FDA Pushes for Tougher Defibrillator Regulations
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iStockphoto/Thinkstock(WASHINGTON) — A device meant to help save lives is failing too often for government regulators’ liking, which has prompted a push for new rules on the devices.
Defibrillators are found in airports, malls and medical centers to help a failing heart reestablish its rhythm. But Dr. William Maisel of the U.S. Food and Drug Administration said that too often the devices don’t work during critical emergencies. From 2005 to 2012, the FDA received approximately 45,000 reports of malfunctions and adverse events associated with automated external defibrillators, or AEDs, he said.
Malfunctions in the devices, he cautioned, could mean life or death. However, the number of deaths directly related to operational problems with the AEDs is not clear.
“It’s difficult to state conclusively how many deaths have resulted from these malfunctions because typically the devices are used in life critical situations and many patients die even when the devices work perfectly well,” he said.
The proposed new rules would require manufacturers to submit more data on the products’ safety and effectiveness. They would also call for the FDA to inspect how defibrillators are designed and built before they come to market, a change the FDA says “will go a long way toward improving this life-saving technology.”
Dr. William Maisel says he doesn’t want this move to be seen as a distrust of the devices.
“These devices are critically important. They serve a very important public health need and the importance of early defibrillation for patients who are suffering from cardiac arrest is well established,” he explained.
“Today’s action,” said Maisel, “is designed to help manufacturers improve the quality and reliability of the devices.”
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