FDA launches the External Defibrillator Improvement Initiative

The External Defibrillator Improvement Initiative has been launched by the FDA to improve the engineering design and manufacturing practices of external defibrillators. During the past five years, the FDA’s Center for Devices and Radiological Health (CDRH) has received more than 28,000 medical device reports associated with the failures of external defibrillators and manufacturers conducteddozens of recalls involving hundreds of thousands of the devices.

Goals of the initiative include:

• Promoting the innovation of next-generation external defibrillators to improve safety and effectiveness
• Enhancing the ability of industry and the FDA to identify and resolve problems with devices currently on the market to address safety risks more quickly and effectively
• Designating an appropriate premarket regulatory pathway for AEDs that promotes best practices for design and testing.

To learn more, visit the FDA website.