As of February 3, 2022, accessories for non-FDA approved automated external defibrillators (AEDs) and professional defibrillators, “must no longer be supported by manufacturers,” according to the U.S. Food and Drug Administration (FDA).
The FDA informed the manufacturers, distributors, owners, users and prescribers of all AEDs and defibrillators about this update.
For a unit to be considered non-FDA approved, that means the manufacturer failed to file for a premarket approval application (PMA) prior to the modified deadline of February 3, 2022. The revised compliance policy deadline was intended to give facilities additional time, especially during the coronavirus pandemic, to acquire FDA-approved AEDs, and for manufacturers to file the necessary PMA for accessories.
What are AEDs?
When someone’s heart unexpectedly stops beating, which is known as sudden cardiac arrest, an AED is designed to help save their life. These devices are portable and the system includes accessories (e.g. a battery and electrodes). These supporting components play a critical role in the device delivering an electrical shock to the heart. There are two main types of AEDs — a version for use in public spaces, and a version for use by professionals such as paramedics.
What is the consequence of these requirement changes?
It means that, in the United States, no individual or organization has the ability to buy or sell accessories for non-FDA approved AEDs. In other words, non-approved AEDs and defibrillators are no longer viable products.
Which units are impacted?
To comply with these new requirements, “accessories” will no longer be available for these non-FDA approved devices, such as adapters, batteries, cables, hardware keys, pad electrodes, and other parts. Additionally, service will not be available for these units. The mandate effects a number of medical devices. Please contact us at Auxo Medical if you have questions about particular devices. Visit the FDA’s website for a full list of approved AEDs.
What steps should you take if your device is out of compliance?
Upgrade to a compliant AED or defibrillator. Call us at (804) 233-4424 if you’d like assistance in choosing the best device based on your needs.