FDA seeks to improve manufacturing of AEDs

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The FDA has launched a new initiative to improve the manufacturing practices and design of automated external defibrillators (AEDs) in hopes of making them safer and more effective for patients with shockable heart rhythms.

The initiative is an attempt to hinder the over 28,000 medical device reports that have surfaced in the past five years that have been associated with external defibrillator failures, which have led to a slew of recalls.

“Many of the types of problems that CDRH [the FDA’s Center for Devices and Radiological Health] has identified are preventable, correctable, and can impact patient safety,” said the agency. Most of the problems have been associated with the design and manufacturing practices, the FDA said.

“These devices play an important role in healthcare,” said CDRH Director Jeffrey Shuren, MD. “The purpose of our initiative is to improve these technologies so we can save more lives.”

Under the initiative, CDRH said that it will:

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

The agency will collaborate with the University of Colorado’s department of emergency medicine to develop a multi-city AED registry to collect information about AED usage and attempt to integrate AED features such as automated integration into local 9-1-1 systems.

A public meeting will be held Dec. 15-16 at FDA headquarters to discuss the initiative with stakeholders.