FDA Approves Defibrillator for Over-the-Counter Sale
Sep 17, 2004
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Royal Philips Electronics announced that the U.S. Food and Drug Administration (FDA) approved the sale of the company's HeartStart Home Defibrillator without a prescription.
The decision follows the favorable consensus of the Circulatory System Devices Panel, which met on July 29, 2004 and supported removing the prescription requirement. The company says its HeartStart Home Defibrillator was the first new-generation defibrillator specifically designed for home use. It is now the first defibrillator cleared for over-the-counter sale, a move that will help make the HeartStart Home Defibrillator more easily available to consumers for home use, where the majority of cardiac arrests occur.
"It is important to recognize that for a substantial percentage of SCA victims, cardiac arrest is the first sign of heart disease," said Dr. Jeremy Ruskin, Director of the Cardiac Arrhythmia Service at Massachusetts General Hospital. "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."
According to Philips, the unit was designed around the user and provides voice instructions. In addition, advanced SMART Pad technology senses the responder's actions with the pads and automatically adjusts the pace of the voice instructions to meet the individual responder's needs. Patented voice coaching for adult and infant/child CPR provides audio cues for each breath as well as the appropriate number and rate of chest compressions.
The unit is said to perform daily self-tests, including a check for pads readiness, and a loud chirp alerts family members when any part of the system needs attention. Specially designed infant/child pads make the HeartStart Home Defibrillator appropriate for use on infants and children under the age of 8 or weighing less than 55 lbs. The Infant/Child SMART Pads cartridge will continue to be available by prescription.
The HeartStart Home Defibrillator, along with an owner's manual and instructional video, is sold for U.S. $1,995.
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