FDA launches External Defibrillator Improvement Initiative to prevent AED Injury

Each year, nearly 300,000 Americans collapse from sudden cardiac arrest. In sudden cardiac arrest, the heart unexpectedly stops pumping blood to the body and brain. If normal heart rhythms are not restored quickly, sudden cardiac arrest can cause brain damage and death.
 
Automated external defibrillators (AEDs) are life-saving devices designed to diagnose cardiac arrest and restore normal heart rhythms when the heart stops.  However, AEDs can malfunction. The FDA has received thousands of reports of AED failures, including some where malfunctions have contributed to patient injury or death. In the last five years, the FDA has issued dozens of recalls of AEDs.
 
In response, the FDA has launched the External Defibrillator Improvement Initiative.  The initiative has three purposes:
 
1. To improve the safety and effectiveness of future AED models.
 
2. To allow the FDA and AED manufacturers to effectively identify and respond to problems with devices and to address potential safety risks.
 
3. To designate better regulations for the pre-market testing of AEDs.
 
If you have lost a loved one to a malfunctioning AED, you understand how just important this initiative is.  Unfortunately, it comes to late to help your loved one.  But, Florida heart attack injury lawyer Craig Goldenfarb can help you get accountability. To learn more, contact The Law Offices of Craig Goldenfarb, P.A. at 1-800-GOLD-LAW.
 
For more information and a list of recalled AEDs, see our library article “Have You Lost A Loved One Because of a Defective AED?”