Supporting Families. Saving Lives.
This week the FDA announced they are beginning an initiative to foster the development of safer and more effective external defibrillators through improved design and manufacturing practices, and urge industry to address current practices for identifying, reporting, and acting on the device complaints.
FDA’s External Defibrillator Improvement Initiative has the following three goals:
1. Promote innovation of next generation external defibrillators to improve safety and effectiveness.
2. Enhance the ability of industry and the FDA to identify and respond to problems with devices currently on the market to address potential safety risks more quickly and effectively.
3. Designate an appropriate premarket regulatory pathway for AEDs that promotes best practices for design and testing.
In addition, the FDA is holding a public workshop with multiple stakeholders to facilitate the development of next-generation defibrillators, enhance surveillance of defibrillators in community settings, and improve the rapid delivery of treatment for sudden cardiac arrest patients.
More information on the public workshop
Read the FDAs official statement
More information on the initiative
Part of the initiative includes establishing registries of AEDs to be easily located and utlized during an emergency situation. THis week the University of Colorado, Denver announced their participation in the initiative by creating an AED registry for the greater Denver area. Local coverage of the story features the Badger family who tragically lost their 3 1/2 year old daughter, Brianna, five years ago upon suffering a cardiac arrest at an elementary school.
Read the news story
Watch the video