Heart Defibrillator Failures Lead FDA to Propose Stronger AED Standards

The FDA has proposed new guidelines that are aimed at improving the standards for automated external defibrillators (AEDs), which have been linked to a number of serious problems that may cause the devices to fail when needed to provide a life-saving jolt. 

The proposal is focused on improving the quality and reliability of AEDs following many deaths and more than 45,000 adverse event reports submitted to the FDA between 2005 and 2012.

The proposal would require manufacturers of AEDs to submit pre-market approval applications for the devices and allow them to closely monitor how the devices are manufactured. The FDA first began looking at new standards for defibrillators in January 2011, after a string of AED recalls.

AEDs are portable electronic devices which jump-start a person’s heart in emergency situations after it has stopped beating. It re-establishes a normal heart rhythm through the means of electrical stimulation.

Many of the adverse event reports are connected to failure of the devices, such as battery failures or improper maintenance of the device. The adverse event reports have resulted in dozens of recalls by the manufactures, Physio-Control Inc., Zoll Medical Corp and Royal Philips Electronics NV.

Experts indicate that it is impossible to accurately estimate the number of deaths caused each year by the malfunction of defibrillators because many of the deaths may have occurred anyway as a result of cardiac arrest.

The FDA considers many of the problems as correctable and preventable. During the proposed change and reclassification, they plan to continue to allow the AEDs to be available for use in the more than 2.4 million public places they are available for use across the country, like restaurants, shopping malls and airports.

“Automated external defibrillators save lives,” said William Maisel, M.D., M.P.H., deputy director of science at the FDA’s Center for Devices and Radiological Health. “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.”

Officials feel AEDs are a valuable tool to help save lives and the life saving benefits outweigh the risk of removing AEDs from the market completely during the proposed changes.

One complaint that continues to surface during the proposed changes is the lack of control of manufactured components from other suppliers. An FDA approved panel recently proposed to require pre-market applications (PMAs) for AEDs. PMAs must contain clinical data to support the devices approval, safety and effectiveness data, review of manufacturers quality systems information and inspection of the manufacturers facilities.

The FDA will take comments on the proposal for 90 days, if passed they will exercise enforcement discretion for a year and a half to manufacturers who notify the FDA of their intent to file a pre-market application.