FDA to Defibrillator Makers: Enough

02-22-2011
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Following years of mounting safety issues with defibrillators, the U.S. Food and Drug Administration (FDA) earlier this month recommended more stringent safety measures for the devices.

Defibrillators are those devices, available in places like hospitals, schools and airports that use an electric shock to jolt the heart of a person experiencing cardiac arrest back to a regular rhythm. By one estimate, they save almost 500 lives a year. According to the FDA, though, design and manufacturing problems with defibrillators have resulted in 68 recalls of the devices in the last five years. Worse, the agency has received over 23,000 reports of defibrillator malfunctions—including malfunctions that occurred during rescue attempts, possibly contributing to injuries and deaths.

Currently, defibrillator makers can get FDA approval for their products on a sort of “fast track” meant for low-risk devices. But the manufacturers’ poor record has now prompted the agency to propose that they be held to the same, higher standard as makers of implantable defibrillators and other heart devices. The manufacturers, unsurprisingly, are lobbying against this, and even if the FDA does implement the improved measures, until then every person who collapses, heart spasming, risks injury at the hands of a well-meaning bystander.

Do you believe you were injured by a defibrillator or another faulty medical product? Contact Hodes Milman Liebeck for a free case evaluation. We’re aggressive personal injury and medical malpractice lawyers based in Orange County, serving all of California. We have the experience to take on the medical industry and have achieved multi-million dollar verdicts for our clients.

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