Manufacturers of these life-saving devices will need to send in pre-market approval (PMA) applications if the proposed order is finalized.
AEDs are medical tools that are portable and electronic. By using electrical stimulation, they are able to automatically re-establish regular heart rhythms when they sense possibly fatal cardiac arrhythmia.
Many lives have been saved over the years because of AEDs. A previous study demonstrated that victims of sudden cardiac arrest who are treated with AEDs by bystanders are much more likely to survive.
However, there have been about 45,000 adverse events reported to the FDA between 2005 and 2012 linked to the failure of these devices.
Dozens of recalls have also been conducted by manufacturers. The issues that are being called to the FDA's attention regarding AEDs are ones that can be prevented and fixed.
The most common problems include:
- insufficient management of components bought from other suppliers
- the design and manufacture of the devices
"Automated external defibrillators save lives. However, the agency is concerned about the number of recalls and manufacturing problems that have been associated with these devices and we're committed to working with manufacturers to address these issues."
An AED - The FDA is concerned about the number of recalls and manufacturing problems
The FDA promises to ensure that automated external defibrillators continue to be obtainable in order to keep saving the lives of patients.
Even though there have been issues related to AEDs, the experts explained, the fact that they are life-saving is greater than the risk of making them unobtainable during the classification process.
The agency will essentially be able to more closely examine how these devices are designed and manufactured through this proposed review process. In the end, this life-saving tool will undergo significant improvement.
The Food and Drug Administration Safety and Innovation Act, which was recently passed, demands that the FDA issue a proposed and final order to reclassify or call for PMAs for a pre-amendments device.
The FDA's Circulatory System Devices Panel suggested that AEDs continue to be Class III medical devices and call for PMAs. As part of the 515 Program, the FDA is publishing this proposed order and requiring PMAs to establish the proper regulation of Class III pre-amendments devices.
In order to include clinical data to support the approval of a product, PMA applications are necessary.
Maisel added, "If our proposed order is finalized, the FDA intends to focus its review of the pre-market applications on the more problematic aspects of AEDs."
A PMA must contain:
- data on the clinical safety and successfulness
- an analysis of a manufacturer's quality systems data
- an examination of its manufacturing facilities
The experts said:
"The FDA will take comments on the proposed order for 90 days. If the proposed order is finalized, the FDA intends to exercise enforcement discretion for those manufacturers that notify the FDA of their intent to file a PMA in a timely manner. The FDA intends to exercise enforcement discretion for a year and a half."
Written by Sarah Glynn