The questions that need to be asked and answered before you can make an informed decision on this controversial industry issue.
Editor’s Note: This is the first in a series of Special Reports that will appear in IDEA Health & Fitness Source throughout the year. The goal of these Special Reports is to investigate timely industry issues in an impartial manner to create a dialogue among fitness professionals.
The use of automated external defibrillators (AEDs) in fitness facilities is a hotly debated issue right now. Fueling the controversy is the growing number of older exercisers, who can pose unique risks in the fitness setting. With seniors the fastest-growing membership segment in clubs today, the AED issue shows no signs of abating. Should clubs adopt AEDs as a matter of standard practice? Is a fitness facility at greater risk of liability by choosing to adopt this emergency equipment or by choosing not to? And perhaps most important, if a club does embrace AED technology, what does it take to implement an effective program?
While most people would be quick to advocate any measure that could potentially save a life, the answers to these questions are far from simple. To help you formulate the answers that best fit your own facility’s needs, this article provides an overview of the current state of AED technology and its relation to existing fitness industry emergency standards and guidelines. Also described are the steps necessary to implement an AED program in a fitness facility, the potential liabilities incurred when using AEDs and the questions club owners and managers need to ask before adopting this technology. The information in this article is not intended to be legal or risk management advice and should not be considered a substitute for legal or other risk management counsel.
An AED is an external medical device that delivers an electrical shock to the heart to restore a normal heart rhythm in people who have suffered a specific type of cardiac arrest known as sudden cardiac arrest (SCA). In the majority of cases, SCA is caused by ventricular fibrillation (VF), a complete lack of heartbeat, which can be fatal within minutes; however, SCA can also result from ventricular tachycardia (VT), a rapid heartbeat that can occur after fever, exercise or nervous excitement.
It is important to note that SCA is not the equivalent of a heart attack, nor are AEDs used to treat all heart conditions. Rather, AEDs are indicated only for the treatment of sudden cardiac arrest.
Other factors besides heart disease can cause SCA. They include electrocution, drowning, choking and trauma. In fact, SCA can strike people of all ages and races and either gender. Although certain individuals are genetically predisposed to the condition, most people who suffer SCA have no prior symptoms or warning. Often, when you read about an apparently healthy young athlete collapsing during a game, SCA is the cause. Still, the majority of SCA cases do occur in older adult males.
It is also important to understand that defibrillation is not the recommended emergency treatment for every patient whose heart has stopped beating. In many cases, cardiopulmonary resuscitation (CPR) is the more appropriate response. Even when AED use is indicated, CPR is still the first line of treatment before the defibrillator is applied. In other words, using an AED is not a substitute for performing CPR on victims of sudden cardiac arrest.
Defibrillation is the appropriate emergency treatment in those cases when an electrical malfunction of the heart has stopped its normal rhythm. In these cases, restoration of a regular pulse requires a shock via the AED within the first 10 minutes of the SCA.
An AED can restore the heart’s normal rhythm if treatment takes place within minutes of the arrest. According to the American Heart Association (AHA), with every minute that passes without defibrillation, a victim’s chances of survival decrease by 10 percent (AHA 2001). This is significant when you consider how long it can take for emergency medical services (EMS) to respond to treat a victim of SCA. According to David Freeman, worldwide marketing manager of Cardiac Resuscitation Solutions for Philips Medical Systems in Andover, Massachusetts, “In this country, the average [EMS] response time is six to nine minutes.” Of course, community response times vary greatly, depending on factors such as traffic, remoteness and available emergency resources.
Attesting to the efficacy of AEDs are the findings of a recent study that looked at survival rates in Las Vegas casinos, which were some of the first establishments to implement the use of these devices. The study, published in the New England Journal of Medicine, found that the overall survival rate for victims with VF was 53 percent when trained security personnel in the casinos used AEDs (Valenzuela et al. 2000). This survival rate is most impressive compared to that of victims who don’t receive defibrillation.
