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Regulations on installation and use of external defibrillators in Galicia
Regulations on the use, training and installation of defibrillators in safe cardio spaces in Galicia.
XUNTA DE GALICIA HEALTH CONSULTATION - Regulations on external defibrillators
DECREE 38 / 2017, of 23 of March, by which regulates the installation and the use of external defibrillators outside the sanitary field, and its registry is created
I. Article 43.1 of the Spanish Constitution recognizes the right to health protection, for which the public authorities have a constitutional duty to protect the establishment of preventive measures and provision of services necessary for the protection of health.
In accordance with Article 149.1.16ª of the Spanish Constitution, the State has exclusive competence in matters of external health, bases and general coordination of health, and legislation on pharmaceutical products. Based on this competition, the Law 14 / 1986, of 25 of April, general of health, was approved. Thus, in its article 3 declares as an objective of the health system that the means and actions of it will be oriented primarily to the promotion of health and the prevention of diseases. Likewise, in its article 6, it establishes that the actions of the public health administrations will be oriented to the promotion of health and to guarantee that whatever health actions are developed are directed to the prevention of diseases and not only to the cure of them, guaranteeing health care in all cases of loss of health.
Article 33.1 of the Statute of Autonomy of Galicia attributes to the Autonomous Community the legislative development competence and the execution of the basic legislation of the State in matters of internal health, and the number 4 of the same article establishes that the Autonomous Community may organize and administer for all such purposes and within its territory all services related to the aforementioned matters, and exercise the protection of institutions, entities and foundations in matters of health and social security, reserving the State the high inspection leading to compliance with the functions and competences contained in this article.
Article 32.3 of the Law 8 / 2008, of 10 of July, of health of Galicia, gathers as a guiding principle of the public health system of Galicia the integral conception of health, which includes the promotion of health, protection against situations and circumstances that pose a risk to health, in particular protection against environmental risks, prevention of disease and health care, as well as rehabilitation and social integration, from the perspective of health care. In this sense, the aforementioned Law 8 / 2008, of 10 of July, CVE-DOG: 4bji5rm5-bdc4-qh53-hn60-emkemc4emm71 DOG No. 70 Monday, 10 of April of 2017 Page. 16950 ISSN1130-9229 Legal deposit C. 494-1998 http://www.xunta.gal/diario-oficial-galicia in its article 12.8, establishes that the holders of the right to health protection and health care have the right to establish measures to prevent disease of proven effectiveness and safety.
II. In Galicia, cardio vascular diseases are one of the most important health problems. Of all the emergency situations, cardiopulmonary resuscitation represents the paradigm in which early intervention and with appropriate means conditions the prognosis in terms of the recovery of life and the minimization of possible sequelae.
The most frequent causes of cardiorespiratory arrest in adults are ventricular fibrillation and ventricular tachycardia without a pulse, and the main treatment in cardiopulmonary resuscitation and the chain of survival is electrical defibrillation. In these situations, the immediate availability of technical means, defibrillators, are essential to successfully address resuscitation maneuvers, with the support of health emergencies ensuring continuity of care. According to the 2015 Resuscitation Recommendations 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 was contained until now in Decree 99 / 2005, of 21 of April, which regulates the training and use of external defibrillators by non-medical personnel. This regulatory norm included the conditions for the extrahospital use of external defibrillators, the authorization of the training entities and training for the management of external defibrillators, according to the rubrics of their different chapters.
III. Within the National Quality Plan of the National Health System, the 28 of June of 2006 was approved in the Interterritorial Council of the National Health System, the Ischemic Heart Disease Strategy, which included the recommendation to establish a legal framework for the implementation and development of a program to encourage the use of semiautomatic defibrillators in public places. This legal framework is currently constituted by Royal Decree 365 / 2009, of 20 of March, which establishes the conditions and minimum requirements for safety and quality in the use of external automatic and semi-automatic defibrillators outside of the health field, as well as for the Royal Decree 1591 / 2009, CVE-DOG: 4bji5rm5-bdc4-qh53-hn60-emkemc4emm71 DOG No. 70 Monday, 10 for April of 2017 Page. 16951 ISSN1130-9229 Legal deposit C.494-1998 http: // www. xunta.gal/diario-oficial-galicia of 16 of October, by which the sanitary products are regulated. These provisions have the status of basic norms in that they are issued under Article 149.1.16º of the Spanish Constitution.
Article 5 of the aforementioned Royal Decree 365 / 2009, of 20 of March, establishes that the health administrations of the autonomous communities will promote and recommend the installation of external semiautomatic defibrillators following the recommendations of international organizations, in those places where Concentrate or transit a large number of people, and promote the mechanisms of timely coordination with devices such as civil protection, fire, local police and others that are 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 private individuals who intend to install a semiautomatic defibrillator device, must notify the health authority of the Autonomous Community of the place or of the establishment in which it will be available, making a declaration responsible that they meet the requirements provided in section 2 of this article.
In this same line, the 28 of December of 2006 entered into force to Directive 2006 / 123 / CE of the European Parliament and of the Council, of 12 of December of 2006, relative to the services in the internal market. In the spirit of the aforementioned directive, the mere invocation of the "general interest" is not sufficient to justify the a priori requirement of certain authorizations, since administrative control can be carried out through the procedure of responsible declaration and subsequent monitoring. The State transposed said regulations through the 17 / 2009 Law, of 23 of November, on the free access to the services activities and their exercise, and the 25 / 2009 Law, of 22 of December, of modification of various laws for their adaptation to the law on free access to service activities and their exercise.
