DECREE 38/2017, of March 23, pole that regulates the installation and use of external defibrillators for the health field, and its registration is created.
The article 43.1 of the Spanish Constitution recognizes the right to protection of health, so that the public authorities have a constitutional obligation to protect or establish preventive measures and provision of services necessary for the protection of health.
Pursuant to article 149.1.16a of the Spanish Constitution, the State has exclusive jurisdiction in matters of foreign health, bases and general coordination of health, and legislation on pharmaceutical products. Based on this competence, I approve Lei 14/1986, of April 25, General of Health. Thus, its article 3 does not declare as an objective of the health system that the means and actions of this system will be oriented primarily to health promotion and disease prevention. Likewise, its article 6 establishes that the actions of the public health administrations will be aimed at promoting health and guaranteeing that all health actions are carried out and are directed at prevention of diseases and not only at their cure, guaranteeing health care in all cases of loss of health.
Article 33.1 of the Galician Statute of Autonomy attributes the Autonomous Communities to the competence of legislative development and the execution of the basic legislation of the State in matters of internal health, and number 4 of the same article establishes that the Autonomous Communities may organize and administer for such purposes and Within its territory, all services related to the aforementioned matters, will be exercised under the supervision of institutions, entities and foundations in matters of health and social security; The State reserves for itself a high inspection leading to the fulfillment of the functions and powers contained in this article.
The article 32.3 of Law 8/2008, of July 10, of Galician health, includes as a guiding principle of the Galician public health system the integral conception of health, which includes health promotion, protection against situations and circumstances that pose a risk to health, in particular protection against environmental risks, disease prevention and health care, as well as rehabilitation and social integration, from a health care perspective. In this sense, the aforementioned Law 8/2008, of July 10, in its article 12.8, establishes that the holders of the right to health protection and health care have the right to establish disease prevention measures of proven effectiveness and safety .
In Galicia, cardiovascular diseases constitute one of the two most important health problems. Of all the emergency situations, cardiopulmonary resuscitation represents the paradigm in which early action and with adequate means conditions or prognosticates the recovery of life and the minimization of possible sequelae.
The most frequent causes of cardiorespiratory arrest in adults are ventricular fibrillation and pulseless ventricular tachycardia, and electrical defibrillation is considered the fundamental treatment within cardiopulmonary resuscitation and the survival rate. In these situations, due to the immediate availability of technical means, defibrillators are essential to successfully address resuscitation maneuvers, together with the support of Health emergencies, guaranteeing continuity of care. According to the 2015 Recommendations for resuscitation of the European Resuscitation Council, "the installation of DESA in areas where cardiac arrest can be expected every five years, is considered cost effective and comparable to other medical interventions."
In our autonomous community, the regulation of the matter continues until now in Decree 99/2005, of April 21, pole that regulates the training and use of external defibrillators by non-medical personnel. This regulatory standard included the conditions for the extrahospital use of two external defibrillators, with the authorization of training entities and the training for or handling of two external defibrillators, according to the headings of two different chapters.
Within the National Quality Plan of the National Health System, approved on June 28, 2006 by the Interterritorial Council of the National Health System, the Strategy of
ischemic heart disease that included a recommendation to establish a legal framework for the implementation and development of a program to encourage the use of two semiautomatic defibrillators in public places. This legal framework is currently constituted by Royal Decree 365/2009, of March 20, which establishes the conditions and minimum safety and quality requirements for the use of external automatic and semi-automatic defibrillators for the health field, as well as by Royal Decree 1591 /2009, October 16, pole that regulates sanitary products. These provisions have the condition of basic rules xa that are issued to the abeiro do artigo 149.1.16o of the Spanish Constitution.
Article 5 of the aforementioned Royal Decree 365/2009, dated March 20, establishes that the health administrations of the autonomous communities will promote and recommend the installation of two external semi-automatic defibrillators following the recommendations of two international organizations, in those places where a large number of people are concentrated or transit number of people, and will promote the appropriate coordination mechanisms with devices such as civil protection, firefighters, local police and others that may be necessary to extend the installation and use of those devices.
In addition, article 4 of Royal Decree 365/2009, of March 20, provides that public or private entities, as well as individuals who intend to install a semiautomatic defibrillator device, must notify the health authorities of the Autonomous Community of the place or of establishment in which it will be disposed of, making a responsible declaration that they meet the requirements set forth in number 2 of this article.
