Pharmaceutical

Defibrillator recall reinforces need for tougher quality standards

A nationwide recall is underway for a type of automated external defibrillator (AED) manufactured by Cardiac Science. The device, designed to resuscitate patients who are in cardiac arrest, has a defect that may cause it not to deliver adequate defibrillator therapy, which could lead to serious injury or death. This recall is listed as a Class 1, which is the most serious type of recall and involves situations in which there is a reasonable probability that use of these products may cause serious adverse health consequences or death.

AEDs by various manufacturers have been plagued by defects over the years, resulting in recalls of dozens of devices. In 2009 alone, the Food and Drug Administration (FDA) issued 17 recalls on the devices for problems ranging from confusing instructions to wiring problems to memory chip defects.

Between January 2005 and May 2010, the FDA received more than 28,000 adverse event reports for external defibrillators, including malfunctions, patient injuries and deaths. Details in the reports varied greatly among manufacturers, which left the FDA limited in its ability to identify, track and address device safety problems.

As a result of the mounting problems with AEDs, the FDA held a meeting with manufacturers to discuss solutions to problems with the devices. The meeting is part of an External Defibrillator Improvement Initiative designed to foster the development of safer and more effective external defibrillators through improved design and manufacturing practices for identifying, reporting and acting on the device complaints.

To further its effort to remedy the problems with AEDs, the FDA is also teaming up with the University of Colorado’s Department of Emergency Medicine to develop a multi-city AED registry that will collect information about AED usage and provide the infrastructure to allow development of innovative AED features, such as automated integration into local 9-1-1 systems.

Sources:
FDA
Beasley Allen Personal Injury
Cardiac Science