Archive - Jan 26, 2011

Archive - Jan 26, 2011

FDA Panel Considers Classification of AEDs as High-Risk Devices

Action could reduce access to lifesaving devices

GAITHERSBURG, Md - The Food and Drug Administration (FDA) Circulatory System Devices Panel met Tuesday to discuss and make recommendations regarding the regulatory classification of automated external defibrillators (AEDs). AEDs are used to resuscitate people who suffer sudden cardiac arrest (SCA) and are clinically dead.

The panel considered whether to reconfirm that AEDs should remain Class III high-risk medical devices or be reclassified as Class II moderate-risk devices. Class II devices are subject to a pre-market “510(k)” notification process, whereas Class III devices are subject to a more rigorous pre-market approval (PMA) application process.

AEDs currently are considered Class III devices, but due to a grandfathering clause, they have been regulated as Class II devices.

High School Referee Saved at High School Basketball Game

With about three minutes left to go in a tie game between the Raymond and Epping junior varsity girls' basketball game on Monday night, a referee collapsed on the gymnasium floor, unconscious and not breathing.

What happened next was nothing short of a miracle.

Mission & Vision

The mission of the Sudden Cardiac Arrest (SCA) Foundation is to prevent death and disability from sudden cardiac arrest. The vision of the SCA Foundation is to increase awareness about sudden cardiac arrest and influence attitudinal and behavioral changes that will reduce mortality and morbidity from SCA.

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