On this same line, on December 28, 2006, Directive 2006/123/CE of the European Parliament and Council entered into force, on December 12, 2006, relating to services in the internal market. According to the spirit of the aforementioned directive, the simple invocation of "general interest" does not abound to justify the a priori requirement of certain authorizations, since the administrative control can be carried out through the procedure of responsible declaration and subsequent vigilance. The State transposed this regulation through Law 17/2009, dated November 23, on free access to service activities and its exercise, by Law 25/2009, dated December 22, modifying various laws for its adaptation to the law on free access to the activities of services and their exercise.
Law 20/2013, dated December 9, on the guarantee of market unity, establishes in its article 3 that «no provision of a general nature, administrative action or quality standard that refers to the access or exercise of economic activities may contain Conditions or requirements that have as a direct or indirect effect discrimination based on establishment or residence of the economic operator.» Article 16 of the aforementioned law contains the principle of free economic initiative, in such a way that "access to economic activities and its exercise will be free throughout the national territory and can only be limited according to or established in this law and not provided for in the regulations of the Union European Union or in international treaties and conventions.” For this reason, not that it pertains to training entities, the new regulation dispenses with prior authorizations for training entities and private training activities, prior to the necessary a posteriori controls.
In compliance with the provisions of Decree 198/2010, of December 2, the pole that regulates the development of the electronic Administration in the Xunta de Galicia and the dependent entities, in its own services directive and in the regulations on electronic access for citizens to public services It is also facilitated the presentation of the responsible declarations by telematic means in the electronic office of the Xunta de Galicia.
Taking into account the accumulated experience, or development of the two available technological resources, and the regulatory changes that have been made, it is worth adapting to pre-existing regulations in this matter to these changes, seeking greater accessibility to these resources for the immediate approach of cardiorespiratory arrest situations.
The decree is made up of four chapters that are collected, respectively, as xerais provisions; The requirements, installation, notification and registration of external defibrillators; a qualification and precise training for or handling two defibrillators and the conditions of their use; and the provisions related to inspection and disciplinary regime. This regulation is completed with two additional provisions, a transitory one, to adapt spaces and services, a repeal, and two spillovers, referring to the regulatory development and entry into force.
In his virtue, by proposal of the competent minister in health matters, in agreement with the Consultative Council, the logo of the deliberation of the Council of the Xunta de Galicia, at his meeting on March XNUMX, two thousand twenty
The purpose of this decree is:
- a) Establish the conditions and requirements for the installation, use and maintenance, for the health field, of automatic and semi-automatic external defibrillators.
- b) Determine the places where it is advisable to have two digital defibrillators, or notify them of their installation and their correct signaling.
- c) Establish the minimum requirements related to the training of handlers.
- d) Create the Registry of External Defibrillators of Galicia.
For the purposes of this decree, it shall be understood as:
- a) External semiautomatic defibrillator: medical device intended to analyze the heart rhythm, identify deadly arrhythmias requiring defibrillation and administer an electric shock for the purpose of restoring the viable heart rhythm with high levels of safety. This definition also includes so-called automated external defibrillators.
- b) External automatic defibrillator: medical device that differs from the previous one in that, by analyzing the heart rhythm and identifying deadly arrhythmias, it performs the indication of administering an electric shock.
Promotion of the installation and use of external defibrillators for the health field
- To improve the survival expectations of people who suffer a cardiorespiratory arrest, it is recommended to install external defibrillators, especially in the following spaces:
- a) Large establishments and commercial centers, individual and collective.
- b) Airports.
- c) Commercial ports.
- d) Bus or railway stations and stops, or interchange stations.
- e) Facilities, public establishments or open spaces in which recreational activities and public shows are carried out.
- f) Sports facilities or non-conventional sports spaces for public use or
- g) Educational centers.
- h) Places where there is a high risk of a cardiac arrest occurring, cardiac rehabilitation centers, non-urgent medical transport vehicles, medical establishments and clinics.
- i) Administrative dependencies of the General Administration of the Autonomous Community or
of the autonomous public sector of Galicia, where a large number of people are concentrated or transit.
- j) Other spaces that are considered of interest in relation to the activities they carry out,
or you cause a large number of people to concentrate or transit.
- The health administrations of the Autonomous Community of Galicia and the entities
dependent instruments, not within the scope of their powers:
- a) They will promote training in basic life support contents and defibrillator management.
