Tuesday, November 16, 2010

Shocking! - Over 28,000 Reports Of External Defibrillator Problems In Five Years, Says FDA

The FDA's Center for Devices and Radiological Health (CDRH) has received over 28,000 reports of external defibrillators going wrong over the past five years. Manufacturers have subsequently issued dozens of recalls.

The CDRH says that many of the problems it identified are unnecessary and correctable. Improvements in engineering design and manufacturing practices related to the proper control of the components bought from other suppliers would go a long way to sorting out the current problems.

Jeffrey Shuren, M.D., director of CDRH, said:

"These devices play an important role in health care. The purpose of our initiative is to improve these technologies so we can save more lives." CDHR says it is currently liaising with users, experts, and manufacturers, the aim is to make sure the next generation of external defibrillators have addressed the current problems.

CDRH says it will release a White Paper, describing its actions to improve the safety of these medical devices, as part of its External Defibrillator Improvement Initiative.

The initiative has the following aims:

  • To steer innovation towards safety and effectiveness
  • Make it easier and faster for the FDA and industry to respond to problems that exist with current devices
  • Set out an appropriate premarket regulatory pathway for automated external defibrillators that encourages good design and testing practices
A public meeting on December 15-16 at FDA headquarters in Silver Spring, Maryland, will mark the start of the Initiative. Together with the University of Colorado's Department of Emergency Medicine, the FDA says it will define enhancements which should improve ease of use and outcomes.

"External Defibrillator Improvement Initiative"

Posted via email from Jack's posterous

No comments: