Nearly 90% of AEDs are located outside the hospital. But who’s maintaining these life-saving devices? Here’s how you can help.

By Binseng Wang, ScD, CCE

As a reader of 24×7 Magazine, you are likely a clinical engineering (CE)/HTM professional who has already helped to save quite a few lives through medical equipment management and maintenance—and are finally receiving overdue recognition for these efforts—during the COVID-19 pandemic. However, I think you can save even more lives if you are willing to join me and many others in managing a new challenge I’d like to share with you.

You’re probably very familiar with the automated external defibrillators (AEDs) that exist in your healthcare delivery organizations (HDOs) and what needs to be done to keep them operational. But have you thought about the AEDs that are located outside of HDOs and scattered in public and private locations, such as schools, churches, office buildings, shopping malls, and fire departments?

According to the American Heart Association, almost 90% of AEDs are located outside of HDOs. Since the total number of AEDs in the United States has been estimated to be around 3.2 million, this means almost 3 million AEDs are in locations where there is no HTM professional to manage them.

Granted, some AED owners may have learned that they need to check these devices for battery status and the electrode pads’ expiration dates (this is because only some state laws require routine maintenance while others only “encourage” it[3]). However, how many of them are aware that in less than a year, they may no longer be able to buy accessories (electrode pads, batteries, and replacement parts) for those older AEDs? Even if they have stocked up on those accessories, their AEDs are still “living on borrowed time” until the expiration dates of those accessories have been reached.

Highest-Risk Devices

The origin of this challenge goes back to 2015. Up to that time, the U.S. FDA “cleared” AEDs—through the 510(k) premarket clearance process—without requiring controlled clinical trials. After noticing the high number of patient incident reports (more than 28,000) and recalls (68) motivated by engineering design, manufacturing, and supplier control problems over a five-year period, the FDA decided in 2015 to reclassify AEDs to the highest risk level of medical devices (i.e., Class III).

This reclassification means AED manufacturers now must submit premarket approval (PMA) requests for both AEDs and the associated accessories (electrode pads, batteries, and replacement parts). The FDA started to enforce the PMA requirement for AED machines in April 2019 and had initially scheduled the enforcement deadline for related accessories for February 2020. Twice, the FDA postponed the deadline for PMA submission for the accessories, first to Feb. 3, 2021, and then to Feb. 3, 2022[6], considering the challenges imposed by the pandemic.

In other words, in less than a year, owners of AEDs—including HDOs—must proactively address this challenge. While it is unlikely that “previously cleared” AEDs will fail to function (unless the accessories or batteries have expired) or that the FDA will go out and seize them, it will be difficult, if not impossible, to acquire the necessary accessories to operate or repair them some time after the Feb. 3, 2022, deadline.

There is also the remote possibility that a negligence lawsuit could be filed against and AED owner/operator by the family of an unsuccessfully revived patient because of an illegal—aka “adulterated”—and/or allegedly inoperable AED being used. Therefore, AED owners must start planning to replace “previously cleared” AEDs and accessories with “PMA-approved” ones as soon as possible or, at least, stock up on the “previously cleared” accessories until their capital budget allows for replacement.

Unfortunately, this action is not easy to implement. Many AED owners have lost significant income during the pandemic and, thus, are severely limited in their capital investment capabilities. In addition, manufacturers of “previously cleared” accessories are also unlikely to commit to increasing production because they know that after Feb. 3, 2022, it will be illegal (in U.S.) for them to market those accessories, so there will likely be a shortage of accessories by the deadline.

Finally, the worst issue of all is AED owners’ and operators’ lack of knowledge about this predicament. AED manufacturers do not—and are not required by the FDA to—maintain a current list of all AED owners. Some, but not all, states have established AED registries and/or requirements for entities that sell, supply, or acquire an AED to provide notification of the AED to the appropriate emergency medical services (EMS) system.

How to Save a Life

Complicating the issue? Some AEDs were received as donations, instead of being purchased by their current owners. This means that manufacturers’ alerts likely never reached them or got lost between the original purchaser and the current owner. No one knows exactly how many “previously cleared” AEDs are out there, but the number could be as high as 1 million if we assume—optimistically—that two-thirds have already been replaced with PMA-approved ones.

To help you appreciate the significance of this challenge, I would like to share some data. According to the American Heart Association, each year roughly 360,000 people suffer from sudden cardiac arrest (SCA). Patients experiencing SCA, or malignant arrhythmias followed by SCA can be successfully resuscitated with an AED if the shocks are delivered within eight minutes after the onset of SCA. Even then, the success rate is only 25% at most. After this short period of time, the potential for successful defibrillation by electric shocks decreases almost exponentially.

I am quite confident that most of you reading this have already advised your respective HDOs to take appropriate action because you are competent and dedicated CE/HTM professionals who take your responsibilities seriously. However, there are few, if any, similar professionals in charge of AEDs outside of HDOs.

So, it is critical that you help spread the word about this upcoming challenge in your city, county, or state, through friends and acquaintance in EMS organizations, fire departments, civic organizations, CE/HTM associations, etc. In doing so, you could help save dozens or more lives, including those of your family members, relatives, friends, colleagues, or even yourself.

Binseng Wang, ScD, CCE, fAIMBE, fACCE, is vice president of program management at Sodexo HTM. Questions and comments can be directed to 24×7 Magazine chief editor Keri Forsythe-Stephens at editor@24x7mag.com.

References:

  1. https://www.heart.org/idc/groups/heart-public/@wcm/@adv/documents/downloadable/ucm_301646.pdf
  2. https://readisys.com/the-aed-shortage/#:~:text=We%20estimate%20there%20are%20approximately,number%20of%20people%20experiencing%20SCA
  3. https://www.cdc.gov/dhdsp/pubs/pad_slfs.htm
  4. https://www.emsworld.com/article/10319027/fda-sets-sights-improved-defibrillator-performance
  5. https://www.todaysmedicaldevelopments.com/article/medical-device-design-manufacturing-fda-defibrillator-111810-tmd/
  6. https://www.fda.gov/medical-devices/cardiovascular-devices/automated-external-defibrillators-aeds#check
  7. https://www.cdc.gov/dhdsp/pubs/pad_slfs.htm
  8. https://www.heart.org/idc/groups/heart-public/@wcm/@adv/documents/downloadable/ucm_301646.pdf
  9. https://psnet.ahrq.gov/web-mm/resuscitation-errors-shocking-problem#table