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News of the Day ... in Perspective


FDA to debate OTC defibrillator sales

Should Americans have the right to decide for themselves whether to purchase a home defibrillator? Philips Heart Systems, maker of the HeartStart home defibrillator, argues that they should. The devices are now available by prescription, but many physicians are reluctant to prescribe them.

The FDAs scientific advisors will debate the request to approve over-the-counter sales next week. The FDAs concern is whether ordinary people can figure out proper use on their own. What if they waste time looking for the device instead of dialing 911?

Dr. Thomas Lee, editor of the Harvard Heart Letter, thinks people would be better off buying a health club membership. Dr. Jeremy Ruskin of Massachusetts General Hospital points out that widespread availability of the device could double the survival rate from cardiac arrest. Every minute of delay waiting for the paramedics cuts survival by 10 percent.

Additional information:

OIG Targets Innovators, and FDA Halts Research on CPR Device, AAPS News, August 1994.

Pediatric Rule could deny lifesaving drugs to patients, www.aapsonline.org/legis/pedrule.htm

Court overturns Pediatric Rule, www.aapsonline.org/press/nrpedrule.htm

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