Use of this Guide
AED Program Best Practices Guide
A Practical Framework for the Placement, Retrieval and Use of AEDs in Workplace and Community Settings
Developed and published by:
Richard A. Lazar
The nation’s leading AED program compliance expert.
© Readiness Systems, LLC – All rights reserved
This AED Program Best Practices Guide is protected by copyright. A link to this page and the PDF version of this Guide may be freely shared without alteration. However, the contents of this Guide may be used, referenced and reproduced only as specified, only with proper attribution and only with the express written consent of Readiness Systems. Publishing, displaying, creating derivative works of or reproducing this Guide without the express written consent of Readiness Systems is prohibited.
For more information about this AED Program Best Practices Guide, please contact:
Readiness Systems, LLC
NOTICE TO THE LEGAL COMMUNITY
The information provided in this AED Program Best Practices Guide is not intended to establish a legal standard of care and deviation from the concepts described in this Guide does not indicate or imply that an AED program is operating below a reasonable level of conduct.
Table of Contents
Why this Guide was Created
Despite more than 30 years of effort, the sheer magnitude of sudden cardiac arrest (SCA) as a public health threat remains as challenging as ever. Nearly 400,000 people experience SCA outside of hospitals in the United States every year. Approximately 120,000 of these events — roughly 30 percent — happen in workplace and community settings outside of the home. Quickly delivering cardiopulmonary resuscitation (CPR) and defibrillation with an automated external defibrillator (AED) can save many lives. Yet, the survival rate for SCA — the third-leading cause of death in the U.S. — remains at a stubbornly low 6 percent, in part because there are too few AEDs and too few volunteer rescuers willing to help.
Only a small number of laws require the placement of AEDs resulting in a critical AED shortage. Commendably, and despite the absence of mandates, many organizations have voluntarily added these life-saving devices to their health and safety programs. Countless other organizations, however, are reluctant to buy AEDs due to perceived complexities surrounding the creation and management of AED programs and, as importantly, because of well-founded legal liability concerns.
This Guide tackles programmatic barriers by offering a complete and structured building-block approach to AED program setup and operations – essentially a “how-to” guide for AED program managers. It tackles the
liability risk barrier by establishing a realistic administrative and operational framework based on common sense community expectations. Having written policies in place that thoughtfully embody these reasonable expectations helps organizations defend themselves in the event of a lawsuit. By taking the mystery out of AED program management and providing effective risk management strategies, the hope is to get more organizations to say “yes” to AEDs.
When it comes to getting people to help when faced with SCA events, current approaches are not working. Few SCA victims get bystander-performed CPR and fewer still are aided with bystander-used AEDs. Why? There is a widescale perception that only formally trained people with a valid course completion card can try CPR or retrieve and use AEDs. This perception severely limits the pool of potential rescuers who may be available to try to save a life.
This Guide offers strategies that empower AED programs to utilize anyone and everyone, trained and untrained alike, to help in SCA emergencies. The more people expressly permitted to respond to SCA emergencies, the more likely SCA victims will live.
Bottom line, the goals of this Guide are to get more AEDs out there and empower and encourage more people to help. The result – more SCA survivors.
CONTACT READINESS SYSTEMS FOR CUSTOM-CRAFTED AED PROGRAM POLICIES
Keep in mind this Guide gives AED programs the tools to develop policies and practices for each AED program building block. But because every AED program is unique, it is impractical to include the policies themselves. Your AED program policies and associated practices should be based on the needs and resources of your organization. Need help? Contact Readiness Systems for custom-crafted policies for your AED program.
About this Guide
This AED Program Best Practices Guide was developed to encourage and support the placement and use of AEDs in workplace and community settings. AEDs are medical devices designed to be put in publicly-accessible locations and used by untrained or minimally-trained volunteer bystanders to treat sudden cardiac arrest. Sudden cardiac arrest is a life-threatening heart condition that is 100 percent fatal if not treated quickly. Prompt cardiopulmonary resuscitation and rapidly used AEDs improve the chances of SCA survival.
Organizations craft programs around publicly placed AEDs. These programs exist to do two very important but rare things: Use volunteer bystanders to start CPR and get functioning AEDs to the people who need them. Responding to SCA is a logistics rather than a medical challenge since AEDs diagnose the heart’s condition and deliver defibrillation treatment.
An AED program consists of policies and practices that ready an organization for SCA emergencies, suggest what actions should be taken if SCA is encountered and help manage the legal risks that come with owning AEDs. Industry standards and AED laws guide what to include in an AED program’s policies and practices.
INDUSTRY STANDARDS AND AED LAWS EXPLAINED
Industry standards: Industry standards reflect common sense community expectations that guide how AED programs should be set up, managed and operated. Organizations that develop and follow common sense policies and practices, tailored to their unique situations, accomplish four important things including: 1) Responsibly meeting industry standards; 2) being reasonably prepared for SCA emergencies; 3) lowering the risk of bad outcomes; and 4) improving their ability to defend themselves in court if they get sued
AED laws: AED laws vary widely by jurisdiction and generally do one or more of three things: 1) Tell organizations what they should do to administer and operate an AED program; 2) define what if any legal protections may be available to the organizations and people involved in AED programs (so-called Good Samaritan immunity); and 3) identify the types of organizations that must have AEDs. Fulfilling AED law requirements may help preserve Good Samaritan legal protections in some jurisdictions and may help a legal defense in the unlikely event of a lawsuit. Just meeting these legal obligations, however, will not help organizations responsibly prepare for or perform well during SCA events.