- b) They will promote the appropriate coordination mechanisms with devices such as
civil protection, firefighters, local police and others that are necessary to reach out to
installation and use of external defibrillators.
- The General Administration of the Autonomous Community and the autonomous public sector of
Galicia will take into account and value the installation of external defibrillators in the tenders that are called for the construction or management of infrastructures or facilities, as well as in the public calls for the provision of public services under concession with a significant flow of people.
Requirements, installation, notification and registration of two devices
- The external defibrillators referred to in this decree must comply with the provisions of Royal Decree 1591/2009, dated October 16, by which the products are regulated.
sanitary, they will carry the CE marking that guarantees their conformity with the essential requirements that are applicable to them.
The external defibrillators must be used under the conditions specified by the manufacturer, and be properly maintained in such a way that they maintain the security and the expected benefits during their period of use.
Likewise, it will be ensured that the equipment is equipped with software that allows the extraction of two of its data, directly through the necessary adaptations.
- The defibrillation devices that are installed must be marked clearly and clearly:
- a) Their situation must be identified by specifying their location on our maps or informative maps of the place, so that the people and the emergency services can access them if necessary.
- b) Display in a visible manner the instructions for its use, as well as for contact
with emergency services.
- c) The signaling of the availability of a defibrillator must be clear and simple, and comply with the signaling recommendations established by the International Liason Committee on Resuscitation (ILCOR). For its realization, use standard RAL 6032 or its equivalent: RGB:0-152-100.din 616421.7:6.5.4; Pantone 348C. Below the signal, a box must be placed in the part of the word DESA, in a minimum size of 1⁄4 of the upper box.
Both designs must follow the conditions defined by ILCOR and established according to ISO 7010, 3864-3 and 9186-1 standards. The location of the defibrillator must be duly identified, specifying its location on our plans or informative maps of the place and the way to address a possible user person.
- The physical or legal persons who install an external defibrillator will be obliged to notify it in accordance with the provisions of article 5 and will be responsible for guaranteeing its maintenance and conservation, in accordance with the manufacturer's instructions. The same notification obligation will exist in the event of the withdrawal of two defibrillators.
- The external defibrillation devices will have a minimum supply that is indicated no
- The physical or legal persons referred to in number 3 of article 4 must notify the installation or withdrawal of two defibrillators to the competent department of health, as well as the variations that occur in the declared data, through the Public Foundation for Sanitary Emergencies of Galicia-061, making a responsible statement.
- The aforementioned responsible declarations will preferably be submitted electronically through the standard form that appears in Annex I, and that will be available at the Xunta de Galicia electronic office, https://sede.xunta.gal
The electronic submission will be mandatory for public administrations, legal persons, entities without legal personalities, people who exercise a professional activity for which compulsory registration is required for the procedures and actions carried out by public administrations not exercising their professional activity , as well as for the people representing the previous days.
If some interested persons obliged to submit electronically submit to
Your request in person will be required to be amended through your electronic submission. For these purposes, it will be considered as presentation data of
Request the one in which the amendment was made. For the submission of applications
Two identification mechanisms and signatures accepted by the electronic headquarters of the Xunta de Galicia may be ordered, including the Chave365 user and password system (https://sede.xunta.gal/chave365).
- Those interested persons who are not required to submit electronically may optionally submit a responsible declaration in person in Calquera at two places and records established in the regulations governing the common administrative procedure, using the standard form available at the Xunta de Galicia electronic office.
- Together with the responsible declaration, the following documentation must be submitted:
- a) Copy of the national identity document or equivalent identification document,
Only in case of not denying your query.
- b) Descriptive memory of the location of the defibrillator and access routes.
- c) Document that does not identify the person responsible for the defibrillator.
- d) Document that does not indicate the xeolocation data of the device, if applicable.
- It will not be necessary to submit the documents that have been previously presented.
For these purposes, the person concerned must indicate at what time and before what order
Administrative win I present the aforementioned documents. It is presumed that this consultation is authorized by the interested persons, unless there is evidence of no proceeding to their express opposition.
We assume material impossibility of obtaining the document, or competent body
may require the interested person to submit, or, in his absence, to provide proof
by other means two requirements to which it refers or document.
- Complementary documentation should preferably be submitted electronically.
