DECREE 9/2008, of January 31, which regulates the use of semi-automatic external defibrillators by non-health personnel.
Article 43 of the Spanish Constitution recognizes the right to health protection and declares that it is the responsibility of the public powers to organize and protect public health through preventive measures and the necessary benefits and services. Likewise, article 13.2 of the Statute of Autonomy of Castilla y León provides that all people have the right to comprehensive protection of their health and the public powers of the Community will ensure that this right is effective.
This Decree is issued within the framework of the powers that the Community of Castilla y León has assumed in matters of health in article 74 of the Statute of Autonomy of Castilla y León.
Law 14/1986, of April 25, General Health, establishes the general regulation of all actions that make it possible to make effective the right to health protection and guides the actions of Public Administrations.
In the area of Castilla y León, Law 1/1993, of April 6, on the Organization of the Health System, contemplates, among its guiding principles, an integral conception of health, including promotion, prevention, assistance and rehabilitation activities.
Likewise, this Law includes in article 33 the actions that the Administration must carry out in relation to public and private activities that, directly or indirectly, may have an impact on individual or collective health.
Similarly, Law 16/2003, of May 28, on the cohesion and quality of the National Health System, in its article 2, when establishing the general principles, includes the provision of comprehensive health care, comprehensive both its promotion as well as disease prevention, assistance and rehabilitation, seeking a high level of quality.
For its part, the Strategic Plan for Emergencies and Health Emergencies of Castilla y León, approved by Decree 228/2001, of September 27, includes among its objectives the reduction of the mortality rate associated with cardiovascular diseases.
Agreement 164/2004, of December 23, of the Junta de Castilla y León, which approves the Regional Cardiovascular Health Strategy in Castilla y León, 2005-2007 (Cerebrovascular Disease and Ischemic Heart Disease), includes, among its actions, the development and execution of immediate medical intervention mechanisms from the point of demand, which cover care for all persons with signs of suspicion of Acute Coronary Syndrome.
Action in a situation of cardiorespiratory arrest must be part of a comprehensive action that allows the patient to be assisted in the shortest possible time and that guarantees continuity of care and medical control over the affected person.
The first person acting, the so-called "first responder", who is the one who has the initial contact with the patient in the place where he is, has to identify the cardiorespiratory arrest, alert the emergency services and initiate life support maneuvers. .
Primary ventricular fibrillation is the cause of most deaths that occur in the first hours of Acute Myocardial Infarction. The possibility of identifying and reversing lethal arrhythmias (defibrillation) is the most effective tool to improve the patient's survival expectation.
Semiautomatic external defibrillators are devices that allow for the error-free identification of potentially serious arrhythmias that require the administration of electric shocks. These devices, due to their characteristics, can be used by properly trained non-health personnel for use anywhere, allowing a first action that, due to its immediacy, can improve the chances of survival of people affected by these pathologies.
Different international scientific societies are promoting the use of these devices by non-health personnel, under the control and coordination of the medical emergency system, making it necessary to regulate training and guarantee the level of competence of these personnel in the use of defibrillators. external.
By virtue, the Junta de Castilla y León, at the proposal of the Ministry of Health, in accordance with the opinion of the Advisory Council of Castilla y León and after deliberation by the Governing Council at its meeting on January 31, 2008
HAS
CHAPTER I
General disposition
Article 1
Object
The purpose of this Decree is to regulate the requirements for the installation and use of semi-automatic external defibrillators by non-health personnel, the training requirements for these personnel as well as for the entities or companies in charge of providing it, the inspection and control tasks and the creation of the Registry regarding the use of semiautomatic external defibrillators by non-health personnel in Castilla y León.
Article 2
Area of application
The regulation established in this Decree related to the use of semi-automatic external defibrillators by non-health personnel, will be applicable in the Community of Castilla y León.
Article 3
Semiautomatic External Defibrillator Concept
A semiautomatic external defibrillator (hereinafter DESA) is understood to be an approved technical device with the capacity to analyze the heart rhythm, identify fatal arrhythmias susceptible to defibrillation, and administer an electric shock that restores a viable heart rhythm with high levels of safety.
