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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


But the FDA was not convinced.

“[The] 510(k) clearance process for these devices has failed to protect American consumers,” Dr. William Maisel, now the deputy director of the FDA’s Center for Devices and Radiological Health and formerly director of the medical device safety institute at Beth Israel Deaconess Medical Center, said in a speech before the House subcommittee on health a few years ago.

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Of the nearly 1 million AEDs on the market at that time, one-fifth had been recalled by the FDA, mostly because of electrical or software problems, he testified. In a nearly 10-year period ending in 2005, AED-related device malfunctions were linked to hundreds of deaths. In total, there were 52 FDA recalls, he said.

“Although they’re relatively on their face simple devices, they are complex in terms of their hardware, their maintenance and their software, and so there’s lots of areas where things can go wrong with them,” Caroome, with Public Citizen, explains. “So when you look at reasons for some of the recalls, there can be failures at multiple levels.”

There have been devices at risk of voice prompt failures, where the computerized voice that instructs the user how to apply the AED doesn’t work properly. In another recall, which affected almost 10,000 AEDs, the devices could shut down during attempted resuscitation. There were others that wouldn’t give a shock when the patient’s rhythm required it, or it gave a shock when the patient’s rhythm was normal enough to sustain blood flow to the body, which could then be disrupted by a bad shock, Caroome says.

Perhaps a more common problem is that if the device is defective, the time spent trying to apply it is time that could have been spent trying CPR. “When you use the device you stopped CPR or chest compressions,” he says.

“There are always going to be some of these devices that are going to fail, just because of the nature of them,” Caroome adds. “But with appropriate testing this can be minimized.”

For its part, the FDA said the PMA rules would help improve patient safety. Medical device reports for AEDs doubled from 2005 to 2010, and were still increasing from 2011 to 2012. But this data-collecting, at least, could be better under the new rules. “Annual reporting (which occurs with PMA devices) would improve overall surveillance by providing denominator data for device distribution as well as current trend information on issues being followed by the manufacturer,” the agency said in the proposed order.

The agency also said in its analysis of recalls most were linked to purchasing and design controls. Plus, the company said it noted a “significant number of violative AED manufacturing facility inspections.” Thus, as part of the PMA process, companies would have to undergo a premarket review of quality-control procedures and preapproval inspections, as well as post market follow-up.
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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.

More on this can be found at:
www.readisys.com/aed-reclassification-when-near-perfect-is-not-enough-for-the-fda/

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