Well managed AED programs should sensibly follow industry standards and AED laws while considering their own unique circumstances, e.g., operating environment, resources and goals. Most AED programs, however, operate on an ad hoc basis which creates a risk of operational gaps that can lead to avoidable SCA death and hard-to-defend lawsuits.
This Guide helps organizations avoid these gaps by describing all AED program elements, or building blocks, and recommending best practices for meeting the requirements of each.
AED Program Best Practices
Best practices are methods or techniques designed to produce results that are better than alternatives because they represent a standard way of doing things. Understanding and applying best practices to the unique circumstances of an organization’s AED program helps take the guesswork out of the process and improves the chances of better outcomes with less risk.
THE THREE ‘P’S
Following the best practices for each of the AED program building blocks described in this Guide can help AED programs achieve three key goals:
Being reasonably prepared for SCA emergencies.
Performing responsibly when SCA occurs.
Having policies and practices in place that lower legal liability risks and help defend lawsuits.
When considering common sense expectations for AED program preparation, performance and protection, it is essential to acknowledge that SCA is a very rare yet challenging risk facing organizations with AEDs. Here is why.
Approximately 120,000 of the nearly 400,000 SCA events that occur each year in the U.S. happen in workplace and community settings – but it is impossible to know who, where or when SCA will strike.
The chances of SCA occurring at any specific workplace or community setting are very low – in most locations an SCA event can be expected once every 10 or more years.
For most volunteer bystanders called upon to perform CPR or use an AED, SCA is a once-in-a- lifetime event – one they have never encountered before and will likely never face again.
The best practices described in this Guide recognize these realities and limitations. AED program sites are not hospital emergency departments and most people who volunteer to help SCA victims are not trained healthcare professionals. Judging how workplace and community AED programs prepare for and respond to SCA emergencies must be measured against realistic expectations, not perfection.
AED programs can improve the chances of SCA survival but cannot guarantee survival.
AED PROGRAM BUILDING BLOCKS
An effective AED program is made up of many different building blocks. These building blocks create a framework of people, places, equipment and activities that prepare an organization for SCA events and influence actions taken when SCA strikes. Policies and practices established within this framework bring an AED program to life.
This Guide offers recommended best practices for all AED program building blocks including those guided by industry standards – by far the most important – and those guided by AED laws. Here are the AED program building blocks covered:
AED PROGRAM REQUIREMENTS AT-A-GLANCE
Each building block of an effective AED program has a unique set of requirements that are defined by the organization, written into policies and implemented as practices. The following list offers an overview of these requirements which, taken together, put the entire AED program into perspective.
— AED Program Personnel: Define roles and responsibilities for the people involved in your AED program and assign people to those roles.
— AED Response Time: Establish an AED response time goal for each AED response area you define for your organization.
— AED Response Areas: Define one or more AED response areas for your organization, each of which can be covered by one AED within your response time goals.
— AED Placement Locations: Designate AED placement locations within each of your AED response areas, considering your AED response time goals.
— AED Storage, Security and Access: Develop and implement AED storage, security and access policies and methods that balance the need for immediate device accessibility and device protection.
— Phased AED Deployment: Develop and execute a phased AED deployment plan if you are unable to acquire all desired AEDs at one time.
— Equipment Placement, Inspection and Maintenance: Place equipment and supplies at each AED placement location and implement a comprehensive equipment inspection and maintenance program.
— AED Use: Adopt and implement an AED use strategy that creates the best chance of helping those experiencing SCA.
— SCA Response Team: Establish an AED response team that leverages trained and untrained volunteer bystanders willing to help those experiencing SCA.
— AED Program Communications: Create and communicate information about your AED program to a wide audience letting everyone know what your program is about and how they can help in SCA emergencies.
— AED Prescription: To comply with FDA requirements, obtain a documented prescription authorizing your organization to have AEDs.
— Medical Direction: Engage an AED program medical director in those states with AED law medical direction requirements.
— Agency Notifications and Registrations: In those states that require it, make good faith efforts to report AED location information and/or register your AED program with designated agencies.
— Post-SCA Notifications: In those states that require it, make good faith efforts to fulfill AED use reporting requirements.
— Other AED Law Requirements: Learn about other AED law requirements that may apply in the places you have AEDs and make good faith efforts to comply with them.
These building blocks and their respective requirements are covered in detail in the following sections of this Guide. Background context and recommended policies and practices are included for each. Organizations that take the time and effort to understand and embrace these best practices are best positioned to have effective and risk managed AED programs.
AED Program Building Blocks Guided by Industry Standards
AED Program Personnel
People, of course, represent the core of your AED program. Having the right people in the right roles and performing the right tasks helps support the short- and long-term success of your program. From an industry standards perspective, there are five key roles to consider.
