Public Access Defibrillation (PAD)

Thank you for your interest in starting a Public Access Defibrillation (PAD) program in Contra Costa County. Early Defibrillation has been proven to save lives and improve the lives of people that have suffered a sudden cardiac arrest.

• More than 460,000 Americans die each year from Sudden Cardiac Arrest
• Sudden Cardiac Arrest a major public health problem and a leading cause of death in the United States
• The most common cause of Sudden Cardiac Arrest is ventricular fibrillation-when the heart's electrical impulses become irregular and the heart is unable to pump oxygen- rich blood through the body
• Currently, a person who suffers Sudden Cardiac Arrest outside of a hospital has a 5% chance of survival
• Once a victim has suffered a cardiac arrest, every minute that passes before returning the heart to a normal rhythm decreases the chance of survival by 10%
• Communities that have implemented programs ensuring widespread public access defibrillation, combined with training, maintenance, and coordination with local emergency medical systems, have dramatically improved the survival rates from cardiac arrest.

PAD IMPLEMENTATION GUIDE

There are 4 key elements to establishing a PAD program. These include:

• Having designated rescuers trained in CPR and in how to use an automated external defibrillator (AED)
• Having a physician to provide medical oversight and direction
• Integrating your program with local Emergency Medical Services (EMS) System
• Using and maintaining AEDs according to the manufacturers specifications

1. Gain consensus
   Within your company or organization, begin to identify the key decision makers and arrange a meeting to gain support. The American Heart Association or your local EMS Agency can assist you with presentation materials.
   
   
2. Review the laws and regulations
   Review Federal, State and local laws and regulations regarding Public Access Defibrillation program requirements.
   
   
3. Consult your local Emergency Medical Services (EMS) Agency
   The local EMS Agency can provide you with information regarding training, purchasing AEDs, medical direction and laws and regulations.
   
   
4. Identify your response team
   Identify who would be most likely to respond in an emergency- this will help determine how and where AEDs are mounted and stored.
   
   
5. Arrange for medical direction
   Since the Food and Drug Administration classifies AEDs as medical devices, they cannot be purchased without a prescription from a physician. This physician may serve as the "medical director" of the AED program, providing ongoing medical oversight. The medical director provides the "standing orders" to be followed in an emergency. The physician may also assist with training plans and the development of policies and procedures, updates as needed and evaluation of data. Suggestions for identifying a physician to provide medical oversight may be obtained by calling your local EMS Agency, the American Heart Association, or individual vendors.
   
   
6. Select equipment and vendor
   Some considerations in selecting an AED may include: Reputation of the AED manufacturer for the product's quality and customer service, compatibility with the equipment used in the local EMS system and ease of operation of the AED.
   
   
7. Design Policies and Procedures-and keep improving them
   These may include:
   
   
   • Who manages the AED program
   • Who provides medical direction
   • Standing orders that address when the AED should be used, when it should not be used, and the training required to use it
   • Locations of AEDs and other equipment (such as gloves and pocket mask for CPR)
   • Notification process for internal AED responders and external emergency medical services responders
   • Maintenance schedule for equipment
   • Training and refresher training policies
   
   
   
8. Determine the quantity and locations for AEDs
   The American Heart Association recommends defibrillation in less than 4 to 5 minutes, ideally in less than 3 minutes. When determining the quantity and location for AEDs, use this 3 minute response time as a guideline.
   
   
9. Develop a budget
   Consider costs related to equipment, training, and promotion of your program.
   
   
10. Purchase and deploy AEDs and other supplies
    
    
11. Required notification
    Once your AED(s) is/are purchased and training is complete, notification of the local EMS Agency as to the location of the AED is required by regulation. Use of the AED is to be reported to the EMS Agency as well.
    
    
12. Promote your program
    Everyone within your organization needs to know about the program. They should know how to alert trained responders if they witness a sudden cardiac arrest.
    
