FDA Regulations Push To Reclassify Automated External Defibrillators as Class III

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The FDA is pushing toward making AEDs a class III medical device. Organizations, Manufacturers, SCA survivors, and AED.com fight to avoid increased regulation.

...progress toward improving survival rates nationwide could be stymied.

The FDA reclassification of AEDs (automated external defibrillators) from class II to class III medical devices would cause the devices to undergo strict, costly, pre-market approval process (http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/CardiovascularDevices/ExternalDefibrillators/ucm232302.htm). AEDs, due to a grandfathering clause, are currently regulated as class II devices. The FDA’s External Defibrillator Improvement Initiative states “According to a 1990 amendment to the 1976 legislation, the FDA must either down-classify AEDs to Class II or keep AEDs as Class III and require they go through the more stringent pre-market Approval (PMA) process,”(http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/CardiovascularDevices/ExternalDefibrillators/ucm232302.htm). This initiative is years in process and began with a letter sent to AED manufacturers pushing the need for more stringent regulatory processes.

In the letter, the FDA noted the 68 total recalls from all manufacturers from January 1, 2005 to July 10, 2010 and 28,000 medical device reports received in that period (http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/ucm233396.htm). Mary Newman, President of the Sudden Cardiac Arrest Foundation, stated in a letter to the editor of the New York Times, “While there were 22,000 malfunction reports over the last five years, most resulted from routine device self-checks not the actual use of A.E.D.’s. Further, considering that more than one million A.E.D.’s have been deployed in the United States, that’s an extremely low failure rate.” According to the numbers given by Newman, that is a 2.2% of all AEDs in a 5 year period.

Organizations, like the Sudden Cardiac Arrest Foundation, distributors, like AED.com, and Manufactuers including Zoll, Cardiac Science, Physio-Control, Heartsine, Phillips, and Defibtech are urging the FDA to considering classifying AEDs as Class II devices (http://www.sca-aware.org/sites/default/files/fda_110212_0.pdf). If AEDs are changed to Class III devices, the effects would be detrimental to the cost, availability and innovation of future AEDs (http://www.sca-aware.org/sca-news/fda-panel-considers-classification-of-aeds-as-high-risk-devices). SCA survivor and Sudden Cardiac Arrest Foundation survivor David Belkin said, “If designating AEDs as Class III devices reduces their distribution and access—due to increased costs and regulatory hurdles—progress toward improving survival rates nationwide could be stymied.” Keeping AEDs available at the lowest price and highest availability is a nationwide goal of Manufactuers and distributors alike. The Sudden Cardiac Arrest Foundation Started a petition to the FDA to keep AEDs readiliy available. The petition can be found here: http://www.gopetition.com/petitions/keep-automated-external-defibrillators-accessible.html

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