AEDS AND THE CHALLENGE OF SUDDEN CARDIAC ARREST
AED PROGRAM RULES – INDUSTRY STANDARDS AND AED LAWS
“AED Program” Explained
“Industry Standards” Explained
State AED Laws Explained
Industry Standards and AED Laws Are Different
U.S. AED LAW HIGHLIGHTS AS OF OCTOBER 2017
AED Law Requirements
Good Samaritan Legal Protections
Who Gets Good Samaritan Legal Protections?
What Kinds of Conduct Get Good Samaritan Legal Protections?
What Kinds of Activities Get Good Samaritan Legal Protections?
Are Good Samaritan Legal Protections and AED Law Requirements Linked?
Are Broad Good Samaritan Legal Protections Available Anywhere?
When Do Good Samaritan Legal Protections Matter?
AED Placement Mandates
AED LAW REPORT CARD
A MODEL AED LAW TO MODERNIZE AED PUBLIC POLICY
SUMMING IT UP
ABOUT THE AUTHOR
You have automated external defibrillators (AEDs) or are thinking about buying them. Great! There are lots of good reasons to have these life-saving devices in your organization. But you’re wondering what the rules are for having and using AEDs. You’ve learned about things like “the standard of care,” AED laws and “compliance.” Perhaps you are concerned you might get sued in court if something goes wrong and wondering what legal protections you have. You may also be pondering whether you are required to have AEDs. But you’re not sure what all of this really means. Guess what? You’re not alone.
The fact is there is a great deal of confusion about what the AED program rules are. (Hint: AED program rules = industry standards + AED laws.) Widespread misunderstandings about AED program industry standards and the existence of 51 different sets of bewildering state AED laws contributes greatly to this confusion.
To bring clarity to the muddle, this special report:
Before launching into the details, some context about how important these topics are . . .
AEDs are medical devices placed in publicly accessible locations and used by non- or minimally-trained volunteer bystanders to treat sudden cardiac arrest (SCA). SCA is a life-threatening heart condition that strikes over 360,000 people annually in the U.S. and is fatal if not addressed quickly. It is impossible to know who, when or where SCA will strike.
AEDs, when used quickly and together with cardiopulmonary resuscitation (CPR), can help a person experiencing cardiac arrest regain a normal heartbeat and survive. But today in the U.S., only 32 percent of people having cardiac arrest receive bystander CPR and less than 4 percent are treated with a bystander-used AED before emergency medical services personnel arrive. Major reasons why so few are helped with CPR and an AED include:
All of these reasons can be addressed. To explain how, let’s get clear on some terms and concepts . . .
An AED program is a set of policies that prepare an organization to help a person having cardiac arrest. These policies organize the people, systems, equipment and activities of an AED program. AED program rules guide what to include in an organization’s AED program policies. AED program rules include industry standards and AED laws.
Industry standards (also known as the “standard of care”) are a set of guidelines for organizing the people, systems, equipment and activities of an AED program and a set of practices ensuring an organization performs responsibly before and during a sudden cardiac arrest. These standards apply to every organization that has AEDs though specific practices will vary for every organization.
Knowing and following industry standards is important to ensure an organization:
Readiness Systems publishes the national AED Program Design Guidelines™ that fully describe AED program industry standards. These Guidelines help organizations put the right AED program policies and practices in place.
State AED laws are a set of statutes (from state legislatures) and regulations (from state agencies) defining how to own, place and use AEDs. These laws cover three topics:
Each state’s AED laws are different and not every state’s AED laws include AED law requirements or AED placement mandates. Knowing and following AED laws is important to ensure an organization:
Readiness Systems publishes the AED Law Center™ that includes and explains the AED laws for every state. The AED Law Center helps organizations accurately know and understand state AED laws so they can properly follow state AED laws.
