AUTOMATIC EXTERNAL DEFIBRILLATOR AVAILABILITY TO GENERAL PUBLIC
This article was originally published in The Gray Sheet
Executive Summary
AUTOMATIC EXTERNAL DEFIBRILLATOR AVAILABILITY TO GENERAL PUBLIC would raise unique pre- and postmarket issues of safety and effectiveness, Susan Alpert, director of FDA's Office of Device Evaluation, said Dec. 8 at an American Heart Association conference in Washington, D.C. The conference, entitled "Public Access Defibrillation: A New Strategy to Prevent Sudden Death," was held to explore the feasibility of making the devices available in such public gathering places as office buildings, stadiums, or homes, to enable faster treatment of patients needing defibrillation.