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Delaware - AED Statutes & Regulations

AED owners are legally responsible to ensure compliance and emergency readiness of their AEDs. Each unit must meet certain requirements from the FDA, the local state, and individual AED manufacturers, which can be a challenging task to maintain. Thousands of customers rely on us to manage their AED compliance through our easy to use tool called LifeShield. Learn more about how we support our clients with an unmatched AED compliance program offering here.


Delaware Summary
RequirementSummary
Good Samaritan LawAny person or entity, who in good faith and without compensation, renders emergency care or treatment by the use of an AED shall be immune from civil liability for any personal injury as a result of such care or treatment.
AED TrainingEntities that have AEDs should ensure that each prospective defibrillator user receives appropriate training.
MaintenanceDefibrillators should be maintained and tested according to the manufacturer’s guidelines.
RegistrationAED registration is required.
CPR/AED TrainingTwo hours of CPR and AED training are required in grades 9-12.
Delaware Statutes and Regulations
StatuteAbstract
Delaware Code - 16 Del. C. § 3001C. Findings and purpose.

The General Assembly of the State has found that each year more than 350,000 Americans experience out-of-hospital sudden cardiac arrest. More than 95% of them die. In many cases, people die because life saving defibrillators arrive on the scene too late, if at all. It is estimated that more than 100,000 deaths could be prevented each year if defibrillators were more widely available to designated users (responders). Many communities around the country have invested in 911 emergency response systems, emergency personnel and ambulance vehicles. However, many of these same communities do not have enough defibrillators. It is therefore the intent of this General Assembly to encourage greater acquisition, deployment and use of automated external defibrillators in communities within the State.
Delaware Code - 16 Del. C. § 3002C. Definitions

The following words, terms and phrases, when used in this chapter, shall have the meanings ascribed to them herein, except where the context clearly indicates a different meaning:

(a) Automated external defibrillator, (AED) shall mean a medical device which is both a heart monitor and defibrillator that has received approval of its premarket notification, filed with the Food and Drug Administration pursuant to United States Code, Title 21, section 360(k).

(b) Records shall mean the recordings of interviews and all oral or written reports, statements, minutes, memoranda, charts, statistics, data and other documentation generated by the State EMS Medical Director.

Delaware Code - 16 Del. C. § 3003C.Correct use of defibrillator; training in order to ensure public health and safety.

a) Any entity to whom AEDs are distributed shall insure that:

(1) Each prospective defibrillator user receives appropriate training by the American Red Cross, the American Heart Association, Delaware State Fire School or by another nationally recognized provider of training for cardio-pulmonary resuscitation and AED use; provided however, that such training shall be approved by the State EMS Medical Director;

(2) The defibrillator is maintained and tested according to the manufacturer’s guidelines; and

(3) Any person who renders emergency care or treatment on a person in cardiac arrest by using an AED shall notify the appropriate EMS units as soon as possible and report any clinical use of the AED to the appropriate licensed physician or medical authority.

(b) The State EMS Medical Director shall maintain a file containing the name of each person or entity that acquires an AED with State funding.
Delaware Code - 16 Del. C. § 3004C.Quality Review Program

All quality management proceedings shall be confidential. Records of the State EMS Medical Director, and EMS quality care review committee relating to AED reviews and audits shall be confidential and privileged, are protected, and are not subject to discovery, subpoena or admission into evidence in any judicial or administrative proceeding. Raw data used in any AED review or audit shall not be available for public inspection; nor is such raw data a “public record” as set forth in the Delaware Freedom of Information Act.
Delaware Code - 16 Del. C. § 3005C.Provision of limited liability protections.

(a) Any person or entity, who in good faith and without compensation, renders emergency care or treatment by the use of an AED shall be immune from civil liability for any personal injury as a result of such care or treatment, or as a result of any act or failure to act in providing or arranging further medical treatment, if such person acts as an ordinary, reasonably prudent person would have acted under the same or similar circumstances and such act or acts do not amount to willful or wanton misconduct or gross negligence.

(b) Any individual who authorizes the purchase of an AED, any person or entity who provides training in cardiopulmonary resuscitation and the use of an AED, and any person or entity responsible for the site where the AED is located shall be immune from civil liability for any personal injury that results from any act or omission that does not amount to willful or wanton misconduct or gross negligence.
Delaware Code of Regulations - 16 Del. Admin. Code § 4303Automatic External Defibrillation

1.0 Purpose

1.1 This regulation establishes:
1.1.1 The criteria for administering semi-automatic external cardiac defibrillation by the general public in the pre-hospital environment.
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.
1.1.3 The procedures to assure quality assurance and uniform data collection.

2.0 Authority
This regulation is written and promulgated by the Delaware Department of Health and Social Services pursuant to 16 Del.C. Chapter 9705 and 16 Del.C. Chapter 30C.
3.0 Definitions
CPR means Cardiopulmonary Resuscitation
FDA means Federal Food and Drug Administration
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 Semi-Automatic External Defibrillator. 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.
Service Coordinator means the appointed possessor of an SAED who coordinates the agency’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 Early Defibrillation Program.
The Board means the Delaware Board of Medical Licensure and Discipline.

