Frequently Asked Questions, HHS Guidelines
- WHAT DO THE HHS PUBLIC ACCESS DEFIBRILLATION PROGRAM GUIDELINES PROVIDE?
The Guidelines provide a general framework for designing Public Access Defibrillation (PAD) Programs in Federal facilities and provide basic information about the essential elements of a PAD program. These Guidelines outline the key elements of a PAD program so that facility-specific, detailed plans and programs can be developed in an informed manner.
- WHAT MATERIALS ARE THE GUIDELINES BASED UPON?
The information provided in these Guidelines is based upon the best practices of current Automated External Defibrillation (AED) Programs as well as recommendations and literature on AED’s from the American Heart Association (AHA) and the American Red Cross (ARC).
- WHAT DOES “PUBLIC ACCESS DEFIBRILLATION” MEAN IN THE GUIDELINES?
“Public access'' refers to the accessibility of the AED device itself. “Public access” does NOT mean that any member of the public who witnesses a person in cardiac arrest or ventricular fibrillation should use an AED to treat them. While AEDs are reasonably uncomplicated to use, they should be used only by persons who have received proper AED training and education and who have been certified to use an AED by a competent authority.
- WHAT IS THE DIFFERENCE BETWEEN PAD PROGRAMS AND AED PROGRAMS?
AED stands for Automated External Defibrillator. This is the actual machine that is used to defibrillate victims of sudden cardiac arrest. PAD is defined in the question above. The terms AED (Automated External Defibrillator) and PAD (Public Access Defibrillation) are often used interchangeably when referring to first responder programs. AED programs include PAD programs, but also may include other programs, such as those associated with hospitals, where lay responders are not a part of the response team.
- WHAT ARE THE ESSENTIAL PARTS OF A PAD PROGRAM AT A FEDERAL AGENCY?
Each PAD program should include the following major elements:
- Support of the Program by Agency leadership.
- On-going PAD Program Medical direction and oversight.
- Development and regular review of PAD Operational Protocols.
- Cardiopulmonary Resuscitation (CPR) training/refresher training and certification for designated personnel.
- Training/refresher training and certification for designated personnel in the use of the AED and its accessories.
- Development of an Emergency Response Plan and Protocols, including a Notification System to activate First Responders.
- Program integration with facility security and Emergency Medical Services (EMS) Systems.
- Regular Maintenance Programs for hardware and support equipment in between and after each use.
- Development and utilization of a Quality Assurance Program and AED Data/Information Management Systems.
- Development of Measurable Performance Criteria, documentation criteria and periodic program review.
- Understanding the legal aspects of AED use.
- Periodic review of new technologies.
- ARE PROTOCOLS OR STANDARD OPERATING PROCEDURES NECESSARY FOR A SUCCESSFUL PAD PROGRAM?
A key element in assuring that your PAD program will be clearly understood and will function well is the development of protocols. These protocols should be periodically reviewed and revised, when appropriate, by the Medical Director.
- WHO SHOULD BE INVOLVED IN THE DESIGN AND DEVELOPMENT OF THE PAD PROGRAM?
Given the wide variation in Federal work facilities, there will be significant variation in the complexities associated with program design. In addition to having PAD Program experts involved in the design and development of a PAD Program for your facility, it is recommended that those personnel who are likely to be the actual responders to a medical emergency participate. Both individual employee and union interests, in accordance with union contracts, should be considered as well. Officials in the facility's management “chain of command'' must have close involvement in every step, as specified for occupants of facilities under GSA custody and control in 41 CFR 101-20.103-4, entitled “Occupancy Emergency Program''.
- HOW SHOULD MULTI-TENANT BUILDINGS PROCEED?
In facilities that have multiple tenants, special attention should be paid to involving all tenant agencies as appropriate and to communicating program development activities. Such efforts will help avoid confusion about decision-making processes and authority for the development and operation of a PAD Program. It is recommended that the Federal agencies in multi-tenant circumstances follow the guidelines described in 41CFR 101-20.103 to assure clarity of responsibility and accountability.
- DOES YOUR AGENCY NEED A PHYSICIAN’S PRESCRIPTION TO OBTAIN AN AED?
Yes. AEDs are prescription devices. In a PAD Program, plans and protocols that are approved by a supervising physician are considered a prescription. Once the physician has approved and signed off on AED selection and placement, this becomes the authorizing prescription for procurement of the device(s).
- WHEN SHOULD AEDS BE PURCHASED?
The actual selection and procurement of AEDs should be one of the last steps in the design of a facility's PAD program and should be done under the guidance and written authorization of the PAD Program's supervising physician.
- DOES MY AGENCY NEED AN AED PROTOCOL?
Yes. The protocol for AED usage that is developed as part of a facility's PAD Program is an integral part of the physician's prescription and serves as the authorizing document for AED use. Essentially, the protocols that are signed by the Medical Director set the medical standards and criteria for the operation of the PAD Program and all of its components. Systems operated within the boundaries and criteria of these signed protocols are considered to be under a physician's supervision.
- WHO PROVIDES MEDICAL OVERSIGHT OF PAD PROGRAMS?
AEDs are medical devices that are to be used under the advice and consent of a physician. This oversight can be provided either by a facility's own medical staff such as a Health Unit physician, contract physician or by the agency-wide designated Federal physician. It is best to seek medical input from the very beginning of the design of your program.
- DOES AN AGENCY‘S PAD PROGRAM NEED TO BE REVIEWED BY THEIR LEGAL DEPARTMENT?
Yes. Any PAD program should be reviewed by legal counsel to ensure that the program is in compliance with all applicable Federal, State and local rules and regulations.
- WILL THE GOOD SAMARITAN LAWS PROTECT USERS OF AEDS?
Many states have enacted legislation to provide some degree of immunity to lay individuals who provide assistance to people in distress. The laws are called “Good Samaritan” laws. Because these laws vary from state to state, management of individual facilities should be aware of the laws that apply to users of AEDs. Congress recently provided additional protection from civil liability for AED use in the Public Health Improvement Act, Public Law 106-505 (November 13, 2000). Subtitle A of Title IV of the Act, the Cardiac Arrest Survival Act of 2000, provides persons who use or attempt to use an AED, and persons who acquire an AED, immunity from civil liability for harm resulting from the use or attempted use of the AED, subject to a number of important exceptions.
- SHOULD LAY RESPONDERS/RESCUERS (LRR) BE TRAINED AT FEDERAL AGENCIES?
Yes. The greater the number of well-trained LRRs who are available, the more effective a PAD Program will be. Overall effectiveness will be improved as the number of personnel who are fully trained and willing to respond increases.
- WHERE SHOULD AEDS BE PLACED?
While there is no single “formula” to determine the appropriate number, placement, and access system for AEDs, there are several major elements that should be considered. However, all considerations are based upon (1) an optimal response time of three minutes or less and (2) assessing the level of risk in a facility's environment.
- WHAT ARE THE CHARACTERISTICS OF PROPER AED PLACEMENT?
There are several elements that contribute to proper AED placement. The major elements are:
- An easily accessible position (e.g., placed at a height so shorter individuals can reach and remove the AED).
- Unobstructed access to the AED.
- A secure location that prevents or minimizes the potential for tampering, theft, and/or misuse, and precludes access by unauthorized users while at the same time making it readily accessible for responders.
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