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AED manufacturers get regulatory jolt

by Brendon Nafziger, DOTmed News Associate Editor | May 07, 2013
From the May 2013 issue of HealthCare Business News magazine

This is where an AED comes in. The battery-powered system, which comes equipped with a pad electrode to put on the victim’s body, uses a computer to monitor heart rhythm. If it thinks the patient could benefit by the shock — generally for ventricular fibrillation or pulseless ventricular tachycardia — it either administers the jolt itself, or urges the responder to do so, according to the FDA.

While SCA is fairly common, AED use is not. A 2010 study in the Journal of the American College of Cardiology examined 13,700 out-of-hospital cardiac arrests, and found only 2.1 percent had an AED applied before the paramedics came. But when it is used, it can save lives. The same study found that AEDs helped bump up survival rates, going from about 9 percent with CPR alone to 24 percent with AED use and 38 percent if the AED delivered a shock. (The AED can instruct the user to perform CPR and skip the shock.)

New rules
On March 22, the FDA said it would require AEDs to be regulated as Class III devices, its highest-risk category, largely following recommendations it received from an advisory panel in January 2011. Previously, AEDs had been regulated as Class II, medium-risk devices (a category that includes most X-ray equipment). The reason is fairly convoluted — AEDs had a “predicate” or earlier device that was the basis for their regulation, which was a so-called pre-amendment device, meaning it came out before the FDA’s current device rules took shape in the 1970s. Thus, AEDs were grandfathered in as Class II products. But under congressional orders, the FDA has to look at AEDs and other grandfathered devices and either downgrade their classification or regulate them according to their “real” status — which is what the FDA is doing now.

Under the old rules, AED manufacturers needed only to obtain 510(k) clearance for their product and accessories, which typically just requires evidence that the device is “substantially equivalent” to another device already on the market. But now, if FDA’s proposed order goes into effect, manufacturers will have to get premarket approval, or PMA, a much more expensive and involved process.

Now, this doesn’t mean AEDs currently on the market will be pulled right away. According to the agency, companies will have a 15-month “enforcement discretion” period if they notify the FDA within 90 days of whenever the final rules are published.

Reasons for the rules
When the agency was still mulling over how to treat AEDs, manufacturers had asked the agency to keep them as Class II, but with “special controls.” These included testing to industry standards, certain labeling and guidance documents, and post market surveillance, according to the proposed rules.

Richard Lazar

AED Reclassification – When Near Perfect is Not Enough for FDA

May 17, 2013 04:27

The FDA is proposing to reclassify AEDs as Class III medical devices. This change will require manufacturers to go through a much more time consuming and costly regulatory process before their AEDs can be sold. Why? According to the agency’s proposed rule, the primary purpose of reclassification is to reduce the risk of illness or injury resulting from AED failures. Yet, a study relied upon by the agency finds that AEDs work as intended during rescue attempts greater than 99% of the time. This is a clear example of the perfect as the enemy of the good (or even great) driving a regulatory action that will cost lives and money with very little public health benefit.

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