What is a Recall?
AEDs (automated external defibrillators) are used to resuscitate people who have suffered from a sudden cardiac arrest (SCA). In case of SCA, an AED will send a shock to the victim’s heart by analyzing the heart rhythm to check for a beat.
AEDs are classified as Class III medical devices; as such they are regulated by the Food and Drug Administration (FDA). This means the FDA monitors the safety and effectiveness of all AED devices and they have the power to enforce device recalls. A device recall is an action taken to remove or correct problems with products that are in violation of regulations and/or laws administered by the FDA. If an AED is recalled by the FDA it is important to adhere to the instructions that they provide in order to keep your AED safe and effective in case of an SCA event.
An AED manufacturer will recall a device in one of three scenarios:
- The AED is defective.
- The AED could be a risk to health.
- The AED is both defective and a risk to health.
Depending on what action must take place, a recall will be either a correction or a removal.
A correction, or corrective action, is a recall that addresses the problem with the AED by correcting the issue in the place where the device is used or sold.
A removal addresses the problem by removing the product from the field.
Although the FDA can require a company to recall a device, recalls are usually voluntary. Because companies have a responsibility to protect the public health and well-being from products that present a risk of injury or are defective, the FDA rarely must mandate a recall.
To respond to an issue, the manufacturer will compose a plan of action called a recall strategy. It will provide the outline of how to proceed and will address the depth of the recall, public warning and effectiveness checks. The FDA will review the adequacy of the strategy and monitor the implementation. The recall will end when the FDA determines that all reasonable efforts have been made to remove or correct the product in accordance with the recall strategy and desired end results. In this case, if your specific AED was part of the recalled defibrillators, you would need to call the company directly and they would provide you with future directions on how to mitigate the problem.
How do I Know if my AED is Recalled?
Manufacturers are required to report to the FDA a correction or removal of a product if it involves a risk of health within ten working days of the recall. If the manufacturer cannot make direct contact with the end user, they may use the news, social media or even post public flyers in an effort to reach the maximum number of people.
You can access the database for medical device recalls on the FDA's website. If you’re not sure whether your AED device has been recalled, you can contact ThinkSafe. They can answer any questions you might have regarding the recall or upgrade status of your specific AED device. The FDA also publishes a weekly FDA Enforcement Report where you can find all enforcement actions including recalls, field corrections, seizures, and injunctions.
What Does a Recall Mean for Me?
There are various outcomes to a recall. It does not always mean you must stop using the AED or return it. A recall may mean the medical device needs to be checked, adjusted or repaired. If your product has been recalled you will receive a letter via telegram, mailgram or first class letters unmistakably marked on the letter and the envelope. It will include specific instructions on what should be done regarding the AED. If you do not receive a letter but are made aware of the recall to your AED device you should contact the manufacturer and follow their instructions.
AED Recall vs. AED Update
It’s important to keep your AED defibrillator in working condition in case of an SCA. One way that you can make sure your AED is rescue-ready is by conducting updates on your AED device. The American Heart Association (AHA) has guidelines that you can use to monitor the effectiveness of your AED to prevent it from becoming outdated. Most AED manufacturing companies release free updates for both software and hardware of their AED devices, which can be found on the FDA recall website. These updates are critical for the health and life of your AED.