External Defibrillator Improvement Initiative
MedSun: Newsletter #55, December 2010

FDA Medical Device Safety

FDA is beginning an initiative to foster the development of safer and more effective external defibrillators through improved design and manufacturing practices, and urge industry to address current practices for identifying, reporting, and acting on the device complaints. FDA will host a public workshop on December 15 - 16, 2010, with multiple stakeholders to facilitate the development of next-generation defibrillators, enhance surveillance of defibrillators in community settings, and improve the rapid delivery of treatment for sudden cardiac arrest patients.

Additional Information:

FDA Medical Device Safety. External Defibrillator Improvement Initiative. November 15, 2010.
http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/CardiovascularDevices/ExternalDefibrillators/ucm232302.htm


MedSun Newsletters are available at www.fda.gov/cdrh/medsun