Department of Health and Social Services

Division of Public Health

Emergency Medical Services

4303 Automatic External Defibrillation

1.0 Purpose

1. 1.1 This regulation establishes:

   1. 1.1.1 The criteria for administering semi-automatic external cardiac defibrillation by the public in the pre-hospital environment.
   2. 1.1.2 The State Emergency Medical Director’s standards and training requirements for authorized semi-automatic external defibrillation equipment throughout the State of Delaware.

2.0 Authority

This regulation is promulgated by the Delaware Department of Health and Social Services pursuant to 16Del.C.Ch. 9705 and 16Del.C.Ch. 30C.

3.0 Definitions

The following words and terms, when used in this regulation, have the following meaning:

"AED"means an automated external defibrillator, which is a device capable of: (1) analyzing cardiac rhythm, (2) determining the need for defibrillation, (3) automatically charging, and (4) advising a provider to deliver an electrical impulse or automatically deliver an impulse to restore the sudden cardiac arrest victim to a normal sinus rhythm.

"CPR" means cardiopulmonary resuscitation.

"Delaware Early Defibrillation Program" means a coordinated program provides early access to defibrillation for individuals experiencing sudden cardiac arrest using automated external defibrillation and related care.

"Early defibrillation service" means a person or agency who is registered to provide care to victims of cardiac arrest, who wishes to employ or retain personnel within their organization who are trained in the use of automated external defibrillation and related care.

"Emergency Medical Service" or "EMS" means an ambulance, paramedic or prehospital service that provide urgent prehospital treatment and stabilization for serious illness or injuries and transport to definitive care facilities.

"FDA"means the Food and Drug Administration of the U.S. federal government.

"First responder team"means an organized group of individuals within a public access defibrillation agency designated by that agency to respond to emergency situations.

"Office"or"OEMS"means the Delaware State Office of Emergency Medical Services.

"SAED" means a semi-automatic external defibrillator, an electronic device capable of: (1) analyzing cardiac rhythm, (2) determining the need for defibrillation, (3) automatically charging, and (4) advising a provider to deliver an electrical impulse to restore the sudden cardiac arrest victim to a normal sinus rhythm.

"Service"means an organization that provides an early defibrillation program.

"Service coordinator" means the appointed possessor of an SAED who coordinates an organization's early defibrillation program.

"State Coordinator" means the Director of the State Office of Emergency Medical Services appointee who administers the Early Defibrillation Program at the state level.

"State Medical Director" means the State Office of Emergency Medical Services State EMS Medical Director who provides medical control supervision and quality control for the Delaware Early Defibrillation Program.

4.0 General Provisions

1. 4.1 This regulation applies to any organization or individual participating in the Delaware Early Defibrillation Program.
2. 4.2 The OEMS, or its designee, shall retain the right to inspect any early defibrillation service's State funded defibrillation equipment or any records or documentation associated with that agency’s early defibrillation program.
3. 4.3 Automated or semi-automated external defibrillators are classified as medical devices by the Delaware Board of Medical Licensure and Discipline.
4. 4.4 AED manufacturers and their representatives or agents are required to notify the OEMS of the sale and placement of an SAED within the State of Delaware.
5. 4.5 The OEMS shall be responsible for notifying the jurisdictional public safety answering point of the placement of an AED/SAED within the boundaries of their jurisdiction.
6. 4.6 AED/SAED providers, agencies, and training organizations have limited immunity protection as specified in Section 11.0 of this regulation.

5.0 Eligibility

1. 5.1 Any individual, agency, school, organization, or business, within the State of Delaware is eligible to become an early defibrillation service.
2. 5.2 Any agency, school, organization, or business from another state operating within the State of Delaware, is eligible to become an early defibrillation service as approved by the State Emergency Medical Services Medical Director.

6.0 Early Defibrillation Service Requirements

1. 6.1 Agencies, schools, corporations, or businesses desiring to provide early defibrillation services must make application to the OEMS prior to implementation of the program.

2. 6.2 Information to be provided with the application package shall include:

   1. 6.2.1 The OEMS approved application; and
   2. 6.2.2 Other information as required by the OEMS.

