The Food and Drug Administration said Friday that it will begin looking into how to increase defibrillator regulations for manufacturers, according to the New York Times.
Recently defibrillators, tools that use electricity to revive a dying heart, have experienced a number of malfunctions and been the cause of many deaths.
According to the Times, the FDA provided one example in which a nurse was attempting to treat a patient having a heart attack. While attempting to stop the cardiac arrest, the screen on the defibrillator read “memory full” and the device proceeded to shut down. The patient did not survive.
FDA officials said there have been 45,000 reports of malfunctions since 2005, the Times reported. Since 2005, manufacturers of the device has been recalled 88 times. Malfunctions have been caused by either manufacturing problems or, at times, failure to take proper care of the device.
“We think tens of thousands of adverse events is too many and 88 recalls is too many,” said Dr. William Maisel, chief scientist at the FDA’s Center for Devices and Radiological Health to the Times.
The FDA has proposed a way to keep tabs on how manufactures are making the devices. There are about 2.4 million A.E.D.’s, or automated external defibrillators, in the country according to the Times.
Royal Phillips Electronics NV is based in Amsterdam and a manufacturer of A.E.D.’s. According to Bloomberg.com, Spokesman Steve Klink said Phillips is not too worried about the regulations. The company does not believe newer regulations will have an effect on distributions.
Though the new regulations might not effect distribution, they could possibly effect other areas.
Dr. Mickey Eisenberg, the emergency medical services director for King County in Seattle, said the new regulations could slow innovation to the device, the Times reports. He also believes the price of A.E.D.’s must go down, so more people can have them in the home.
“A.E.D.’s in public places will never solve the problem,” he said. “They need to become consumer items, to enter people’s bedrooms and homes.”
Maisel said the cost of heeding to the new regulations would rise from $5,000 to $220,000. He said if companies have more than one model then they would only have to pay the cost once. The onetime payment could be used for future versions of the various models.
Maisel added that he believes companies will have enough time to comply with the new regulations. Upon completion, the new rules would go into effect at the end of 2014.
