FDA Launches External Defibrillator Improvement Initiative

Inviting manufacturers to a Dec. 15-16 public workshop, the agency says it intends to facilitate the development of safer, more effective "next-generation" devices.

The U.S. Food and Drug Administration announced a new External Defibrillator Improvement Initiative on Monday, noting that its the FDA’s Center for Devices and Radiological Health has received more than 28,000 medical device reports associated with the failures of external defibrillators during the past five years and dozens of recalls have been made. FDA said the program will facilitate the development of safer, more effective external defibrillators, including automated external defibrillators.

A Nov. 15 letter invites defibrillator manufacturers to a Dec. 15-16 workshop at FDA headquarters in Silver Spring, Md. The online page for the workshop says it has been called "to share FDA's understanding of the risks and benefits of external defibrillators, clarify FDA's current expectations for how industry should identify, report, and take action on problems observed with these devices, and to promote innovation for next-generation devices that will bring safer, more effective external defibrillators to market."

Many of the problems CDRH has identified are preventable and correctable, and they include engineering design and manufacturing practices related to the adequate control of components bought from other suppliers, according to the agency.

"These devices play an important role in health care," said CDRH Director Jeffrey Shuren, M.D., the letter's author. "The purpose of our initiative is to improve these technologies so we can save more lives."

CDRH will release a white paper that describes the program. Listed as goals are:

  • Promoting the innovation of next-generation external defibrillators to improve safety and effectiveness
  • Enhancing the ability of industry and the FDA to identify and resolve problems with devices currently on the market to address safety risks more quickly and effectively
  • Designating an appropriate premarket regulatory pathway for AEDs that promotes best practices for design and testing.

FDA said it is collaborating with the University of Colorado's Department of Emergency Medicine "to define the enhancements that will improve ease of use and outcomes, such as conducting a multi-city pilot of connecting AEDs with local emergency medical services so that when an AED is used, an emergency rescue team is rapidly dispatched."

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