    

Understanding Statutes, Regulations and Liability Issues Associated with AED Users, Public Access Defibrillation Programs and Prescribing Physicians

From the beginning stages of promotion of Public Access Defibrillation (PAD), concerns regarding liability for those using or authorizing use of AED's have existed. Fortunately, the state has passed a series of bills and has authorized development of regulations that help to greatly limit liability concerns with regard to PAD programs.

Since the patchwork of statutes and regulations can be somewhat difficult to follow, we have prepared a summary of statute and regulation. Source documents are listed below.

For the most recent update to statute (AB 2041), click here.

For state regulations on layperson AED, developed by the State EMS Authority, click here.

The regulations, unfortunately, do not reflect the latest statute, so statute supercedes some of the regulations. The EMS Authority has issued an explanatory letter regarding these issues.

Summary of Information in Statute and Regulation Regarding AED and Public Access Defibrillation

It is our hope that this document provides some clarity on the issue to organizations and physicians who wish to participate in PAD programs. In looking at liability with regard to public access defibrillation, there are four levels of participants to consider: 1) persons who use AED's in a lifesaving effort, 2) persons or entities that provide training on CPR and AED use, 3) persons or entities that obtain an AED or have an AED on their premises for use by laypersons and 4) physicians who prescribe the AED machine.

AB 2041 modified the California Civil Code [Section 1714.21 (b-f) to provide the following protections:

• Persons using AED's: Any person who, in good faith and not for compensation, renders emergency care or treatment by the use of an AED at the scene of an emergency is not liable for any civil damages resulting from any acts or omissions in rendering the emergency care.
• Persons that provide training: A person or entity who provides CPR and AED training to a person who renders emergency care ... is not liable for any civil damages resulting from any acts or omissions of the person rendering the emergency care.
• Persons or entities (e.g. businesses, organizations) that acquire an AED for use: A person or entity that acquires an AED for emergency use pursuant to this section is not liable for any civil damages resulting from any acts or omissions in the rendering of the emergency care by use of an AED, if that person or entity has complied with subdivision (b) of Section 1797.196 of the Health and Safety Code.
• Physicians involved with AED program and entities responsible for a site where an AED is located: A physician who is involved with the placement of an AED and any person or entity responsible for the site where an AED is located is not liable for any civil damages resulting from any acts or omissions of a person who renders emergency care ... if that physician, person, or entity has complied with all of the requirements of Section 1797.196 of the Health and Safety Code that apply to that physician, person, or entity.
• Exceptions to the above: The protections specified in this section do not apply in the case of personal injury or wrongful death that results from the gross negligence or willful or wanton misconduct of the person who renders emergency care or treatment by the use of an AED.

So there are broad protections from liability present in the law. The law also refers to requirements for entities, persons, and physicians that are listed in another portion of statute, section 1979.196 of the Health and Safety Code.

Requirements of Section 1979.196 (b) of the Health and Safety Code:

• Maintenance and testing:
  • The AED must be maintained and regularly tested according to manufacturer standards, an in compliance with standards such as the American Heart Association, American Red Cross, and the federal Food and Drug Administration.
  • The AED is checked after each use and at least once every 30 days if not used, and records of these checks shall be maintained.
• Interface with EMS and prescribing physician:
  • Persons using an AED activates the emergency medical services (calls 911) as soon as possible.
  • The local EMS agency and the prescribing physician should be notified of the use of the AED.
• Training and availability of employees
  • For businesses or other entities, there must be at least one employee per AED (up to 5 AED units on the premises) trained in the use of AED to the standards of the American Heart Association or the American Red Cross and in compliance with EMS regulations.
  • The law states that acquirers of AED's must have "trained employees available during normal operating hours." It does not delineate how many must be available.
  • For businesses or other entities with more than five AEDs, an additional one person must be trained for every 5 additional AED units.
• Written Plan
  • Describes procedures to be followed in an emergency
  • Assures compliance with the above requirements
  • Must include plan to immediately call 911 and notify trained office personnel on site at the start of AED procedures
• Compliance with all state regulations governing the placement of an AED (see below)

Layperson AED Regulations (Title 22, California Code of Regulations, Division 9, Chapter 1.8)

These regulations are the latest version but statute supercedes some parts of the regulations.

