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FDA Launches Initiative to Develop Innovative External Defibrillators
Date:11/15/2010

SILVER SPRING, Md., Nov. 15, 2010 /PRNewswire-USNewswire/ -- The U.S. Food and Drug Administration today announced a program aimed at facilitating the development of safer, more effective external defibrillators used to treat abnormal heart rhythms through improved design and manufacturing practices.

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External defibrillators are medical devices designed to diagnose life-threatening abnormal heart rhythms and treat them by delivering electrical energy to the heart to restore its normal rhythm. When used in the first few minutes following a cardiac arrest, they can save lives.

External defibrillators are used successfully thousands of times each year to treat sudden cardiac arrest. Automated external defibrillators (AEDs) are found in public settings and increasingly in homes, airports and office buildings. More complex external defibrillators are used in hospitals by trained health care professionals.

Nearly 300,000 Americans collapse each year when the heart stops pumping blood to the body (sudden cardiac arrest). Those who experience the condition may die if normal rhythms are not restored quickly. Survival depends on a rapid sequence of rescue events that can include the successful delivery of a high-energy shock from an external defibrillator.

During the past five years, the FDA's Center for Devices and Radiological Health (CDRH) has received more than 28,000 medical device reports associated with the failures of external defibrillators and manufacturers conducted dozens of recalls involving hundreds of thousands of the devices.

Many of the types of problems that CDRH has identified are preventable, correctable, and can impact patient safety. These
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SOURCE U.S. Food and Drug Administration
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