Too many defibrillator recalls, need stronger approval process

Dr. Michael Carome, deputy director of Public Citizen’s Health Research Group, testifies today before an FDA advisory committee regarding defibrillators.

Some highlights:

  • There have been 68 recalls of automatic external defibrillators (AEDs) from January 2005-August 2010, 17 of which were serious enough to be Class I recalls, involving situations in which there is a reasonable probability that using the product will cause serious injury or death.
  • Collectively, these 17 Class I recalls alone involve well over 100,000 AEDs distributed and have resulted in deaths or life-threatening situations for many patients. The details of one such recall, involving 14,054 units and occurring only after two patients had died, are included in today’s testimony.
  • Unless the FDA rejects the AED industry’s attempt to deregulate these devices and not require the kind of premarket studies that could clearly reduce the serious dangers of these inadequately tested devices, patients using these devices will be subjected to a continuation of this de facto human experimentation, with more recalls, more deaths and more life-threatening situations.
  • In the interest of protecting public health and promoting innovation, it is imperative that FDA reject industry wishes and instead maintain the class III categorization of AEDs and require AED manufacturers to submit premarket approval applications.  Such applications must include data from robust clinical trials that reasonably assure that AEDs are safe and effective.

Check out our work on medical device approval processes.