillators (AEDs), are becoming more ubiquitous in public settings, such as homes, airports and office buildings.

Though the FDA continues to "strongly encourage" the use of AEDs, it has become increasingly concerned about rapidly rising reports of problems with the devices. After studying the problem, the agency concluded that many of the failures could be prevented by improving the design and manufacturing practices of the companies that make the devices. For example, in one case a firm knew about a defect in its device and fixed the problem on a case-by-case basis but never systematically notified other users of the problem so their devices could be checked and fixed if necessary before any problems occurred. In several other cases, companies bought components for the devices from suppliers that did not meet the required specifications.

"These devices play an important role in health care," said the Centers for Disease Control and Prevention's Jeffrey Shuren in a news release announcing the new initiative. "The purpose of our initiative is to improve these technologies so we can save more lives."

The program will start with a public meeting Dec. 15 and 16 at the FDA's headquarters in Silver Spring to bring together representatives from companies and others to discuss ways to improve the devices. The agency also is working with the University of Colorado's Department of Emergency Medicine to develop improvements that will make it easier to use the devices more effectively.

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