While it may not seem so on the surface, the Food and Drug Administration’s action to tighten regulations on AEDs was an affirmation of the important role these devices play in reducing the incidence of sudden cardiac arrest, the number-one killer of Americans.
“Automated external defibrillators save lives,” said William Maisel, M.D., deputy director of science and chief scientist at the FDA’s Center for Devices and Radiological Health. While expressing his concern about recalls and manufacturing problems associated with some devices, he said, “we’re committed to working with manufacturers to address these issues.”