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By:  Richard A. Lazar

Copyright © Readiness Systems, LLC – All rights reserved

Legislation enacted in Minnesota (2014 legislative session) requires automated external defibrillator (AED) owners to register their devices with an AED registry. While I understand the desired objectives of this type of legislation, the unfortunate reality is that the Minnesota law will not result in greater AED deployment, more effective AED programs or more lives saved. Rather, the law will discourage organizations from buying AEDs and will dramatically increase liability risks for AED owners and users. Read on for a detailed explanation about why this new law is bad public policy.

Click here to view the text of the law which became effective August 1, 2014.

WHY THE REGISTRY MANDATE IS BAD PUBLIC POLICY

Each of these reasons is discussed in detail below.

It is not clear what problem the law is trying to solve

The law provides that “[a] person who purchases or obtains a public access AED shall register that device with an AED registry within 30 working days of receiving the AED.”  But the purpose of this registration mandate is nowhere specified. As a general matter, reasons for registration could include: 1) making AED location data available to 911 dispatch agencies for real-time use during sudden cardiac arrest emergencies, or 2) promoting AED maintenance. The law hints at both but does not fully or understandably address either.

With regard to 911 integration, the law fails to specify whether or how AED registration information is to be used by any agency, and does not require or authorize AED registration information to be used by any agency for any purpose. With regard to AED maintenance, the law appears to dictate one specific method of tracking AED status among many available to AED owners. If the legislative objective of the law is to ensure the proper maintenance of AEDs, then an amendment to Minnesota Statutes section 604A.01 will better accomplish this goal. For example, a straightforward requirement that AED owners take reasonable steps to ensure AEDs are properly inspected and maintained is a less onerous and more effective approach than the registry mandate described in the law. Because industry standards already require proper AED inspection and maintenance, even this legislative change is not really necessary.

The law will increase liability risks for AED owners

The law imposes an AED registration mandate on AED owners but specifies no administrative sanctions for non-compliance. Thus, it is left to lawsuits to impose consequences for failing to register. Notwithstanding Subd. 11 of the law, lawyers suing AED owners will use any registration non-compliance as ammunition in negligence lawsuits whether or not such non-registration impacts the outcome of an underlying emergency response. (Note:  Minnesota’s existing Good Samaritan immunity laws offer no liability protection to AED owners.)

Further, the law is very poorly crafted meaning the courts will be required to interpret what the statute means in the context of contentious negligence litigation. For example, as noted below, the definition of “AED registry” is impossible to comply with. The definition of “Maintenance program or package” can be interpreted to mean an AED registry (ill defined) or a manual program of replacing expiring AED accessories. The law mandates that certain information be provided to AED registries yet no purpose for or use of the information is specified. Critically, the law fails to require that accessory expiration dates be included in reported registry information, though this is the most essential data attribute needed if AED maintenance is indeed the objective of the law. These are but a few of many internal and definitional inconsistencies found in the law. Unfortunately, AED owners will suffer the consequences of the law’s drafting deficiencies in the form of increased liability risks with no corresponding public health or safety benefits.

Named registries do not meet the “AED registry” definition contained in the law

The law defines “AED registry” to mean “a registry of AEDs that requires a maintenance program or package.” Neither of the specifically named third-party “registries” found in the law meet this definition. Indeed, there is no situation in which an existing AED registry “requires a maintenance program or package.” While a legislature can impose specific maintenance requirements on AED owners (as Subd. 5 of the law purports to do), registries themselves do not impose such operational requirements (rather, they support them) and thus no registry is capable of meeting the definition found in law. Indeed, an Excel spreadsheet coupled with a corporate AED maintenance policy arguably meets the registry definition contained in the law.

Criteria for specific AED registry naming are not specified in the law

Atrus (which operates the Minnesota AED Registry and the National AED Registry) and the EMS Safety Foundation (which operates iRescU) are both effectively named in the law. When the law was passed, Atrus was a very small for-profit corporation based in Florida. The EMS Safety Foundation is a very small not-for-profit “Think-Tank” based in New York. iRescU is described by the EMS Safety Foundation as a proof of concept application. Neither organization offers comprehensive AED program services to AED owners. Legislative criteria justifying or explaining the naming of these organizations in the law is not specified and thus there is no way to judge whether these organizations, or others, meet intended legislative purposes, particularly as here where legislative objectives are unclear. Further, specifically naming third-party organizations in legislation creates significant risk since these organizations may or may not continue to operate in the future.

The better approach is to clearly define legislative objectives associated with the registry mandate, link these objectives to a precise AED registry definition, and then allow any qualifying registry system (known in the industry as tracking systems of which there are many) to provide these services to AED owners. Unfortunately, the law does not take this approach.

