Pilot registry to identify AEDs in the community

Part of broad FDA initiative to improve heart care

Three-year-old Denver resident Brianna's favorite color was yellow and her favorite restaurant was the hot dog stand outside Home Depot. At 18 months she strapped on her first pair of skis and spent Saturdays forever chasing a soccer ball. She loved playing with her brother and noticed everything.

Brianna died suddenly one April afternoon a few years ago from a cardiac arrhythmia known as Long QT Syndrome. Brianna's life might have been saved if there had been access to an automated external defibrillator (AED) in the local elementary school she was visiting that day.

Monday, Food and Drug Administration officials announced that the University of Colorado School of Medicine will work with the FDA to develop a pilot registry in Denver to identify AEDs in the community. This registry will link AEDs to emergency medical dispatch. It also could increase the ability of bystanders to save a life and help ensure that AEDs are located where they might be needed. Seattle and San Diego are the only other cities that will launch this effort.

"Had this registry been in place in Brianna's case, 911 operators could have told bystanders where the closest AED was located, and this device could have been used to potentially save her life," says Comilla Sasson, MD, with the Department of Emergency Medicine of the CU medical school.

Right now, Denver and other cities collect some information on AEDs, but little is known about the location and number of these devices in places such as homes, airports and office buildings, according to Sasson, who practices at the University of Colorado Hospital.

Brianna's parents and others are willing to discuss how the Denver program can save lives.

The ultimate goal, Sasson says, is to integrate AEDs into 911 systems across the country.

AEDs save lives if they are accessible within minutes of heart arrest. But they are used in fewer than 3 percent of those cases. The devices diagnose life-threatening, abnormal heart rhythms and deliver electrical energy to the heart to restore its normal rhythm.

The Denver pilot project is part of a broader FDA initiative, announced Monday, to improve AEDs. The FDA is encouraging development of safer, more effective external defibrillators through improved design and manufacturing practices.

The FDA said that in the last five years it has received more than 28,000 reports associated with the failures of external defibrillators and manufacturers conducted dozens of recalls involving hundreds of thousands of the devices.