Contrary to popular belief, AED laws ARE NOT industry standards. An organization can follow AED law requirements and still be unprepared for, or perform poorly during, a cardiac arrest. This is because AED law requirements don’t include many of the things found in industry standards and do include many things having nothing to do with proper AED program preparation or performance.
AED programs meeting industry standards are best prepared and most likely to perform well when faced with a cardiac arrest emergency. But many AED programs focus a great deal on following AED law requirements under the mistaken notion this is the same as following industry standards. It is not. The following comparison shows why.
*** A special note about the 3-minute AED response time trap: “AED response time” is the total time between SCA recognition and AED use. AED response time has four segments: SCA recognition, AED retrieval request, AED retrieval and AED use. An organization’s AED response time policy sets an accountable goal for how quickly these activities are expected to happen and guides how many AEDs are needed to meet the goal.
It is certainly true that, from a purely scientific perspective, SCA survival rates are directly related to how quickly a defibrillator is used. That said, reasonable AED response time goals for organizations with AEDs must balance costs and benefits and recognize the operational challenges of responding to SCA in a layperson environment. While it might be ideal for organizations to be able to reliably meet a 3-minute or less AED response time target, it is simply unrealistic to expect organizations to bear the costs and operational burdens necessary to achieve this goal. This is similar to how communities balance costs and benefits to set ambulance response time goals.
AED Program Design Guideline 3.4 recommends an AED response time objective of 5 minutes or less. This objective is consistent with American Heart Association Emergency Cardiac Care Guidelines and 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 a cardiac arrest emergency. Organizations with AEDs benefit by having a written AED response time policy that avoids the unrealistic 3-minute AED response time trap.
This section provides a snapshot of the current state of U.S. AED laws as of October 2017. Highlights are included for each of the core elements of the laws: AED law requirements, Good Samaritan legal protections and AED placement mandates. Remember, each state’s AED laws are different and not every state’s AED laws include AED law requirements or AED placement mandates.
AED law requirements describe those things an organization with AEDs must do to administer and operate an AED program. Common examples include maintenance, training, medical direction and agency reporting. Many states require much more.
Because each state’s laws are different, the matrix of AED law requirements by state is complicated. To give a sense of the challenge, here are state AED law requirements by the numbers.
AED law requirements were placed in AED laws beginning in the late 1990s when modern AEDs first came to market. The view at the time was that people had to be told how to buy, place and use AEDs. These legacy requirements remain in most state AED laws even though they are roadblocks to today’s public access model which seeks to encourage more organizations to get AEDs and urges everyone to use AEDs. More importantly, legacy AED law requirements include things having nothing to do with proper AED program preparation or performance, serve no useful purpose and create legal risks for organizations with AEDs.
What are the consequences of not following AED law requirements? Generally, there is no risk of a state “AED police” agency shutting down an AED program or going after financial penalties since AED laws don’t give agencies these powers (with a couple of exceptions). The primary risk of noncompliance is legal. If something goes wrong and an organization is sued, plaintiff’s lawyers try to use noncompliance as a way to keep an organization from getting Good Samaritan legal protections and to get financial damages. Thus, compliance is about risk management rather than AED program preparation or performance.
There are many more reasons why AED law requirements are not very helpful to the organizations and people involved in AED programs. Here are some examples.
Confusion: AED law requirements create confusion about what organizations with AEDs must do to be prepared for, and perform responsibly during, SCA emergencies. Remember, following AED law requirements is not the same as following industry standards. The existence of and focus on AED law requirements causes organizations to mistakenly believe they are properly prepared for SCA, even if they are not.
AED Maintenance: Seventeen states do not include AED maintenance as an AED law requirement. Does that mean AED owners are free in these states to ignore AED maintenance warnings or allow batteries and electrodes to expire? Of course not. Industry standards and manufacturer guidelines for all AEDs require the devices to be regularly inspected and properly maintained. Having AED maintenance as an AED law requirement offers no benefit.
