Tuesday, February 21, 2006

Response to Food and Drug Administration clearance of automated external defibrillator for home use

Response to Food and Drug Administration clearance of automated external defibrillator for home use: "Response to Food and Drug Administration clearance of automated external defibrillator for home use

November 13, 2002

The Food and Drug Administration recently gave clearance for an automated external defibrillator (AED) designed for use in the home. AEDs are portable medical devices that provide the most effective treatment for sudden cardiac arrest victims who have a deadly abnormal heart rhythm known as ventricular fibrillation.

Sudden cardiac arrest is responsible for approximately 340,000 adult deaths per year in the U.S. Approximately 95 percent of those who suffer sudden cardiac arrest outside a hospital die. For many people, sudden cardiac arrest is the first sign of cardiovascular disease.

More than 70 percent of all out-of-hospital sudden cardiac arrests occur in the home. Therefore, it has been suggested that family members of individuals at risk of sudden cardiac arrest should be trained and equipped to provide CPR and attempt defibrillation. The American Heart Association recommends early defibrillation as a potentially life-saving treatment and recognizes there are different approaches to making early defibrillation possible. Data from lay rescuer defibrillation programs in public locations have shown that the highest survival from sudden cardiac arrest occurs when the arrest is witnessed an and when bystanders provide immediate CPR and defibrillation within three to five minutes of the arrest.

Prior to making a formal recommendation about home defibrillation, the American Heart Association needs more data on the overall effectiveness of this approach. Data is limited on the number of times a cardiac arrest in the home is witnessed and who is most at risk. Questions also exist about the level of training necessary to make successful resuscitation likely. The American Heart Association looks forward to reviewing the results of an ongoing scientific trial, funded by the National Heart, Lung, and Blood Institute, which will provide valuable data about the home use of AEDs in a few years.

At this time, in the absence of scientific evidence of effectiveness, the American Heart Association can not recommend broad adoption of the home use of AEDs. The association does encourage anyone with questions about their risk factors for heart disease to discuss their treatment options with their physicians. Families of those at risk should learn to identify the signs of sudden cardiac arrest and call 9-1-1 immediately if any of the signs occur. In addition, the American Heart Association recommends that family members learn CPR so they’re prepared to help a loved one survive sudden cardiac arrest.

The American Heart Association is working to improve survival from sudden cardiac arrest by strengthening the chain of survival in every community. The chain of survival includes rapid recognition of a cardiac emergency, early access to emergency medical services (EMS) system by calling 9-1-1, effective bystander CPR, early defibrillation and early access to advanced care.


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