Are Your Facility's Defibrillators FDA Approved?

Over the last several years, the U.S. Food and Drug Administration (FDA) has been adding more stringent regulatory requirements for manufacturers of Automated External Defibrillators (AEDs) to ensure their safety and effectiveness. After serious concerns about reported adverse events and several high-profile recalls of these units, the FDA deemed additional oversight was necessary and issued a final ruling in 2015 requiring AED manufacturers to receive “pre-market approval” (PMA) for their AEDs, the most stringent type of review required by the FDA. Because of the importance of these life-saving medical devices, only AEDs that provide valid scientific evidence and demonstrate an assurance of safety and effectiveness may obtain premarket approval, which includes all necessary AED accessories including pads and batteries, for these affected defibrillators.

The final ruling allowed manufacturers five (5) years to comply with the order if their AEDs were previously cleared and currently on the market. However, in October 2020, the FDA extended the deadline 1 year to comply with the final order from February 2021, until February 2022 so that the medical community can concentrate efforts on combating the on-going COVID-19 pandemic. This deadline extension gives both owners of non-FDA approved units, and manufacturers of these units more time to produce the necessary accessories required for AEDs to effectively operate and function during cardiac arrest events. There are several implications for owners of defibrillators that are far reaching if facilities have AEDs installed that are not FDA-approved or have yet to obtain FDA approval. We will cover this later.

After the effective date of the final order, newly developed AEDs and necessary AED accessories must now have pre-market approval to be legally marketed and sold in the United States.  The FDA website recommends the following concerning FDA-approved and non-approved AEDs:

There are now FDA-approved AEDs available, and we encourage you to ensure your AED is FDA-approved; if it is not, we encourage you to begin making plans to transition to an FDA-approved AED.

If you or your organization own(s) an AED system, the FDA recommends you:

• Check the table {sic} to see if your AED is FDA-approved. Contact the manufacturer of your AED if you are not sure if your AED is FDA-approved.
• Contact the manufacturer of your AED if your AED is not FDA-approved and you have not received a letter about your AED.
• Be aware that if your AED is not FDA-approved, compatible necessary AED accessories may no longer be available to support your AED after February 3, 2022.
• Contact the manufacturer of your AED or AED accessories for information specific to your product.
• Given the importance of these devices in emergency situations, the FDA recommends you continue to keep your AED available for use until you receive an FDA- approved AED.
• Report problems with AEDs to the FDA by submitting a voluntary report online at MedWatch: (MedWatch: The FDA Safety Information and Adverse Event Reporting Program | FDA)

So, what does this mean to facilities and industries with AEDs installed for the protection of employees, contractors and visitors? Quite simply, once the final deadline arrives and a device PMA is not filed by February 3, 2022, the manufacturer must cease marketing their accessories.  The inability to purchase pads, batteries and other accessories will essentially make non-approved FDA AEDs obsolete. For those organizations with hundreds or thousands of units installed, this can be a monumental undertaking to remove and replace these units with FDA-approved devices. 

There are a couple key reminders to owners of defibrillators to ensure AEDs are complaint and ready for unexpected cardiac arrest events. It is important to note that each state is different with regards to defibrillators.  To minimize risk and tort liability exposure, facilities with AEDs should ensure compliance with each state’s legislation where their AEDs are installed.  Legal operational requirements generally require that all AEDs are maintained, operational, and personnel are not only trained on AEDs, but also have obtained CPR certification (by completing a hands-on CPR training course) from a nationally recognized training provider.

In addition to training, several states legally require EMS agency notification, medical oversight and a written AED plan. Obtaining Medical Oversight can ensure your AED program meets legal compliance and is a key step in reducing lability due to negligence. Written AED plans outline day-to-day responsibilities that cover general maintenance, inspections, deployment strategies and the tracking of important equipment, such as expiration dates of pads and batteries so they remain operational. According to the Sudden Cardiac Arrest Foundation, 34 states offer limited liability protection for AED-related activities, but almost none cover gross negligence such as removing batteries due to chirping (signifying a low battery warning) or failing to replace expired pads or dead batteries.

Automated External Defibrillators have been proven to save thousands of lives.  But in order to do so, they must be properly maintained so they remain operational. The Sudden Cardiac Arrest Foundation also highlights an analysis of AED failures reported to the FDA that reveals “problems with pads and connectors accounted for 23.7 percent of the failures and battery power problems accounted for 23.2 percent of the failures.” Further, “only 1.5% of adverse event reports included records of a maintenance program or schedule. It is impossible to know whether “AED failures” occurred in well-maintained devices—or devices that were inadequately maintained.” 

Out of an abundance of caution it should be restated, do not remove non-approved AEDs from service until they are physically replaced with an FDA-approved device. Non-approved AEDs can remain in-service until the accessories can no longer be purchased from the manufacturer. Without speculating too much on what specific manufacturers will do, but if they maintain adequate stock of supplies of batteries and pads, owners of non-approved AEDs may have up to a year or two (at most) to replace these AEDs with FDA-approved ones. However, there is simply no guarantee that AED manufacturers of non-approved AEDs will continue to manufacture accessories for units that can no longer be marketed or sold after February 2022, so the time to plan for replacing non-approved AEDs is now.

To find out if your AED is FDA approved, visit the FDA website at Automated External Defibrillators (AEDs) | FDA (https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P160022)

The official letter from the FDA to owners of AEDs about FDA-approved AEDS can be accessed here: https://www.fda.gov/media/131108/download . (Please note that the official letters has the original deadline of February 2021, not the deadline extension until 2022.)

Visit the Sudden Cardiac Arrest Foundation to read more about the importance of implementing and maintaining a viable AED management program to minimize unexpected device failures that can be prevented through normal inspections and maintenance schedules. https://www.sca-aware.org/sca-news/report-on-aed-failures-a-reminder-that-maintenance-is-vital.