Agency Notification of AED Locations: A majority of states direct AED programs to report AED location information to local public safety agencies. A typical example looks something like this (or some variation on this theme):
Sample Agency AED Location Notification Requirement
In order to ensure public safety, a person or entity that acquires an AED shall do the following:
Notify an agent of the local [EMS, 911, fire or other (agency type varies by state)] agency of the existence, location, and type of AED acquired.
Here’s the thing: These AED law requirements do not identify specific local agencies to be notified leaving it to organizations with AEDs to figure out. There are over 3,000 counties and more than 35,000 municipalities and townships in the U.S. so this is no small task, especially for large, multi-location AED programs. Further, the laws do not describe the purpose of notification, or authorize or require receiving agencies to use reported AED location data for any purpose. Most astounding of all, with a very, very small number of exceptions, public safety agencies do nothing with AED placement information (e.g., the information is not added to computerized 911 dispatch systems or otherwise used to help get AEDs more quickly to people having SCA). Thus, agency reporting requirements do not promote public safety, impose cost and operational burdens without benefits and create legal risks for AED programs.
Formal Training: Over half the states include formal AED/CPR training as an AED law requirement. A typical example says that AED programs must “ensure expected AED users” receive formal training. These AED law requirements do not define who an “expected AED user” is or what role expected AED users, and others, are to play during an SCA emergency.
As a general rule, the “expected AED user” model does not improve an organization’s overall preparation for, or performance during, SCA emergencies. In fact, it appears the opposite may be true. The perception this model creates is that individuals without “formal” training are prohibited from retrieving or using an AED – and they typically don’t. Further, a card saying “formal training” has been completed is no guarantee the card holder will be willing to respond to SCA emergencies or perform well if they do. Others without formal training may be ready and willing to act and may be able to act more quickly. But current formal training requirements lock organizations into a formal training model and create legal liability risks due to the lack of clear definitions or operational context.
The fact is, a well-designed AED program will use a mix of formally trained, informally trained and untrained volunteer bystanders as part of an AED response team (after all, AEDs provide real-time training during SCA emergencies), a model consistent with American Heart Association Emergency Cardiac Care Guidelines and the national AED Program Design Guidelines. Removing formal training from AED law requirements will allow organizations to utilize flexible, industry-standards-based training approaches that more effectively increase the chances people having SCA will be helped and reduce legal risks for AED programs.
Medical Direction: Nearly 40 percent of states include medical direction/oversight as an AED law requirement. There is no common or uniform language in the laws regarding who is to be the AED program medical overseer, how the person is to be engaged or what tasks the person is to perform. Here are some examples of the tasks AED program medical directors are expected perform under current laws:
So-called “medical direction” requirements were included in early AED laws with the view that organizations needed a physician to tell them how to treat sudden cardiac arrest or operate an AED program. That premise has never been true yet this AED law requirement remains in many states.
Helping people having SCA requires organizations to be properly prepared and to get and use AEDs quickly. These are operational rather than medical responsibilities. AEDs diagnose the cardiac problem, decide defibrillation is needed and deliver the therapy. There is no physician/patient relationship created, no physician diagnoses SCA during an event and no physician prescribes or provides the therapy of defibrillation to the person having SCA. Virtually all of the tasks described in medical direction AED law requirements are administrative or operational in nature, not medical. They are tasks that do not require or benefit from physician involvement. The bottom line? Medical direction requirements do not promote public safety, impose cost and operational burdens without benefits and create legal risks for AED programs.
There is widespread belief that today’s AED laws offer strong Good Samaritan legal protections to the organizations and people involved in AED programs. They do not. Read on the learn why.
Generally, so-called “Good Samaritan immunity laws” offer legal protections to organizations and people who provide reasonable assistance to someone who is ill or injured. These laws are intended to encourage volunteer bystanders to help by addressing the fear of getting sued if they make mistakes (e.g., are negligent). Good Samaritan laws don’t prohibit lawsuits but good laws make it more difficult for people suing to win money damages. The public policy objective is to get more people to help by making it harder (though not impossible) to sue.
