FDA Proposal Aims to Improve Reliability of Emergency Defibrillators
Following 45,000 reported emergency defibrillator failures over the past seven years, the U.S. Food and Drug Administration (FDA) is planning to introduce new rules that will improve the reliability of the devices.
Automated emergency defibrillators deliver an electric shock to jump-start the heart after a sudden stop. They were subject to 88 recalls from 2005 to 2012 in addition to thousands of reported malfunctions. The exact number of deaths resulting from malfunctions is impossible to estimate, as some deaths may have occurred regardless of defibrillator use.
The FDA states that their new proposal will require defibrillator manufacturers to provide clinical data proving their devices are safe and effective for the products to enter or remain on the market. Furthermore, manufacturers will have to submit inspection reports detailing any changes made to their devices.
The FDA indicates that the most common problems result from the design or manufacture of the defibrillator, as the manufacturers use inadequate controls on components purchased from suppliers. The FDA will focus on tightening regulations on this process when implementing their new proposal.