DECREE 22 / 2012, of 14 of February, by which the use of automated external defibrillators is regulated outside the sanitary field and its Registry is created.
The Constitution, in its article 43, recognizes the right to health protection and establishes that it is the responsibility of the public powers to organize and protect public health, through preventive measures and the necessary benefits and services.
The Statute of Autonomy for Andalusia establishes in its article 55.2 that the Autonomous Community of Andalusia has shared competence in matters of internal health and, in particular and without prejudice to the exclusive competence attributed to it by article 61, management, planning, determination, regulation and execution of public health, socio-sanitary and mental health services and benefits at all levels and for the entire population and the ordering and execution of measures aimed at preserving, protecting and promoting public health at all levels. scopes.
Law 14/1986, of April 25, General Health, has as its purpose the general regulation of all actions that make it possible to make effective the right to health protection, as established in its article 1.1, and establishes in its Article 6.4 that the actions of the Public Health Administrations will be aimed at guaranteeing, among other things, health care in all cases of loss of health. Likewise, the aforementioned Law 14/1986, of April 25, provides in its article 24 that public and private activities that directly or indirectly may have negative consequences for health, will be subjected by the competent bodies to preventive limitations of an administrative nature, according to the basic regulations of the State.
In a similar sense, Law 2/1998, of June 15, on Andalusian Health, in its article 21.1 provides that the Public Administrations of Andalusia, within the framework of their respective powers, will establish and agree on limitations of an administrative nature with respect to those public and private activities that, directly or indirectly, may have negative consequences on health. On the other hand, in its article 6.1.a), it provides that citizens, under the aforementioned Law, are holders and enjoy, with respect to public health services in Andalusia, the right to health benefits and services individual and collective, in accordance with the provisions of current regulations. Likewise, it requires the Public Health Administration of the Autonomous Community, in its article 18.1, to develop comprehensive health care, guaranteeing the continuity of care, including as many health actions as are necessary.
Law 2/2002, of November 11, on Emergency Management in Andalusia, in its article 1.1 considers as emergency management the set of actions of natural or legal persons, public or private, aimed at the protection of life and integrity of people and property, contemplating, among others, non-catastrophic situations that require actions of a multisectoral nature and the adoption of special coordination measures for operational services, and in article 1.2 it provides that in order to carry out said actions, the Public Administrations will establish an integrated system that responds to an effective coordination, direction and control of the necessary actions, based on collaboration between them and, where appropriate, with private entities and the general public. Cardiovascular diseases are the first cause of death in the Western world and, among them, sudden cardiac death occupies a prominent place, as a result of cardiac arrest secondary mainly to ventricular fibrillation. Most sudden cardiac deaths occur outside of the hospital setting.
Correct attention to cardiorespiratory arrest consists of the early application of a series of actions known as the chain of survival that includes, in this order, recognition of the situation and activation of the health emergency system, the immediate start of support maneuvers basic life support, early electrical defibrillation and the rapid introduction of advanced life support techniques.
The only effective treatment against ventricular fibrillation is early electrical defibrillation, so the participation of the first responder is essential.
Technological advances have allowed the appearance of a series of defibrillators that, due to their characteristics and operation, and according to the available scientific evidence, make them suitable for use by personnel outside the health profession outside the health environment. They are called automated external defibrillators.
A key objective of the Andalusian Emergency and Emergency Plan since its implementation is emergency health care in the shortest possible time and with high levels of quality and efficiency, where the key factor is continuity of care and the integration of the actions of all the people involved.
Royal Decree 365/2009, of March 20, basic state regulations, establishes the minimum conditions and requirements for safety and quality in the use of external automatic and semi-automatic defibrillators outside of the health field.
In Andalusia, the use of external semiautomatic defibrillators by non-medical personnel is regulated by Decree 200/2001, of September 11, which regulates the use of external semiautomatic defibrillators by non-medical personnel in the Autonomous Community of Andalusia.
The accumulated experience since the approval of Decree 200/2001, of September 11, the innovations introduced in the basic state regulations, the current scientific evidence available in this regard, the high degree of awareness of society regarding the problem of sudden cardiac death , and the interest of the Health Administration of the Junta de Andalucía in promoting and facilitating the use of defibrillators outside the health field, given the evident possibility of improving survival expectations thanks to citizen solidarity, advise proceeding with the approval of a new norm that regulates in the Autonomous Community of Andalusia the use of automated external defibrillators, the mandatory nature of their availability in certain spaces where there is a high concurrence of people and there is a probability of a cardiac arrest, and the creation of the Andalusian Registry of Defibrillators Automated External. By virtue, at the proposal of the Minister of Health, in accordance with the provisions of articles 21.3, 27.9 and
44 of Law 6/2006, of October 24, of the Government of the Autonomous Community of Andalusia, in accordance with the Consultative Council of Andalusia and after deliberation by the Governing Council, at its meeting held on February 2012,
The purpose of this Decree is to regulate the use of automated external defibrillators, hereinafter defibrillators, outside the health field, to establish the obligation of their availability in certain spaces, public or private, and to create the Andalusian Registry of Automated External Defibrillators.