The law fails to address registry system limitations

As noted above, the purpose of the registry mandate contained in the law is unclear. As a general matter, the concept of registry systems aspirationally revolves around making AED registry data available to 911 dispatch agencies and populating mobile apps so that bystanders might be guided to nearby AEDs. While this sounds good in theory, in reality there are many reasons why it is not yet feasible for AED registries to meaningfully increase AED utilization or survival rates. Reasons include real-world data and AED program operational limitations, risk management and legal liability concerns of AED owners, counterproductive and poorly crafted AED immunity laws, and technology limitations, among others. The law does not appear to be targeted toward 911/bystander cardiac arrest response and, in any event, fails to address any of these limitations.

CONCLUSION

While I understand the desired objectives of this type of legislation, the unfortunate reality is that the law will not result in greater AED deployment, more effective AED programs or more lives saved. Rather, the law will discourage organizations from buying AEDs and will dramatically increase liability risks for AED owners and users. For these reasons, we downgraded Minnesota’s AED Law Report Card grade from “D” to “F”.

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.

Copyright © Readiness Systems, LLC – All rights reserved

For organizations with AEDs, there is no real ability to outsource a true “turn key” AED program solution. This is because third-party service providers (e.g., AED program management services providers, equipment vendors and training organizations) are not on-site to witness sudden cardiac arrest, call 911, perform CPR or retrieve and use an AED. Nor do they have authority to direct organizational staff or sign off on an AED program’s operational design or documentation.

AED program management, equipment and training organizations can, however, play an important role supporting AED programs. The following charts illustrate the AED Program Lifecycle. The charts show those tasks owned exclusively by organizations with AEDs and those tasks that can appropriately be supported by third-parties. Even where third-party service providers are involved, AED program managers remain primarily responsible for how AED programs function.

Relatively few people get formal training, while the public generally perceives that only formally trained people can do CPR.

By:  Richard A. Lazar  |  Originally published February 1, 2020 in Occupational Health & Safety Magazine

Looked at objectively, the current emphasis on formal CPR training—go to a class, get a card—isn’t succeeding very well according to some key measures. Relatively few people get formal training, while the public generally perceives that only formally trained people can do CPR. As a result, the vast majority of sudden cardiac arrest (SCA) victims don’t get CPR. This misconception is one reason for the low SCA survival rates in this country. Alternative approaches, however, have the potential to educate massive numbers of people and dramatically in- crease the number of SCA victims who get CPR. That, in turn, could give us the much-needed power to finally improve survival rates.

Anatomy of Sudden Cardiac Arrest

The sheer magnitude of SCA as a public health threat is easy to describe. Nearly 400,000 people experience SCA outside of hospitals in the United States every year. Approximately 120,000 of these—roughly 30 percent— are stricken in public places outside of the home. Now, imagine a map of the United States—all 3.8 million square miles—with a dot on every office building and campus, shopping mall, retail store, hotel, manufacturing plant, airport, amusement park, gambling establishment, government building, health club, school, church, sports arena, public park, side- walk, and every other similar workplace and community setting (that’s a lot of dots!). These are the public locations where one of the 120,000 SCA events per year might happen at any given moment.

But, of course, it is impossible to predict precisely who, when or where SCA may strike. At any one of these given locations, SCA can only be expected roughly once every 10 to 40 years. We know that quickly delivering CPR can help keep an SCA victim’s heart “defibrillation-ready” for a time and, along with AED use, can contribute to saving the lives of many more SCA victims. This means there must be someone nearby at the time SCA strikes who is equipped and willing to do CPR. But today, only about six in 100 SCA victims are likely to survive, in part because there are too few volunteer bystanders allowed, willing and able to quickly start CPR (and because of the AED shortage).1

CPR Training, Effectiveness and Success Barriers Today

The dominant training model today harkens back to the 1960s, the dawn of CPR education for the general public. It emphasizes (or requires) formal, in-person, fee-based, instructor-led, card-issuing CPR training and is widely touted as the best way to educate and get volunteer lay-bystanders to do CPR. Is this model working? Arguably not.

Logistically, a very large volunteer “SCA responder squad” is needed to ensure someone is almost always nearby who is willing to help.2 But less than five per- cent of the U.S. public is formally trained in CPR due to time and cost barriers, among other reasons. And only about one-quarter of SCA victims receive bystander CPR in public. There are many reasons for this persistently low CPR rate, but here are some of the biggest barriers:

Widespread public perception that only formally trained people, with a valid course completion card, are permitted to try CPR. This perception is created by AED laws (see below), training organizations, lawsuits, social media, etc., and dramatically reduces the number of people who might otherwise try to help.

Difficulty recognizing SCA. Upwards of 50 percent of trained and untrained bystanders fail to accurately identify SCA and start CPR. This is not surprising since a SCA situation is one they may encounter perhaps once in a lifetime.

Persistent concerns about legal liability. As an expert witness in SCA lawsuits where CPR is not started, I see first-hand how real the liability risk is and why many bystanders remain fearful of helping, a sentiment that is not likely to wane in our highly litigious society.

