FDA issues new rules for defibrillators

The Food and Drug Administration is working to improve the quality and reliability of automated external defibrillators, medical devices used to help people in cardiac arrest.

The agency issued a final rule Wednesday that will require AED manufacturers to go through more rigorous reviews and submit premarket approval applications.

“Automated external defibrillators save lives,” Dr. William Maisel, the FDA’s deputy director for science, said in a statement.

“These changes to the way these devices are reviewed will allow us to more closely monitor how they are designed and manufactured. This will go a long way towards correcting long-standing problems and ultimately improving the reliability of these devices.”
From January 2005 to September 2014, the FDA said it received 72,000 reports of device failures. Since 2005, manufacturers have issued 111 recalls for more than 2 million AEDs.

The FDA said the problems stem from design and manufacturing issues, like inadequate control of the components that are purchased from other suppliers.

The devices, which automatically sense potentially life-threatening cardiac arrhythmias and either automatically deliver or advise the user to deliver electrical stimulation to re-establish normal heart rhythms, come with a number of accessories including batteries, pad electrodes, adapters and hardware keys for pediatric use.

AEDs in the market now will remain available while manufacturers work to meet new premarket approval application requirements including pre-approval inspections, reviews of changes in manufacturing facilities where the devices are made and reviews of design and manufacturing changes.