4.0 General Provisions

4.1 This regulation applies to any organization or individuals participating in the Delaware Early Defibrillation Program.

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.

4.3 Semi-Automated External Defibrillators are classified as medical devices by the Delaware Board of Medical Licensure and Discipline.

4.4 SAED manufacturers, their representatives or agents are required to notify the OEMS of the sale and placement of an SAED within the State of Delaware.

4.5 The OEMS shall be responsible for notifying the jurisdictional public safety answering point of the placement of an SAED within the boundaries of their jurisdiction

4.6 SAED Providers, SAED agencies and SAED training organizations have limited immunity protection as specified in Chapter 11 of this regulation.

5.0 Eligibility

5.1 Any individual, agency, school, organization or business, within the State of Delaware is eligible to become an Early Defibrillation Service.

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

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.

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

6.2.1 OEMS approved application;

6.2.2 Other information as required by the OEMS.

6.3 Responsibility of the Service

6.3.1 The Service shall:
6.3.1.1 Appoint a Service Coordinator to act as a liaison between the Service and the State Coordinator.
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.
6.3.1.3 Ensure defibrillators used by the service are of the type specified by this regulation.
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

7.1 A State Coordinator shall:
7.1.1 Be appointed by the State EMS Director.
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 will have successfully completed an SAED training course.

9.0 Early Defibrillation Provider Requirements

9.1 Guidelines for the validation of credentials of Early Defibrillation Providers are established by the Board of Medical Licensure and Discipline.

9.2 Individuals requesting validation as an Early Defibrillation Provider shall:
9.2.1 Apply for SAED training through an SAED training agency recognized by the OEMS.

10.0 Defibrillation Equipment
10.1 Defibrillators acceptable for use in the State of Delaware will:
10.1.1 Be FDA approved;
10.1.2 Be of the semi-automatic type requiring provider intervention to initiate a defibrillation shock or other device as approved by the State EMS Medical Director;
10.1.3 Be capable of automatically collecting data;
10.1.4 Be capable of producing a printed summary report as approved by the State EMS Medical Director.
10.1.5 SAEDs utilizing alternate waveform technologies are approved for use provided that the treatment algorithm has been approved by the FDA.

10.2 Defibrillation Equipment Modification
10.2.1 No modifications are to be made to defibrillation equipment, by a provider on the service, which results in:
10.2.1.1 Deviation from the original manufacturer’s specification;
10.2.1.2 Deviation from Early Defibrillation Program protocols.
10.2.2 Defibrillation Protocol changes may only be authorized by the State EMS Medical Director.
10.2.3 Necessary defibrillator modifications shall be coordinated by the Service Coordinator.
10.2.4 Defibrillator preventive maintenance will be maintained in accordance with manufacturer’s recommendations.

10.3 Financial Responsibility
10.3.1 Purchase of 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 SAED in attempt to resuscitate another person have limited immunity protection under 16 Del.C. Chapter 3005C.

12.0 SAED Deployment Guidelines

12.1 SAEDs are used in cases of cardiac arrest.

12.2 SAED providers shall follow the most current American Heart Association/Emergency Cardiac Care Committee guidelines and/or additional guidelines as promulgated by the State EMS Medical Director.

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.
12.3.1 EMS and First Responder agencies must contact medical control while enroute for additional orders.

12.4 Non-EMS/First Responders must continue CPR and repeat rhythm analysis until EMS arrives.
12.4.1 Non-EMS/First Responders must re-contact 911 assuring help is on the way.

12.5 Complete the SAED download data management form.
12.5.1 For non-EMS/First Responders without download capabilities:
12.5.1.1 Turn the SAED over to the responding EMS agency for data download.
12.5.1.2 After the data has been downloaded and printed out have the EMS agency return the SAED to the owner agency.
12.5.1.3 Send a hard copy of all data downloads to the State AED Coordinator.
Delaware Code of Regulations - 14 Del. Admin. Code § 851 K to 12 Comprehensive Health Education Program

1.1.3.4 In grades 9 to 12, one half (1/2) credit of comprehensive health education is required for graduation of which fifteen (15) hours of this 1/2 credit course must address drug and alcohol education. In addition, no less than two (2) hours of this 1/2 credit course shall include a cardiopulmonary resuscitation (CPR) instructional program which uses the most current evidence-based emergency cardiovascular care guidelines, and incorporates psychomotor skills learning into the instruction, use of an Automated External Defibrillator (AED) as well as a component on the life saving and life enhancing effects of organ and tissue donation. This 1/2 credit course may be provided in the 9th, 10th, 11th or 12th grade. In each of the remaining three grades, fifteen (15) hours of drug and alcohol education must be provided for all students. CPR instruction, use of an AED and organ/tissue donation awareness shall be integrated into each high school Health Education Program no later than the 2015-2016 school year.

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