Another giant barrier is created by AED laws in 30+ states that require formal CPR training for volunteer lay-bystanders in public access AED programs. While these requirements have little impact on AED program preparation or performance, they dramatically increase the cost of having AEDs and contribute to the perception that current training is a precondition to being allowed to perform CPR. This is particularly true when the training requirement is linked to the availability of Good Samaritan legal protections.

Bottom line: The current emphasis on formal, instructor-led, course completion card-based training, coupled with other barriers to success, leaves most SCA victims without a potentially life-saving intervention they desperately need.

Reimagining CPR Training for Meaningful Impact

So, how do we create a large-scale SCA responder squad that gets more people to learn and do CPR? Let’s break things down into bite-size pieces to help us reimagine new models for success.

Measure the right things. In a reimagined SCA responder model, the most important measures are the number of general public members who learn CPR skills from any source and the number of SCA victims who get early CPR. It is not the number of course completion cards issued.

Clearly define the limited skills expected of the general public for effective hands-only CPR. We want SCA responder squad members to:

Expressly allow and encourage lots of different ways to communicate CPR skills. Deem members of the general public as “trained” regardless of where they learn CPR skills. Leverage on- line-only learning platforms, augmented reality (AR) technologies, social media, video platforms, stadium video screens, kiosks, and every other medium that can communicate CPR content. Studies show that good CPR effectiveness can be achieved using online training only—even without skills practice—and ultra-brief videos. These technologies are the only way to scalably “train” large numbers of people. We should not hesitate to put them to good use.

Don’t let perfection be the enemy of the good. Good CPR is hard to do for both volunteer bystanders and professional health- care workers alike. Simply put, CPR is a difficult skill for anyone, at any skill level, to perform well, particularly for people who may first be called upon to perform the task unexpectedly at one highly stressful and emotional point in time. CPR quality under a mass- training model admittedly won’t be perfect, but for the three out of four SCA victims who don’t get CPR now, less-than-perfect CPR is much better than none.

Recognize the limitations of formal training. Formal CPR training does not result in “certification” from any regulatory body. Trainees simply receive a course completion card saying they successfully completed a class as determined by a course instructor. Importantly, such training is not evidence of competence nor a predictor of how lay bystanders will act when faced with an actual emergency. Given these limitations, it is better to scalably train masses of people in lots of different ways than limit the pool of potential rescuers willing to help by requiring formal training.

Change the laws. There is certainly a role for formal CPR training for those types of jobs that should require it, and many organizations will continue to formally train employees even under a reimagined model. For lay-bystanders working in places with AED programs, formal training should not, however, be a legal requirement. AED laws should be changed to reflect this and to encourage everyone to learn CPR skills in whatever way works best for them. Good Samaritan laws should also be strengthened to provide real legal protections for everyone who steps in to try and help SCA victims.

Let the market evolve a wide variety of CPR training business models. Fee-based, formal CPR (and AED) training is big business with revenues of about $500 million annually. But, because of time and cost barriers, it necessarily limits the number of people trained and willing to help. If allowed to emerge and thrive, one can imagine a wide range of new business models supporting alternative training methods. Examples might include free, advertising- based, subscription-based, traditional fee-based and many others. The training market will find its own path, orders-of-magnitude more members of the general public will be trained, and more SCA victims will get early CPR. Win-win-win.

Wrapping Things Up

Arming massive numbers of the general public with CPR skills and allowing and encouraging everyone to try CPR when faced with a person believed to be in SCA are critical steps if we truly want to meaningfully increase SCA survival rates. Reimagining and implementing a new CPR training model can realistically help us achieve that goal. We simply can’t ignore that change is needed in order to make it happen. This matters too much. Lives are in the balance, just waiting for us to act.

REFERENCES

1 https://readisys.com/the-aed-shortage/
2 https://readisys.com/squad-goals-moving-the-needle-on-sudden- cardiac-arrest-requires-a-new-model/

About the Author

Richard A. Lazar is a leading national AED program design, operations, and compliance expert and President of Readiness Systems. Readiness Systems designed and offers AED Sentinel, the industry’s first remote AED monitoring system built for every AED program; provides AED program compliance support; publishes national AED Program Design Guidelines that describe industry standards for AED programs; and manages the AED Law Center. Learn more at www.readisys.com. SOURCE: Occupational Health & Safety, reprinted with permission.

In a world with more AEDs, setting up and running a thoughtfully designed, well-prepared, and high-performance AED program is a very attainable goal.

By:  Richard A. Lazar  |  Originally published June 1, 2019 in Occupational Health & Safety Magazine

This is the third in a series of articles on the state of affairs in public access automated external defibrillator (AED) programs and the challenges and opportunities we face in deploying them for optimum community preparedness.