“Most studies show survival rates for VF/VT to be about 10 percent,” according to Brian Loveridge, MD, chief resident in emergency medicine at Wright State University in Dayton, Ohio, and an IDEA contributing editor. “Having rapid access to an AED could improve survival rates by as much as 40 percent. In plain terms, that’s four lives saved for every 10 people afflicted.”
Because AEDs can be so effective at saving lives in certain cases, both federal and state governments and major organizations are recommending widespread deployment of these devices. The AHA recommends that police, firefighters, security personnel, lifeguards and flight attendants who respond to emergency events be equipped with AEDs. Toward that end, local communities are spearheading early-defibrillation and CPR training programs geared to these types of first responders and to lay people who have coworkers or family members at high risk for SCA.
In August 2000, the AHA released new guidelines for CPR and the treatment of cardiovascular emergencies. An international panel of experts developed these guidelines, which are referred to as the “Guidelines 2000 for Cardiopulmonary Resuscitation and Emergency Cardiovascular Care.” The guidelines cite the most effective methods for treating cardiovascular emergencies, including SCA, heart attack and stroke.
The AHA promotes a concept known as the “chain of survival” to describe the sequence of events required to improve survival from SCA. The chain features the following four steps:
1. Early Access. Recognize an emergency and call 911 or the local EMS system.
2. Early CPR. Start CPR immediately.
3. Early Defibrillation. Use an AED to treat VF, which accounts for the majority of SCA cases.
4. Early Advanced Care. Transfer the victim to EMS personnel for treatment with medications and advanced oxygen therapies.
The AHA strongly supports early defibrillation because it is the only known treatment for most cases of SCA. Yet the guidelines also emphasize activating the emergency response system by calling 911 or the appropriate emergency number as soon as possible. According to the AHA, a victim of cardiac arrest needs effective CPR and oxygen, intravenous medications, often endotracheal intubation and rapid transport to an emergency department. Remember, not every cardiac emergency is a case of SCA.
Even when defibrillation is indicated, the AHA recommends starting CPR in order to provide some circulation of oxygen-rich blood to the victim’s heart and brain. This circulation delays brain death and death of heart muscle. CPR buys time until emergency providers arrive to implement defibrillation; it also makes it more likely that the SCA victim will respond to defibrillation shocks. Victims who receive early CPR are also more likely after electrical shock to return to a regular cardiovascular rhythm that will restore spontaneous circulation.
Because EMS providers often arrive on scene too late to serve as primary initiators of CPR, the AHA guidelines recommend that trained bystanders initiate CPR as soon as possible after a victim suffers cardiac arrest. According to the AHA, deaths from cardiac arrest would be significantly reduced if 20 percent of adults were trained in CPR (AHA 2000). In the hope of reaching that goal, the AHA and other advocates urge all adults to get trained in CPR.
Recognizing that many people who do receive CPR training will never witness a cardiac emergency and many of those who do encounter an emergency will have no training, the AHA guidelines also propose targeted CPR training. This effort is directed at encouraging training for those most likely to witness an SCA.
The trick to this approach is reaching the people who most need the training—people like security personnel, sports marshals and ski patrol members.
While public access to AEDs can help save lives, the majority of SCA incidents occur in private homes. (Research indicates that most victims are older men who suffer SCA at home.) Therefore, in overall terms, public access to defibrillation will not result in major changes in mortality rates for the population at large. According to Richard Cummins, MD, professor of medicine at the University of Washington’s Division of Emergency Medicine and past medical director of Washington’s King County Early Defibrillation Programs, “Until we solve the problem of in-home sudden death, community early defibrillation will appear to have little effect from a population-based perspective.”
Although the YMCA of the USA recently published a technical assistance paper on AEDs (YMCA 2002), the defibrillator guidelines that are probably most salient for the fitness industry at large are those the AHA developed in conjunction with the American College of Sports Medicine (ACSM). Published in June 1998, these guidelines are titled “Recommendations for Cardiovascular Screening, Staffing and Emergency Policies at Health/Fitness Facilities” (Balady et al. 1998). Because they were reviewed by representatives from the AHA; ACSM; the American College of Cardiology; the International Health Racquet and Sportsclub Association (IHRSA); and the YMCA, these recommendations represent the latest consensus on national standards for various types of health and fitness facilities
The AHA-ACSM guidelines recognize that, with more than 15,000 health and fitness facilities in the United States, the fitness industry can and should play an important role in addressing the health challenges of a sedentary society (Balady et al. 1998).
