FDA to launch a program to promote manufacture of safer and superior external defibrillators

The FDA says in a news release that it will launch a program to promote manufacture of safer and superior external defibrillators. Defibrillators are used to correct heart rhythms. External defibrillators are used thousands of times a year to treat cardiac arrest. Automated external defibrillators (AEDs) are conspicuous in public places. They are even more conspicuous in homes, airports and office buildings. Complex external defibrillators are handled by health care professionals in hospitals. Almost 300,000 Americans suffer cardiac arrest each year. They may die if normal rhythm is not restored promptly. Amongst the many steps taken immediately to revive the patient is the delivery of a high-energy shock from an external defibrillator. 

 

During the past five years, more than 28,000 instances of failure of external defibrillators have been reported to the Center for Devices and Radiological Health (CDRH) of FDA. Manufacturers have recalled hundreds of thousands of the device. Many of the failures reported to CDRH can be traced to engineering design and manufacturing practices, among others. These failures which can impact patient safety can be prevented and corrected. Hence CDRH is all set to work with manufacturers, users and experts to develop the next generation of the product. 

 

CDRH is to release a white paper explaining the steps it is initiating to enhance the safety of external defibrillators and encourage the development of safer and superior technologies in the days to come as part of its External Defibrillator Improvement Initiative. 

 

 

Promoting innovation of next-generation external defibrillators to enhance their safety and effectiveness

Honing the capability of industry and FDA to identify and address problems associated with the devices being marketed so safety risks can be addressed quicker and better. 

Defining a premarket regulatory pathway for AEDs to promote best practices for design and testing.

 

The initiative will be launched with a public meeting on Dec 15-16, 2010 at the FDA headquarters. Industry and other stakeholders will thrash out ways to improve the defibrillators. Jointly with the University of Colorado’s Department of Emergency Medicine, FDA will make the AEDs more user-friendly. A multi-city pilot project will be undertaken to link AEDs with local emergency medical services so that as soon as an AED is used, an emergency rescue team can be rushed.