FDA looks to tighten regulations on public defibrillators
Wed, 27 Mar 2013 03:02:43 GMT —
The U.S. Food and Drug Administration proposed new regulations for Automated External Defibrillators last week after reports of malfunction.
According to the FDA, they received approximately 45,000 reports of failure with the devices between 2005 and 2012. The new proposal would require that manufacturers get pre-market approval to ensure that the products are safe and reliable.
Grace Stringer, trained specialized for the North Texas Region for Health and Safety said that she's glad to know there is a defibrillator around in case of a crisis.
"I think the defibrillators are very important. You never know when you're going to have an emergency," said Stringer.
According to the American Heart Association, as many as 400,000 people are killed a year in the United States from cardiac arrests.
Local Pediatric Cardiologist Gene Luckstead said the devices are needed for emergency situations when someone has a cardiac arrest or cardiac problem. His main concern about the FDA's proposal is how the regulations will affect defibrillators.
"I'm concerned that if they want to put too many regulations on something and some of them might be unwarranted, you're going to end up not having access to the defibrillators that you need," said Luckstead. "And to me that would be a giant step backwards."
He said that FDA should not be the only ones involved in making changes to the device.
"I think it should be involved at manufacturing level. I think it should be involved at the medical levels and the crossover with the public," Luckstead said.
The FDA said they will make sure that Automated External Defibrillators remain available so that they can continue to save lives.
"Although there have been problems associated with AEDs, their life-saving benefits outweigh the risk of making them unavailable during the classification process."
The FDA will take comments on the proposed order for 90 days. For more information on the FDA proposal, visit www.fda.gov