Defibrillator regulations Madrid

Regulations on external defibrillators in the Community of Madrid

Regulation / obligation to install and use external defibrillators in the Community of Madrid, BOCM, decree 78 / 2017, of 12 of September, of the Council of Government, which regulates the installation and use of external defibrillators outside the health field.


Legislation on the use and installation of external defibrillators in the Community of Madrid

The Constitution, in its article 43, recognizes the right to health protection and establishes that it is up to the public authorities to organize and protect public health, through preventive measures and the necessary services and benefits. At the state level, the Law 14 / 1986, of 25 of April, General of Health, has for its object the general regulation of all the actions that allow to make effective the right to the protection of health, and establishes in its article 6.4 that The actions of the Public Health Administrations will be aimed at guaranteeing, among others, healthcare in all cases of loss of health.

On the other hand, the 16 / 2003 Law, of 28 of May, of cohesion and quality of the National Health System, includes in its article 2 the provision of comprehensive health care, comprehensive both in its promotion and in the prevention of diseases. , of assistance and rehabilitation, detailing in its article 11 public health benefits.

The Statute of Autonomy of the Community of Madrid, approved by Organic Law 3 / 1983, of 25 of February, establishes in its article 27.4 that within the framework of the basic legislation of the State corresponds to the Community of Madrid the legislative development, the power regulation and execution, among other matters, of health.

The Law 12 / 2001, of 21 of December, of Sanitary Regulation of the Community of Madrid, in its article 9.1.i), indicates that corresponds to the Ministry of Health, the direction of the own services, the elaboration of the plans of health emergency and the operational coordination of health assistance devices for emergencies, catastrophes and emergencies in the Community of Madrid, whatever their ownership, as well as coordination with similar ones of the Central State Administration and the rest of the Autonomous Communities , without prejudice to the provisions of the 25 / 1997 Law, of December 26, of Regulation of the 112 Emergency Care Service.

Likewise, Law 12 / 2001, in its article 12.c), establishes that the Ministry of Health of the Community of Madrid exercises the function of Health Authority, as a guarantee of the rights of citizens and the public interest, and in particular the execution of legislation on pharmaceutical and health products.

The Royal Decree 365 / 2009, of March 20, which establishes the conditions and minimum requirements for safety and quality in the use of external automatic and semi-automatic defibrillators outside the sanitary field, as basic state regulation establishes the minimum conditions and requirements of safety and quality in the use of external automatic and semiautomatic defibrillators outside of the health field. Cardiovascular diseases are the leading cause of death in the Western world and, among them, sudden cardiac death is a prominent feature, as a result of cardiac arrest secondary mainly to ventricular fibrillation.

The majority of sudden cardiac deaths occur outside the hospital setting. The correct attention to cardiorespiratory arrest consists of the early application of a series of actions known as survival chain that includes, in this order, the recognition of the situation and activation of the health emergency system, the immediate start of support maneuvers basic vital, early electric defibrillation and the rapid establishment of advanced life support techniques.

The only effective treatment against ventricular fibrillation is early electrical defibrillation, so the participation of the first person involved is essential for the prognosis and survival of a person suffering from cardiorespiratory arrest. Technological advances have allowed the appearance of sanitary products called external defibrillators that, due to their characteristics and easy operation, and according to the available scientific evidence, make them suitable for use by non-health personnel outside the healthcare environment.

The high degree of awareness of society before the problem of sudden cardiac death, and the interest of the Government of the Community of Madrid in promoting and facilitating the use of defibrillators outside the health field, given the obvious possibility of improving survival expectations thanks to citizen solidarity, they advise to proceed with the approval of a regulation that regulates the installation and use of external defibrillators, as well as the obligatory nature of their availability in certain areas of the Community of Madrid where a high number of people is expected and there is the probability of a cardiac arrest occurring, and the creation of the Madrid Registry of external defibrillators.

This Decree has been processed in accordance with the procedures set out in the 31 Agreement of October of 2016, of the Government Council, which establishes general instructions for the application of the legislative initiative procedure and the regulatory authority envisaged in the Law 50 / 1997, of 27 of November, of the Government. In particular, it has been subjected to prior public consultation and public hearing, having been collected, among other mandatory reports, the Consumer Council of the Community of Madrid.

By virtue of this, in accordance with the provisions of article 21 of the 1 / 1983 Law, of 13 of December, of the Government and Administration of the Community of Madrid, on the proposal of the Health Officer heard by the Legal Advisory Committee and after deliberation of the Governing Council in its meeting of the 12 day of September,

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Article 1 Object and scope

The purpose of this Decree is to regulate, within the framework of the Community of Madrid, the installation and use of external defibrillators, outside the health area, to establish the obligatory nature of their availability in certain public or private spaces and to create the Madrid Registry of defibrillators. external.