Article 4
Consideration of non-health personnel
For the purposes of this decree, non-health personnel are considered to be all those persons who do not hold a Bachelor of Medicine and Surgery degree or a University Diploma in Nursing.
CHAPTER II
Requirements and obligations for the installation and use of DESA
Article 5
Conditions for the installation of AEDs
1.– Entities or companies that wish to install or have a DESA, for use by non-health personnel, must have a visible and signposted space for its location, have the brand, model and serial number identified and be authorized and registered in the Registry regarding the use of AEDs by non-health personnel in Castilla y León.
2.– In addition, the entities or companies that have a DESA must guarantee its conservation and maintenance, being the owner of the company or entity responsible.
Article 6
Requirements for the use of AEDs
1.– The AEDs may be used by those non-health personnel with adequate training, who are in possession of the authorization regulated in article 13 of this Decree and registered in the Registry regarding the use of AEDs by non-health personnel of Castilla y Lion.
2.– Likewise, non-health personnel who have an authorization from another autonomous community and who are registered in the aforementioned Registry may use the AEDs.
Article 7
Documentation and communication of interventions
Each use of a DESA entails the obligation to immediately contact the Emergency Coordination Center, hereinafter, (CCU), through telephone 112 and the preparation of a report that will be sent, within a maximum period of one week, to the General Directorate of Planning, Quality, Organization and Training, together with the information of the episode registered in the DESA. The model for the drafting of this report will be the one established by the Emergency Coordination Center (CCU).
CHAPTER III
training requirements
Article 8
Requirements to provide training related to the use of DESA
The entities or companies that wish to provide training related to the management of AED by non-health personnel must meet the requirements regulated in Annex I of this Decree, be in possession of the authorization regulated in article 14 and be registered in the Registry related to the AED use by non-health personnel in Castilla y León.
Article 9
Training program and teaching staff
1.- The training program will be adapted to what is established in Annex II.
2.– The teaching staff who provide the training must have accreditation or certification as an instructor in basic or advanced life support and comply with the provisions of Annex III in relation to the teaching staff.
Article 10
Education and training activities
1.– The authorized training entity or company will notify the General Directorate of Planning, Quality, Management and Training, two months in advance, of the start of the training activity, providing a report describing the activity to be carried out, as referred to in Annex III already mentioned. This General Directorate will verify the adequacy of the established requirements.
2.– Once the activity is finished, and within a period of fifteen days, the training entity or company must send to this General Directorate, a report, signed by all the instructors or the course coordinator, which will include the nominal list of students who have passed the training.
Article 11
Certificates
1.- The entities or companies that provide the training, will issue, after carrying out and passing the corresponding evaluation tests, a certificate of use of the same.
2.– This certificate will conform to the model presented in the authorization report and will include, at least, the information contained in Annex I of this decree.
3.– The certification will be valid for two years, and it is essential to pass the recycling course within two years of its issuance, for its renewal. In the case of not passing the recycling course, it will be necessary to pass the initial training course again to obtain the certification.
CHAPTER IV
Authorizations
Article 12
Authorization for the installation of a DESA
1.– Entities or companies that have a DESA must request authorization and registration from the General Directorate of Planning, Quality, Management and Training, accompanying their request with the documentation in Annex IV.
2.– The General Directorate will issue the appropriate resolution and, if it is favorable, will agree to its registration in the Registry regarding the use of AEDs by non-health personnel in Castilla y León. The maximum period in which the express resolution must be notified will be two months.
3.- The validity of the authorization will be five years. The interested party must request the renewal at least three months before the end of its validity date, which will be granted after verifying that the requirements are met. If the conditions that allowed the authorization are maintained, an affidavit will be provided, if they have been modified, supporting documentation will be provided.
4.– At any time, the General Directorate may revoke the authorization granted for non-compliance with the required requirements.
Article 13
Authorization for the use of AEDs
1.– Non-health personnel, who, once the certification of having completed the established training has been obtained, wish to use the AEDs, must request their authorization and registration from the General Directorate of Planning, Quality, Management and Training, accompanying your request, certified copies of the DNI and the certification of the training carried out.
