FDA Claims 72,000 Cases of Public Defibrillator Failure

5efbd64f09bc51512b3921a93efae7f01efe4c71_defibrillatorPublic defibrillators save lives, if they work. When your heart stops it doesn’t care where you are. It happens whether you’re 5 miles or 50 miles from the nearest hospital. Cardiac arrest is life threatening. The more time that passes between when the heart stops and when it re-starts, the more likely there will be damage to the heart.
Automated external defibrillators are installed in many public spaces to treat patients suffering from cardiac arrest as soon as it happens. These portable devices automatically detect potentially deadly heart rhythm problems and deliver an electrical shot to restore normal rhythm. The goal of these devices is immediate treatment and increased survival rates.
The U.S. Food and Drug Administration recently released an alarming press release claiming that since 2005, they have received 72,000 reports of defibrillator failure.
In order to remedy the growing problem, the FDA will develop a stricter approval process for defibrillators and their accessories including batteries, pad electrodes, adapters, and more.
These new changes, “will allow us to more closely monitor how [defibrillators] are designed and manufactured, said Dr. William Maisel, deputy director for science, acting director of the Office of Device Evaluation in the FDA’s Center for Devices and Radiological Health. “This will go a long way towards correcting long-standing problems and ultimately improving the reliability of these devices.”
In addition to strengthening their approval process, the FDA will carry out inspections of manufacturers’ facilities and require an annual report on each devices performance. Manufacturers will be required to inform the agency about any changes made to the defibrillators that affect safety and effectiveness. New requirements take effect January 2020.
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References:
U.S. Food & Drug Administration, news release, January 28, 2015
National Heart, Lung, and Blood Institute: “When Should an Automated External Defibrillator Be Used?”

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