Yet, research has shown that almost 40 percent of facilities do not routinely screen or evaluate new members for history of cardiovascular disease and 10 percent do not conduct any type of initial cardiovascular health history screening (McInnis et al. 1997). This is significant because physical inactivity is a proven risk factor for cardiovascular disease. And heart disease continues to be the leading cause of death in many developed nations worldwide. More than one-fourth of all Americans have some form of heart disease (AHA 2001).
Even more noteworthy from the perspective of a fitness facility, the risk of a cardiac event increases when people with cardiovascular disease engage in moderate physical exertion. When the activity is more strenuous, the consequences can be even greater. According to William Haskell, PhD, professor of medicine at Stanford University School of Medicine in Palo Alto, California, “In relatively inactive American men aged 50 to 70 years without diagnosed coronary heart disease, sudden cardiac death is seven to 25 times more likely during vigorous exercise than while at rest.”
The AHA-ACSM guidelines are based on evidence from numerous research studies that indicate that facilities can take measures to promote safe and effective physical activity and exercise. Toward that end, the guidelines include the following recommendations (Balady et al. 1998):
- Screen all new members prior to exercise participation. (Evidence supports the value of using even a simple screening questionnaire, such as the Physical Activity Readiness Questionnaire [PAR-Q]).
- Communicate with the member’s health care provider if the pre-exercise screening indicates a need for medical evaluation.
- Use a health appraisal questionnaire before exercise testing and/or training, to initially classify participants by risk.
- Educate members about the importance of preparticipation health screening and medical evaluation; also inform members about the risk of failing to take these precautions.
- Establish written emergency policies and procedures; review and practice these regularly; and have in place professional personnel who are trained and ready to handle emergencies.
- Advise all those seeking a health and fitness facility (regardless of health status) to choose one that provides equipment, programs, staff, services and membership contracts appropriate for their needs and that meets accepted professional and industry standards.
One of the most important points highlighted in the AHA-ACSM guidelines is the fact that equipment doesn’t save lives; people do. In fact, the guidelines emphasize that “equipment alone may offer a false sense of security if it is not backed up with appropriate staffing” (Balady et al. 1998). Trained and prepared professional personnel who know how to effectively use equipment in a life-threatening emergency are the key to saving lives. Staff members need to know their facility’s emergency plan and exactly how to implement it when the need arises.
The guidelines do advise fitness facilities to acquire equipment for evaluation and resuscitation purposes, based on the risk level of their own participants, available personnel and medical coverage (Balady et al. 1998). At a minimum, the guidelines recommend, all facilities should have a readily accessible telephone to activate the local emergency response system. “Supervised facilities” (see below for definition) are also advised to have a sphygmomanometer and a stethoscope (Balady et al. 1998).
Additionally, the guidelines classify fitness facilities based on the types of populations served and the level of supervision provided. A Level 1 facility (a hotel gym, for example) provides unsupervised exercise rooms (Balady et al. 1998). On the other end of the spectrum, a Level 5 facility serves “clinical populations” (e.g., members with known cardiovascular disease) and provides “medically supervised clinical exercise programs.” This type of facility should be fully equipped with AEDs, oxygen and a fully stocked crash cart, and trained personnel who are medically and legally empowered should be available during business hours to operate these devices (Balady et al. 1998).
When we read guidelines about what fitness facilities should be doing to prepare for medical emergencies, it’s sobering to learn how little most clubs do in reality. Bill Howland, national director of public relations and research for IHRSA, has a theory as to why there is such a disparity: “What we often see in this industry is the ‘reluctant’ business owner—someone who got into the industry for the lifestyle and suddenly finds that he or she is running a business,” he says. “This type of owner has a blind spot to many business issues, from employment law to emergency plans.”
