Fix heart defibrillator problems, FDA tells manufacturers
Heart defibrillators are a vital emergency treatment in cases of sudden cardiac arrest occurring outside hospitals, but they also have harmful and occasionally deadly shortcomings that must be fixed, the Food and Drug Administration said Monday, unveiling a plan for safety upgrades on the widely used devices.
The agency called for improvements in design and manufacture, refinements in the regulatory approval process for new defibrillators and creation of a multi-city registry to track how the devices are used and, eventually, to connect them to local 911 emergency phone systems.
Nearly 300,000 people in the U.S. collapse each year when their hearts stop pumping. At least 500 are saved by swift administration of electrical shocks from defibrillators designed for use by lay people, according to Myron Weisfeldt, a cardiologist at Johns Hopkins University and past president of the American Heart Assn.
Weisfeldt, who spoke during an FDA telephone news conference, said about 200,000 automated external defibrillators were sold annually, and about 1 million were thought to be in use.
Similar but more sophisticated defibrillators are used in hospitals.
The devices have “a pattern of widespread safety problems,” said Jeffrey Shuren, director of the FDA’s Center for Devices and Radiologic Health. Over the last five years, Shuren said, the agency has received more than 28,000 reports associated with failures of the devices, and manufacturers have conducted dozens of recalls involving hundreds of thousands of units.
The reports of device failures and the number of recalls have been trending upward, and some defibrillator malfunctions have been linked to patient harm, including deaths.
But from a public health perspective, Shuren said, the benefits of having defibrillators available in offices, public buildings and other spaces outside of medical centers far outweigh their shortcomings.
“These are lifesaving devices and should continue to be widely used,” he said.
Key manufacturers include Philips Healthcare, Defibtech, HeartSine Technologies and Cardiac Science Corp.
Among the problems identified by the FDA are inadequate testing, confusing design and use of parts that don’t meet manufacturers’ specifications. Other shortcomings involve engineering flaws, such as allowing a voltage-monitoring circuit to draw power from the same source it’s supposed to be monitoring, which can render the device unable to deliver a shock.
The FDA said some manufacturers had fixed defects in individual defibrillators without notifying all users of those models so that all units could be examined for similar problems.
