AEDs Save Lives. Let's Keep Them Readily Available.
Sudden Cardiac Arrest (SCA) is a leading cause of death in the U.S., affecting more than 1,000 people of all ages every day. On average, only 10% of victims survive. Survival rates increase to 38% when victims are treated by bystanders with automated external defibrillators (AEDs). If the national survival rate increased to 38%, more than 100,000 additional lives could be saved each year.
The FDA, however, is considering new regulations that will drastically reduce access to the user-friendly lifesaving devices. The FDA is in the process of reclassifying “pre-amendment class III devices,” including AEDs. If AEDs are reclassified as class III devices, unnecessary regulatory hurdles will increase and access to early defibrillation will decrease, drastically reducing the odds of survival for victims of sudden cardiac arrest.
If you are someone who works every day to help save lives, or if you have been personally affected by SCA and understand the critical importance of early defibrillation, please express your concerns to the FDA now, before their determination is made. A decision is anticipated by June 2013.
We, the undersigned, urge the Food and Drug Administration to refrain from reclassifying automated external defibrillators (AEDs) as class III devices requiring pre-market approval. Decades of research and experience support the fact that AEDs are safe and effective user-friendly devices that can and do save lives.
We urge you to do everything within your power to ensure that AEDs are widely deployed and readily available for use by bystanders, whenever sudden cardiac arrest strikes.