Thus, interested persons will take responsibility for the veracity of two documents that they present. Exceptionally, the Administration may require the display of the original document for the comparison of the electronic copy submitted.
- The electronic presentation will be obligatory for those subject to the electronic presentation of the declaration. If any of the interested persons present complementary documentation in person, they will be required to make it through their electronic presentation. For these purposes, the date on which the amendment was made will be considered the presentation date.
- Those people not obligated to submit electronically, optionally, may
present complementary documentation in person in Calquera two places and
records established in the regulations governing the common administrative procedure.
Registry of External Defibrillators of Galicia
- Create the Registry of External Defibrillators of Galicia, managed by the Ministry
responsible for health.
- The installation of external defibrillators in the Autonomous Community of Galicia will be subject to ex officio registration, in accordance with the responsible declarations presented. Likewise, all the xeographic data and location coordinates, use and responsible personnel will be included, as well as all the variations that occur, so that the information is kept updated.
- The department responsible for health matters will assign a registration number to
each defibrillator, which must be visible next to its signage.
- The record may be consulted through the corresponding computer applications,
in order to increase accessibility to defibrillation, through the elaboration of a map
of defibrillators in the Autonomous Community of Galicia. The registered defibrillators do not
devandito record will be incorporated into the map of resources available to Central de
Coordination of Health Emergencies of Galicia-061 for emergency care, with the aim of improving accessibility to defibrillation and prognosis of cardiorespiratory arrest.
- The communication of the withdrawal of the defibrillator will lead to the cancellation of the registration.
Certification, training and use
- They may use the external defibrillation devices:
- a) The person who is in possession of two following titles:
1st. Degree in Medicine and Surgery or degree of Medicine.
2nd. University Diploma in Nursing or Nursing degree.
3rd. Professional training of technician in sanitary emergencies or certificate of pro-
4th. Official qualifications equivalent to the previous ones, issued by a Member State of the European Union.
- a) The older people who demonstrate that they have passed the training program
basic with official accreditation in cardiopulmonary resuscitation, life support
basic and use of external defibrillators.
- In the event of an exceptional situation in which it is not possible at that time to have a person with the necessary training or qualifications for the use of the defibrillator, the Galician Health Emergencies Coordination Center-061 may authorize another person to manage the defibrillator, the Central will maintain, at all times, supervision of the process.
The training of personnel who do not have the degree indicated in line a) of number 1
of the previous article, it may be given by training units in two health centers of the Public Health System of Galicia, by the Public Foundation Urxencias Sanitarias de Galicia-061, by labor risk prevention centers dependent on calquera Public Administration, by mutual accidents work and professional diseases, by entities or institutions that are part of the Spanish Cardiopulmonary Resuscitation Council or by physical or legal persons who are recognized as instructors by the institutions or entities that form the said council.
Contents and minimum skills of training activities
The training will have, as a minimum, the content established in Annex III, so that it does not
moment of his auction or students demonstrate skills to:
- a) Initiate the survival chain, including adequate interaction with the security system.
- b) Quickly recognize a cardiorespiratory arrest.
- c) Apply the airway permeabilization techniques, including the initial measures
before obstruction by a foreign body (choking).
- d) Perform high-quality cardiopulmonary resuscitation.
- e) Use the defibrillator in an effective and safe manner.
Accreditation of training
- The training of the personnel referred to in line b) of number 1 of article 9 will be accredited by means of the corresponding individual certification, which must be recognized by the Spanish Council of Cardiopulmonary Resuscitation (CERCP) through the Public Foundation for Sanitary Emergencies of Galicia-061, or other equivalent entity in the case of personnel trained in our autonomous community or in our state.
The training obtained by the Autonomous Community of Galicia will be recognized if the conditions established in the previous paragraph are met or if it is recognized in accordance with the specific regulations of the autonomous community in which the training was carried out and the degree was obtained.
The same criteria will be applied to qualifications obtained in member countries.
bros of the European Union according to its regulations.
- Either original or duly certified copy of two certified data must be pre-
established by requirement of the health authority, both for its verification and to validate its effectiveness in view of its undertaking in any functionalities or registers that it requires within the Autonomous Community.
- The individual certifications will be valid for two years, counted from
- The training entities will maintain an updated record of two certificates issued
two and its validity.