For the purposes of this Decree, it is understood by:
- a) Automated external defibrillator or AED: The medical device intended to analyze the heart rhythm, identify fatal arrhythmias requiring defibrillation and administer, with the intervention of a person, an electric shock in order to restore a viable heart rhythm with high levels of security. This definition also includes the so-called automated external defibrillators.
- b) Large retail area: Any individual or collective establishment in which retail business activity is carried out and has a useful area for exhibition and sale to the public of more than two thousand five hundred square meters.
- c) Public establishments: Those premises, venues or public facilities listed in the List and Catalog of Public Shows, Recreational Activities and Public Establishments of the Autonomous Community of Andalusia, approved by Decree 78/2002, of February 26, in those that celebrate or practice public shows or recreational activities.
- d) Sports space: Physical area in which the sporting activity takes place.
- e) Sports facility: Set made up of one or more sports spaces and the auxiliary service spaces essential for its operation.
- f) Sports center: That sports facility that has a set of sports spaces under the same management unit in a joint location thereof.
- g) Sports complex: Set of sports facilities close and related to each other, with several different access points to the different sports spaces.
- h) Sports facilities with restricted accessibility: Those sports facilities attached to priority non-sports use centers and which are not accessible to the general population, but provide exclusive service to military, police and security forces centers, seminaries and prisons. .
- i) Capacity: Maximum public occupancy allowed by current regulations in establishments intended for the celebration or practice of public shows or recreational activities.
- j) Average daily influx: Average number of people who go to a specific space or place daily, obtained by dividing the total annual influx of people in that specific space by the number of days that specific space has been available to the public that year. .
- k) Intervening person: The person who makes use of an automated external defibrillator outside the healthcare setting.
Spaces required to have a defibrillator
The natural or legal persons responsible for the management or operation of the following spaces or places will be obliged to have a defibrillator in suitable operating conditions and ready for immediate use:
- a) Large retail stores.
- b) The following transport facilities: Airports and commercial ports, bus or railway stations or stops in towns with more than 50.000 inhabitants, and metro stations with an average daily influx of 5.000 people or more.
- c) Sports facilities, centers or complexes in which the number of daily users, taking into account all its available sports spaces, is equal to or greater than 500. Sports facilities with restricted accessibility are excluded.
- d) Public establishments with a capacity equal to or greater than 5.000 people.
Defibrillator Installation Requirements
- The defibrillators that are installed, in accordance with Royal Decree 365/2009, of March 20, must comply with the provisions of Royal Decree 1591/2009, of October 16, which regulates medical devices, bearing the CE marking that guarantees its conformity with the essential requirements that are applicable to them.
- The natural or legal persons responsible for the management or operation of those spaces or places where a defibrillator is installed for use outside of the health field will be responsible for guaranteeing its maintenance and conservation, in accordance with the manufacturer's instructions.
- Places where a defibrillator is available will have a visible and adequate space for its installation, and its location must be marked clearly and simply using the universal signage recommended by the International Resuscitation Coordination Committee (ILCOR), according to the model that appears in Annex III. Said location must be duly identified in the plans or informative maps of the place, if any. Next to the defibrillator, the instructions for its use will be visible.
Communication of the installation of defibrillators
- The natural or legal persons responsible for the management or operation of those spaces or places that are either required by this Decree to have a defibrillator, or are not, and voluntarily intend to install it for use outside the healthcare environment, In accordance with Royal Decree 365/2009, of March 20, which establishes the minimum conditions and requirements for safety and quality in the use of external automatic and semi-automatic defibrillators outside the health field, they must communicate said installation to the Ministry competent in health.
- This communication must specify the place where the defibrillator will be installed and its technical characteristics. Likewise, it must contain a declaration under the responsibility of said person by which it will commit to comply with the installation and use requirements of the defibrillators included in this Decree and will guarantee the availability of personnel with basic and minimum knowledge in the field of cardiopulmonary resuscitation, basic life support and use of the defibrillator in the environment in which the defibrillator is installed during all opening hours to the public.
- The communication of installation of the defibrillator will be made according to the model that appears as Annex I.
