DOTmed: AED Manufacturers Get Regulatory Jolt

Posted May 10th, 2013 by SCAFoundation

The automated external defibrillator industry is about to get a bit of a jolt, according to Brendon Nafiger in DOTmed Business News. In March, the Food and Drug Administration released a long-in-the-works proposed order that will toughen the procedure for getting the devices on the market after a number of high-profile recalls. It’s unclear exactly how this will affect AED-makers, but it could dramatically increase the money and time needed to commercialize the life-saving equipment.

Not everyone is happy about this. The fear is that the new regulations could, by making it harder and more expensive to commercialize devices, discourage innovation or raise the costs of AEDs. Pricier automated defibrillators, which already run between $1,000 and $2,500 per unit, could make it less likely that budget-strapped public facilities will have them on hand in an emergency.

“I hope the public won’t be confused by reports of device failures and think they shouldn’t be involved in helping to save a life,” says Mary Newman, the head of the Sudden Cardiac Arrest Foundation. “As it is, it’s an uphill battle for people to understand how simple these devices are to use.”

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Sudden Cardiac Arrest Foundation position