WASHINGTON — Defibrillators, devices designed to shock heart-failure patients back to life, are malfunctioning far too often, costing people their lives, according to a report released Monday 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 the thousands of faulty devices. And the problems appear to have been increasing rapidly over that period of time.
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 the 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 lifesaving 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, are becoming more ubiquitous in public settings, such as homes, airports and office buildings.
But the FDA 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.
The FDA is working with the University of Colorado’s Department of Emergency Medicine to develop improvements making it easier to use the devices more effectively. They plan to conduct a pilot program to test connecting the devices with local emergency medical services so that when the device is used an emergency rescue team is quickly dispatched to the scene.
