Newswise — If your heart should seize up, contracting wildly and out of synch so that it no longer serves as a pump, your life hangs in the balance. Your only chance is if some passerby grabs a public-access defibrillator and uses it to shock your heart back into its normal rhythm, keeping you stable until emergency medical professionals can arrive.
In the United States, there are now 1.5 million public-access defibrillators deployed in gyms, malls, offices, and schools--that's five for each of the 300,000 people in the country who need them every year. Yet despite this enormous investment, the death rate from sudden cardiac arrest is no better than it was 20 years ago. It still kills more Americans than lung, breast, and prostate cancers and AIDS combined. Worldwide, it kills about 7 million people a year.
The problem is reliability. A public-access defibrillator spends days, months, and even years hanging on a wall, gathering dust. Most of them reach the end of their expected 5- to 10-year lifetimes without ever having been used. Yet they must remain fully charged, functional, and ready to operate at a moment's notice, often by people who have never seen a defibrillator outside of a TV hospital drama.
And last year, officials at the U.S. Food and Drug Administration (FDA) noticed a disturbing trend. Between 2005 and 2009, the annual number of problems reported for public defibrillators increased by 85 percent. In that five-year period there were more than 28,000 such reports--one malfunction for every 50 devices in the country. More than 750 of the reports followed a death.
A big reason for this problem is lax regulation. Defibrillators qualify for a loophole in the FDA rules, called 510(k), that leaves it all too easy to make and market a new device by claiming that it is merely a new version of an approved design.
Clearly, the public-access defibrillator industry is not in the best of health. It's ready for a good shock to the system. There are two on the way: reclassification by the FDA and a potentially industry-shifting lawsuit. Whether these jolts will prove fatal or therapeutic remains to be seen.
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