Article 2 Definitions

For the purposes of this Decree, it is understood as:
a) External defibrillator: Approved health product capable of analyzing the heart rhythm, identifying deadly arrhythmias tributary of defibrillation and administering, if necessary, an electric shock in order to restore the viable heart rate, with high levels of safety. This definition includes both semi-automatic external defibrillators in which the discharge, after indication of the device, must be carried out by a person or by the so-called automatic external defibrillators in which the discharge does not require human intervention.
b) Defibrillator holder: Is responsible for the management or exploitation of the space where the device is installed.
c) Public establishment: Any building, venue, venue or facility accessible to public gatherings in which shows or recreational, cultural or religious activities are held.
d) Sports facilities, centers and complexes: Fields in which the sports activity takes place.
e) Educational center: Teacher establishment where non-university and university education is taught, public or private.
f) Capacity: Maximum occupation granted or declared for each establishment in the municipal license or equivalent document issued or accepted by the corresponding municipal authority.
g) Average daily inflow: Average number of people who daily go to a certain space or place, obtained by dividing the total annual influx of people in that particular space by the number of days in that year that particular space has been available to the public .
h) Person involved: The person who makes use of an external defibrillator outside the health field.

Article 3 Spaces forced to have a defibrillator

They will be obliged to have at least one defibrillator in suitable conditions of operation and ready for immediate use the following spaces or places:
a) Large commercial establishments, individual or collective, whose commercial area of ​​exposure and sale is greater than 2.500 m2.
b) The airports.
c) The following transport facilities: bus and railway stations in towns with more than 50.000 inhabitants, metro, rail and bus stations with an average daily influx equal to or greater than 5.000 persons.
d) Public establishments, with a capacity equal to or greater than 2.000 persons.
e) Dependent establishments of the Public Administrations in populations of more than 50.000 inhabitants and with an average daily influx equal to or greater than 1.000 users.
f) Installations, centers or sports complexes in which the number of daily users is equal to or greater than 500 persons.
g) Hotel establishments with more than 100 seats.
h) The educational centers.
i) Work centers with more than 250 workers.
j) Residential centers for the elderly that have at least 200 places for residents.

Article 4 Installation and maintenance requirements for defibrillators and voluntary installation

1 The defibrillators foreseen in the spaces related in article 3 of this Decree, as well as the spaces that, not being obligated to install them voluntarily, must comply with the provisions of Royal Decree 1591 / 2009, of 16 of October, by the that the sanitary products are regulated, showing the CE marking that guarantees its compliance with the essential requirements that result from its application. These defibrillators will be permanently connected to the emergency network of the Community of Madrid SUMMA 112, so that at the time of use they activate the action of the emergency network.
2 The places where defibrillation devices are installed will have a visible and adequate space for their installation. These devices must be duly signaled by the universal signaling recommended by the International Coordination Committee on Resuscitation (ILCOR). Together with the defibrillator, the instructions for its use will be clearly displayed, as well as the 112 telephone for contacting the emergency services. The location of the same must be properly identified by specifying its location in the maps or informative maps of the place, so that users can access them.
3 The physical or legal persons responsible for the management or operation of those spaces or places where an external defibrillator is installed will be responsible for ensuring its maintenance and conservation, in accordance with the instructions of the manufacturer of the equipment so that the defibrillator and its accessories are located in perfect condition of use.

Article 5 Notification of installation, variation and removal of the defibrillator

1 Individuals or legal entities that are either bound by this decree to have a defibrillator for use outside the health area, or are not obligated to install it voluntarily, in accordance with the provisions of Royal Decree 365 / 2009 , of 20 of March, which establishes the conditions and minimum requirements of safety and quality in the use of external automatic and semi-automatic defibrillators outside the sanitary field, must notify it by means of a responsible declaration to the Ministry responsible for health, indicating the where it will be installed, the technical characteristics of the same and the data listed in Annex I of this Decree.
2 Variations in the ownership of the defibrillator, in its location or any other substantial modification, must be notified by means of a responsible declaration.
3 The removal of an installed defibrillator must also be notified by means of the corresponding responsible statement.
4 The declarations responsible for installation, change of ownership, removal or modification of the location of the defibrillator, as well as other assumptions that affect it, must be made within a maximum period of fifteen days, by presenting the model that is incorporated in Annex I of this decree.

Article 6 Use of defibrillators

1 Each use of the defibrillator outside of the health field will be preceded by the notification and activation of the Emergency Services through the 112 telephone or through the immediate connection and activation devices, in order to urgently activate the survival chain.
2 After using the defibrillator, the person responsible for the management or operation of the space in which the defibrillator used is installed must notify it, within a maximum period of 72 hours, adjusting to the notification model included in Annex II of this Decree. This completed form, as well as the digital record of the event stored in the memory system of the defibrillator, will be sent to the General Directorate with powers in matters of Health Inspection of the Community of Madrid.

