Regulations on external defibrillators in the Community of Madrid, DECREE 78/2017, of September 12, of the Governing Council of the Community of Madrid, which legislates the use of external defibrillators in the Community of Madrid.
Regulations on defibrillators Community of Madrid
DECREE 78/2017, of September 12, of the Government Council of the Community of Madrid, which regulates the installation and use of external defibrillators outside the health field and creates its Registry.
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.
At the state level, Law 14/1986, of April 25, General Health, has as its purpose the general regulation of all actions that allow the right to health protection to be made effective, 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.
For its part, Law 16/2003, of May 28, on the cohesion and quality of the National Health System, includes in its article 2 the provision of comprehensive health care, comprehensive of both its promotion and the prevention of diseases. , assistance and rehabilitation, detailing in its article 11 the public health benefits.
The Statute of Autonomy of the Community of Madrid, approved by Organic Law 3/1983, of February 25, establishes in its article 27.4 that within the framework of basic State legislation, the Community of Madrid is responsible for legislative development, the power regulation and execution, among other matters, of health.
Law 12/2001, of December 21, on Sanitary Regulation of the Community of Madrid, in its article 9.1.i), states that it is the responsibility of the Department of Health, the management of its own services, the preparation of health plans. health emergency and the operational coordination of health care devices for emergencies, catastrophes and emergencies in the Community of Madrid, regardless of their ownership, as well as coordination with the similar ones of the Central State Administration and the rest of the Autonomous Communities , without prejudice to the provisions of Law 25/1997, of December 26, Regulation of the Emergency Care Service 112.
Similarly, Law 12/2001, in its article 12.c), establishes that the Department of Health of the Community of Madrid exercises the function of Health Authority, as a guarantee of the rights of citizens and of the public interest, and specifically, the execution of the legislation on pharmaceutical and health products.
Royal Decree 365/2009, of March 20, which establishes the minimum safety and quality conditions and requirements in the use of external automatic and semi-automatic defibrillators outside the health field, as basic state regulations establishes the minimum conditions and requirements of safety and quality in the use of automatic and semiautomatic external defibrillators outside the health field.
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 for the prognosis and survival of a person who suffers a cardiorespiratory arrest.
Technological advances have allowed the appearance of medical devices called external defibrillators which, due to their characteristics and easy operation, and according to the available scientific evidence, make them suitable for use by non-medical personnel outside the medical environment.
The high degree of awareness in society regarding 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 healthcare setting, given the obvious possibility of improving survival expectations thanks to citizen solidarity, advise proceed to the approval of a standard that regulates the installation and use of external defibrillators, as well as the mandatory nature of their availability in certain areas of the Community of Madrid where a high number of people is expected and there is a probability that a stop will occur cardiac, and the creation of the Madrid Registry of external defibrillators.
This Decree has been processed in accordance with the procedures included in the Agreement of October 31, 2016, of the Governing Council, which establishes general instructions for the application of the procedure of legislative initiative and regulatory power provided for in the Law 50/1997, of November 27, of the Government. In particular, it has been submitted to prior public consultation and a public hearing, having obtained, among other mandatory reports, that of the Consumption Council of the Community of Madrid.
By virtue, in accordance with the provisions of article 21 of Law 1/1983, of December 13, on Government and Administration of the Community of Madrid, at the proposal of the Minister of Health after hearing the Legal Advisory Commission and after deliberation by the Governing Council at its meeting on September 12,
Purpose and scope of the defibrillator regulations
The purpose of this Decree is to regulate, within the Community of Madrid, the installation and use of external defibrillators, outside the health field, to establish the obligation of their availability in certain spaces, public or private, and to create the Madrid Registry of defibrillators. external.
Definitions of cardioprotection
For the purposes of this Decree, it is understood as:
- a) External defibrillator: Duly approved medical device capable of analyzing the heart rhythm, identifying fatal arrhythmias requiring defibrillation and administering, if necessary, an electric shock in order to restore a viable heart rhythm, with high levels of safety.
This definition includes both semiautomatic external defibrillators in which the discharge, prior indication of the device, must be carried out by a person, as well as the so-called automatic external defibrillators in which the discharge does not require human intervention.