These are the people responsible for creating and authorizing your program, setting goals and objectives, allocating a budget, making key decisions about policies and practices and assigning operational tasks to AED program managers, site managers and others.
These are the people responsible for administering and keeping the program current. Ideally, you will have at least one overall AED program manager and each AED program site should have at least one site manager. These roles can be combined, and one person can certainly be responsible for multiple AED program sites.
This is the physician responsible for meeting AED law medical direction requirements that exist in about one-third of states. From an industry standards perspective, there is no need to have a physician involved in the remaining two thirds of states. This is because AED programs are administrative and operational rather than medical in nature.
These are the people allowed to do CPR and access, retrieve and use AEDs in SCA emergencies.
Equipment inspection and maintenance
These are the people responsible for inspecting and maintaining your equipment and ensuring your AEDs remain ready for use.
RECOMMENDED POLICIES AND PRACTICES
This Guide recommends that you create a written policy defining roles and responsibilities for the people involved in your AED program.
In practice, it is important to assign people to these roles with responsibilities and expectations clearly explained. Because of the nature of AED programs, different people may fill these roles over time and some roles may be assigned to more than one person.
AED Response Time
The purpose of having a defined and documented AED response time policy is to ensure your AED program performance is measured against real-world, legally accountable targets rather than ideal-world, unrealistic expectations. This is one of the more complicated and misunderstood building blocks. To understand why, let us first define what the AED response time is.
AED RESPONSE TIME DEFINED
The elapsed period from the time a suspected SCA collapse is first reasonably recognized to the time an AED is first used. There are four segments that make up the total AED response time. These include:
- Recognizing SCA (not always easy for volunteer bystanders)
- Deciding to retrieve or asking another person to retrieve an AED
- Retrieving an AED
- Using an AED
Many factors influence how quickly volunteer lay-bystanders in workplace and community settings can be reasonably expected to retrieve and use AEDs. Examples include unpredictable human behavior, costs, the operating environment, the size and characteristics of the areas being covered and other AED program policies that are put in place.
Your AED response time policy sets a goal (not a guarantee) for the maximum desired AED response time taking these factors into account. In addition, the response time goal guides AED program policy and practice decisions you make about the number of AED response areas and AEDs you have, where and when you place AEDs and who to include in your AED response team, among others. The key is setting a response time goal that is reasonably achievable under most circumstances. Because your response time policy may be used to establish legal accountability, it is essential to differentiate between the ideal world and the real world.
In the ideal world, the science of SCA resuscitation says the faster CPR is started and an AED is used, the better the chances of SCA survival. Solely because science suggests faster is better, many online and offline resources claim, without reference to any reliable sources, that workplace and community AED programs must use AEDs within three minutes. But no law, industry standard or other source of authority requires AED programs to meet this mythical three-minute response time target. (In fact, these claims create a 3-minute response time trap which you can learn about here.)
But in the real world, actual AED response times are affected by the many factors described above. Common sense community expectations require only that AED programs set an AED response time policy that makes good faith efforts to help those experiencing SCA while recognizing the inherent limitations of workplace and community AED programs explained under Managing Expectations above.
RECOMMENDED POLICIES AND PRACTICES
This Guide recommends that you create a written policy setting a 5-minute AED response time goal for each AED response area you define for your organization. From a risk management perspective (protection), your policy should specifically say that your AED response time goal is not intended as a guarantee that AEDs will be used within 5-minutes 100 percent of the time. While people may respond more quickly during actual SCA events, the purpose of this policy is to set a reasonable and elastic legal accountability target surrounding what are very rare situations.
This 5-minute target is consistent with published emergency cardiac care sources and recognizes that AED programs rely on non-medical people, under no obligation to act, in a setting not primarily focused on emergency medical care. It also allows for the reasonable uncertainty that results from asking volunteer lay bystanders to respond to cardiac arrest emergencies.
Related Policies and Practices that affect AED response time performance:
AED Response Areas (the places where you have AED coverage); AED Placement Locations (the locations where you place your AEDs); AED Storage, Security and Access (how you store and who you allow to access your AEDs); AED Use (who you allow to use your AEDs); and AED Response Team (the people you allow to do CPR and retrieve and use AEDs).
AED Response Areas
An AED response area is an AED program site, or a defined physical area within an AED program site, that can be effectively covered by one AED within set AED response time goals. Factors including speed, response time, obstacles and distance influence how big an area one AED can safeguard.
Because time to AED use directly affects the chances of SCA survival, a single AED can cover only a limited geographic area which can be calculated. As a rule, 2-minutes of the 5-minute AED response time goal are allocated to AED retrieval. On average, adults walking rapidly can travel approximately 300 feet per minute. So, a 300 foot radius can be used to calculate the maximum potential AED coverage area that will allow an AED retrieval time of up to 2-minutes (one minute out and one minute back).
