It’s official: The FDA has announced it will strengthen its review process for AEDs, to help improve their quality and reliability. That includes necessary AED accessories, such as batteries, pad electrodes and adapters.
For aquatics facilities that keep automated external defibrillators (AEDs) on hand in case of emergencies, it's welcome news. These portable, electronic medical devices are used to administer shocks to persons who have gone into cardiac arrest.
There has been much talk about AED reliability over the years. From January 2005 to September 2014, the FDA received 72,000 medical device reports associated with AED failures. Manufacturers have conducted 111 recalls affecting more than 2 million AEDs since 2005. The problems seem to revolve around design and manufacturing issues.
The FDA first came out with a proposed order in 2013 to require AED makers to submit premarket approval applications, or PMAs. After that, the agency studied comments from the public. The final order was announced on Jan. 28, 2015. (A PMA is the FDA process of scientific and regulatory review to evaluate the safety and effectiveness of Class III medical devices.)
So what will all of this mean for the manufacturers? As the FDA explains it, by requiring premarket approval for AEDs, the agency will receive key data about a manufacturer’s quality systems. The FDA also will inspect the manufacturing facility. If approval is granted, the devices are good to go. But that isn’t the end of it. The manufacturer must submit to the FDA any changes made to the AEDs that affect safety or effectiveness – and turn in annual reports on the devices’ performance.
AEDs now on the market will remain available as manufacturers prepare to meet the new PMA requirements. “Automated external defibrillators save lives. These changes to the way these devices are reviewed will allow us to more closely monitor how they are designed and manufactured,” stated William Maisel, acting director of the Office of Device Evaluation in the FDA’s Center for Devices and Radiological Health. “This will go a long way toward correcting long-standing problems and ultimately improving the reliability of these devices.”
-- Photo by Owain Davies