Starting in the mid-1990s, states began passing AED-related Good Samaritan immunity laws. Every state now has laws describing legal protections for AED programs and people but every state’s laws are different. Presumably, the goal of these laws was to encourage more organizations and individuals to buy, place and use AEDs in publicly accessible locations. If this was the aim, today’s laws represent an epic failure by policymakers. This is because most AED-related Good Samaritan laws offer little protection. Read on to find out why.
AED-related Good Samaritan immunity laws have four elements. These include descriptions of:
Good Samaritan legal protections are available only if all four elements are in place.
There are four types of participants involved in AED programs who can potentially benefit from legal protections. These include:
Not every state covers every participant and states define and describe participants in different ways. How do the states stack up? Here are the numbers.
Only 31 states offer Good Samaritan legal protections to all four AED program participants.
AED-related Good Samaritan laws protect only certain kinds of conduct. In negligence law (which is where Good Samaritan laws come into play), there are varying degrees of conduct (or misconduct) that fall along a continuum. This continuum goes from good to bad and starts with so-called “reasonable” conduct meaning not negligent. The next level is called “ordinary negligence” which means mistakes but not really bad mistakes. Up from there are gross negligence, recklessness, willful and wanton misconduct and intentional misconduct. Different states sometimes use different words to describe these categories but the continuum concept is the same.
By design, AED-related Good Samaritan laws are intended to make it harder for someone to successfully sue the organizations and people involved in AED programs (remember, the goal of putting higher lawsuit barriers in place is to get more organizations to voluntarily place AEDs and more bystanders to voluntarily use AEDs). Only laws that cover mistakes (ordinary negligence) offer meaningful (that is, real) legal protection. Laws that do not cover negligence offer no protection at all. Reasonable, non-negligent conduct doesn’t need protection and really bad misconduct, like gross negligence or worse, is generally not protected. The following chart illustrates these concepts.
Knowing what actions fall into what conduct category can be difficult. Courts grapple with this all the time and there are no easy answers. For AED programs, an example of ordinary negligence might be the failure to timely replace expiring AED batteries or pads. An example of gross negligence might be locking AEDs in inaccessible locations.
How do states stack up in terms of protecting AED program conduct? Here are the numbers:
As it stands, AED programs and people in 12 states can’t be sure if meaningful conduct protections are available. In the other 39 states, conduct protections appear to be available but only if the other three Good Samaritan law elements are met as well.
Many activities take place within an AED program long before an AED is needed and during a cardiac arrest emergency. Examples of preparation activities include deciding how many AEDs to buy and where to put them, setting an AED response time goal, deciding which people to train and training them, deciding who can retrieve and use AEDs, inspecting and maintaining equipment, developing written policies to organize the AED program, following AED law requirements, and many more. Examples of event-related activities include recognizing SCA, starting CPR, summoning emergency medical services, asking for an AED to be retrieved, retrieving an AED, using an AED, and more.
Virtually all of these activities will influence or impact how an organization responds during SCA events. And all of these activities taken together make up an AED program and should be evaluated together if something goes wrong and an organization is sued. Yet . . .
This AED use requirement is perhaps the biggest weakness of AED-related Good Samaritan immunity laws and the primary reason overall AED program legal protections in the U.S. are so limited.
Some states link Good Samaritan legal protections and AED law requirements. Twenty states offer protections only if some or all of the state’s AED law requirements are followed. This is true whether or not following or not following particular AED law requirements has any impact on how the organization prepares for or responds to an SCA emergency. For example, Good Samaritan legal protections may unavailable to an AED program that fails to notify a local public safety agency it has AEDs. Even if the agency throws this information away.
Comprehensive AED-related Good Samaritan legal protections are available in only five states. These include Arizona, Maine, Ohio, Oregon and Utah. These states protect all AED program participants, cover at least ordinary negligence, cover a broad range of AED program activities and do not link legal protections and AED law requirements. Good Samaritan protections in the other 46 states are quite limited if they exist at all.
