FDA Proposes Tighter Regulation of Public Defibrillators FRIDAY,
March 22 (HealthDay News) -- To improve the quality of
lifesaving devices called automated external defibrillators, the
U.S. Food and Drug Administration proposed Friday that the seven
manufacturers of these devices be required to get agency
approval for their products. Automated external defibrillators
(AEDs) are portable devices that deliver an electrical shock to
the heart to try to restore normal heart rhythms during cardiac
arrest. Although the FDA is not recalling AEDs, the agency said
that it is concerned with the number of recalls and quality
problems associated with them. "[The] FDA is not questioning the
clinical utility of AEDs," Dr. William Maisel, chief scientist
in FDA's Center for Devices and Radiological Health, said during
a press conference on Friday announcing the proposal. "These
devices are critically important and serve a very important
public health need. The importance of early defibrillation for
patients who are sufferin