In the first article1 in this series, “Squad Goals: Moving the Needle on Sudden Cardiac Arrest Requires a New Model,” we highlighted reasons the survival rate from sudden cardiac arrest (SCA)—the third-leading cause of death in the United States—remains at a stubbornly low 6 percent, despite more than 30 years of effort, and we offered a new model called the “AED Response Squad” for moving the survival needle. In the second article,2 “A New Model for Increasing Cardiac Arrest Survival Requires We Fix the National AED Shortage, Too,” we exposed the shocking shortage of automated external defibrillators (AEDs) in the United States and offered a Model AED Law that, if enacted in every state, would ensure an abundance of these life-saving devices and move us closer to our ultimate goal.

In this third and final installment, we imagine that we’ve been successful in broadly applying the AED Response Squad model and passing the Model AED Law, dramatically increasing available AEDs and improving SCA response. As we imagine this new world with lots of AEDs, we explore what it will take to fully leverage these critical public health resources to maximize SCA survival. In order to be successful, this new world must also include AED program preparation and performance.

Sudden Cardiac Arrest Response in Context

At a macro level, the sheer magnitude of sudden cardiac arrest as a public health threat is easy to describe. Nearly 400,000 people experience SCA outside of hospitals in the United States every year. Approximately 120,000 of these—roughly 30 percent—are stricken in public settings outside of the home. We know conclusively that quickly delivering cardiopulmonary resuscitation (CPR) and defibrillation with an AED can save the lives of many SCA victims. But as of 2019, only 6 in 100 survived in public settings because there were too few volunteer rescuers willing to help and too few available AEDs.3 That’s the macro story.

In a world where states pass the Model AED Law,4 resulting in the placement of millions more AEDs, it will certainly be true that a life-saving device will more often be nearby when SCA strikes. But, for AED programs, the timely application of CPR and defibrillation therapies to the people who need them when they need them is the most critical requirement. It is at this micro level where things get challenging.

To understand this challenge is to understand that AEDs alone do not save lives. Rather, people quickly performing CPR and using AEDs save lives. For this to happen, organizations with AEDs must be properly prepared and must perform responsibly (not perfectly) in sudden cardiac arrest emergencies.

AED Program Preparation

The term “AED program” is used extensively in and around this industry. But if you ask 10 people what the term means, you’re likely to get 10 different answers. So let’s start by defining the concept.

An AED program is comprised of a set of policies—sometimes written; often not—that prepare an organization to help someone experiencing sudden cardiac arrest. These policies organize the people, systems, equipment, and activities of an AED program. Industry standards,5 applied in the context of an organization’s particular physical and human characteristics, guide what to include in AED program policies (see Get to Know the AED Program Rules6 to learn why AED laws are not industry standards).

The first step in AED program preparation involves the development of an AED program design. AED program design decisions dictate the content of an AED program’s policies, influence how well-prepared an organization is for SCA emergencies and impact how well it performs when one occurs.

Two important factors must be kept in mind when constructing an AED program’s design and policies. First, it is impossible to predict the precise locations where any of the annual 120,000 public setting SCA episodes will occur. And because these episodes are so geographically disbursed (e.g., a health club, shopping mall, office, warehouse, manufacturing plant, school, place of worship, coffee shop, grocery store, etc.), SCA occurrence in any single location is incredibly rare, with an episode expected perhaps once every 10 to 40 years. This means that, in a world with tens of thousands more AED programs, each AED program site must remain prepared for SCA emergencies that may happen at any time over long periods of time.

With this background in mind, here are some AED program design elements and policy examples (not an exhaustive list) that can help prepare an organization for long-term success.

Many other design and policy elements guide and support a successful AED program. Learn more about these in the national AED Program Design Guidelines™.8

AED Program Performance

AED program performance is gauged by what people do and how equipment functions at an AED program site when SCA strikes. Key performance elements include SCA recognition, 911 call for help, CPR, and AED retrieval and use.

Many other performance elements make up a successful AED program. Again, learn more about these in the national AED Program Design Guidelines™.12

In a world with more AEDs, setting up and running a thoughtfully designed, well-prepared, and high-performance AED program is a very attainable goal. AED programs offer significant benefits to an organization’s health and safety program, its employees and visitors, and, ultimately, to the survivors of sudden cardiac arrest. It’s a worthy endeavor indeed, and one that shouldn’t wait for a new, idyllic world in order for us to start taking the steps toward achieving it.

