Automated external defibrillator maker CardioReady advises caution on the FDA's new regulatory proposals, urging that increased oversight not stand in the way of public proliferation.
MASSDEVICE ON CALL — The FDA this month issued a new proposal on the regulatory oversight of automated external defibrillators, but at least 1 medical device maker is worried that enhanced oversight may harm public safety.
Philadelphia-based CardioReady, maker of AED systems, urged that the FDA ensure that any new oversight not jeopardize the proliferation of AEDs, in the interest of public health.
"While much of the public commentary to date has focused on issues with a small subset of AEDs, the more important question should center on what is being done to save the hundreds of thousands of people who die in the United States every year from Sudden Cardiac Arrest," CardioReady chief medical officer Dr. Kevin Campbell said in prepared remarks. "Deployment and use of an AED within minutes of an SCA is the only practical lifesaving tool at our disposal."
The company noted that the few instances in which AEDs have failed to work as designed should not deter the public from turning to the potentially life-saving devices in case of emergency.
"It is imperative that the general public understand that AEDs perform as intended in the vast majority of circumstances and are overwhelmingly effective lifesaving tools," Campbell noted.
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