By: Richard A. Lazar
Copyright © Readiness Systems, LLC – All rights reserved
Sudden cardiac arrest (SCA) remains a challenging public health problem in the U.S. Over 360,000 people experience out-of-hospital SCA each year and over 90 percent will not survive. Today, less than 3 percent of people experiencing SCA are treated by bystanders using automated external defibrillators (AEDs) before professional emergency medical services (EMS) personnel arrive.
Over the past several years, numerous organizations, including the U.S. Food and Drug Administration (FDA), have begun promoting the idea of AED registries as a potentially life-saving tool that will lead to higher bystander AED use rates and result in more SCA victims receiving bystander defibrillation more quickly. The suggested concepts of making AED registry data available to 911 dispatch agencies and populating mobile apps so that bystanders might be guided to nearby AEDs sound good in theory. Unfortunately, there are many reasons why it is not yet possible for AED registries to meaningfully increase AED use or survival rates. Reasons include real-world data and AED program limitations, risk management and legal liability concerns of AED owners, counterproductive and poorly written AED Good Samaritan immunity laws and technology limitations, among others.
Potential Public Health Risks
Public health awareness efforts have long focused on the American Heart Association’s Chain of Survival, including early activation of 911 and the importance of bystander CPR and early defibrillation. There is a risk that promoting AED registries and mobile apps (effectively adding another link to the Chain of Survival) will create the real possibility of confusing bystanders and causing delays in calling 911, beginning CPR and delivering early defibrillation. Moreover, focusing on AED registries may detract from efforts to further expand AED placements and encourage bystander CPR.
Unreliability of AED Registry Data
Today, AED location and operational status information is supplied solely by people because AEDs are not capable of broadcasting location or status data electronically. Various AED registry websites encourage AED owners to register their devices and a number of crowdsourcing and gamification efforts have sought to gather this information. There is no reliable way, however, to validate the accuracy of the data when first entered and much of the data in registries is rarely updated. AEDs may move, be taken out of service or become inoperable and these status changes are most often not reflected in registries. More importantly, only a minuscule fraction of the estimated 3.2 million plus public access AEDs now deployed in the U.S. are now “registered.” Furthermore, there are currently no cost-effective methods of delivering real-time indoor GPS-like functionality so mobile apps tied to AED registries cannot deliver reliable directions to nearby AEDs. As a result of these limitations, AED registry data cannot and should not be relied upon by 911 dispatch agencies or mobile app users involved in actual SCA emergencies. This limitation may be fixed in the future if and when AEDs are capable of broadcasting real-time location and status information and indoor GPS functionality matures.
AED Registry System Limitations
Several public and private AED registry systems are now operating throughout the U.S. with more expected to come online in the near future. No single registry serves as the central repository for all AED location and status data nor is a central repository feasible. Moreover, AED manufacturers and service providers maintain separate AED databases for a variety of purposes. As a result, there is no reliable, operationally efficient or effective way to distribute aggregated AED data to 911 dispatch agencies or mobile apps for real-time use in SCA emergencies. Thus, the utility of this approach is quite limited.
The FDA may be considering efforts to impose an AED registry mandate. Whether primarily for epidemiological purposes or for 911 agency use, this approach is unlikely to work. This is because the agency has no regulatory authority to force AED owners to register their devices or to require local 911 dispatch agencies to consume AED registry data. Further, in contrast to the national ICD Registry which ties hospital reimbursement to ICD registration, the federal government lacks equivalent economic leverage to force AED registration or AED data utilization. Given these limitations, the better approach is for the FDA to refrain from considering an AED registry mandate until effective methods exist to capture and utilize AED location data.
911 Dispatch Agency Fragmentation
There are nearly 6,000 911 dispatch agencies in the U.S. and less than a handful have developed systems and methods for integrating and utilizing AED location data in the SCA emergency call process. In fact, few agencies view the ability to direct callers to nearby AEDs as an operational priority. Dispatch agencies electing to leverage AED location information must be able to accept data from multiple registries (see previous limitation) each with its own proprietary data format and distribution methodology. Implementing such a complex system is a burdensome proposition that will be viewed by many as a poor use of public resources.
Legal Liability Constraints
The theory behind the AED registry operating model is that bystanders will be directed to nearby AEDs either by 911 dispatchers or mobile apps. Even if AEDs are registered, this presumes that AED owners will allow their devices to be taken from the owner’s site to another location. This is unlikely in the current legal environment. AED owners remain highly sensitive to liability risks and their lawyers will legitimately resist allowing AEDs to be removed from the owner’s property. Current AED Good Samaritan immunity laws offer few legal protections to the organizations and people involved in AED programs. These laws are of little help in encouraging the broader AED operating model envisioned by AED registry proponents. While the risks associated with this limitation can be mitigated using creative AED program design and risk management approaches, absent significant changes in the litigation environment and existing AED laws, liability concerns will remain a barrier to the widespread real-time use of AED registry data in SCA emergencies.
Meaningful Short-Term Solutions
The limitations associated with AED registries are daunting and will act as barriers for years to come. In the short term, energy and resources are better directed toward more effective approaches. Examples include:
There may come a time in the future when AED registries can play a role in saving lives from SCA, but today they are not an effective tool that should be pursued for use in real-time SCA response situations.