References
1. https://ohsonline.com/articles/2018/10/01/squad-goals.aspx
2. https://ohsonline.com/articles/2019/01/01/a-new-model-for-increasing-survival.aspx
3. https://readisys.com/the-aed-shortage/
4. https://readisys.com/get-to-know-the-aed-program-rules/
5. https://readisys.com/aed-program-design-guidelines/
6. https://readisys.com/get-to-know-the-aed-program-rules/
7. https://readisys.com/avoid-the-3-minute-aed-response-time-trap/
8. https://readisys.com/aed-program-design-guidelines/
9. Bystander-witnessed cardiac arrest is associated with reported agonal breathing and leads to less frequent bystander CPR. Brinkrolf et al. Resuscitation 127 (2018) 114-118.
10. Abnormal breathing of sudden cardiac arrest victims described by laypersons and its association with emergency medical service dispatcher-assisted cardiopulmonary resuscitation instruction. Fukushima et al. Emerg Med J 2015;32:314-317.
11. See also, ‘She’s sort of breathing’: What linguistic factors determine call-taker recognition of agonal breathing in emergency calls for cardiac arrest? Riou et al. Resuscitation 122 (2018) 92-98. (“[L]ay rescuers often mistake agonal breathing for effective breathing and thus [cardiac arrest] patients can be incorrectly assessed as breathing.”)
12. https://readisys.com/aed-program-design-guidelines/

About the Author

Richard A. Lazar is a leading national AED program design, operations, and compliance expert and President of Readiness Systems. Readiness Systems designed and offers AED Sentinel, the industry’s first remote AED monitoring system built for every AED program; provides AED program compliance support; publishes national AED Program Design Guidelines that set the industry standards for AED programs; and manages the AED Law Center. Learn more at www.readisys.com.

SOURCE: Occupational Health & Safety, reprinted with permission.

By:  Richard A. Lazar  |  Originally published January 1, 2019 in Occupational Health & Safety Magazine

This is the second in a series of articles on the state of affairs in public access automated external defibrillators (AEDs) and the challenges and opportunities we face in deploying them for optimum community preparedness. For the first, see “Squad Goals: Moving the Needle on Sudden Cardiac Arrest Requires a New Model.” (October 2018 OH&S).

In the previous article in this series, we discussed that sudden cardiac arrest (SCA) is the third-leading cause of death in the United States and one of the most challenging public health issues to address. Sadly, less than 6 percent of SCA victims survive, despite 30 years of effort to combat this scary statistic. We know that CPR and the use of an AED soon after SCA occurs are the keys to saving more lives. Yet, today, only one in four people who experience SCA get bystander CPR, and fewer than four in 100 benefit from bystander use of an AED.

So, while device makers innovate the AED technology and community leaders increase SCA awareness, why haven’t we made more progress? The biggest reason is the scarcity of these life-saving devices in public places throughout the country. As AEDs have become more commonplace, many believe they can be found “everywhere.” But the truth is, because of an AED shortage in the United States, most SCA victims experience their life-or-death emergency where no AED can be found. The solution? We must have a clearer understanding of the magnitude of the problem and then concerted public policy action by policymakers, thought leaders, national advocacy organizations, SCA survivors, victims’ families, and others who care to effect positive change.

Quantifying the AED Shortage

The AED shortage can best be understood as a math problem. Using the key variables explained below, we can calculate how many AEDs are needed to cover a given area. Comparing this number to the number of AEDs currently available helps shed light on the critical gap.

AED Response Time: Time is the most critical factor to survival. In fact, the time it takes to deliver the first AED shock has a direct effect on the chances an SCA victim will survive at all. Longer times to defibrillation equal lower survival rates. In non-medical settings such as health clubs, shopping malls, retail stores, government and office buildings, schools, and similar locations, it is reasonable to expect that AEDs should be used within four to five minutes from the time SCA is first recognized. This concept of “AED response time” refers to the time it takes someone to recognize SCA (not an easy thing for volunteer bystanders), start CPR (which requires bystanders to be willing and at least minimally trained), tell people nearby to call 911 and retrieve an AED (assuming other people and an AED are available), and apply and use an AED.

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Beware the AED Response Time Trap: Many wrongly suggest that public access AED programs should enable lay responders to retrieve and use AEDs within three minutes of recognizing SCA. The fact is, most bystander AED programs cannot consistently meet this three-minute response time target (actually, neither can most professional medical environments). We shouldn’t put AED owners in legal jeopardy by imposing an unreasonable and mostly unachievable AED response time objective. Rather, a four to five minute organizational response time policy properly balances the benefits of early defibrillation with the need to rationally manage the legal accountability risks of owning AEDs. You can read more about this in How to Avoid the 3-Minute AED Response Time Trap. (http://www.readisys.com/avoid-the-3-minute-aed-response-time-trap/)

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AED Retrieval Time: Because of time considerations, AEDs can cover only a limited geographic area. Given the known time constraints associated with treating SCA, we can calculate the area a single AED can cover within a four to five minute AED response time goal. Factors impacting an AED’s coverage area include time, distance, and obstacles. Generally, two minutes of the AED response time are allocated to AED retrieval. On average, adults walking rapidly can travel approximately 300 feet per minute. At 300 feet per minute, it will take up to one minute to reach the AED and another minute to return to the person having SCA. So we use a 300-foot radius to calculate the maximum potential AED coverage area that will allow an AED retrieval time of up to two minutes.