Use of two devices and assistance coordination
- Each act of use of the external defibrillator entails, in any case, the obligation to immediately contact the Galician Health Emergencies Coordination Center-O61, by telephone call, or through the connection devices that may be installed or device, with the purpose of Guarantee due continuity of care and medical follow-up of the affected person.
- Once used, or by the person who carried out the defibrillation or by the person responsible for the device, they must cover the sheet of assistance provided, which is collected as CVE-DOG: annex IV, and sent to the competent department of health within 72 days. following hours, together with electronic information of the event collected in the data system of the external defibrillator.
Said information will be incorporated into the Fund's Cardiopulmonary Resuscitation Registry.
Public dation Urxencias Sanitarias de Galicia-061, in order to monitor and evaluate or use two devices for the health field, detect needs for promotion of the installation in certain places and propose actions to improve our procedures for use, as well as encourage training and research in basic life support and non-use of defibrillators.
- The transmission of the data will be respected, in any case, or established in the personal data protection regulations.
Inspection and disciplinary regime
inspection and control
A department with competences in matters of health, through two services of institutions
With regard to health, he may inspect the activities and facilities provided for in this decree, with the purpose of verifying the adequacy of these and two defibrillators, as well as the training of the personnel in charge of their management, the provisions contained in this decree.
You may also request the timely reports from the Public Foundation for Sanitary Emergencies of Galicia-061, with the aim of maintaining a constant and updated knowledge of the location and status of the defibrillators, as well as for the detection of non-communicated discharges or discharges.
Without prejudice to regulations that may be applicable, the infractions committed against or provided for in this decree will be considered as infractions in matters of health, and the corresponding responsibility will be demanded according to or provided for in chapter IV of title II of Law 8/2008, do 10 from xullo, from Galician health; in chapter VI of title I of Law 14/1986, of April 25, general of health; Logo of the processing of the corresponding compliance file as provided for in Law 39/2015, dated October 1, and in Law 40/2015, dated October 1, of legal regime of the public sector.
First additional provision
Personal data protection
The treatment of the data to which this decree refers shall in any case be adjusted to or determined by the applicable legislation regarding the protection of personal data.
In accordance with Organic Law 15/1999, of December 13, on data protection,
personal nature, the personal data collected, whose treatment and publication authorize the interested persons through the presentation of the responsible declarations, will be included in a file called "users and professionals of the health system", with the purpose of managing the present procedure, as well as to inform the people interested in their processing. The body responsible for this file is the General Technical Secretariat. The rights of access, rectification, cancellation and opposition may be exercised before the same body responsible for the file, by sending or sending a communication to the following address: Ministry of Health, San Lázaro Administrative Building, s/n, 15703 Santiago de Compostela, or through dunha electronic communication.
Second additional provision
Updating of the responsible declaration form
For the presentation of the responsible declarations regulated in this decree, it will be necessary
You must use the standard form, available at the Xunta de Galicia electronic office, where it will be permanently updated and accessible to interested persons.
With the objective of keeping it adapted to current regulations, or the form included as annex I may be updated at the electronic headquarters of the Xunta de Galicia, without the need to publish it again in the Official Gazette of Galicia, provided that the modification or update does not imply a substantial modification of this in no way. do contido das declarations foreseen in this decree.
The updating of the form must be approved by means of a resolution of the person in charge of the department with competences in matters of health, before its publicity through the electronic headquarters of the Xunta de Galicia.
Single transitional provision
Adaptation of spaces and devices
The organizations, companies and entities that have defibrillation devices
External relations will be provided for a period of six months, counted from the date of
entry into force of this decree, to adapt to the provisions contained in nel.
After this period, the department with powers in matters of public health
shall make use of its powers of inspection and control, in the manner indicated in chapter
title IV of this decree.
Single repeal provision
Decree 99/2005, April 21, pole that regulates training and
or use of external defibrillators by non-medical personnel, and the provisions of the same or
lower rank who oppose or dispose not present decree.
Primera deradera provision
The person in charge of the Ministry with powers in the field of health is empowered, not
scope of the organization and matters specific to his department, to issue the necessary provisions for the development of the disposition in this decree.
Second derradera provision
Entry into force
This decree will enter into force twenty days after its publication in the Official Gazette of Galicia.
Santiago de Compostela, March XNUMX, XNUMX
Alberto Nunez Feijoo
Jesus Vazquez Almuina
Minister of Health
Download here the regulations on DEA DESA defibrillators in Galicia
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