Portions of regulations that still apply:

• Training program requirements (hours, subject matter) are outlined. Training programs that teach non-licensed or non-certified personnel need to have a physician medical director.
• A California licensed physician and surgeon must be involved in the development of the written plan for response. The plan is termed "Internal Emergency Response System" by the regulations.
• The EMS Agency needs to be notified of the existence of the AED when acquired. The supplier of the AED is also required to do this by law.

Portions of regulations no longer applicable:

• Users of AED (lay public) no longer are required to have prior training. Businesses or other entities must train a minimum number of persons (as listed in statute), but the statute doesn't limit use to the trained persons.
• Physicians no longer are required to authorize individuals to use AEDs.

• Must be currently licensed as a physician and surgeon in California
• Must be involved in the development of a plan for a business or other entity that has acquired the AED, and the plan must include contacting 911, alerting trained personnel, and the provision of maintenance and testing of the AED.
• Must be assured that adequate numbers of persons are trained at the site of the AED.
• Must be assured that the training meets the requirements of statute and regulation.

Many manufacturers/vendors who supply the AEDs also can supply or direct purchasers of AEDs to a program that includes a basic plan and training. Vendors also may have qualified physicians available to prescribe the AED.

PAD FAQ's

1) What is public access defibrillation?

2) Where should Automated External Defibrillators be placed?

3) How many AEDs do I need at my worksite?

4) How can I get an AED?

5) What does training involve?

6) If AEDs are so easy to use, why do people need formal training in how to use them?

7) Am I legally liable for using an AED?

8) Why can't I just buy an AED and keep it at my worksite?

9) Why must there be oversight by a medical doctor?

10) Why is notifying the local EMS Agency important?

Public access to defibrillation (PAD) means making an automated external defibrillator available in public and/or private places where large number of people gather or people who are at high risk for heart attacks live.

Studies have demonstrated that there is a higher incidence in certain locations. Some of these include: airports, shopping malls, community/senior citizen centers, athletic clubs, sports arenas, gated communities, jails, large industrial sites, nursing homes, private businesses and cardiology/internal and family medicine practices.

This is usually determined by the size of your facility. In addition, if your facility is spread out or on several floors, more than one may be recommended. The goal of a successful AED program is to deliver a shock to a victim within 3-5 minutes of collapse. When determining where to place an AED, us a 3 minute response time as a guide.

AEDs can be purchased through one of several manufacturers and/or vendors. A list is provided in this packet.

Training involves a four hour course in CPR and the use of an AED. A list of training organizations is provided in this packet. Local CPR/AED course information is also available at 1-800-GIVE-CPR.

An AED operator must know how to recognize the signs of sudden cardiac arrest, when to activate the 911 system, and how to do CPR. Training also teaches the operator how to avoid potentially hazardous situations.

The Cardiac Arrest Survival Act (CASA) was part of the Public Health Improvement Act signed into law in November 2000. The law provides nationwide Good Samaritan protection that exempts from liability anyone who renders emergency treatment with a defibrillator to save someone's life. As awareness of AEDs grows, companies and organizations may face greater threat of liability if they are not properly prepared to respond to a cardiac emergency in a timely manner. This trend can be seen by three cases in which lawsuits were filed against companies that were not prepared.

AED's are regulated by the FDA and require medical oversight.

An AED is a medical device and must be prescribed by a physician. The physician's main duties include: providing medical leadership and expertise, coordinating the program with the local EMS agency, ensuring that rescuers are properly trained and their skills maintained, and to assume responsibility for how the program is planned and conducted.

It is important for the local EMS system to know where AEDs are located in the community. In the event of a sudden cardiac arrest , the 9-1-1 dispatcher will know if an AED is on the premises and will be able to notify the EMS responders as well as assure that the individuals already on the scene know that the AED is onsite and assure that it is being or gets used.

