Originally Published MDDI October
2004
NEWSTRENDS
FDA Allows OTC Defibrillators |
| The HeartStart Home Defibrillator is now available without a prescription. |
In a significant move keeping with today’s trend of giving the patient
more control over his or her treatment, on September 16, FDA approved over-the-counter
sales for an automatic external defibrillator (AED).
Consumers will now be able to buy the HeartStart Home Defibrillator, made by
Philips Medical Systems (Andover, MA), without a prescription. In 2002,
the HeartStart became the first external defibrillator designed specifically
for home use to gain FDA approval.
AEDs administer an electric shock through the chest wall to the heart, using
conductive adhesive pads. They have computers to analyze heart rhythm and alert
the user when a shock is needed.
Philips was able to prove to FDA that its AED could be used without medical
supervision. It demonstrated that the device and its instructions could be safely
and effectively used and understood by lay people. Tests studied the ability
of untrained users to set up the device, place the pads in their proper place,
follow voice and visual prompts, and safely deliver shocks. The company also
wrote a new set of instructions and training manuals.
“It is important to recognize that for a substantial percentage of [sudden
cardiac arrest] victims, cardiac arrest is the first sign of heart disease,”
said Jeremy Ruskin, director of the cardiac arrhythmia service at Massachusetts
General Hospital (Boston). “We know that access to early defibrillation
helps save lives. Removal of the prescription requirement for the HeartStart
Home Defibrillator gives people freedom of choice to be better prepared for
unexpected cardiac arrest—a rare but life-threatening emergency.”
The OTC approval came after a recommendation by the agency’s Circulatory
Systems Panel in July. At that meeting, physicians, industry representatives,
and sudden cardiac arrest survivors came to a consensus that greater access
to defibrillators should save lives.
Copyright ©2004
Medical Device & Diagnostic Industry
