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FDA Says Build a Better External Defibrillator And Starts a Program-Too Many Recalls

Posted Nov 16 2010 2:30am

The FDA has begun an extensive look at the design and use of the devices.  According to this article there have been too many mishaps and the FDA believes better designs with incorporating new technologies would improve the process by working with the manufacturers.  image In addition the FDA stated they would look at current products on the market as well.  BD 

The Food and Drug Administration wants to strengthen automated external defibrillators, or AEDs.  They are the lifesaving devices used to treat sudden cardiac arrest. The FDA plan, dubbed the "External Defibrillator Improvement Initiative", aims to improve the safety and effectiveness of AEDs currently available and to work with manufacturers to create newer models that are more effective.

"There have been more than 28,000 adverse event reports [associated with AEDs]," says Dr. Jeffrey Shuren, Director of the FDA's Center for Devices and Radiological Health. There also have been more than 700 deaths, although Shuren cautions that it's difficult to link cause of death to external defibrillators because the patients being treated with them are already extremely ill.

The plans also calls on the FDA to identify flaws in the models currently on the market. One shortcoming the FDA has already identified is that in one AED model, a button needs to be pushed in order to give a person an electric charge.

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