- b) Holder of the defibrillator: He is responsible for the management or exploitation of the space where the device is installed.
- c) Public establishment: Any building, premises, enclosure or facility accessible to public attendance in which shows are offered or recreational, cultural or religious activities are carried out.
- d) Sports facilities, centers and complexes: Areas in which sports activities take place.
- e) Educational center: Educational establishment where non-university and university education, of a public or private nature, is taught.
- f) Capacity: Maximum occupancy granted or declared for each establishment in the municipal license or equivalent document issued or accepted by the corresponding municipal authority.
- g) Average daily influx: Average number of people who daily go to a specific space or place, 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. .
- h) Intervening person: The person who uses an external defibrillator outside of the healthcare setting.
Spaces required to have a defibrillator in the Community of Madrid
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 display and sales area exceeds 2.500 m2.
- b) Airports.
- c) The following transport facilities: bus and railway stations in towns with more than 50.000 inhabitants, metro, railway and bus stations with an average daily influx of 5.000 people or more.
- d) Public establishments, with a capacity equal to or greater than 2.000 people.
- e) Establishments dependent on 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) Sports facilities, centers or complexes in which the number of daily users is equal to or greater than 500 people.
- g) Hotel establishments with more than 100 beds.
- h) Educational centers.
- i) Work centers with more than 250 workers.
- j) Residential centers for the elderly that have at least 200 resident places.
Defibrillator installation and maintenance requirements and voluntary installation
- The defibrillators provided for in the spaces listed in article 3 of this Decree, as well as the spaces that, without being obliged, intend to install them voluntarily, must comply with the provisions of Royal Decree 1591/2009, of October 16, by the sanitary products are regulated, bearing the CE marking that guarantees their conformity with the essential requirements that apply to them. Said defibrillators will be permanently connected to the emergency network of the Community of Madrid SUMMA 112, so that when they are used they activate the action of the emergency network.
- The places where defibrillation devices are installed will have a visible and adequate space for their installation. These devices must be duly marked using the universal signage recommended by the International Resuscitation Coordination Committee (ILCOR). Next to the defibrillator, the instructions for its use will be displayed in a visible way, as well as the 112 telephone number for contacting the emergency services. Their location must be duly identified, specifying their location on the information plans or maps of the place, so that users can access them.
- The natural or legal persons responsible for the management or operation of those spaces or places where an external defibrillator is installed will be responsible for guaranteeing its maintenance and conservation, in accordance with the instructions of the equipment manufacturer so that the defibrillator and its accessories are in perfect state of use.
Notification of installation, variation and removal of the defibrillator
- Individuals or legal entities that are either required by this decree to have a defibrillator for use outside the healthcare environment, or are not required to intend to install it voluntarily, in accordance with the provisions of the Royal Decree
365/2009, of March 20, which establishes the conditions and minimum safety and quality requirements in the use of external automatic and semi-automatic defibrillators outside the health field, they must notify the competent Department of Health by means of a responsible declaration. , indicating the place where it will be installed, its technical characteristics and the data that appear in Annex I of this Decree.
- Variations in the ownership of the defibrillator, in its location or any other substantial modification, must be notified by means of a responsible declaration.
- The withdrawal of an installed defibrillator must also be notified by means of the corresponding responsible statement.
- The statements responsible for the installation, change of ownership, withdrawal or modification of the location of the defibrillator, as well as other cases that affect it, must be made within a maximum period of fifteen days, by presenting the model that is included in Annex I of this decree.
Use of defibrillators Community of Madrid
- Each use of the defibrillator outside the health field will be preceded by the notification and activation of the Emergency Services through the 112 telephone number or through the immediate connection and activation devices, in order to urgently activate the chain of survival.
- After the use of the defibrillator, the person responsible for the management or operation of the space in which the used defibrillator is installed must notify it, within a maximum period of 72 hours, adjusting to the notification model that appears as Annex II of this Decree. Said completed form, as well as the digital record of the event stored in the defibrillator's memory system, will be sent to the General Directorate with competences in matters of Sanitary Inspection of the Community of Madrid.