AED Consultant, Distributor & Training Organizations

The following organizations have notified the EMS Agency that they provide program development and/or training in the use of AEDs. Some are also distributors of AEDs. You are encouraged to independently evaluate these organizations and determine which one will best meet your needs.

PD = Program Development T = Training D= Distributor

American Heart Association- (PD, T)
426 17th Street
Oakland, CA 94612
Phone: (510) 904-4000
www.americanheart.org

American Health & Safety Training, Inc.- (PD, T, D)
3180 Crow Canyon Place, Suite 103
San Ramon, CA 94583
Phone: (877) 369-5888
www.americanhealthsafety.com

American Red Cross (T)
1300 Alberta Way
Concord, CA 94521
Phone: (800) 520-5433

CPR F.A.S.T. (PD, T, D)
2063 Main St. #275
Oakley, CA 94561
Phone: (925) 625-3278
Fax: (925) 625-7768
www.cprfast.org

CPR Training Center (PD, T, D)
2300 Clayton Road, Suite 110
Concord CA 94520
Phone: (925) 934-6223
www.cprtrainingcenter.com

DiPietro & Associates, Inc. (PD, T)
664A Freeman Lane, #311
Grass Valley, CA 95949
Phone: (530) 477-6818
Fax: (925) 530-477-6850
www.dipietroassociates.com

Fast Response (T)
1015 University Avenue
Berkeley, CA 94710
Phone: (800) 637-7387
www.fastresponse.org

Fontaine Fire Inc. (T, D)
171 Front Street, Suite 105
Danville, CA 94526
Class Info: (925) 858-9789
Phone: (925) 831-9263
Fax: (925) 831-9283
www.fontainefire.com

Health Education Services (PD, T, D)
200 Waverly Street, Suite 8
Menlo Park, CA 94025
Phone: (650) 321-6500
www.healtheducationservices.net

ICE Safety Solutions (PD, T)
43236 Christy Street
Fremont, CA 94538
Phone: (877) 743-8423
www.getice.com

Life Safety Associates (PD, T)
1876 Hartog Drive
San Jose, CA 95131
Phone: (888) 552-5433
www.lifesafety.com

Life Support Services (T, D)
4588 Peralta Blvd. #15
Fremont, CA 94536
Phone: (510) 790-2778
www.lifesupportservices.net

Rescue Training Institute (PD, T)
2091 Portsmouth Drive
El Dorado Hills, Ca. 95762
Phone: (916) 939-2277
www.rescuetraininginstitute.com

Automated External Defibrillator Manufacturers

There are currently six companies in the United States that manufacture AEDs. All AEDs on the market have been cleared by the Food and Drug Administration and thus are considered safe and effective. The information below is provided as a convenience for anyone interested in establishing an AED Program. Interested parties are encouraged to contact several manufacturers/vendors to compare all equipment/services prior to making a selection. AED manufacturers are listed below.

Cardiac Science, Inc.
3303 Monte Villa Parkway
Bothell, WA 98021-8969
Phone: (888) 274-3342 x2
Fax: (425) 402-2001
www.cardiacscience.com

Defibtech
Sold by authorized distributors
Phone: (866) 333-4248
www.defibtechmd.com

Heart Sine Technologies, Inc.
105 Terry Drive
Newton, PA 18940
Phone: (866) 478-7482
Fax: (215) 860-8192
www.heartsine.com

Medical Research Laboratories, Inc.
4341 State Street Road
Skaneateles Falls, NY 13153
Phone: (800) 462-0777
Fax: (315) 685-3361
www.welchallen.com

Medtronic Emergency Response Systems
P.O. box 97006
Redmond, WA 98073
Phone: (800) 442-1142
Fax: (800) 426-8049
www.medtronic-ers.com

Philips Medical Systems
3000 Minuteman Road
Andover, MA 01810
Phone: (800) 934-7372
Fax: (800) 947-3299
www.medical.philips.com

Zoll Medical Corporation
269 Mill Road
Chelmsford, MA 01824
Phone: (800) 348-9011
Fax: (978) 421-0015 or (978) 421-0016
www.zoll.com

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