Assuming a 300 foot retrieval distance, one AED can cover up to 283,000 square feet – about the size of 5 football fields (Pi*r2 where r is a radius of 300 feet). But, because AEDs are most often not placed in open areas, obstacles like people, doors, hallways, stairs, elevators, escalators, physical barriers and obstructions, AED storage methods and similar constraints must be considered since they reduce an AED’s coverage range. Assuming, for example, that obstacles reduce the distance that can be covered in 1-minute to 150 feet, an AED can safeguard about 70,650 square feet (about the size of 2.5 football fields).
Using this approach, you can determine the size of your AED response areas and how many areas you need to fully cover your AED program site(s).
A NOTE ABOUT HOW TO ACHIEVE TRUE PUBLIC ACCESS AED USE
You may have AED program sites that are significantly smaller than your calculated AED response areas. If you support a true public access model, you may consider allowing the use of your AEDs outside your AED program sites (i.e., neighboring tenants or businesses). This approach is commendable and encouraged but requires thoughtful collaboration with nearby businesses, careful crafting of unique operating policies and implementation of additional risk management strategies. All doable and all for the public good.
While full coverage is the ideal, there may be reasons you elect to exclude some areas from AED response area coverage. Here are some examples:
- Low population or use density.
- Very low expected SCA frequency.
- Unreasonable implementation or operating expense.
- Limited financial resources.
- Legal constraints.
- Dangerous conditions.
- Proximity of emergency medical services resources.
RECOMMENDED POLICIES AND PRACTICES
This Guide recommends that you create a policy that specifically defines and documents AED response areas for each of your AED program sites. It is important to address reasons for excluding any AED program sites or areas of AED program sites from AED response area coverage. This is particularly important for phased AED rollouts (covered under Phased AED Deployment).
Related policies and practices used to implement your AED Response Area policy:
AED Placement Locations (the locations where you place your AEDs).
AED Placement Locations
Now that you have defined your AED response areas, it is time to select AED placement locations within each. There are several factors to consider when selecting where to place your AEDs. Here are some examples:
- Visibility and accessibility of the AED.
- Proximity to higher population traffic areas such as entry doors, stairs, elevators, kitchens, meeting areas, etc.
- Proximity to AED response team members.
- Proximity to high population density areas.
- AED response time considerations.
Once you have identified your AED placement locations, you will place one AED and other equipment and supplies at each. How best to store, secure and access your AEDs are topics covered under AED Storage, Security and Access.
RECOMMENDED POLICIES AND PRACTICES
This Guide recommends that you create a policy that specifically designates and documents each of your AED placement locations.
Related policies and practices used to implement your AED Placement Locations policy:
AED Storage, Security and Access (how you store and who you allow to access your AEDs); AED Use (who you allow to use your AEDs); Equipment Placement, Inspection and Maintenance (the equipment you place at each location and how you take care of it).
AED Storage, Security & Access
The ability to easily access AEDs is a key factor affecting how long it takes to retrieve and use AEDs. The way you physically store your AEDs directly impacts their ease and manner of access. However, it is also true that AED equipment can become a target for theft or tampering. Because of this concern, and the importance of having AEDs available when SCA strikes, the key is implementing AED storage and security policies that strike a proper balance between device accessibility and device protection.
RECOMMENDED POLICIES AND PRACTICES
This Guide recommends that you adopt policies and practices that reasonably assure easy AED access while protecting each device from theft or tampering. Examples of AED storage and security strategies you may consider include:
― Placement under the control or visual supervision of one or more people stationed near your AEDs during most business hours.
― Placement within an unlocked storage cabinet which emits an audible alarm when opened capable of being heard nearby.
― Placement within an unlocked storage cabinet that automatically detects and immediately alerts when the cabinet door is opened.
― Placement within a locked or unlocked storage environment accessible to an identifiable number of people capable of quickly and reliably retrieving the AED whenever people are present within the AED response area.
― Placement within an area monitored by real-time video surveillance.
This Guide also recommends that you adopt policies and practices authorizing any willing person to access and retrieve your AEDs. If you elect to limit AED access, your written policy should clearly identify those people restricted from accessing AEDs and the specific reasons why.
Phased AED Deployment
Some organizations electing to start AED programs may have insufficient resources or face other obstacles that can hinder the ability to deploy all desired AEDs at one time. In this situation, it is perfectly reasonable to implement a phased AED rollout strategy. This allows AEDs to be procured and placed over time based on available resources and operational feasibility. If your organization is phasing AED placements over time rather than all at once, it is important to plan carefully, fully document your strategy and deploy your AEDs on schedule to manage the legal risks this approach can raise.
Deploying a targeted number of AEDs over time will necessarily result in the existence of some AED program sites or AED response areas without AED coverage and AED response times that may exceed the AED response time goal you set. From a public health and site safety perspective, it is reasonable, if done thoughtfully, for your AED program to deploy the targeted number of AEDs over time rather than deploying no AEDs at all.
RECOMMENDED POLICIES AND PRACTICES
When developing a phased deployment policy, here are some things to consider when prioritizing the placement of your AEDs as they are acquired:
― The number and characteristics of the people present in each AED response area.
― The types of activities occurring in each AED response area.
