Royal Philips Electronics announced that it will offer the HeartStart OnSite Defibrillator for sale without a prescription. Philips says it is the first to market a defibrillator over-the-counter (OTC) to commercial users, which will help make the HeartStart OnSite Defibrillator more easily available for early defibrillation programs in communities, schools, and businesses. This follows the FDA's clearance of the Philips HeartStart Home Defibrillator in September 2004.
Defibrillators provide treatment for sudden cardiac arrest (SCA), a leading cause of death in the U.S., claiming 340,000 lives each year.
Philips's defibrillator, first introduced with a prescription requirement in November 2002, is designed to help lay responders save a life. Voice commands guide the responder through each step of the defibrillation process, even reminding them to call for emergency help. Patented voice coaching for adult and infant/child CPR provides instructions and audio cues for each breath, as well as the appropriate number, rate, and depth of chest compressions.
In addition, the defibrillator can be used on infants and small children when equipped with specially designed infant/child pads, which reduce the amount of energy delivered by the defibrillator to a more appropriate level. Sale of the infant/child SMART pads cartridge requires a prescription, as does device configuration software.
To support customers' implementation efforts, Philips is also offering HeartStart Essentials, a suite of products and services designed to help customers deploy a successful defibrillation program -- from planning and medical direction, to training and post-sales support.
"In pursuing our mission to save more lives from sudden cardiac arrest, Philips is committed to making defibrillators broadly accessible, whether in the home or in public settings where people work and play," said Deborah DiSanzo, vice president and general manager for cardiac resuscitation at Philips Medical Systems. "Offering the HeartStart OnSite Defibrillator without a prescription further establishes Philips at the forefront of removing barriers to saving more lives."
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