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FDA Launches New AED Initiative

Posted by Wayne Roberts on 11/16/2010 to AED News
The U.S. Food and Drug Administration announced yesterday a new program dedicated to facilitating the development of safer and more effective AEDs via improved design and manufacturing practices. Goals of the new FDA initiative include:
  • Promoting the innovation of next generation AEDs in an effort to improve safety and AED effectiveness
  • Enhancing the ability to identify and resolve problems with AEDs currently on the market and to address safety issues more quickly and effectively
  • Designating an appropriate premarket regulatory pathway for AEDs that promotes best practices for both design and testing
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 AEDs. Manufacturers conducted dozens of recalls as a result, which affected hundreds of thousands of AEDs.

"These [AEDs] play an important role in health care," said CDRH Director Jeffrey Shuren, M.D. "The purpose of our initiative is to improve these technologies so we can save more lives."

The FDA's new AED initiative will kick-off with a public meeting on December 15th - 16th at the FDA headquarters in Maryland. The FDA is working in collaboration with the University of Colorado's Department of Emergency Medicine in order to best define the needed enhancements.

Be sure to regularly check out the AED Blog for further information and how the FDA's new AED initiative might affect you. To read the full story, click here. To read the official statement by the FDA, please click here.

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