OTC defibrillator for cardiac arrest

For the first time, the FDA has granted clearance for the over-the-counter (OTC) sale of an automated external defibrillator (AED) designed specifically for use by the general public. The HeartStart Home Defibrillator shocks the heart to restore rhythm in people who are experiencing cardiac arrest. The device is already available for home use with a prescription.

AEDs are used to treat someone with cardiac arrest whose heart is beating irregularly (fibrillating). If the heart does not return to a regular rhythm within five minutes, the fibrillation could be more difficult to treat or be fatal. The defibrillator administers an external electric shock through the chest wall to the heart with the use of conductive adhesive pads. Built-in computers analyze the person's heart rhythm and interpret the rhythms that require defibrillation shocks. Voice and visual prompts guide the user.

The HeartStart Home Defibrillator, manufactured by Philips Medical Systems of Andover, Mass., is cleared for use on adults or on children who are 8 years old or older or who weigh at least 55 pounds. Special small pads are available by prescription for use on infants and young children. The device is intended for use when a person is believed to be in sudden cardiac arrest, does not respond when shaken, and is not breathing properly, it should not be used if the person is responsive when shaken or breathing normally.

The AED comes with a training video and also instructs users that they should obtain training in cardiopulmonary resuscitation (CPR) in case that is needed instead of a shock. The instructions remind users that, in the event of a possible cardiac arrest, they should also call 911 immediately. Philips plans to conduct a postmarket study to further determine the device's performance when used in the general population without physician oversight.