This theory seems to be borne out by the facts. According to a recent study, many health and fitness clubs do not comply with national standards regarding cardiovascular emergency procedures (McInnis et al. 2001). In fact, researchers who randomly sampled 122 fitness facilities throughout the state of Ohio found that 28 percent of responding clubs failed to employ prescreening to identify members with signs, symptoms or a history of cardiovascular disease. This is alarming considering that 52 percent of the clubs surveyed offered special programs for older adults and cardiac patients. Even more striking is the finding that 17 percent of the clubs reported having experienced one or more cardiovascular emergencies, such as myocardial infarction or sudden cardiac death, in their facility within the past five years.
As far as policies and procedures go, the majority (53%) of the clubs had no written emergency response plans, while almost all of the clubs surveyed (92%) failed to conduct emergency response drills (McInnis et al. 2001). Only 18 percent of the clubs were even aware there were published guidelines regarding cardiovascular screening and emergency procedures in fitness facilities. Finally, only 3 percent of the clubs reported having AEDs on hand. While this study was limited in scope, many industry experts feel it is a fair reflection of the industry at large. If so, these findings raise questions about the professionalism of an industry that promotes fitness programs to older adults who are at greater-than-average risk for medical emergencies.
To address this concern, fitness facility owners and managers need to consider what is required to create a safe and effective exercise setting for all membership populations served. “More and more clubs continue to work with local physician groups and hospitals to market to more mature members, and the question of whether you can respond to emergencies comes up more when you’re dealing with those segments,” says Howland. Since exercise activity poses known risks, fitness facilities should—at a minimum—have a written emergency response plan in place and should conduct regular drills to ensure that the staff knows how to execute that plan.
Whether or not this emergency plan needs to include an AED program should be carefully decided after club management has evaluated all of the variables. This evaluation process should take into consideration membership demographics, the level of medical supervision provided and available funding for emergency preparedness/training. Making such an evaluation is part of executing due diligence against reasonably forseeable risks and could offer a club legal protection in future lawsuits if the process is properly documented.
In the United States, use of an AED as a medical device is heavily regulated on both state and federal levels. The Food and Drug Administration (FDA) and state agencies determine who can operate AEDs and how they may be used. For example, for a facility (or an individual) to purchase an AED, the FDA requires that a physician “prescribe” the device. The prescribing physician then provides “medical direction” to the facility, makes recommendations regarding how many AEDs should be installed and monitors data from any incidents when staff members use the equipment. However, these regulations may soon be revised.
Richard Lazar Esq. is a legal expert on EMS topics and an advisor to the National Center for Early Defibrillation, a not-for-profit information resource center based at the University of Pittsburgh. The center promotes optimal immediate care for SCA victims. According to Lazar, “The FDA is reviewing whether AEDs should remain prescription devices and whether more extensive use of these devices should be permitted. It is likely federal requirements affecting the sale and use of AEDs will change in the near future.”
Because securing medical approval and ensuring compliance can be challenging, certain AED manufacturers have created partnership programs that make it simpler for fitness facilities to adopt and implement an AED program. Often, the manufacturers will assume responsibility for ensuring medical approval and compliance and for training staff in use of the equipment.
An example of such a partnership program is the arrangement between Philips Medical Systems and IHRSA. The program offers Philips Medical Systems Heartstream FR2 AEDs, along with implementation and training, to participating IHRSA member clubs. Program participants receive discount pricing on the AEDs, as well as a site analysis, an AED response plan, medical direction and on-site training from the American Red Cross.
According to company spokesperson Freeman, “For $3,000, we provide a package program that includes medical direction, implementation, consultation and the product [itself]. We work with the AHA and the American Red Cross to provide training.”
TRAINING, MAINTENANCE AND STAFFING ISSUES
When adopting an AED program, a fitness facility needs to make a long-term commitment to maintaining the equipment; collecting data on its use; training and certifying staff; and arranging the schedule so that a trained person is always available during operational hours. Keep in mind that only trained staff can operate AEDs, and only personnel who are CPR certified can be trained to use the devices. The AHA HeartSaver AED training and certification program takes approximately four hours and is good for two years.