Article 7 Interveners

1 External defibrillators may use health personnel and technicians in health emergencies.
2 The defibrillators may also use all those persons who are in possession of the minimum and basic knowledge necessary for this, after carrying out a training program whose minimum content shall, at least, be that established in the second additional provision of this Decree.
3 In the case of an exceptional situation in which it is not possible to have at that moment a person with the necessary training or qualification for the use of the defibrillator, the emergency service through the 112 telephone may authorize any other person to use it. of the defibrillator, maintaining the service of the process at all times.

Article 8 Madrid registry of external defibrillators

1 The Madrid Registry of External Defibrillators is created, which will be attached to the General Directorate with powers in matters of Health Inspection of the Community of Madrid as the organ responsible for its maintenance, updating, organization and management.
2 In the Registry the data contained in the installation, modification and removal of the defibrillator communications referred to in Article 5 of this Decree will be registered.
3 The data included in the communications on the use of the defibrillator referred to in article 6.2 shall also be recorded.
4 The purpose of the Registry will be to provide the Community Health Emergency Services of Madrid with a complete geographic map of the deployment of defibrillators that are installed outside the health area, in order to improve the efficiency and effectiveness of the assistance response to a stoppage. heart, and know the data related to the use of them.

Article 9 Coordination and Inspection

Appropriate coordination mechanisms will be promoted between civil protection, fire and local police and other mechanisms that are necessary for the application of the measures contemplated in this Decree. The General Directorate with powers in matters of health inspection will inspect the external defibrillators installed to ensure the correct notification to the health authority and the maintenance of the conditions that led to its registration.

Article 10 Infractions and sanctions

Failure to comply with the obligations established in this Decree will be considered administrative infractions, which may give rise to the corresponding sanctions, in accordance with the provisions of Chapter II, Title XIII, of the 12 / 2001 Law, of December 21, of Sanitary Management of the Community of Madrid and in a supplementary manner what is established in Chapter VI of Title I of Law 14 / 1986, of 25 of April, General of Health. For this purpose, administrative offenses applicable to this decree are considered as minor infractions, in article 144.2, sections a), b) e) and g); as serious infractions, in article 144.3, sections a), c), d), e), f), i) and m); and as very serious infractions, in article 144.4, sections a), b), c), g), i), j) and k). Likewise, the sanctions included in article 145 of the same Law will be applicable in accordance with its classification and graduation criteria indicated therein.

FIRST ADDITIONAL PROVISION

Creation of the personal data file By order of the holder of the Ministry with powers in matters of health, the creation of the corresponding file for the management and conservation of personal data contained in the Madrid Registry of external defibrillators will be regulated. it will comply with the applicable legislation on data protection.

SECOND ADDITIONAL PROVISION

Training

1 The training program, both initial and continued for the use of external defibrillators outside the health field, by non-health personnel, which enables the acquisition of the minimum and basic knowledge necessary for this, will have to develop the following content:
a) Theoretical introduction: - Survival chain. - Cardiorespiratory arrest. - Basic cardiopulmonary resuscitation. - Automated external defibrillator.
b) Practices: - Basic cardiopulmonary resuscitation. - Use of the external defibrillator.
2 By order of the head of the Ministry of Health, the procedure and requirements for the authorization of the training entities that provide said program will be determined, as well as the certification that accredits the training of the students for the use of defibrillators after the completion of the program. training and period of validity of said accreditation.

FIRST TRANSITORY PROVISION

Entities or individuals obliged to install defibrillators Natural or legal persons, who are required by this Decree to have a defibrillator for use outside the health area, will have a period of twelve months from the entry into force of this Decree for proceed to its installation and present the responsible declaration established in article 5.

SECOND TRANSITORY PROVISION

Defibrillators already installed Individuals or legal entities that, at the date of entry into force of this Decree, already have external defibrillator devices installed in their facilities will have a period of three months, counted from the date of entry into force of this Decree, to adapt to the provisions contained in it.

FIRST FINAL PROVISION

Enabling regulations The head of the Ministry is empowered with powers in matters of health, to dictate the necessary provisions for the development and execution of this decree.

SECOND FINAL PROVISION

Entry into force This Decree will come into force the day following its publication in the OFFICIAL BULLETIN OF THE COMMUNITY OF MADRID.

Given in Madrid, to 12 of September of 2017.

The Minister of Health, JESÚS SÁNCHEZ MARTOS

The President, CRISTINA CIFUENTES CUENCAS

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