― Expected AED response times in contiguous AED response areas.
― The proximity of emergency medical services resources.
― Site complexity and/or available infrastructure to implement and operate your AED program.
If electing this phased approach, this Guide recommends that you carefully document your organization’s AED deployment plan and timeline. Your phased deployment plan and policy should include the following key components:
― The total number of AEDs targeted for your AED program and each AED program site.
― The identified AED placement locations for each AED.
― The number of AEDs to be acquired at AED program inception (initial AEDs).
― The number of AEDs to be acquired after AED program inception (phased deployment AEDs).
― Dates on which initial and phased deployment AEDs are likely to be deployed to specific AED placement locations.
Because predicting where and when SCA will occur is not possible, you will need to use reasonable judgment in developing and documenting your phased AED deployment policy.
You will then place your AEDs at the times and locations specified in your phased deployment policy. From a risk management perspective, it is important to document these activities.
Equipment Placement, Inspection & Maintenance
AEDs are complicated electronic devices that use hardware and software to analyze a heart rhythm and deliver an electric shock (defibrillation) if needed. They perform periodic self-tests of internal components and have visual status indicators showing their state of readiness. In addition, AED batteries and pads have specified expiration dates before which they must be replaced.
From the perspectives of both industry standards and AED law compliance, your AED program is legally responsible for properly placing, inspecting and maintaining your AEDs. While individual AEDs are used very infrequently, these life-saving devices are expected to work every time they are needed. The consequences of AED failure flowing from lapses in inspection and maintenance can include avoidable death and lawsuits. Following industry standards and AED law requirements can help ensure your AEDs are always ready, reduce legal liability risks and demonstrate AED law compliance.
RECOMMENDED POLICIES AND PRACTICES
From both industry standards and AED law perspectives, this Guide recommends that you develop equipment placement, inspection and maintenance policies that address equipment and supplies to be stored at each of your AED placement locations, the method and frequency of equipment inspections and how you will properly and reliably maintain your equipment.
In practice, you will place AEDs and related equipment and supplies at each AED placement location. Manufacturer user guides for each AED make and model should be available to the people responsible for equipment inspection and maintenance.
Inspection and Maintenance
Your AEDs are designed to deliver life-saving defibrillation therapy which requires that your AED hardware be in proper working order, your AED batteries be within useful life and have a enough stored energy and your AED pads be physically intact within sealed packaging and within useful life.
To ensure proper functioning, all your AED-related equipment requires periodic inspection, maintenance and replacement when necessary. To ensure a responsible inspection, maintenance and replacement program, this Guide recommends that you assign these tasks to designated individuals who are familiar with your equipment inspection and maintenance policies. From a risk management perspective, your inspection program should include a mechanism to initiate, document, track and report your inspection and maintenance results.
AED inspections can be performed by humans or, for more reliable results, by a remote AED monitoring system. Human or remote AED monitoring inspections of visual status indicators should be performed at regularly scheduled intervals. Equipment maintenance should be performed periodically and after AED use. Computer-based tracking and reminder systems offer greater reliability and document preservation benefits than paper or spreadsheet-based systems.
A NOTE ABOUT MANUFACTURER GUIDELINES
Manufacturer user guides are available for each specific AED make and model. Your AED program should review these manufacturer recommendations to ensure they are considered as you develop your inspection and maintenance policies and practices. Keep in mind, however, that manufacturer guidelines vary widely by AED make/model, tend to contain substantively general content and are incomplete in comparison to an industry standards-based AED inspection and maintenance program. Manufacturer guidelines can be used to augment your program but should not be relied upon as a substitute for a well-designed inspection and maintenance regime.
A NOTE ABOUT AED LAW COMPLIANCE
Approximately two-thirds of states have AED laws requiring AED owners to properly inspect and maintain AEDs (industry standards require this everywhere, regardless of what AED laws say). The failure to follow these requirements can lead to the potential loss of Good Samaritan legal protections in some of these states and make it difficult to defend an AED lawsuit relating to an AED’s readiness or failure in any state. Well designed and properly documented and executed AED inspection and maintenance practices will, by definition, show compliance with these AED law requirements and minimize the risks of noncompliance.
Policies that allow or restrict who can use AEDs (this is different from AED access policies, covered under AED Storage, Security and Access) directly affect whether and how quickly these life-saving devices are used during SCA events. Unfortunately, there is a general perception that only formally trained people (i.e., those who have attended a CPR/AED course and possess a current course completion card) are permitted to use AEDs.
The truth is, both industry standards and AED laws permit anyone to use AEDs. Put differently, neither industry standards nor AED laws prohibit anyone from using AEDs. So, your organization is free to develop AED use policies leveraging all available resources, an approach that creates the best chance of success.
AED use policy options fall along a continuum. They may allow only formally trained individuals to use AEDs, allow any willing volunteer to use AEDs regardless of training status or allow some combination of the two.
RECOMMENDED POLICIES AND PRACTICES
This Guide recommends that you adopt a policy that allows and encourages any willing volunteer bystander to use AEDs should one be needed. This approach empowers and enables employees and other willing bystanders to take prompt, life-saving action in the event of an SCA emergency.
