AEDs: Legal issues
SCA occurs when the flow of blood to the heart slows or is stopped, often caused by abnormal heart rhythms called ventricular fibrillation (VF). The only recognized treatment for SCA is early defibrillation to shock the heart back into a normal rhythm. Without access to automated external defibrillators (AEDs) and trained care, SCA can lead to the victimâ€™s death shortly after symptoms appear.
However, when care is provided within five to seven minutes, including early treatment with an AED, survival rates can improve dramatically.
Legalities unclear?When first introduced, AEDs were not as lightweight or easy to use as the current generation of AEDs. New AEDs are reliable, practically maintenance-free, featuring automated voice prompts that walk the lay responder through the necessary treatment steps.
AEDs automatically assess the condition of the victim and determine if a shock is advised. They deliver a shock only if the victimâ€™s condition can be corrected by one. If a shock is not warranted, the AED prompts the operator to perform CPR or to provide other care as needed. It cannot and will not deliver a shock if it is not advisable.
The case for having AEDs is clear. What may not be so clear are the legal issues surrounding AEDs. In the case of AEDs, state and federal laws are starting to catch up to recent medical developments. It often seems that the laws on AEDs are more complex than the equipment. Letâ€™s look at some of the key legal issues employers need to know.
AEDs and public lawThe purchase and availability of AEDs is controlled through a myriad of state and federal laws and regulations. Various federal and state agencies oversee how AEDs may be used and who may use them.
As AEDs are considered â€œmedical devices,â€ the U.S. Food and Drug Administration oversees their manufacture and purchase. Most commercial aircraft are required to have an AED on flights that have at least one flight attendant. Flight attendants are required to be trained in CPR and the use of the AED.
All 50 states have enacted laws or regulations regarding AEDs. While state laws vary widely, they generally address AED availability in public buildings, conditions of use, medical oversight, training requirements or post-event reporting. Some states require that schools be equipped with AEDs, while others mandate their availability at health clubs or physical fitness facilities.
Federal lawIn 2000, the federal Cardiac Arrest Survival Act (CASA) was signed into law, giving immunity from civil liability to a person who uses or attempts to use an AED on a victim of a perceived medical emergency. If the state law protects only one of the two classes, i.e., either the user or the acquirer, or if the state law only protects trained users, CASA is designed to provide the missing coverage. AED trainers and medical oversight physicians are not covered under this law.
The federal Community AED Act, passed in June of this year, provides federal grants to states and localities to purchase AEDs for placement in public places, where cardiac emergencies are most likely to occur.
Public access defibrillation (PAD)SCA events are most likely to occur outside of a medical facility, typically in workplaces, hotels, airports, country clubs and shopping malls. In order to have AEDs available in an emergency, many of these facilities are purchasing them under what is called a Public Access Defibrillation (PAD) program.
Public access defibrillation (PAD) laws refer to accessibility for trained users to use AEDs in public places. Public access does not mean that any member of the public witnessing a sudden cardiac arrest should have unlimited access to the devices. AEDs are to be used only by individuals with the proper training and certification in accordance with state and local laws. PAD users are first responders who use AEDs as part of basic life support until more trained responders arrive and take over.
However, since AEDs are prescription devices and must be labeled with the prescription statement required by law (21 CFR 801.109), a physician who oversees the PAD program at a facility must write a prescription for the AED in order for the facility to purchase it.
Legal requirement to provideExcept in a few state-specific circumstances, there are currently no nationwide requirements that employers provide AEDs in the workplace.
However, considering their success rate and how inexpensive AEDs have become, look for states to begin passing legislation requiring them where people typically gather: in hotels, sports arenas and other workplaces.
It is also prudent for companies to consider placing AEDs in the workplace and training responders in their use. While there are no guarantees against legal action, it has been generally accepted that employers acquiring AEDs and providing trained responders are better protected than those who do not.
TrainingSome states and localities require specific AED training for responders. AED and CPR training is available from a variety of sources, such as the American Red Cross, American Heart Association, or local first responders. Training should be provided as a matter of course when you install AEDs.
Good Samaritan lawsAll states have Good Samaritan laws protecting volunteer responders who, in emergencies, may use AEDs. The specifics of and conditions imposed by these laws vary from state to state.
The various state laws can be found at the National Conference of State Legislatures Web site, www.ncsl.org, or the American Heart Association Web site, www.americanheart.org. If you must know how the law in your state would affect you, consult a legal professional.
In the final analysis, determine what state laws apply to AEDs, and comply with them. Become an advocate for the availability of AEDs in your workplace, and in the public arenas in which you are involved. After all, it may be your life that depends upon it.
SIDEBAR 1: Improve your oddsThe city of Las Vegas requires AEDs in all buildings where large numbers of people gather. Since passage of that law, the Clark County, Nev., Fire Department reports that the survival rates from SCA have risen to nearly 70 percent.
SIDEBAR 2: Where OSHA stands on AEDsOSHA states that certain occupations, such as those with shift work, high stress and exposure to certain chemicals and electrical hazards increase the risks of heart disease and cardiac arrest. OSHA has also stated that up to 13 percent of all workplace fatalities reported during the previous two years were a result of SCA.
In December 2001, OSHA released Technical Information Bulletin (TIB) 01/12/17, which urged employers to â€œconsider the use of AEDs at their work site to reduce the time to defibrillation with the goal of improving survival.â€
In the Federal Register of May 4, 2005, OSHA requested public comment on the â€œusefulness and efficacy of automatic external defibrillators (AEDs) in occupational settings.â€ The Federal Register entry continues, â€œOSHA estimates that as many as 8,700 fatal heart attacks and other fatal cardiac events might occur at workplaces annually... Based on the costs of AED equipment, associated training, and program management requirements and the potential value of the lives saved, OSHA believes the use of such equipment in establishments is cost-effective from a societal perspective.â€
OSHA states that it will use the information collected to â€œidentify the occupational settings in which AEDs are more cost-effectiveâ€ and to help design â€œoutreach programs to encourage establishments to install AED equipment.â€