AED Coverage Area: Going back to high school math, we use the formula Pi*r2, where r is a radius of 300 feet, to calculate that the maximum theoretical area an AED can cover is 283,000 square feet (equal to about five football fields). But because AEDs are most often not placed in open areas, we must also account for obstacles such as people, doors, hallways, stairs, elevators, escalators, physical barriers and obstructions, AED storage methods, and similar constraints that reduce the effective area an AED can cover within the two-minute AED retrieval time. Let’s assume that obstacles reduce the coverage area radius by half to 150 feet. This means, on average, an AED can cover about 70,650 square feet.

Calculating the AED Shortage: The factors described above serve as the foundation for quantifying the AED shortage. To calculate the breadth of this shortage, I also make the following assumptions:

Putting all this together, we can now estimate our need to be more than 30 million AEDs to cover the 70 percent of the population found in the non-residential, urbanized areas of the United States. We’ll need at least 10 million more to cover the non-urbanized areas and remaining 30 percent of the population. (For those who care to dig into the math, take a look at The AED Shortage post for more, http://www.readisys.com/the-aed-shortage/.)

An estimated 4.5 million AEDs have been sold in the United States since the 1990s (though not all remain in service, of course). This means we have only about 10 percent (perhaps less) of the total number of AEDs required if rapid defibrillation is going to be available to most people experiencing SCA. So you can see how this AED shortage may help explain why, in public settings, AEDs are used by bystanders a minuscule 2.1 percent to 3.7 percent of the time.

How to Fix the AED Shortage

The obvious reason for the AED shortage is the fact these life-saving devices are, with a few exceptions, not legally required at most locations. As a result, the vast majority of publicly accessible AEDs in the United States are there only because organizations voluntarily chose to place them—decisions that should certainly be commended. But voluntary deployments, along with well-meaning fundraisers and charitable donations, are clearly not getting the job done on their own.

Only two states (Oregon and Rhode Island) broadly require AEDs at many places. Some states have targeted mandates for places such as health clubs, schools, government buildings, and the like. But these limited mandates lead to only a small increase in the number of AEDs in a community, cover very small response areas, and protect a fraction of a community’s population. Broad mandates, in contrast, have the power to increase the number of AEDs in a community more rapidly, cover larger response areas, and protect a much larger percentage of a community’s population.

So how do we solve the AED shortage? The answer is clear: state legislative mandates requiring AEDs at most public locations. Large-scale mandates, coupled with true Good Samaritan legal protections, will lead to a rapid increase in the number of AEDs and will improve the odds of survival for thousands more people experiencing sudden cardiac arrest. And for those who push back with arguments over SCA prevalence in any given location, we need only look at the broad mandates for fire extinguishers—whereas fires occur with much lower frequency—as an example that blows any such objection out of the water.

To make things easy for would-be public policy advocates willing to take on the challenge of pushing for this new approach, we should look to the Model AED Law below. This law, if enacted in every state, would require lots of AEDs, provide meaningful legal protections to AED owners and users, and rid us of the silly and unhelpful regulatory requirements found in most state AED laws today.

We’ve already discussed the importance of a new “SCA response squad” model with the goal of a 50 percent rate of bystander CPR, 50 percent rate of public access AED use, and enough AEDs so that defibrillation can be delivered within five minutes for most SCA victims. If we pair this new model with effective legislative action that helps bridge the gap left by the national AED shortage, we may very well be on our way to seeing meaningful change in SCA survival.

MODEL AED LAW
An act to repeal [insert statutory references] and enact new provisions relating to the placement and use of automated external defibrillators (AEDs).

Section 1. Repeal and replacement of existing AED laws:

[Insert statutory references] are hereby repealed and replaced with the following:

Section 2: Definitions:

(a) “Automated external defibrillator” or “AED” means an automated external defibrillator approved for sale by the U.S. Food and Drug Administration.

(b) “Person” means an individual, corporation, partnership, limited liability company, association, trust, unincorporated organization, or other legal entity or organization, or a government or governmental body.

(c) “Public place” means an enclosed indoor or outdoor area capable of holding one hundred (100) or more people and to which the public is invited or in which the public is permitted but does not include a private residence.

Section 3. Good Samaritan legal protections:

(a) The following persons are not subject to civil liability for damages arising out of any acts or omissions relating to the placement and availability of automated external defibrillators absent gross negligence or willful or wanton misconduct:

(i) Any person that acquires an AED;

(ii) Any person that owns, operates, manages or is otherwise responsible for the location where an AED is placed;

(iii) Any person who retrieves or fails to retrieve an AED;

(iv) Any person who uses, attempts to use or fails to use an AED;

(v) Any person who was present at a location where an AED was used or not used;

(vi) Any physician or other authorized healthcare provider or person who issues a prescription for the purchase of an AED or provides medical oversight services to a location where an AED is placed;

(vii) Any person that is involved with or responsible for the design, management or operation of an AED program; and

(viii) Any person or entity that provides instruction in the use of an AED.

