FDA Tells Makers of Heart Defibrillators to Get Moving on Safety Upgrades

The Food and Drug Administration has called on manufacturers to improve the design and reliability of external heart defibrillators, devices that can save the lives of heart attack victims but have had widespread safety problems leading to dozens of recalls.

The devices are designed to deliver an electrical shock to people who collapse when their hearts stop pumping. During the past five years, however, the FDA’s Center for Devices and Radiological Health has received more than 28,000 reports of failures of external defibrillators, and manufacturers have conducted 68 recalls involving hundreds of thousands of the devices.

Calling many of the problems ”preventable and correctable,” and noting the impact they have on patient safety, the agency called for upgrades in design and manufacture, and creation of a registry to track how the devices are used and eventually connect them to local 911 emergency phone systems.

The FDA published a White Paper on the issue and sent a letter to manufacturers warning about potential future regulatory action and recommending that manufacturers meet with the agency early in the development process for any new devices.

The first step in the initiative will be a workshop to be held December 15-16 in Silver Spring, Md., on the risks and benefits of external defibrillators, clarifying steps the agency expects the industry to take.

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