3. 6.3 Responsibility of the Service

   1. 6.3.1 The service shall:

      1. 6.3.1.1 Appoint a service coordinator to act as a liaison between the service and the State Coordinator.
      2. 6.3.1.2 Notify the OEMS of changes of any information contained in the original application within 14 days of the changes. This includes changes in the service coordinator or changes in equipment or operational procedure.
      3. 6.3.1.3 Ensure defibrillators used by the service are of the type specified by this regulation.
      4. 6.3.1.4 Supply appropriate resources to providers to assure the capability to comply with the reporting procedures required under this regulation.

7.0 State Coordinator Responsibilities

1. 7.1 A State Coordinator shall:

   1. 7.1.1 Be appointed by the State EMS Director.
   2. 7.1.2 Act as a liaison between the OEMS and the recognized training agencies, services, providers, and medical facilities.

8.0 Service Coordinator

A Service Coordinator shall have successfully completed an SAED training course.

9.0 Early Defibrillation Provider Requirements

1. 9.1 Guidelines for the validation of credentials of early defibrillation providers are established by the Board of Medical Licensure and Discipline.
2. 9.2 Individuals requesting validation as an early defibrillation provider shall apply for AED/SAED training through a training agency recognized by the OEMS.

10.0 Defibrillation Equipment

1. 10.1 Defibrillators acceptable for use in the State of Delaware shall:

   1. 10.1.1 Be FDA approved;
   2. 10.1.2 Be of the automated type requiring no provider intervention to deliver an electoral impulse, or be of the semi-automated type requiring provider intervention to initiate an electrical impulse approved by the State EMS Medical Director.

2. 10.2 Defibrillation Equipment Modification

   1. 10.2.1 No modifications are to be made to defibrillation equipment, by a provider in the service, which results in:

      1. 10.2.1.1 Deviation from the original manufacturer’s specification; or
      2. 10.2.1.2 Deviation from Early Defibrillation Program protocols.
   2. 10.2.2 Defibrillation protocol changes may only be authorized by the State EMS Medical Director.
   3. 10.2.3 Necessary defibrillator modifications shall be coordinated by the service coordinator.
   4. 10.2.4 Defibrillator preventive maintenance will be maintained in accordance with manufacturer’s recommendations.
3. 10.3 Financial Responsibility. Purchase of AED/SAED units, electrodes or pads, data collection hardware/software, and any required inspections, repairs, or replacement parts shall be the sole responsibility of the service.

11.0 Provisions of Limited Immunity Protections

Persons using an AED/SAED in attempt to resuscitate another person have limited immunity protection under 16Del.C.Ch. 3005C.

12.0 AED/SAED Deployment Guidelines

1. 12.1 AEDs/SAEDs are to be used in cases of cardiac arrest and in accordance with manufacturer's guidelines only.
2. 12.2 AED/SAED providers shall follow the most current American Heart Association/Emergency Association's Emergency Cardiovascular Care Committee guidelines and additional guidelines as promulgated by the State EMS Medical Director.
3. 12.3 EMS and first responder agencies must transport to the closest appropriate medical facility when a paramedic unit has not arrived on the scene. EMS and first responder agencies must contact medical control while enroute for additional orders.
4. 12.4 Non-EMS/first responders must continue CPR and repeat rhythm analysis until EMS arrives. Non-EMS/first responders must redial 911 until confirmation that help is on the way is established.

5. 12.5 Complete the public access AED use report as follows:

   1. 12.5.1 Non-EMS/first responders without download capabilities shall complete the public access AED use report and restock the AED/SAED. The AED/SAED shall be placed back in service and ready for use.
   2. 12.5.2 Non-EMS/first responders with download capabilities shall complete the public access AED use report, download/print the AED report, and send a copy of all the data to the State AED coordinator.
   3. 12.5.3 EMS/first responders shall include all AED data in the patient care/police documentation. Police and correction agencies shall forward all AED documentation to the State Coordinator.

1.1.3The procedures to assure quality assurance and uniform data collection.29 DE Reg. 131 (08/01/25)

29 DE Reg. 131 (08/01/25)

29 DE Reg. 131 (08/01/25)

29 DE Reg. 131 (08/01/25)

29 DE Reg. 131 (08/01/25)

29 DE Reg. 131 (08/01/25)

29 DE Reg. 131 (08/01/25)

29 DE Reg. 131 (08/01/25)

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4 DE Reg. 1543 (03/01/01)

17 DE Reg. 438 (10/01/13)

29 DE Reg. 131 (08/01/25)