Promotion of the installation of defibrillators outside the health field
The health administrations of the Autonomous Community of Andalusia, within the scope of their powers, will promote and recommend the installation and use of defibrillators outside the health field in places and spaces where, even though they are not obliged to do so, their installation may be considered appropriate. Likewise, training will be promoted with contents in basic life support and defibrillator management.
Persons authorized to use the defibrillator
- Any person may use a defibrillator, provided they have basic and minimum knowledge that can be verified in terms of cardiopulmonary resuscitation, basic life support and use of the defibrillator, or are in possession of a Bachelor's Degree in Medicine and Surgery or a Degree in Medicine, or University Diploma in Nursing or Nursing Degree, or Professional Training for Health Emergencies Technician.
- By Order of the person in charge of the Ministry of Health, the necessary training to use a defibrillator will be determined.
Use of the defibrillator and coordinated assistance
- Each use of the defibrillator outside the health field will be preceded by the notification and activation of the Health Emergency Service of Andalusia, with the immediate activation, where appropriate, of the internal emergency or self-protection plan of the place or space in question, or by telephone call to the emergency numbers established for this purpose, or also through the immediate connection and activation devices that the defibrillators may have installed, in order to urgently activate the entire chain of survival.
- After each incident in which a defibrillator is used outside the health field, and within a maximum period of 72 hours, the owner or legal representative of the entity in which the defibrillator used is installed must communicate it, adjusting to the communication model which appears as Annex II. Said communication will be sent together with the printed record on paper that the defibrillator itself provides after its use, to the General Directorate responsible for health innovation of the Ministry responsible for health.
Andalusian Registry of Automated External Defibrillators
- The Andalusian Registry of Automated External Defibrillators is created, which will be a centralized registry, attached to the General Directorate responsible for health innovation of the Ministry responsible for health.
- The purpose of the Registry will be to provide the Andalusian Health Emergency Service with a complete map of the deployment in Andalusia of the defibrillators that are installed outside the health field, to improve the effectiveness and efficiency of the care response to cardiac arrest, and know the data related to their use.
- All the data contained in the defibrillator installation communications referred to in article 5 and the model of which appears in Annex I, as well as the data contained in the defibrillator use communications, will be registered in the Registry. those referred to in article 8.2 and whose model appears in Annex II.
Defibrillator Use Monitoring Committee
- The Monitoring Commission for the use of the defibrillator is created as a collegiate body of an advisory and consultative nature attached to the General Directorate responsible for health innovation of the Ministry responsible for health.
- It will be made up of the person who holds the Presidency, the Secretariat, and a maximum of ten members, all of them representatives of the scientific world and experts, chosen for their recognized prestige and competence in cardiopulmonary resuscitation, and appointed by the person in charge of the competent General Directorate. in matters of health innovation of the Department responsible for health, for a period of four years, guaranteeing the principle of a balanced composition between women and men.
- Its operating regime will be determined by Order of the person in charge of the Ministry competent in health matters.
- The functions of the Commission will be the following:
a) Evaluate the use of defibrillators outside the healthcare setting.
b) Advise the competent General Directorate in matters of health innovation of the Ministry responsible for health in matters that it deems appropriate in relation to the use of defibrillators.
c) Make proposals to the General Directorate responsible for health innovation of the Ministry responsible for health to promote the installation and use of defibrillators.
d) Promote those activities that are considered appropriate to promote training and research in basic life support and the use of defibrillators.
e) Update and disseminate the procedures for the proper use of defibrillators.
f) Any other functions that are attributed to it by the Ministry responsible for health matters, in relation to the matters regulated by this Decree.
- Failure to comply with the obligations established in this Decree will be considered administrative offenses, in accordance with the provisions of article thirty-five of Law 14/1986, of April 25, General Health, in article 25 of Law 2/ 1998, of June 15, of Salud de Andalucía, and will give rise, prior instruction of the appropriate procedure, to the imposition of the corresponding administrative sanctions.
- Minor sanitary infractions will be considered, in accordance with the provisions of article thirty-five A) 1.a and 2.a of Law 14/1986, of April 25:
a) The use of a defibrillator without having a minimum knowledge for its use, in accordance with the provisions of the article.
b) Not having an adequate and correctly identified space for the installation of the defibrillator, in accordance with the provisions of article 4.3, when the alteration or health risk produced is minor.
c) Failing to notify the health emergency services immediately before using the defibrillator with the activation, where appropriate, of the internal emergency plan or self-protection of the place in question, to activate the chain of survival, as provided in article 8.1. , when the alteration or health risk produced is minor.