After staff members are trained and certified, there is also the matter of maintaining certifications. Jeanne Kerwin, MMH, EMT-P, director of EMS for Atlantic Health System in Morristown, New Jersey, trains people in the use of AEDs. She recommends that after certification, they either take refresher training or participate in quarterly drills to maintain their skills.
Management also needs to consider the staffing costs associated with maintaining the equipment; conducting and overseeing regular drills and training; managing the overall AED program; and collecting and analyzing usage data.
While most people would agree that AED technology has the potential to save lives in the fitness arena, that should not be construed to mean the devices ought to be required and standard equipment in all fitness facilities. Arguments related to standards of care in the industry turn on theories of negligence and whether or not a facility exercises “reasonable care.” Analysis of an individual case should consider all factors, including whether the facility has written and posted emergency policies and procedures, whether it maintains sufficient staff to implement its emergency plan during operational hours and whether it performs quarterly drills to ensure that personnel remain in a state of readiness.
Additional factors that could be considered include the club membership demographics (e.g., the percentage of senior members and the number of members with known cardiovascular disease) and how foreseeable it is that a cardiovascular emergency would occur. All exercise activity has risks. And certain exercise participants, such as previously inactive older adults or those who have completed cardiac rehabilitation, are at greater risk for cardiovascular events. While clubs are not responsible for the health status of their members, they do need to exercise reasonable care to respond to emergencies. At a minimum, this would seem to include training staff in CPR, writing and posting emergency procedures and conducting regular drills.
Haskell recommends that all clubs have a written, posted emergency plan that includes a section on cardiac arrest. “This plan should be reviewed and rehearsed once per quarter by all key staff. It should be updated at least annually with new emergency phone numbers, etc.,” he says. “All exercise instructors should have CPR training, and ideally one full-time staff member should have ACLS [advanced cardiac life support] training.”
Taking all these factors into consideration, if a facility had a fully CPR trained staff, conducted drills and had emergency policies in place—and the staff executed the emergency plan in a timely manner if an emergency arose—the club would probably be considered to have exercised reasonable care. However, if this facility had a cardiac rehabilitation program in place, the club might be required to meet the highest standards, which could include making use of AEDs, oxygen, a crash cart and specially trained personnel.
According to IHRSA’s Howland, “While we encourage clubs to consider all of the benefits of an AED program, we do not think that this is a standard of care for the industry. We reviewed and considered this issue at length, and we would not have launched a [partnership] program if we’d thought it could jeopardize our clubs. We do recommend clubs use a prescreening test and that those people who are identified to be at risk consult physicians. We also recommend that clubs use liability waivers/releases and have emergency plans, procedures, protocols and documents, among other things. My sense is that when clubs have plans in place, they may get dragged into court, but in general, they come out fine.”
Thomas J. Costello, business development manager for Philips Medical Systems, says the issue of liability centers on whether a club has a duty to act in a medical emergency or is legally required to have an AED. “Only paramedics and other health care officials have a duty to act, and there is no law requiring health clubs to have AEDs. My advice to all clubs is to train as many people as possible [to use the devices] because some states, like New Jersey, have proposed legislation for all clubs to have AEDs. By law, unless you are trained to use the AEDs, you should not do so.”
According to attorney Lazar, many lay people fear that using an AED may increase the risk of a personal injury claim. “Individuals, agencies and companies considering the purchase and use of AEDs sometimes fear negligence liability suits. While the public’s apprehension is understandable, any actual liability risk associated with early defibrillation programs appears to be quite small. Still, perceptions and fears must be addressed if widespread AED availability is to become reality.”
Right now, no federal or state laws require that fitness facilities implement and maintain an AED program. Rather, the legal obligation to have such a program in place has been considered under the broader umbrella of a club’s entire emergency preparedness program. The National Heart, Lung and Blood Institute is currently conducting a clinical study to determine the efficacy and cost-effectiveness of AEDs in a variety of public settings. The final results from this multisite, controlled, prospective clinical trial are not expected until at least 2003.
