Health trends - Improving defibrillators

The United States Food and Drug Administration recently issued a proposed order aimed at helping manufacturers improve the quality and reliability of automated external defibrillators (AEDs). The proposed order, if finalised, will require manufacturers of these life-saving devices to submit pre-market approval (PMA) applications.

AEDs are portable electronic medical devices that automatically re-establish normal heart rhythms with electrical stimulation when they sense potentially life-threatening cardiac arrhythmias. Although these devices have saved lives over the years, the FDA has received approximately 45,000 adverse event reports between 2005 and 2012 associated with the failure of these devices. Manufacturers have also conducted dozens of recalls. The problems the FDA is seeing with AEDs are preventable and correctable. The most common issues involve the design and manufacture of the devices and inadequate control of components purchased from other suppliers.

"Automated external defibrillators save lives," said William Maisel, MD, MPH, deputy director of science and chief scientist 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."

The FDA will make sure that automated external defibrillators remain available so that they can continue to save lives. Although there have been problems associated with AEDs, their life-saving benefits outweigh the risk of making them unavailable during the classification process.

Ultimately, the proposed review process will allow the agency to more closely monitor how these devices are designed and manufactured.

Source: The US Food and Drug Administration