As a facility manager with one or more AEDs on your premises, you likely have a concern about the legal requirements for their use. All fifty states and the District of Columbia, as well as the federal government, have laws regarding AEDs, commonly referred to as Good Samaritan laws. But, what does that mean? Here is a quick look.
The Good Samaritan Law
The Good Samaritan law essentially offers immunity from civil suit to the individual who provides reasonable assistance, including CPR and the use of an automated external defibrillator (AED) device, to someone who appears to be suffering from an out of hospital cardiac arrest (OHCA), sometimes referred to as a sudden cardiac arrest (SCA).
In some states, Good Samaritan laws protect all individuals who find themselves in emergent situations where a person requires assistance, while other states only shield those who have completed basic first aid training and are certified by a national health organization like the Red Cross. Still other states specify that the individual can only use an AED if they have completed a designated AED training course.
These are laws that apply to the individual, "Good Samaritan", user. But the Good Samaritan could not use a life-saving AED unless some entity had purchased it and made it available. So what about the legal protection for the purchasing owner of the unit? What are the legal requirements for owning an AED?
The various states generally address the respective rights and responsibilities of both the user and the owner, but vary greatly in what they say. Here is a summary of the most common responsibilities of the owner.
Acquisition and Notification
Requires a Physician’s Prescription
As a Class III medical device, an AED requires a prescription (or medical authorization) at time of purchase.
Local EMS Notification and Registration
Many states require that when an AED is placed in the community, a business or facility, that the local 911/EMS response agency be notified in order to be included in their emergency response plan. An alternative to the local notification, which generally consists of a paper form with the address and location of the AED, is that of registering the device with an internet computer-based national AED registry which makes the information more widely available.
Physician Oversight and Training
In addition to the federal requirements for a physician prescription to purchase an AED, most states require on-going medical direction for the AED program and some require that the prescribing physician and physician director be licensed in the state where the AED is to be placed. In some states the medical director is required to be part of the post-use assessment team to review and, as necessary, revise the OHCA/SCA response protocol.
Employee (User) Training
The AED operator must know how to recognize the signs of a sudden cardiac arrest, when to activate the AED system, and how to do CPR. For this reason, it is important for those who operate the AED to receive formal physician approved training on the AED model they will be using.
Maintenance and Corrective Actions
Maintenance of the device is essential to ensure that your state’s health and safety code and Good Samaritan laws protect you and your facility. Like any machine, AEDs need to be maintained. Once installed, they may go unused for months or even years. For this reason, state laws require that these devices be maintained according to their manufacturer's recommendations, including routine inspections and periodic replacement of batteries and electrode pads.
The states expect that, if a manufacturer initiates a recall or issues a Corrective Action statement, the owner will comply with the manufacturer's request. Failure to do so could void the owner's immunity status.
Each time your AED is activated, you must replace the electrode pads. Depending on the make and model of your AED, you may or may not need to replace the battery or charge pack. If the unit has been applied to a victim and the patient survives the ECG tracing needs to be sent to the hospital. In addition, a replacement loaner may need to be procured.
Program Review and Report
Some states may require that a review of the AED use incident be reviewed and a report filed with the state or local EMS agency.
If this seems like a lot, that's because it is. That is why the PlusTrac™ AED Program Management solution is here for you. We can manage your AED program in a hassel-free manner so you can have time to worry about other things. For more information on AED laws in your state, contact us today.