While outsized attention is paid to AED-related Good Samaritan immunity laws, they rarely come into play. Only if something goes wrong and an organization is sued do immunity laws matter. Lawyers defending AED lawsuits use immunity laws to get cases tossed out of court and to make it harder for a plaintiff to win money damages. The laws are critically important when they are needed and should be written to offer real protections. But, since AED-related lawsuits don’t happen very often, the laws aren’t used frequently.
So why have these laws? AED-related Good Samaritan laws don’t prevent lawsuits. Well written laws, can, however, restrain plaintiff’s lawyers from suing because the chances of winning are much lower. Most importantly, the existence of broad and effective legal protections can lead more organizations to be comfortable enough to voluntarily buy, place and use more AEDs. This, in turn, will save more lives. That’s why.
Organizations buy and place AEDs either because they voluntarily choose to or because AED laws tell them to. Most AEDs in publicly accessible locations today are there by voluntary choice.
Despite valiant advocacy efforts and many organizations voluntarily stepping up to help, there is a significant AED shortage in the U.S. An estimated 4 million AEDs have been bought for placement in workplace and community locations since the mid-1990s. Over 30 million are needed, however, to ensure an AED is reasonably close to a large number of people having SCA. In other words, millions more AEDs are needed to meaningfully address the public health challenge of sudden cardiac arrest. Read The AED Shortage article to learn how this estimate was calculated.
How do we cure this shortage? Directives requiring organizations to buy AEDs can come from two sources: Courts or legislatures. Courts can create AED placement mandates in negligence cases by saying industry standards require certain types of organizations to have AEDs. Up to now, judges have universally declined to do this.
Legislatures have the power to most directly impact the number and locations of AEDs in the U.S. by passing AED placement mandates. State laws can direct the placement of AEDs within specific types of organizations (targeted mandates) or at locations of a specified size (broad mandates). Targeted mandates lead to only a small increase in the number of AEDs in a community, cover very small response areas and protect a fractional percent of a community’s population. Broad mandates 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.
To date, the majority of state AED placement mandates have been of the targeted variety. Here are some examples of existing mandates:
Targeted mandates –
Broad Mandates –
The precise distribution of U.S. cardiac arrest locations is not known. Of the approximately 360,000 SCA episodes occurring annually, an estimated 80 percent happen in the home. The 20 percent of non-residential SCA events occur in a wide variety of locations and it is impossible to predict who, where or when SCA will strike. Thus, it is challenging to determine where to place AEDs for maximum community benefit.
Available data provide clues about where AEDs should be placed. Race tracks/casinos, jails, hotels, convention centers, rail stations, golf courses, sports arenas, shopping malls and sports fields experience higher SCA occurrence rates than health clubs or schools. Yet, many states have passed mandates for health clubs and schools but very few for higher risk locations. This is counterproductive.
From a public policy perspective, the subject of unfunded AED placement mandates is highly political. It is true that broader AED mandates would require that public and private entities incur significant costs associated with the purchase of large numbers of AEDs and related program expenses. However, when viewed in comparison with other areas of public safety such as fire protection, these costs appear quite reasonable in relation to the benefits obtained.
Approximately 3,400 people in the U.S. die in fires each year. Mandated new building fire protection and suppression costs total over $30 billion annually. In contrast, SCA strikes 360,000 people per year in the U.S. representing a public health threat orders of magnitude greater than fires (3,400 SCA deaths approximately every 3.5 days). The cost of equipping buildings with AEDs is far less than the cost of fire suppression systems and will result in the saving of thousands more lives. From a public health and public policy perspective, it is clear the path to curing the life-saving AED shortage problem requires states to enact broad AED mandates. This approach is essential and worthy of serious policymaker consideration.
