The U.S. Food and Drug Administration has recently announced it will be taking appropriate action to ensure the safety and reliability of automated external defibrillators (AEDs). This announcement comes as a response to the over 72,000 complaints the FDA has received over the past 10 years that these potentially life-saving products had failed.
The AEDs in question were not located in hospitals or medical facilities, but in public places such as airports. When a person is having a suspected heart attack, these devices automatically detect potentially deadly heart rhythm problems and deliver an electrical shock to restore normal rhythm.
However, there have been thousands of reports of the devices malfunctioning. There have also been 11 different recalls of AEDs in the past decade. In its announcement, the FDA says that it will be clamping down on its approval process for not only the devices, but also for adapters, batteries, pad electrodes, and other accessories that are associated with the device.
The agency will also now be conducting inspections at manufacturing plants that produce AEDs and will require companies to file annual reports about the products, as well as report any alterations to the device’s design which could affect how effective the product is, as well as its safety performance.
These new rules will go into effect August 3, 2016.
Our personal injury firm has reported on many defective medical devices, including the large number of products that have been recalled over the past decade. Many of these defective medical product recalls result in thousands of injuries or deaths of victims. If you have suffered serious illness or injury from a defective medical product, contact an experienced Virginia personal injury attorney to find out what compensation you may be entitled to for your pain and loss.