In practice, you will communicate that everyone is encouraged and allowed to use AEDs.
Related policies and practices used to implement your AED Use policy:
AED Response Team (the people you allow to access, retrieve and use AEDs); AED Program Communications (how you inform everyone they are allowed and encouraged to use AEDs).
A NOTE ABOUT THE ROLE OF VOLUNTEER BYSTANDERS
It is important to recognize that AED use policies do not create, imply or assume a requirement or responsibility for any individual to act when faced with an SCA emergency. Generally, formally trained and untrained volunteer bystanders must choose to act. They cannot be required to act, though we hope they will.
SCA Response Team (including training)
An SCA response team is made up of one or more individuals who are empowered and permitted to perform CPR and access, retrieve and use AEDs. The size and characteristics of your SCA response team influence whether someone tries to save a life. This is important because today only about 1 in 4 SCA victims receive bystander CPR and less than 4 in 100 SCA victims are treated with a bystander-used AED. There are many reasons for these low rates but how AED programs typically define SCA response teams is a major factor. The good news is this is a factor over which you have significant control. Members of your SCA response team are established by the policies you set for your organization. Because of the nature of SCA response teams, this section touches on response team membership, AED use policies and training.
HERE ARE SOME THINGS TO CONSIDER WHEN DEVELOPING YOUR SCA RESPONSE TEAM POLICIES AND PRACTICES
SCA response team membership is dynamic
An SCA response team is typically not one specific group of designated individuals. Rather, it will dynamically vary in form and structure over time. This is because staffing will necessarily change as business needs dictate and because onsite non-employee bystanders may be available and willing to help.
Anyone can do CPR and access, retrieve and use AEDs
Perhaps the most important thing to keep in mind is that anyone and everyone, trained and untrained, can be allowed to do CPR and access, retrieve and use AEDs. Neither industry standards nor AED laws prohibit anyone from performing these potentially life-saving skills.
Training policies and CPR/AED policies are different
Training policies determine who and how many staff members receive formal CPR/AED training that results in the receipt of a course completion card. CPR and AED policies determine who you allow to do CPR and access, retrieve and use AEDs, regardless of training status. An SCA response team can and should include both formally trained people and people without formal training, all of whom can try to save a life.
AED law training requirements do not dictate SCA response team membership
Many states have AED law AED/CPR training requirements. While these laws vary widely, a typical example says that AED programs must “ensure expected AED users” receive specified training. These AED laws do not define who an “expected AED user” is or what role expected AED users, and others, are to play during SCA emergencies. Importantly, the way most (not all) AED laws are written appears to allow many different forms of “training” as potentially compliant with AED law training requirements. Examples include online-only platforms, blended on- and offline courses, augmented reality (AR) technologies, social media, video platforms, kiosks, in-person classroom and any other medium that can communicate CPR and AED learning content. This gives you lots of flexibility to develop SCA response team policies and practices that are cost-effective and have the best chance of success.
It is unrealistic to expect response teams to be staffed with only formally trained people
AED laws wrongly create a perception that only formally trained people can do CPR or use AEDs implying that organizations must always have formally trained people available. But, because SCA occurrences are very rare and it is impossible to predict who, where or when SCA will strike, it is not logical, realistic or economically feasible to expect AED programs to have formally trained staff available 100 percent of the time.
RECOMMENDED POLICIES AND PRACTICES
This Guide recommends that you develop policies that recognize two categories of SCA response team members:
Category 1 SCA Responders: SCA response team members who have current, formal CPR/AED training and who voluntarily choose to respond to suspected SCA events as a Good Samaritan.
Category 2 SCA Responders: SCA response team members who lack current formal CPR/AED training but who have general knowledge about the benefits of CPR and AEDs; AED locations; how to respond to suspected SCA emergencies, do CPR and use AEDs; and who voluntarily choose to respond to suspected SCA events as a Good Samaritan.
By leveraging broad and inclusive CPR and AED access, retrieval and use policies, your organization is positioned to adopt a tiered AED response team policy that is best designed to meet industry standards and AED response time goals. To accomplish these aims, this Guide recommends you put in place a written AED response team policy like the following:
Category 1 SCA Responders are encouraged to respond to SCA emergencies if available, and are authorized to do CPR and access, retrieve and use AEDs.
If no Category 1 SCA Responder is immediately available or willing to act, any willing Category 2 SCA Responder is authorized to do CPR and access, retrieve and use AEDs.
This tiered approach offers the best chance that someone will try to save a life.
In practice, you will do two key things to bring your SCA Response Team policies to life. First, this Guide recommends that you formally train a core group of “expected AED users” and make good faith efforts to have at least one formally trained SCA response team member within each AED response area during normal business hours. From both industry standards and AED law perspectives, however, it is unrealistic to expect formally trained SCA response team members to be available 100 percent of the time.
Second, use your AED Program Communications tools to communicate the message that everyone is encouraged and permitted to do CPR and use AEDs if they encounter someone experiencing SCA.
