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FDA Clears First Over-the-Counter Sale of Automatic
External Defibrillator
Studies show cardiac arrest survival doubles when
defibrillators are readily available
Sept. 17, 2004 In a landmark decision, the Food
and Drug Administration (FDA) yesterday granted 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 device, the HeartStart Home Defibrillator
manufactured by Philips Medical Systems of Andover, Mass., is already
available with a prescription for use at home. Today's clearance means
it can now be purchased for home use without a prescription.
Automatic external defibrillators (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, this fibrillation could be more difficult to treat or be
fatal.
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.
Sudden cardiac arrest claims the lives of 340,000
Americans each year, more than from breast cancer, prostate cancer,
AIDS, house fires, handguns and traffic accidents combined. It can
strike anyone, anywhere, at any time-often without warning. For the
majority of victims, cardiac arrest is the first recognized symptom of
heart disease.
Defibrillators treat cardiac arrest. Therapy,
however, must be delivered within minutes to be effective. After ten
minutes, few attempts at resuscitation are successful. The current SCA
survival rate is less than five percent. The decision will make
easy-to-use defibrillators more readily available in the home-where
nearly 80 percent of cardiac arrests occur-which could help save more
lives from one of the nation's leading killers.
Published studies show that survival doubles when
defibrillators are readily available.
FDA based its decision to grant over-the-counter
marketing clearance on a review of data submitted by Philips Medical
that showed the AED could be used without medical supervision. FDA's
decision was also based on the recommendation of an outside advisory
panel that met in July to evaluate the product for non-prescription 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.
The HeartStart home defibrillator is cleared for
use on adults or on children who are at least eight 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 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 that the manufacturer have a process in place to promptly
identify users in the event of a recall. The Philips AED 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.
Copyright: SeniorJournal.com |
