Over the past five years, the U.S. Food and Drug Administration (FDA) has received more than 28,000 reports of adverse effects and 700 reports of death related to the use of external defibrillators. In order to address the increasing number of recalls, the FDA announced a program to assist in the development of safer, more effective defibrillators.
External defibrillators are designed to treat abnormal heart rhythms with electrical energy. Devices have been recalled mostly due to preventable and correctable failures, MedPage Today reports.
Automated external defibrillators (AEDs) are found in homes, airports, office buildings and other public settings. More complex defibrillators are operated by trained health care professionals in a hospital setting.
According to an FDA press release, the new program is intended to promote the innovation of next-generation defibrillators, identify and resolve problems with current devices and design an appropriate premarket regulatory pathway for AEDs that promotes best practices for design and testing.
