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Automatic External Defibrillators (AEDs) and Public Access Defibrillation (PAD) Programs

An automatic external defibrillator (AED) is a device used to treat a patient with cardiac arrest whose heart is beating irregularly (fibrillating). If the heart does not return to a regular rhythm within 5-7 minutes, this fibrillation could be fatal. To stop the fibrillation, an AED is used to administer an external electric shock through the chest wall to the heart with the use of conductive adhesive pads. Built-in computers analyze the patient's heart rhythm, and interpret the rhythms that require defibrillation shocks. Audible and/or visual prompts guide the user through the process. Most AEDs require an operator to initiate the delivery of the shock in some way, such as pushing a button.

In order to have AEDs available more quickly for the persons who need them, some facilities (such as hotels, airports, country clubs) are purchasing these devices under what is called a Public Access Defibrillation (PAD) program. However, since AEDs are prescription devices and must be labeled with the prescription statement required by law (CFR 801.109), a physician who oversees the PAD program at a facility must write a prescription for the AED in order for the facility to purchase it.

Public access refers to accessibility for trained users to use AEDs in public places. Public access does not mean that any member of the public witnessing a sudden cardiac arrest should be able to use the device. AEDs are to be used only by individuals with the proper training and certification in accordance with state and local laws.

While our Division of Small Manufacturers Assistance provides guidance to manufacturers on how to comply with the device regulations pertaining to AEDs, the American Heart Association will provide guidance to person(s) who wish to establish a PAD program. Further information on PAD can be found on the American Heart Association’s web site at http://www.americanheart.org/presenter.jhtml?identifier=3011890#training