AED Program Communications
Internal communications are used to educate people inside and outside your organization about your AED program and prepare your organization and willing bystanders to quickly act when the need arises. Internal AED program communications tools can provide employees and visitors with:
― Information about the existence and benefits of your AED program;
― Information about what to do in the event of a suspected SCA emergency;
― Signs showing where AEDs are located; and
― Ongoing reminders and updates regarding your AED program.
RECOMMENDED POLICIES AND PRACTICES
In policy and practice, this Guide recommends that you periodically develop, distribute or make available AED program communications that match the policies you crafted for your AED program. Consider including information like the following:
General AED program information about:
― The purpose and capabilities of AEDs.
― The AED program and its benefits.
― The presence and location of AEDs;
― How to recognize an individual who may be experiencing sudden cardiac arrest.
― What to do in the event of a suspected sudden cardiac arrest emergency.
― How to quickly start CPR and retrieve and use an AED.
Information about formal AED training opportunities.
AED location signage (this also addresses compliance with AED law signage requirements found in a very small number of states):
― Readily visible signage should be posted at each commonly used entrance of each AED program site letting people know that AEDs are present.
― Readily visible signage should be posted near each AED letting people know of the presence and location of each AED and that anyone is permitted to access, retrieve and use the devices.
AED Program Building Blocks Guided by AED Laws
AEDs are medical devices regulated by the U.S. Food and Drug Administration (FDA). While the traditional prescription model makes little sense in this environment (e.g., there is no physician-patient relationship created between the prescriber and the SCA patient), the FDA currently requires that there by a prescription authorizing the sale or purchase of all but two manufacturer-specific AED models. This is the only federal AED law requirement. All others are state and local.
The federal FDA prescription requirement relates only to the sale/purchase of AEDs. This is different from and unrelated to state medical direction requirements covered under Medical Direction.
RECOMMENDED POLICIES AND PRACTICES
This Guide recommends that you have a documented prescription authorizing your AED program to have AEDs. This can be obtained from your organization’s medical director if you have one, the organization selling you AEDs or from your program management services provider if you have one.
So-called AED program medical direction (also referred to as “medical oversight” or “physician oversight” and sometimes offered by services companies under the umbrella “AED program management”) is purely an invention of state AED laws. Medical direction requirements were included in early AED laws with the view that organizations needed a physician to tell them how to treat SCA (the AED does that) or operate an AED program (a logistical response rather than medical diagnosis and treatment challenge). This premise has never been true, yet these types of AED law requirements persist in about one-third of the states.
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, what tasks the person is to perform or how this role benefits AED programs. In industry practice, the tasks the laws do assign to a medical director are uniformly performed by non-physicians since these tasks have nothing to do with the practice of medicine. Bottom line: Having a physician involved has no meaningful impact on AED program preparation or performance. Meeting these requirements is solely about AED law compliance to support the goal of AED program protection (i.e., risk management).
RECOMMENDED POLICIES AND PRACTICES
From an AED law compliance perspective, this Guide recommends that you have an identified medical director in those states that require it. This role can be fulfilled either by your own staff member or by a third-party AED program services company. The key is structuring and documenting a relationship and scope of work with your medical director that demonstrates reasonable compliance with specific tasks described in the laws of your states. From an industry standards perspective, no medical director is needed or required in the roughly two-thirds of states that have no medical direction obligations specified in their AED laws.
Agency Notifications & Registrations
Over 50 percent of states have AED laws that require AED programs to report AED location information to local public safety agencies. This is another unhelpful invention born of the early wave of AED laws.
Here are the reasons these laws create burdens with no benefits:
― The laws vary widely by state in terms of what type(s) of agencies must be notified (e.g., emergency medical services, 911, fire, police, other).
― Specific agencies are not identified in the laws, just categories, leaving it to you to figure out. With over 3,000 counties and more than 35,000 municipalities and townships in the U.S., this is no small task, especially if your AED program has multiple locations. States do not publish agency lists online making this obligation literally impossible to fulfill.
― The laws do not describe the purpose of notification, nor authorize or require receiving agencies to use reported AED location information for any purpose.
― Most astounding of all, with a very, very small number of exceptions, public safety agencies do nothing with AED placement information you report, e.g., the information is not added to computerized 911 dispatch systems or otherwise used to help get AEDs more quickly to the people who need them.
As a result, AED placement reporting requirements offer no preparation or performance benefits to AED programs. Fulfilling these requirements is solely about AED law compliance to support the goal of AED program protection (i.e., risk management).
Additionally, about 10 percent of states have some form of state-level AED program registration requirements, some quite burdensome. There are no clear preparation or performance benefits that come from registration but, as with AED placement notifications, fulfilling these obligations is important from an AED law compliance/risk management perspective.
RECOMMENDED POLICIES AND PRACTICES
From an AED law compliance perspective, this Guide recommends that you make good faith efforts to fulfill agency notification and registration requirements and fully document the steps you take. The contents of your communications with state and local agencies, if carefully crafted, can help support your AED program protection/risk management goals. From an industry standards perspective, there is no need to report AED location information to any state or local agency in states that lack these requirements.
