The US Food and Drug Administration (FDA) has issued a proposed order aimed at helping manufacturers improve the quality and reliability of automated external defibrillators. The proposed order, if finalised, announced the FDA, will require manufacturers of these life-saving devices to submit pre-market approval applications.
The FDA has reported that although automated external defibrillator devices have saved lives over the years, it received approximately 45,000 adverse event reports between 2005 and 2012 associated with the failure of these devices. Manufacturers have also conducted dozens of recalls. The problems the FDA is seeing with automated external defibrillators are preventable and correctable. The most common issues involve the design and manufacture of the devices and inadequate control of components purchased from other suppliers.
“Automated external defibrillators save lives,” said William Maisel, deputy director of science and chief scientist at the FDA’s Center for Devices and Radiological Health. “However, the agency is concerned about the number of recalls and manufacturing problems that have been associated with these devices and we are committed to working with manufacturers to address these issues.”
The FDA has announced that it will make sure that automated external defibrillators remain available. Although there have been problems associated with these devices, their life-saving benefits outweigh the risk of making them unavailable during the classification process.
Ultimately, the proposed review process will allow the agency to more closely monitor how these devices are designed and manufactured to improve the safety of this technology.
The recently enacted Food and Drug Administration Safety and Innovation Act calls for the FDA to publish a proposed and final order to reclassify or call for premarket approvals for a pre-amendments device. The FDA’s Circulatory System Devices Panel recommended that AEDs remain Class III medical devices and require pre-market approvals. The FDA is issuing this proposed order and calling for pre-market approvals as part of the 515 Program to ensure the appropriate regulation of Class III pre-amendments devices.
Maisel said: “If our proposed order is finalised, the FDA intends to focus its review of the pre-market applications on the more problematic aspects of automatic external defibrillators.”
The FDA will take comments on the proposed order for 90 days. If the proposed order is finalised, the FDA intends to exercise enforcement discretion for those manufacturers that notify the FDA of their intent to file a pre-market approval in a timely manner. The FDA intends to exercise enforcement discretion for a year and a half.