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Defibrillator deemed safe enough for over-the-counter sale     Send a link to a friend

[OCT. 19, 2004]  The Food and Drug Administration recently granted marketing clearance for the first time for the over-the-counter sale of an automatic external defibrillator designed specifically for lay users. The device shocks the heart to restore rhythm in people who are experiencing cardiac arrest.

The HeartStart Home Defibrillator, manufactured by Philips Medical Systems of Andover, Mass., is already available by prescription for use at home. The FDA clearance on Sept. 16 means the device can now be purchased for home use without a prescription.

Automatic external defibrillators 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, this fibrillation could be more difficult to treat or fatal.

The automatic external defibrillator administers an external electric shock through the chest wall to the heart by means 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.

FDA based its decision to grant over-the-counter marketing clearance after a review of data submitted by Philips Medical that showed the automatic external defibrillator could be used without medical supervision. The decision was also based on the recommendation of an outside advisory panel that met in July to evaluate the product for nonprescription use.

In order for FDA to grant over-the-counter clearance, Philips had to demonstrate that its device could be safely and effectively used by lay people, based on written instructions and the device itself.

Philips conducted usability testing that focused on the ability of untrained users to set up the device, place pads promptly, follow voice and visual prompts, and deliver shocks safely. Philips also developed instructions and training materials designed to help lay users know when and how to use the device.

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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 automatic external defibrillator comes with a training video and also instructs users that they should obtain training in cardiopulmonary resuscitation 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 post-market study to further determine the device's performance when used in the general population without physician oversight.

By FDA regulation, all automatic external defibrillators are "tracked" devices. Tracking requires the manufacturer to have a process in place to promptly identify users in the event of a recall. The Philips automatic external defibrillator comes with an enrollment form that should be completed and returned to the company so that users can be notified in the event of a recall.

[Food and Drug Administration news release]

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