Post-SCA Event Notifications
About one-third of states require AED programs to report AED uses. Designated recipients vary widely by state. Examples include state or local agencies, the AED program medical director, a prescribing physician (often not known to AED programs) or some undefined “medical authority.” The laws do not describe the purpose of these reports or authorize or require recipients to do anything with the information. There are no clear preparation or performance benefits that come from reporting AED uses but, as with medical direction and AED placement notifications, fulfilling these obligations is important from an AED law compliance/risk management perspective.
RECOMMENDED POLICIES AND PRACTICES
From an AED law compliance perspective, this Guide recommends that you make good faith efforts to fulfill AED use reporting requirements and fully document the steps you take. The contents of your reports, if carefully crafted, can help support your AED program protection/risk management goals.
From an industry standards perspective, there is no need to report AED use information to anyone in states that lack these requirements.
Mandatory AED Placement
As a rule, organizations are not legally obligated to have AEDs unless there is a law that says they must. Some state AED laws do require certain types of locations to have AEDs. Here are some examples:
― Health clubs
― Dental offices
― Government buildings
― Swimming pools
― Assisted living facilities
― Nursing homes
― Large occupancy buildings
KEEP IN MIND, EACH OF THESE MANDATES APPLIES IN ONLY A SMALL NUMBER OF STATES. NONE APPLY NATIONWIDE.
If your organization falls under an AED placement mandate, you must have AEDs at all your locations within the mandated states. Whether you also have a legal obligation to have AEDs at locations outside mandated states is an open question. From a risk management standpoint, it is better to have AEDs at all locations versus having a partial AED deployment. If you elect to place AEDs only in mandated states, it is very important that you have policies in place that carefully document your reasoning.
Whether you have placed AEDs voluntarily or because of a mandate, the recommended policies and practices included in this Guide apply to each of the locations where you have the devices.
Other AED Law Requirements
Each state has laws addressing public access AED ownership and use but, as you have learned, the laws are different in every state. Unfortunately, some states have other unique requirements that go beyond those included in this Guide. To address them all is beyond what this Guide can reasonably cover. That said, from an AED law compliance perspective, this Guide recommends that you research and document specific requirements applicable to each location where you have AEDs so you can ensure reasonable compliance. Resources are available online that can help with this research like the AED Law Center™ published by Readiness Systems. Readiness Systems can help on a consulting basis and third-party AED program services companies might also be able to help. Whether you do your own research or rely on a third-party, it is important that the AED law information you use be complete, accurate and reliable. Beware, much of the free information you find online is not.
AED PROGRAM DESIGN AND POLICY DEVELOPMENT SERVICES
Need help? Readiness Systems is the only AED program compliance consultancy offering truly comprehensive AED program creation and customcrafted policy development services. We will work with you to design and document your complete AED program. Contact us to get a free consultation.
REMOTE AED MONITORING SERVICES
Readiness Systems developed and sells AED Sentinel, the first remote AED monitoring system built for every AED program. AED Sentinel uses internet-connected hardware that keeps a watchful eye on your AEDs, along with an associated software platform and an intuitive user dashboard for monitoring, alerts and reporting. Click here to learn more about AED Sentinel.
AED PROGRAM COMPLIANCE RESOURCES
Readiness Systems publishes a variety of compliance resources to support AED program preparation, performance and protection. You can find selected resources by clicking on the following links:
The Fine Print
In this Guide, we have worked diligently to provide you with trusted, informed and comprehensive guidance about how to set up and operate an effective, compliant and risk managed AED program that best leverages your AED program resources. But every organization and AED program is different and we, like you, operate in a highly litigious environment. So, we are compelled to include the following “fine print” with this Guide.
Disclaimer of Liability.
Readiness Systems disclaims liability for any personal injury, property or other damages of any nature whatsoever, whether special, indirect, consequential or compensatory, directly or indirectly resulting from the publication, use of, or reliance on this Guide.
Not Legal Advice.
This Guide is provided for informational purposes only and is not intended to be, does not constitute, and should not be relied upon as legal advice or legal services. Readiness Systems does not offer or provide legal advice or legal services.
Limited Services Warranties.
― Readiness Systems makes no representations or warranties regarding the results to be achieved through implementation or operation of any AED program based on this Guide.
― In publishing and making this Guide available, Readiness Systems is not undertaking to render professional or other services for or on behalf of any person or entity. Nor is Readiness Systems undertaking to perform any duty owed by any person or entity to someone else. Anyone using this Guide should rely on his or her own independent judgment or, as appropriate, seek the advice of a competent professional in determining the exercise of reasonable care in any given circumstances.
Laws and Regulations.
Users of this Guide should consult applicable federal, state and local laws and regulations. Readiness Systems does not, by the publication or distribution of this Guide, intend to urge action that is not in reasonable compliance with the intent and purpose of applicable laws, and this Guide may not be construed as doing so.
Not a Standard of Care:
The information provided in this Guide is not intended to establish a legal standard of care and deviation from the concepts described in this Guide does not indicate or imply that an AED program is operating below a reasonable level of conduct.