|
According to the Colorado Department of Public Health and Environment (CDPHE), “Colorado statute does exist that provides limited immunity from liability for use of the AED, and certain conditions must be met to qualify for immunity. Please read the statute carefully to make sure that you are meeting the intent of the standards as defined in the statute.”
“The Federal Food and Drug Administration has declared Automated External Defibrillators (AEDs) a prescription device, which means that they require a prescription from a licensed physician in order to be purchased and placed into use (FDA 21CFR801.109). This is a federal requirement and applies to all sales of AEDs in the USA.”
http://www.cdphe.state.co.us/em/operations/aed/
AED - Immunity Statute for Use
13-21-108.1. Persons rendering emergency assistance through the use of automated external defibrillators - limited immunity.
(1) The general assembly hereby declares that it is the intent of the general assembly to encourage the use of automated external defibrillators for the purpose of saving the lives of people in cardiac arrest.
(2) As used in this section, unless the context otherwise requires:
(a) "AED" or "defibrillator" means an automated external defibrillator that:
(I) Has received approval of its premarket notification filed pursuant to 21 U.S.C. sec. 360 (k), from the federal food and drug administration;
(II) Is capable of recognizing the presence or absence of ventricular fibrillation or rapid ventricular tachycardia, and is capable of determining, without intervention by an operator, whether defibrillation should be performed; and
(III) Upon determining that defibrillation should be performed, automatically charges and requests delivery of an electrical impulse to an individual's heart.
(b) "Licensed physician" means a physician licensed to practice medicine in this state.
(3) (a) In order to ensure public health and safety, a person or entity who acquires an AED shall ensure that:
(I) Expected AED users receive training in cardiopulmonary resuscitation (CPR) and AED use through a course approved by the department of public health and environment;
(II) The defibrillator is maintained and tested according to the manufacturer's operational guidelines and that written records are maintained of this maintenance and testing;
(III) There is involvement of a licensed physician in the program at the site of the AED to ensure compliance with requirements for training, notification, and maintenance;
(IV) There are written plans in place concerning the placement of AED's, training of personnel, pre-planned coordination with the emergency medical services system, medical oversight, AED maintenance, identification of personnel authorized to use AED's, and reporting of AED utilization, which written plans have been reviewed and approved by a licensed physician;
(V) Any person who renders emergency care or treatment to a person in cardiac arrest by using an AED activates the emergency medical services system as soon as possible and reports any clinical use of the AED to the licensed physician affiliated with the program.
(b) Any person or entity that acquires an AED shall notify an agent of the applicable emergency communications or vehicle dispatch center of the existence, location, and type of AED.
(4) (a) Any person or entity whose primary duties do not include the provision of health care and who, in good faith and without compensation, renders emergency care or treatment by the use of an AED shall not be liable for any civil damages for acts or omissions made in good faith 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, unless the acts or omissions were grossly negligent or willful and wanton.
(b) The immunity provided in paragraph (a) of this subsection (4) extends to the licensed physician who is involved with AED site placement, the person or entity who provides the CPR and AED site placement, and the person or entity responsible for the site where the AED is located.
(c) The immunity provided in this subsection (4) applies only if the requirements of subsection (3) of this section are met. (5) The requirements of subsection (3) of this section shall not apply to any individual using an AED during a medical emergency if that individual is acting as a good samaritan under section 13-21-108.
Note: The text of this statute is placed here for the convenience of the reader and does not represent an official copy of this statute. §13-21-108.1. of the Colorado Revised Statute can be accessed through the
LexisNexis
site.
http://www.cdphe.state.co.us/em/operations/aed/aedimmunity.html
Colorado Department of Public Health and Environment Approved AED Training
The Colorado State Emergency Medical and Trauma Services Advisory Council unanimously approved the following on April 4, 2002.
REFERENCE: §13-21-108.1 Colorado Revised Statute (C.R.S.)
"(I) Expected AED users receive training in cardiopulmonary resuscitation (CPR) and AED use through a course approved by the department of public health and environment"
APPROVED AED TRAINING DESCRIPTION: Approved training in the use of an automated external defibrillator (AED) and cardiopulmonary resuscitation (CPR) for the expected AED user, as defined in §13-21-108.1 C.R.S, shall include the completion of training containing the following documented elements:
- Cognitive and psychomotor learning objectives in CPR · Practice time in CPR
- Formal evaluation of student performance of CPR · Cognitive and psychomotor learning objectives for device specific operations
- Cognitive and psychomotor learning objectives for use and integration (protocol) of the specific device with CPR · Practice time on the specific device use with CPR integration
- Formal evaluation of student performance of the use and integration (protocol) of an AED with CPR
Approved training shall be previously reviewed and endorsed by the physician involved in the Public Access Defibrillation program.
DISCUSSION: Effective May 1, 2002:
- This policy shall replace all previous descriptions of automated external defibrillator training approved by the Colorado Department of Public Health and Environment.
- All requirements for application and recognition as an AED Training Group shall become invalid.
- Organizations previously recognized as an approved AED Training Group will no longer be regulated by the Colorado Department of Public Health and Environment and will not be required to renew previously issued recognition on this level.
Organizations and expected AED users wishing to qualify for Good Samaritan status, as defined in §13-21-108.1 C.R.S, may utilize training provided by any source to include any of the following:
- National, regional, or local certifying organizations that provide AED and/or CPR training that meets the above approved description.
- AED and/or CPR training provided by a manufacturer or sales representative that meets the above approved description.
- Training that meets the above approved description that is created and presented by the organization wishing to qualify for Good Samaritan status, as defined in §13-21-108.0 and §13-21-108.1 C.R.S. AED training includes instruction on the specific AED device being utilized by the organization.
It is recommended that the organization keep adequate records of all training that demonstrates compliance with the above-approved description rather than rely upon the provider to maintain such records.
Note: The text of this statute is placed here for the convenience of the reader and does not represent an official copy of this statute. §13-21-108.1. of the Colorado Revised Statute can be accessed through the
LexisNexis
site.
http://www.cdphe.state.co.us/em/operations/aed/aedtraining.html
|