
Sudden cardiac arrest is one of the leading causes of death in the U.S. About 360,000 cases occur yearly, and a person currently has about a 5% chance of surviving an incident of cardiac arrest. It can happen to anyone, anytime, anywhere and at any age. An automated external defibrillator (AED) is the only effective treatment for restoring a regular heart rhythm during sudden cardiac arrest and is an easy to operate tool for someone with no medical background.
Time is of the essence! The average response time for first responders once 911 is called is approximately 8-12 minutes. For each minute defibrillation is delayed, the chance of survival is reduced by 10%.
Time is of the essence! The average response time for first responders once 911 is called is approximately 8-12 minutes. For each minute defibrillation is delayed, the chance of survival is reduced by 10%.
Consequently, it is important that AEDs are readily available and located in public areas such as malls, airports, schools, churches, fitness centers and even medical facilities. Optimal AED placement allows a person to grab the AED and return to the victim within 90 seconds. Unfortunately, these life-saving devices have been associated with malfunctioning problems and 2 million devices have been recalled. The FDA has received approximately 72,000 reports associated with the failure of such devices between January 2005 and September 2014. During this same period, defibrillator manufacturers have issued 111 recalls. |

The FDA will begin requiring more rigorous reviews of defibrillators through a premarket approval process focusing on safety and reliability of machines and their necessary accessories, including batteries, pad electrodes, adapters and hardware keys for pediatric use. Enforcement will begin mid-2016.