Why do we need AEDs?
The American Heart Association estimates that in the United States, over 225,000 people die every year from Sudden Cardiac Arrest (SCA), often because defibrillation, the only effective treatment for SCA, does not reach these victims in time. The only weapon against SCA is defibrillation, which can be delivered with an automated external defibrillator (AED).
Why is calling 911 not enough?
Calling 911 is critical but often response time is not fast enough to save someone in cardiac arrest. In order to be effective, defibrillation must occur within minutes of SCA. The chance of an SCA victim’s survival decreases by about 10 percent with every minute that passes. Having an AED in close proximity increases the survival rate for SCA victims.
Do I need a prescription for an AED?
Yes. Most AEDs are prescription devices. The FDA requires authorization by prescription from a licensed physician for all sales of AEDs in the United States. Physio-Control can assist with obtaining Medical Direction for an AED program through our LIFENET MD Medical Assistance Plan.
Can I hurt someone by using an AED?
Physio-Control AEDs are designed to be safely and easily used by anyone with minimal training. The AED analyzes the heart’s rhythms through the electrode pads placed on the victim’s chest and advises whether a defibrillation shock is needed. Therefore, delivering a defibrillation shock requires very little decision making on the part of the rescuer. Once the electrode pads are placed, it is a two-step process to deliver a shock.
To become a “certified user” of an AED, you usually must complete a training class. Training requirements vary from state to state. Training is available through many organizations including
The American Heart Association, The American Red Cross, The National Safety Council, EMP America or The Canadian Heart and Stroke Foundation. Most programs offer CPR/AED user certification with approximately four hours of classroom training.
We can assist you locate AED training, if necessary. Please ask your sales representative or contact us by e-mail.
What are Good Samaritan Laws?
Good Samaritan laws grant immunity to volunteers who assist strangers in emergency situations, including using an AED on another person. These laws vary from state to state but generally limit or eliminate the liability of a volunteer rescuer. Under most of these laws, liability is also limited or eliminated for the physician who provides medical authorization, the trainer and the deployment personnel, the premises owners and other enablers of an AED program. Good Samaritan AED legislation has been passed in all 50 states and in the District of Columbia. In addition, Federal Good Samaritan Legislation has been enacted under the Cardiac Arrest Survival Act (CASA).
What is the liability for a medical director for taking on the AED program?
This varies from state to state. You may also get complete and up to date information on the unique laws of your state by visiting your state’s website, consulting with an attorney licensed to practice in your state or making an inquiry with your state’s Medical Director.
What is the liability for nurses who use an AED in an emergency situation?
This varies from state to state. You may obtain complete and up to date information on the unique laws of your state by visiting your state’s website, consulting with an attorney licensed to practice in your state or making an inquiry with your state’s Medical Director.
Is there liability for failure to have an AED or an emergency response plan?
There have been lawsuits brought alleging negligence for failure to have AEDs and other elements of emergency response plans available. Some of these actions have resulted in settlements or dismissal on technical grounds, but there has not been any definitive judicial ruling on this issue to date.
AED use is rapidly gaining acceptance as the standard of care. Under CASA, the Federal government is mandating the placement of AEDs in all federal buildings. The Federal Aviation
Administration recently submitted rules pursuant to the Airline Passenger Safety Act requiring most commercial aircraft to be equipped with appropriately stocked medical kits and AEDs.
It is anticipated that future legislation and case law will provide more definitive guidance on this issue. Given the advances in AED technology, their low cost and their proven ability to save lives, it is possible that judges and juries may be more likely to sanction a business for failing to adopt an AED program.
Assessment of Risk
Any analysis of the legal liability risks associated with the deployment of any AED program should consider the following and any other issues that are relevant in your state or to your circumstances:
A victim of sudden cardiac arrest (SCA) will die unless an external defibrillator is promptly used. In some instances, the victim is already technically dead. An AED, properly used, can only help.
AEDs are easy to operate and difficult to misuse.
Good Samaritan laws in every state limit liability.
In addition to state laws, Good Samaritan protection is offered under Federal law.
The failure to have an AED program may cause greater legal exposure than the potential misuse of one. AED use is rapidly becoming the standard of care.
Other laws such as Workers’ Compensation and Strict Products Liability may reduce liability for the organization implementing an AED program.
Planned selection, maintenance, and training are key to successful deployment of an AED program.
Physio-Control offers a Standard Indemnification Policy with every LIFEPAK 500 AED and offers additional indemnification protection through either the Physio-Control Silver or Gold Support Agreements.
What are Physio-Control’s indemnification programs?
We offer a Standard Indemnification Policy with every LIFEPAK 500 AED purchase. In addition, customers can elect either the Physio-Control Silver or Gold Support Agreements for additional protection.
What does the Standard Indemnification Policy cover?
Our Standard Indemnification Policy covers liabilities for personal injuries to patients that occur during the use of a LIFEPAK 500 AED, to the extent the injuries are caused by a design or manufacturing defect.
Who is covered by the Standard Indemnification Policy?
Our Standard Indemnification covers the “First Owner.” A First Owner is the person/company that first purchases or leases a LIFEPAK 500 AED from Physio-Control or its authorized dealers. A First Owner also includes a customer’s corporate affiliates and their respective employees, officers and directors.
The standard indemnification covers liabilities caused by Physio-Control. For expanded coverage that also covers liabilities caused by the First Owner, you may purchase either the Silver or Gold Support Plan Agreements.
What is included in the Silver and Gold Support Plan Agreements?
Both our Silver and Gold indemnification plans cover liabilities for personal injuries to patients caused by an act or failure to act by the First Owner in its use of the LIFEPAK 500 AED on patients. Neither plan covers the First Owner’s gross negligence or intentional acts or failure to act or First Owner’s failure to fulfill its Battery Pak obligations. The Silver and Gold plans cover Owner/User negligence but not gross negligence or intentional acts.
In summary, the standard indemnification covers liabilities caused by Physio-Control and the Silver/Gold Support Plan Agreement indemnification program offers expanded coverage in that it also covers liabilities caused by the First Owner.
What does a customer have to do to receive indemnification?
Physio-Control will indemnify a First Owner if the requirements for indemnification are met. For an example, the First Owner must give notice and cooperate with us in defending claims.
How long does the indemnification program last?
The standard indemnification applies to whenever a customer uses the LIFEPAK 500 AED. The Silver/Gold indemnification duration is valid as long as the customer maintains a Silver or Gold Support Plan Agreement with us for that specific LIFEPAK 500 AED.
Where are Physio-Control indemnification plans valid?
Our standard indemnification applies throughout the world. The indemnification applies as long as a claim arises from an incident occurring in the United States or Canada.
Is indemnification like insurance?
Insurance is when a third party agrees to assume liability for the insured. The indemnification offered by the Standard, Silver, or Gold Plans are “manufacturer’s indemnification”. Extra insurance may be available at additional cost from an insurance carrier. Physio-Control’s indemnification protections are available at a much lower cost and the Silver/Gold Support Plan Agreements provide the additional benefits of regular battery replacement, electrode replacement, and quality inspections.