[Success Story]
A Prescription-less Portable Defibrillator
The HeartStart low-cost automated external defibrillator for home use breaks new ground in consumer health electronics.
Clever design, close attention to human safety issues, and a top man-machine interface make the Philips HeartStart portable home defibrillator one of the hottest medical electronics devices on the market. Although other companies make portable defibrillators (Agilent Technologies, Cardiac Science, Welch Allyn, HeartSine, Defibtech, Medtronic, and Zoll Medical, to name a few), the HeartStart is the first to be available over the counter without a medical prescription.
The device is low enough in cost (which keeps decreasing) to make it affordable for mass-market consumer applications. Though the most recent price for the HeartStart has hovered under $1300, it's expected to drop below $1000 in the near term as more mass retail outlets like Walgreen's, Staples, and Sam's Club, as well as Web sites like amazon.com and drugstore.com, start offering it for sale. The defibrillator can even be purchased through the company's own Web site at heartstart.com.
The HeartStart is part of a new generation of automated external defibrillators (AEDs), a class of life-saving devices made possible thanks to advances in medical electronics technology. These devices allow lay persons to intervene in instances of sudden cardiac arrest (SCA), saving millions of lives (see "A Chronology Of The AED's Development," p. 42).
Interest in portable AEDs is mounting, spurred on by government legislation and decreasing end-user costs. Two driving forces have been the Government's Cardiac Arrest Survival Act (CASA) for federal public buildings and the Rural Access to Emergency Devices Act (RAEDA), which enables rural communities to purchase AEDs and provides local community training.
But until now, three factors have limited widespread acceptance of AEDs in the consumer market: high cost, the general fear of hurting someone while using an AED, and a lack of public awareness and education about the functionality of AEDs. The Heart-Start AED has answered all three factors (Fig. 1).
Over 6000 HeartStart AEDs have been deployed in homes since the U.S. Food and Drug Administration (FDA) approved it for over-the-counter sale last Sept. 16. That action follows the recommendations of the American Heart Association (AHA) and the FDA's System Devices Panel.
The most recent information furnished by Philips shows more than 125,000 HeartStart AEDs deployed, including homes. Other locales include airplanes, airports, stadiums, workplace offices, plants, shopping malls, schools, and casinos. ( According to Philips, it has the largest worldwide market share of AED revenues at 45%. It also claims the largest U.S. market revenue share at 42%.)
Market analyst Frost & Sullivan sees a huge market for home AEDs, also known as public-access defibrillators or PADs. In fact, with 121 million homes in the U.S., that segment will become the largest in the overall market (see "A Glossary Of Terms" at www.elecdesign.com, Drill Deeper 11660). The firm reported $392 million in total AED revenues for U.S., European, and Japanese markets for 1999, and that will grow to over $1 billion by next year.
THE NEED FOR AN AED According to the AHA, SCA is one of the leading causes of death in the U.S., claiming more than 340,000 lives a year—more than breast cancer, prostate cancer, AIDS, house fires, handguns, and traffic accidents combined.
Studies also show that despite the widespread deployment of AEDs in public places, 70% of all cardiac arrests occur in the home, where an AED can potentially save thousands of lives. The same studies show that when an SCA occurs in a home, the event is witnessed in more than half the cases.
Digging into the numbers further,-another study shows that the longer it takes to treat SCA victims, the smaller the chances of survival. Every minute counts. Calling for emergency medical services or looking for the nearest PAD may take too much time to save a life. In fact, chances of survival in such cases, according to the AHA, drop to a dismal 7% to 10%. But according to the AHA, the quickness of home AEDs can save 40,000 lives.
The whole idea behind the HeartStart AED was to give the victim enough time before calling emergency medical services. Shocking the heart back into action, on the spot, provides more time for other help to arrive to stabilize a patient and increases the victim's odds of survival.
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