Automated External Defibrillators (AEDs) are manufactured and sold under guidelines issued by the U.S. Food and Drug Administration (FDA). Current FDA regulations make AEDs, like many drugs, available only to those with a physician's prescription. Simply finding a physician willing to write the necessary prescription, however, is not enough; in order for an AED or Public Access Defibrillation (PAD) program to be safe and effective, the program needs constant oversight by a medical director.
Reasons For Oversight
Active oversight of an AED/PAD program by a qualified medical director [2] is critical for the following reasons:
May be required for registration/application process: Where, as in some states, there is a registration or application process for a PAD program, it is the responsibility of the medical director to complete the process;
Lends expertise and credibility: Having a medical director supervise an AED program adds the authority and expertise of a physician to the program team;
Serves as visible spokesperson, teacher and advocate: Involving a physician as an advocate helps get an AED program off the ground; using the medical director as a spokesperson adds to the program's credibility in the community; the medical director should approve the initial AED training and, depending on the size of the program and the physician's availability and management style, further involvement may range from providing guidance to the program director to active involvement in hands-on training;
Ensures quality through active oversight: Because a medical director is involved in all aspects of the program, from training, development of treatment protocols and program implementation to follow-up review and evaluation after an AED is used, program quality can be maintained and improved; and
Assures system integration: The medical director plays a critical role in coordinating the PAD program with the existing Emergency Medical System (EMS) system by making sure that EMS is not only aware of the program, but that data on any use of an AED by the program is provided to EMS on a follow-up basis.
The roles and responsibilities of a medical director of an AED/PAD program are varied and wide-ranging. They include:
Program Development And Implementation
Helps launch the program by serving as an advocate and spokesperson and performing community outreach to increase support;
Participates in the AED selection [3], purchase and deployment process;
Writes prescription required by FDA for AED purchases, and completes registration/application process (as required by state or local law);
Develops a system to ensure that bystanders alert lay rescuers authorized to respond with AEDs so they can reach victims in the critical first minutes after collapse [4];
Supervises or participates in certification and recertification training programs [5] to instruct rescuers in how to perform CPR and use an AED;
Establishes treatment protocols for rescuers authorized to respond to cardiac emergencies;
Coordinates the program with the local EMS; and
Assists in the development of other program policies and procedures.
Ongoing Program Oversight And Guidance
Provides medical advice along with EMS and 911 dispatchers;
Ensures that the AEDs are properly maintained and used;
Engages in ongoing education and training;
Reviews response data after an SCA event (e.g., ECG rhythm, responder and AED actions, unit performance) to identify system flaws, evaluate knowledge and skills of lay rescuers, and provide feedback;
Works with program coordinator to improve emergency response preparedness and program effectiveness; and
Consults on specific medical issues on an as-needed.
Agreement Recommended
To avoid any misunderstandings and to minimize the risk of legal liability, the relationship between the AED program and medical director should be memorialized in a written agreement covering:
Specific responsibilities: The agreement should contain a job description clearly defining the medical director's duties, responsibilities, and scope of authority in accordance with your state's laws and regulations. Doing so also has helps reduce the medical director's potential legal liability.
Legal liability: In some instances, legal liability for the actions of the medical director can be contractually assumed by the program. Alternatively, the medical director should consult her insurance carrier to see if her existing policy provides coverage for her new responsibilities, or such coverage can be purchased for an additional premium.
Compensation: Whether the medical director will be a volunteer or will be paid will depend on several factors such as:
Size of the community
Number of SCA cases, and
Whether the program is operated by a for-profit or not-for-profit organization.
Links:
[1] https://mail.momsteam.com/users/glenn-laub
[2] http://www.momsteam.com/alpha/features/cardiac_awareness_center/obtaining_medical_direction.shtml
[3] http://www.momsteam.com/alpha/features/cardiac_awareness_center/selecting_aeds.shtml
[4] http://www.momsteam.com/alpha/features/cardiac_awareness_center/cardiac_chain_of_survival.shtml
[5] http://www.momsteam.com/alpha/features/cardiac_awareness_center/AED_training.shtml