From time-to-time we publish the AED Law Report Card™ to help organizations with AEDs better understand the relative quality of state AED laws applicable in the places they operate. These quality assessments are also intended to be a call to action for policymakers interested in improving a state’s AED laws. A Model AED Law to achieve this goal is presented in the next section. Detailed information about each state’s current AED laws can be found in the AED Law Center.
AED Law Report Card grades for each state are based on assessments of the following key AED law attributes:
With this background in mind, here is the 2017 AED Law Report Card:
AED laws are one element of the AED program rules (industry standards and AED laws). These laws have a profound impact on the number of AEDs placed in public locations and the willingness of volunteer bystanders to help those having cardiac arrest. Today’s U.S. AED laws lower the chances people having SCA will survive. Why? Because the laws burden AED programs with meaningless tasks that serve no purpose and increase liability risks, fail to provide comprehensive legal protections to the organizations and people involved in AED programs and direct the placement of AEDs at too few locations. As a result, many organizations choose not to place AEDs and many individuals are reluctant to use AEDs. AED laws can be fixed. Read on to find out how.
Good laws are based on clear and achievable public policy goals, which can’t be said of today’s AED laws. Here are the problems AED laws should be designed to address:
How can AED laws help solve these problems? By eliminating barriers that lead most organizations to say “no” to AEDs, truly reducing legal liability risks for AED programs and people and requiring AEDs at more locations. Elements of an approach designed to modernize U.S. AED laws include:
The following Model AED Law is crafted to be easy to read and understand and to accomplish the goals described above.
SUDDEN CARDIAC ARREST HEROES ACT
MODEL AED LAW
An act to repeal [insert statutory references] and enact new provisions relating to sudden cardiac arrest (SCA) emergencies, the performance of cardiopulmonary resuscitation (CPR) and 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) “Cardiopulmonary resuscitation” or “CPR” means artificial ventilations or external chest compressions applied to a person perceived to be unresponsive and not breathing.
(c) “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.
(d) “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.
(e) “Sudden cardiac arrest” or “SCA” means the sudden, abrupt loss of heart function that causes a person to become unresponsive and stop breathing normally.
Section 3. Good Samaritan legal protections:
(a) Absent gross negligence or willful or wanton misconduct, no person is subject to civil liability for damages arising out of any acts or omissions relating to performing or failing to perform CPR, or the purchase, placement, availability or 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 perform CPR or retrieve and use automated external defibrillators:
(a) A person who owns, operates or manages a public place shall deploy functional AEDs in sufficient quantities to ensure reasonable availability for use during perceived sudden cardiac arrest emergencies.
(b) Any person is permitted to perform CPR or retrieve or use an AED.
This special report explained what industry standards are to help AED programs be better prepared for, and perform responsibly during, sudden cardiac arrest emergencies. The report also described why and how to improve AED laws so that more organizations voluntarily get, and more people voluntarily use, AEDs.
Sudden cardiac arrest is a vexing public health challenge. If organizations with AEDs learn and follow industry standards, and if policymakers remove unhelpful AED law requirements, pass meaningful AED-related Good Samaritan legal protections and enact broad AED placement mandates, many thousands of people experiencing sudden cardiac arrest will have a good chance of surviving. Seems like the right things to do.
Richard A. Lazar is the founder and president of Readiness Systems. Richard has been at the forefront of AED program operations, risk management, legal and public policy issues for over 20 years. He has served as a speaker, AED program operations and risk management consultant, and expert witness for clients nationwide. Richard’s deep understanding of AED program operations and risk management has led him to testify before the U.S. Congress in support of the Cardiac Arrest Survival Act, the FDA on AED over-the-counter and reclassification issues and numerous state legislatures on AED public policy issues and immunity laws.
Earlier in his career, Richard practiced emergency medical services law, designed EMS systems, served as an EMS system administrator and was an emergency medical technician. Richard holds a law degree from Lewis & Clark School of Law and a Bachelor of Science degree in Public Affairs from the University of Oregon.