While the question of whether to implement defibrillation technology in a club is a business decision, it is indisputable that trained and drilled personnel with access to AEDs can save lives. And success stories like the one involving a personal trainer at a club in Ann Arbor, Michigan, are a testament to this. Holly Ontonen, club manager at Liberty Athletic Complex, recounts the event in which a member’s life was saved just months after the club implemented an AED program.
“We had never had an incident, but we are a club with more than 4,500 members, who are very diverse. We have members with a lot of medical needs and many are first-time exercisers. We’re a club that builds relationships. If we lost even one of our members, when we could have done something to assist, it would be unacceptable to us. That’s why we decided [to adopt an AED program].
“Several months after we implemented the program, a 45-year-old man working out on a cross trainer on the fitness floor passed out. He started turning blue. Two nurses, who are members, happened to be there and administered CPR. EMS was called. Someone shouted for the AED. The member was unresponsive to CPR. [The fitness trainer,] Susan, who had just been trained, applied the AED. The first time he was shocked, there was no response. She shocked him twice, using the voice prompts [which are a feature on some AEDs] to assist her. The member then became conscious and alert. In this case, EMS had a hard time getting there. Without the AED, this gentleman would have died.”
According to Ontonen, this member did have a history of heart problems. Since the incident, he has had bypass surgery. Today he’s back working out at the club. “The incident was very emotionally charged,” says Ontonen. “It’s an incredible responsibility to have a life in your hands. All in all, we’re incredibly thankful to have been able to save someone. You can’t put a monetary value on something like that.”
Loverage says that while cost is an issue, “It could be argued that if you have something that can save lives, then why don’t you use it? How much is one life worth? I guess it depends on your perspective.”
According to Margaret Gaffney, HeartSmart program coordinator for Florida Hospital Celebration Health in Celebration, Florida, AEDs in fitness centers do save lives. Gaffney serves as the community nurse liaison for Celebration Health Fitness Centre, the largest hospital-based fitness center in the state of Florida. She says the fitness staff successfully used the hospital’s AED in a case last year. The victim was shocked several times before regaining a normal heart rhythm prior to the paramedics’ arrival. “Yes, even with the center being attached to a hospital, the staff still has to call 911,” she says. “I know we saved that man’s life with early defibrillation.”
For clubs with a large senior or cardiac rehab membership, Haskell says, the risk may be minimized by having an AED progam in place. “It makes sense to locate AEDs and trained staff to use them [in settings] where a large number of men over 50 and women over 60 perform vigorous exercise.”
In recognition of the growing number of older exercisers at its facilities, the YMCA of the USA “endorses the AHA’s position on the use of AEDs and strongly recommends that YMCAs have them available in their facilities and programs” (YMCA 2002).
We’ve seen the fitness industry’s professionalism increase by leaps and bounds over the past 25 years. A hallmark of our professionalism is pride in our ability to provide safe and effective exercise programs for our clients. Certainly the ability to respond effectively to emergencies is an important aspect in promoting our credibility as professionals.
An AED program may not be indicated for every fitness facility. But every facility should evaluate exactly what type of emergency plan is appropriate, given the nature, size and demographics of the membership. Early defibrillation is only one link in the chain of survival. Successful resuscitation after SCA depends on four steps: swift recognition and a prompt call to EMS; early CPR; early defibrillation; and early access to advanced cardiac life support personnel. Unless these steps are taken and a facility has a comprehensive emergency plan and training program in place, the effort to save lives will not succeed.
It is the nature of our profession to want to save lives by promoting regular physical activity. By keeping our members moving, we can reduce the incidence of future cardiac emergencies. We can also proactively screen members for heart disease, obtain necessary physician approvals and communicate with other health care providers to educate clients about ways to prevent heart disease. All of these activities should be part of the continuum of care we employ to help save lives today and tomorrow.