Makers of AEDs: Increase in MDRs Due to the FDA’s Reporting Policy

An increase in serious adverse events tied to automatic external defibrillators (AEDs) may have less to do with faulty manufacturing issues than with industry confusion over the FDA’s medical device reporting (MDR) policy. To address the issue, the agency plans to revamp its 1994 MDR guidance, Megan Moynahan, leader of CDRH’s Cardiac Electrophysiology and Monitoring Devices Network, said. CDRH received more than 28,000 adverse event reports involving AEDs from January 2005 through May; the incidents include deaths, patient injuries and device malfunctions.
Devices & Diagnostics Letter