(b) The immunity described in paragraph (a) of this section applies regardless of where an AED is retrieved from or used.

Section 4: Automated external defibrillators required; persons authorized to retrieve and use automated external defibrillators:

(a) A person who owns, operates or manages a public place shall place functional AEDs in sufficient quantities to ensure reasonable availability for use during perceived sudden cardiac arrest emergencies.

(b) Any person is permitted to retrieve or use an AED.

About the Author

Richard A. Lazar is a leading national AED program design, operations, and compliance expert and President of Readiness Systems. Readiness Systems designed and offers AED Sentinel, the industry’s first remote AED monitoring system built for every AED program; provides AED program compliance support; publishes national AED Program Design Guidelines that set the industry standards for AED programs; and manages the AED Law Center. He resides in Portland with his wife and is a proud, new grandfather. Learn more at www.readisys.com. 

SOURCE: Occupational Health & Safety, reprinted with permission.

A volunteer “SCA responder squad” is needed to ensure someone is almost always nearby who feels ready and willing to help.

By:  Richard A. Lazar  |  Originally published October 1, 2018 in Occupational Health & Safety Magazine

Sudden cardiac arrest (SCA) is the third-leading cause of death in the United States and, for many reasons, one of the most challenging public health issues for our nation. According to a recent National Academy of Sciences Institute of Medicine study, upwards of 395,000 people experience SCA outside of hospitals each year in the United States, equivalent to the population of New Orleans. But nationally, despite decades of awareness initiatives, preventative programs, and treatment innovations, less than 6 percent of these people survive, a frightening number that hasn’t changed in 30 years. That’s why it’s time for an “SCA response squad” model.

The medicine of SCA is well known. It is the abrupt loss of heart function that most often occurs when the electrical impulses in the heart become chaotic (known as ventricular fibrillation), causing it to suddenly stop beating normally. The condition is 100 percent fatal if not treated quickly.

And SCA is very much a treatable condition. Two therapies—cardiopulmonary resuscitation (CPR) and defibrillation—delivered in the first minutes after SCA occurs can have a profound impact on survival. The faster CPR and AED use happen, the higher the chances of survival. Unfortunately, this help rarely arrives in time. Here are some of the reasons why.

These factors are well known in the industry, and many people have written about them in books, journal articles, public relations materials, social media, and elsewhere for years. The real question is: If we know all this, why can’t we save more than 6 percent of the people who experience SCA in public settings each year? The answer is complicated and requires thinking about the problem in new and different ways.

Clearly defining the requirements of an out-of-hospital SCA response system is the first step toward meaningfully improving SCA survival rates. The focus here is on workplace and community settings rather than the home or hospital. Let’s start with the key characteristics of frequency, time, people, and equipment:

Strategies Most Likely to Improve Survival Rates

With these characteristics in mind, what strategies can be employed that are most likely to improve aggregate SCA survival rates? Here are some suggested examples:

Putting these and other related strategies in place doesn’t guarantee we’ll move the SCA survival needle. But they are worth a try. After all, the needle has stayed stubbornly immovable despite repeated efforts over the past 30 years.

So, what are our squad goals? Let’s strive for a 50/50/5 “SCA response squad” model—a 50 percent rate of bystander CPR, 50 percent rate of public access AED use, and enough AEDs so that defibrillation can be delivered within 5 minutes for most SCA victims. If we achieve this much, we’re bound to finally get that stubborn needle to budge.

Rapid Access to CPR and AEDs Makes SCA a Treatable Condition

Cardiopulmonary resuscitation (CPR) and defibrillation, if delivered in the first minutes after SCA occurs, can have a profound impact on survival from sudden cardiac arrest. CPR involves compressing the chest (and, therefore, the heart), which helps keep oxygen in the blood and the heart primed for defibrillation. Automated external defibrillators (AEDs) are medical devices that send an electrical current through the heart muscle (defibrillation) to restore a normal heartbeat. AEDs, when used quickly and together with CPR, can help a person experiencing cardiac arrest regain a normal heartbeat and survive. The faster CPR and AED use happen, the higher the chances of survival.

People of all ages and ethnicities experience SCA without warning. Seventy percent of out-of-hospital SCA events occur in private homes. Among the remaining 30 percent, it is impossible to predict who, where, or when SCA will strike. Some are surprised to learn that SCA strikes approximately 6,000 young people each year. In all, that means nearly 120,000 people each year—more than 300 each day— are at risk of dying from cardiac arrest in workplace and community settings where volunteer bystanders could potentially step in to help save a life.

For more information and resources on SCA, visit the Sudden Cardiac Arrest Foundation at www.sca-aware.org.

About the Author

Richard A. Lazar is a leading national AED program design, operations, and compliance expert and President of Readiness Systems. Readiness Systems designed and offers AED Sentinel, the industry’s first remote AED monitoring system built for every AED program; provides AED program compliance support; publishes national AED Program Design Guidelines that set the industry standards for AED programs; and manages the AED Law Center. He is also a member of the SCA Foundation Advisory Council. He resides in Portland with his wife and is a proud, new grandfather. Learn more at www.readisys.com.