- External defibrillators may be used by health personnel and health emergency technicians.
- Defibrillators may also be used by all those persons who are in possession of the minimum and basic knowledge necessary to do so, after completing a training program whose minimum content must, at least, be that established in the second additional provision of this Decree.
- In the event of an exceptional situation in which it is not possible to have at that moment a person with the necessary training or qualifications for the use of the defibrillator, the emergency service through the telephone number 112 may authorize any other person to manage the defibrillator. of the defibrillator, maintaining at all times said service the supervision of the process.
Madrid registry of external defibrillators
- 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 body responsible for its maintenance, updating, organization and management.
- The data contained in the defibrillator installation, modification and removal communications referred to in article 5 of this Decree will be recorded in the Registry.
- The data contained in the communications of the use of the defibrillator referred to in article 6.2 will also be registered.
- The purpose of the Registry will be to provide the Health Emergency Services of the Community of Madrid with a complete geographical map of the deployment of defibrillators that are installed outside the health field, to improve the effectiveness and efficiency of the care response to a stop cardiac, and know the data related to the use of the same.
Coordination and Inspection
Appropriate coordination mechanisms will be promoted between civil protection devices, firefighters and local police and others that are necessary for the application of the measures contemplated in this Decree.
The General Directorate with competences in matters of health inspection will inspect the external defibrillators installed to ensure the correct notification to the health authority and maintenance of the conditions that gave rise to its registration.
Violations and sanctions for breaching the regulations
Failure to comply with the obligations established in this Decree will be considered administrative offenses, which may give rise to the corresponding sanctions, in accordance with the provisions of Chapter II, Title XIII, of Law 12/2001, of December 21, of Sanitary Ordinance of the Community of Madrid and additionally what is established in Chapter VI of Title I of Law 14/1986, of April 25, General Health.
For this purpose, administrative infractions applicable to this decree are considered to be those included, as minor infractions, in article 144.2, sections a), b) e) and g); as serious offences, in article 144.3, sections a), c), d), e), f), i) and m); and as very serious offences, 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 head of the Ministry with powers in health matters, 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, which
will comply with the applicable legislation on data protection.
SECOND ADDITIONAL PROVISION
1. The training program, both initial and continuous, 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:
chain of survival
Basic cardiopulmonary resuscitation.
Automated external defibrillator.
- b) Practices:
Basic cardiopulmonary resuscitation.
Use of 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 impart said program will be determined, as well as the certification that accredits the training of the students for the use of defibrillators after passing the training program and validity period of said accreditation.
FIRST TRANSITIONAL PROVISION
Entities or individuals obliged to install defibrillators
Natural or legal persons, who are obliged by this Decree to have a defibrillator for use outside the health field, will have a period of twelve months from the entry into force of this Decree to proceed with its installation and present the responsible declaration. established in article 5.
SECOND TRANSITORY PROVISION
Defibrillators already installed
Natural or legal persons who, on the date of entry into force of this Decree, already have external defibrillator devices 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 therein.
FIRST FINAL PROVISION
The head of the Ministry with powers in health matters is empowered to issue the necessary provisions for the development and execution of this decree.
SECOND FINAL PROVISION
Entry into force
This Decree will enter into force the day after its publication in the OFFICIAL GAZETTE OF THE COMMUNITY OF MADRID.
Given in Madrid, on September 12, 2017.
The Minister of Health,
JESUS SANCHEZ MARTOS
CRISTINA CIFUENTES CUENCAS
Download here the regulations on DEA DESA defibrillators in the Community of Madrid
Regulations on defibrillators in dental clinics of the Community of Madrid
Through ORDER 1158/2018, of November 7, of the Health Minister of the Community of Madrid, published in BOCM Official Gazette of the Community of Madrid on December 4, 2018. ORDER 1158/2018 regulating the General and specific technical requirements of health centers and services without hospitalization, of health services integrated into a non-health organization and of health care provided by health professionals at home in the Community of Madrid.
This order requires dental clinics to install AED defibrillators in their offices where dental surgery is performed. Download here ORDER 1158/2018 for the cardioprotection of dental clinics in the Community of Madrid.
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