FDA Sets Sights on Improved Defibrillator Performance

   Citing dozens of recalls of external defibrillators and thousands of reports of the devices malfunctioning, the Food and Drug Administration has announced an initiative to develop safer and more effective defibrillators through improved design and manufacturing practices. It is also urging makers to address current practices for identifying, reporting and acting on complaints.

   Specifically, the new External Defibrillator Improvement Initiative will:

• Promote innovation of safer, more effective next-generation defibrillators;
• Enhance the ability of the industry and the FDA to identify and resolve safety problems with devices currently on the market; and
• Designate an appropriate premarket regulatory pathway for AEDs that promotes best practices for design and testing.

The project will involve all types of external defibrillators, including monitor/defibrillators, manual external defibrillators and AEDs.

   The FDA notes that from Jan. 1, 2005 to July 10, 2010, there were 68 defibrillator recalls. During the same period, it received more than 28,000 reports of problems. It conducted multiple inspections of external defibrillator manufacturers during those years, identifying issues it said are "preventable, correctable, and impact patient safety." Among them: engineering design and manufacturing practices, communicating systemic problems to users and reporting of adverse events.

   As part of this initiative, the FDA is proceeding with formal classification of AEDs. Medical devices are classified into three categories based on the level of control necessary to provide reasonable assurance of safety and effectiveness. Class III devices require the greatest level of control due to their lifesaving impact and potential for injury. AEDs are currently designated Class III, but per Congress the FDA must either downgrade them to Class II or put them through a tougher premarket approval process. A decision is expected in 2011.

   For more: www.fda.gov.