- They will be considered serious health infringements in accordance with the provisions of article thirty-five B) of Law 14/1986, of April 25, and article 25.1.c) of Law 2/1998, of June 15. :
a) Not having an adequate and correctly identified space for the installation of the defibrillator, in accordance with the provisions of article 4.3, when this entails serious damage to people's health.
b) Failing to notify the health emergency services immediately before using the defibrillator, with the activation, where appropriate, of the internal emergency plan or self-protection of the place in question, to activate the chain of survival, as provided in article 8.1, when this involves serious damage to people's health.
c) Failure to comply with the installation requirements of the defibrillators provided for in Royal Decree 1591/2009, of October 16, in accordance with the provisions of article 4.1.
d) Failure to notify the Ministry responsible for health matters of the installation of a defibrillator, or doing so without providing the necessary information as provided in article 5.
e) Failure to notify the Ministry responsible for health matters of the use of a defibrillator outside the health field, within the established period of 72 hours after it, in accordance with the provisions of article 8.2.
f) Not guaranteeing the maintenance and conservation in conditions of use of the defibrillators, as provided for in article 4.2.
g) Recidivism in the last three months in the commission of minor offenses provided for in section 2.
- They are very serious infringements in accordance with the provisions of article thirty-five C) of Law 14/1986, of April 25:
a) The conscious and deliberate breach of the obligations established in this Decree when it produces serious damage to people.
- b) The absolute refusal to provide information or collaborate with the inspection activity.
- c) Recidivism in the last five years in the commission of serious offenses provided for in section 3.
- Violations will be penalized with fines and other measures provided for in article thirty-six, sections 1 and 2 of Law 14/1986, of April 25, and in article 27 of Law 2/1998, of June 15. .
- The competent bodies for the imposition of fines will be those, which, based on the amount thereof, are established in article 27.2 of Law 2/1998, of June 15, and the current regulations on decentralization of powers in sanctioning matters in the field of the Ministry responsible for health.
First additional provision
Processing by telematic means
The Ministry competent in health matters will adopt the appropriate measures so that the communication of the installation of a defibrillator outside the health field, as well as the communication of its use, can be carried out by telematic means, in the terms, with the requirements and with the guarantees provided. in current regulations on electronic processing.
Second additional provision
Effectiveness of the Registry and creation of the file
The effective implementation of the Andalusian Registry of Automated External Defibrillators will entail the creation of the corresponding personal data file, which will be carried out by Order of the person in charge of the Ministry competent in health matters, in accordance with the provisions of article 20.2 of Organic Law 15/1999, of December 13, Protection of personal data.
Third additional provision
Competition of the municipalities.
The City Councils, by virtue of the powers that are attributed to them in public health matters by article 9.13 of Law 5/2010, of June 11, on Local Autonomy of Andalusia, may recommend in their Local Health Plans, the installation of automated external defibrillators in certain public or private spaces in its municipal area.
First transitory provision
Adequacy of spaces and communication
- Spaces, public or private, required to have a defibrillator, within a period of twelve months from the entry into force of this Decree, must comply with the requirements set forth therein.
Within the period provided in the previous paragraph, spaces that already have a defibrillator installed must comply with the established requirements.
- The natural or legal persons responsible for the management or exploitation of those spaces or places, which at the entry into force of this Decree already have a defibrillator installed, whether or not they are obliged to have it, must notify said installation to the Andalusian Registry of Automated External Defibrillators, under the terms provided in article 5, within a period of six months from the entry into force of this Decree.
Second transitory provision
Until the effective constitution and beginning of the operation of the Commission for Monitoring the use of the defibrillator, the Order of the Ministry of Health of May 7, 2002, which regulates the composition and operation of the Commission, will continue in force. Medical Monitoring of the use of semiautomatic external defibrillators by non-medical personnel.
Third transitory provision
Until the regulation on training for the use of automated external defibrillators outside the health field is carried out, by Order of the
person in charge of the Ministry competent in health matters, the Order of the Ministry of Health of May 7, 2002, which determines the center and Institution that will coordinate the Initial and Continued Training programs in basic cardiopulmonary resuscitation and use of external semi-automatic defibrillators and the authorization procedure for Centers and Institutions to teach courses is established.
Unique derogatory provision
All provisions of equal and lower rank that oppose the provisions of this Decree and, in particular, Decree 200/2001, of September 11, which regulates the use of external semiautomatic defibrillators by non-medical personnel in the Autonomous Community of Andalusia.
first final provision
Development and execution
The Minister of Health is authorized to develop and execute this Decree and, in particular, to modify the content of its Annexes.
Second final provision
Entry into force
This Decree will enter into force twenty days after its publication in the Official Gazette of the Junta de Andalucía.
Seville, February 14, 2012
JOSÉ ANTONIO GRIÑÁN MARTÍNEZ
President of the Junta de Andalucía
MARIA JESUS MONTERO CUADRADO
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