FDA Clears 1st Over-the-Counter Defibrillator
Automated External Defibrillator May Now Be Purchased Without a Prescription
Sept. 16, 2004 -- The power to shock an ailing heart back into motion may now be purchased without a doctor's prescription. Today the FDA approved the first over-the-counter sale of an automated external defibrillator (AED).
The device, the HeartStart Home Defibrillator, shocks the heart to restore the normal heart rhythm in people who are experiencing cardiac arrest. Cardiac arrest occurs when the heart suddenly loses function. If the condition isn't treated within five minutes, it's more likely to be fatal. Most cardiac arrests occur when the heart's electrical impulses become chaotic (arrhythmias).
In recent years, AEDs have been placed in public areas and on airplanes to increase access to the potentially lifesaving devices.
The FDA based its decision to grant the over-the-counter sale of the device on a review of data submitted by the manufacturer, Philips Medical Systems, which showed that the AED could be used without medical supervision. The device is already available with a prescription for use at home, and today's decision means that prescription is no longer necessary. Philips is a WebMD sponsor.
The AED 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 through the process.
The HeartStart home defibrillator is cleared for use on adults or on children who are at least 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 get 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.