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FDA issues proposal to improve AEDs
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The FDA today issued a proposed order aimed at improving the quality and reliability of automated external defibrillators.
If the order is finalized, it will require manufacturers to submit pre-market approval applications. Between 2005 and 2012, the FDA received 45,000 adverse event reports of AED failure; according to the FDA, these problems are preventable and correctable. Common device issues involve manufacturer design and inadequate quality control of parts purchased from other suppliers.
"Automated defibrillators save lives," William Maisel, MD, MPH, deputy director of science and chief scientist at the FDA's center for devices and radiologic health, said in a press release. "However, the agency is concerned about the number of recalls and manufacturing problems that have been associated with these devices and we're committed to working with manufacturers to address these issues."
Ultimately, the proposed review process will allow the agency to more closely monitor devices and how they are manufactured and designed.
"If our proposed order is finalized, the FDA intends to focus its review of the pre-market applications on the more problematic aspects of AEDs," Maisel added.