2.– The General Directorate will issue the appropriate resolution and, if it is favorable, will agree to its registration in the Registry regarding the use of AEDs by non-health personnel in Castilla y León. The maximum period in which the express resolution must be notified will be one month.
3.- Non-health personnel who have an authorization granted by another autonomous community must request their registration from the General Directorate, accompanying their request with certified copies of the DNI and the aforementioned authorization. The General Directorate will verify its adequacy to the established requirements and will proceed, where appropriate, to the registration in the Registry regarding the use of AEDs by non-health personnel in Castilla y León. The maximum period in which the express resolution must be notified will be one month.
4.- The validity of the authorization will be that of the certifications. The interested party must request the renewal, which will be granted after verifying that the established recycling courses have been completed, proving by providing a certified copy of the corresponding certifications.
5.– At any time, the General Directorate may revoke the authorization granted for non-compliance with the required requirements.
Article 14
Authorization of training entities or companies
1.- The entities or companies interested in providing the training regulated in this standard must request their authorization and registration from the General Directorate of Planning, Quality, Organization and Training, accompanying their request for a report and the related documentation in Annex I. .
2.– The General Directorate will issue the appropriate resolution and, if it is favorable, will agree to its registration in the Registry regarding the use of AEDs by non-health personnel in Castilla y León. The maximum period in which the express resolution must be notified will be two months.
3.- The validity of the authorization will be five years. The interested party must request the renewal at least three months before the end of its validity date, which will be granted after verifying that the requirements are met. If the conditions that allowed the authorization are maintained, an affidavit will be provided, if they have been modified, supporting documentation will be provided.
4.– At any time, the General Directorate may revoke the authorization granted for non-compliance with the requirements or for not having carried out training activities for an uninterrupted period of two years.
CHAPTER V
Record regarding the use of AEDs by non-health personnel in Castilla y León
Article 15
Membership and functions
The Registry relating to the use of DESA by non-health personnel from Castilla y León attached to the General Directorate of Planning, Quality, Management and Training, whose functions will be the registration and ex officio cancellation of the authorizations provided for in this Decree, is created.
CHAPTER VI
Inspection and penalty regime
Article 16
Inspection and control
The competent bodies of the Ministry of Health in matters of inspection and control, may inspect the training entities or companies as well as all those facilities that have a DESA in order to verify their adequacy to this Decree.
Article 17
Infringements and sanctions
1.- In accordance with the provisions of article 35 of Law 14/1986, of April 25, General Health, the acts or omissions typified will constitute administrative offenses regarding the use of semi-automatic external defibrillators by non-health personnel. in the said Law.
2.- The infractions committed will be penalized with the fines established in article 36 of the General Health Law.
3.- The competent bodies to sanction will be those determined in article 37 of Law 1/1993 of April 6, on Health Organization of the Community of Castilla y León.
additional provision
Processing of procedures by telematic means
1.– The Ministry of Health will promote the implementation of telematic means for the processing of the procedures regulated in this decree or any of its procedures, in accordance with the provisions of Decree 40/2005, of May 19, which regulates the use of electronic administration techniques by the Administration of Castilla y León.
2.– The standardized applications for the authorizations regulated in this regulation can be obtained on the corporate website of the Junta de Castilla y León, www.jcyl.es.
First transitory provision
People trained in the use of AEDs
People who, in the last two years from the entry into force of this Decree, have passed the training established on the management of AEDs, may request their authorization and registration in the Registry regarding the use of AEDs by non-medical personnel of Castile and Leon.
Second transitory provision
entities with defibrillator
Entities that have a DESA must adapt to the provisions contained in this standard within three months.
first final provision
Normative enabling
The Minister of Health is empowered to modify the contents of the Annexes of this decree, as well as to dictate the rules and resolutions and adopt the measures that are necessary for the development and execution of the same.
Second final provision
Entry into force
This Decree shall enter into force the day after its publication in the "Official Gazette of Castilla y León".
Valladolid, January 31, 2008.
The President of the Junta de Castilla y León,
Signed: JUAN VICENTE HERRERA CAMPO
The Minister of Health,
Signed: FRANCISCO JAVIER ÁLVAREZ GUISASOLA
Download here the regulations on DEA DESA defibrillators in Castilla y León
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