SOURCE: Occupational Health & Safety, reprinted with permission.

By:  Richard A. Lazar

Copyright © Readiness Systems, LLC – All rights reserved

WHAT IS THE 3-MINUTE AED RESPONSE TIME TRAP?

Consider this scenario. A person suffers sudden cardiac arrest at a workplace or community location that has automated external defibrillators (AEDs). An AED is retrieved and used 5 minutes after the cardiac arrest is first suspected, but the individual does not survive. A “heart attack lawyer” sues for wrongful death. Should the AED owner be found at fault in this situation for a delay in defibrillation? Well, that depends on how quickly AEDs are expected to be used as judged in negligence cases.

I bring this up because I keep seeing statements – on websites (including those of companies involved in the AED equipment and training industries), in online articles, social media posts and various other places – suggesting AEDs must be used within 3 minutes or less of a sudden cardiac arrest. These suggestions are wrong and provide plaintiffs’ lawyers with ammunition they can use to try and hold AED owners to an unfair response time standard. As a result, these misleading assertions increase the legal risk of owning AEDs by creating what I call the 3-minute AED response time trap.

AED owners can avoid the 3-minute AED response time trap. Read on to find out how.

HOW IS AED RESPONSE TIME DEFINED?

What does the term “AED response time” mean? The national AED Program Design Guidelines define an AED Response Time Objective as the maximum desired elapsed period from the time a suspected sudden cardiac arrest collapse is first reasonably recognized to the time defibrillation therapy is first delivered (Guidelines section 2.10). AED response time includes four distinct time allocation elements: sudden cardiac arrest recognition, request to retrieve an AED, retrieval of an AED and use of an AED (Guidelines section 3.4.2). In an actual cardiac arrest emergency, the total time for these combined activities is the AED response time.

WHAT IS A REASONABLE AED RESPONSE TIME OBJECTIVE?

How quickly should AED owners be expected to use an AED when the question comes up in negligence cases? The answer requires separating the science from the operational realities of having AEDs placed in non-medical settings.

It is certainly true that cardiac arrest survival rates are directly related to how quickly a defibrillator is used. Faster is clearly better from scientific and therapeutic perspectives. But if the science is the sole baseline for setting a legally accountable response time standard, then AED owners (and, by extension, emergency medical services systems) should be required to use an AED within 1-2 minutes. Virtually everyone would agree this is an unreasonable goal operationally and financially.

If 1-2 minutes is an unfair legally accountable response time standard, why is 3 minutes any less so? It seems this number is based purely on the science but without consideration of the many factors that impact actual AED response times in workplace and community settings. Here are some of those factors:

Given these factors, what is a workplace and community AED response time goal that properly balances the benefits of early defibrillation with the need to rationally manage the legal accountability risks of owning AEDs? The AED Response Time Guideline found in section 3.4.3 of the AED Program Design Guidelines suggests the following:

The AED Response Time Objective for each defined AED Response Zone (the area one AED can cover) should have the goal of delivering defibrillation therapy within five (5) minutes or less from the time sudden cardiac arrest is first reasonably suspected.

This 5-minute AED response time goal is consistent with the American Heart Association’s Emergency Cardiac Care Guidelines (2015), which note that cardiac arrest survival rates are highest when bystanders deliver CPR and defibrillation is attempted within 3-5 minutes (page S422) (the AHA does not publish or set AED program operational standards but it does publish science that can be considered when designing AED programs). A 5-minute or less target recognizes that AED programs rely on non-medical people, under no obligation to act, in a setting not primarily focused on emergency medical services. It also recognizes it is impossible to predict how lay bystanders will react when facing cardiac arrest emergencies.

A POLICY THAT PROTECTS ORGANIZATIONS FROM THE 3-MINUTE AED RESPONSE TIME TRAP

For organizations with AEDs, the best way to avoid the 3-minute AED response time trap is to have a written response time policy that incorporates the 5-minute target described above. This policy should also note that the organization’s AED response time objective is a performance goal and not a guarantee.

Keep in mind that an organization’s response time policy is one of many that impact actual response time, and all must be integrated together. Examples include policies relating to response zones, response teams, AED access and use authorization, and number and placement of AEDs, among others. If you need help fully designing your AED program and putting complete policies in place, let me know.

CLOSING THOUGHT

Let me be clear: AED programs should be designed to respond as quickly as is reasonably possible to sudden cardiac arrest emergencies. Nothing in this brief suggests otherwise. That said, risk management is an important goal of AED ownership, and avoiding the 3-minute response time trap is one key to managing risk. A 5-minute AED response time policy properly balances science, practical operations and legal accountability and is the right approach for successful AED programs.

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