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
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.
and Drug Administration