The Law 20 / 2013, of 9 of December, of guarantee of the market unit, establishes in its article 3 that "no provision of a general nature, administrative action or quality rule that refers to access or to the 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, so that" access to economic activities and its exercise shall be free throughout the national territory and may only be limited according to what is established in this law and in the provisions of the European Union regulations or in international treaties and conventions. "For this reason, as regards the training entities, the new regulation dispenses with the previous authorizations CVE-DOG: 4bji5rm5-bdc4-qh53-hn60-emke mc4emm71 DOG No. 70 Monday, 10 of April of 2017 Page. 16952 ISSN1130-9229 Legal deposit C.494-1998 http://www.xunta.gal/diario-oficial-galicia for the training entities and the particular training activities , without prejudice to the necessary a posteriori controls.
In compliance with the provisions of Decree 198 / 2010, of 2 of December, which regulates the development of e-government in the Xunta de Galicia and its dependent entities, in the service directive itself and in the regulations on electronic access of citizens to public services, also facilitates the presentation of responsible statements by electronic means in the electronic headquarters of the Xunta de Galicia.
Taking into account the accumulated experience, the development of the available technological resources, and the normative changes operated, it is necessary to adapt the preexisting regulations in this matter to these changes, seeking greater accessibility to these resources for the immediate approach of the situations of cardiorespiratory arrest.
IV. The decree is formed by four chapters in which the general dispositions are collected, respectively; the requirements, installation, notification and registration of external defibrillators; the qualification and precise training for the handling of the defibrillators and the conditions of their use; and the provisions relating to the inspection and sanctioning system. This regulation is completed with two additional provisions, a transitory one, to adapt spaces and services, a derogatory one, and two final ones, referred to the normative development and entry into force.
By virtue of this, at the proposal of the Regional Minister competent in matters of health, in agreement with the Consultative Council, and after deliberation by the Council of the Xunta de Galicia, at its meeting of March 23, two thousand and seventeen
CHAPTER I General provisions
Article 1. The purpose of this decree is to:
a) Establish the conditions and requirements for the installation, use and maintenance, outside the sanitary field, of automatic and semiautomatic external defibrillators.
b) Determine the places in which it is advisable to have such defibrillators, the notification system of their installation and their correct signaling.
c) Establish the minimum requirements related to the training of the manipulators.
d) Create the Registry of External Defibrillators of Galicia.
Article 2. Definitions for the purposes of this decree, shall be understood as:
a) External semiautomatic defibrillator: a medical device designed to analyze the heart rhythm, identify deadly arrhythmias due to defibrillation and administer an electric shock in order to restore the viable heart rate with high levels of safety. This definition also includes so-called automatic external defibrillators.
b) External automatic defibrillator: a medical device that differs from the previous one in that, after analyzing the heart rate and identifying deadly arrhythmias, it makes the indication to administer an electric shock. Article 3. Promotion of the installation and use of external defibrillators outside the health field
1 In order to improve the survival expectations of those who suffer cardiorespiratory arrest, the installation of external defibrillators is recommended, especially in the following spaces:
a) Large establishments and shopping centers, individual and collective.
c) Commercial ports.
d) Bus or rail stations and stops, or exchange stations.
e) Installations, public establishments or open spaces in which recreational activities and public spectacles are carried out.
f) Sports facilities or non-conventional sports spaces for public or private use.
g) Educational centers.
h) Places where there is a high risk of cardiac arrest, cardiac rehabilitation centers, non-emergency medical transport vehicles, health facilities and clinics.
i) Administrative dependencies of the General Administration of the Autonomous Community or of the autonomous public sector of Galicia, in which a large number of people are concentrated or transited.
j) Other spaces that are considered of interest in relation to the activity they carry out, or in which a large number of people are concentrated or transited.
2 The health administrations of the Autonomous Community of Galicia and the dependent instrumental entities, within the scope of their competences:
a) They will promote training in basic life support and defibrillation management.
b) Promote the mechanisms of timely coordination with devices such as civil protection, firefighters, local police and others that are necessary to extend the installation and use of external defibrillators.
Article 3. The Xunta de Galicia legislates on external defibrillators
General Administration of the Autonomous Community and the public autonomous sector of Galicia will take into account and evaluate the installation of external defibrillators in the tenders that they call for the construction or management of infrastructures or facilities, as well as in the public calls for the provision of public services in concessional regime with significant flow of people.
CHAPTER II Requirements, installation, notification and registration of defibrillation devices
Article 4. Requirements
1 The external defibrillators referred to in this decree must comply with the provisions of Royal Decree 1591 / 2009, of 16 of October, by which health products are regulated, bearing the CE mark that guarantees compliance with the essential requirements that apply to them. they result from application. External defibrillators should be used under the conditions specified by the manufacturer, and should be properly maintained in a manner that preserves the safety and performance expected during their period of use. At the same time, it will be ensured that the equipment is equipped with software that allows the extraction of data from them, either directly or through the necessary adaptations.
2 The defibrillation devices that are installed must be clearly and simply indicated:
a) Your situation should be identified by specifying its location in the maps or informative maps of the place, so that people and emergency services can access them if necessary.
b) The instructions for its use, as well as for contact with emergency services, will be clearly displayed.
c) The signaling of the availability of a defibrillator should be clear and simple, and comply with the signaling recommendations established by the International Liaison Committee on Resuscitation (ILCOR). For its realization, RAL 6032 standard color or equivalent: RGB: 0-152-100.din 616421.7: 6.5.4; Pantone 348C. Below the signal, the word DESA shall be placed in a separate box, at a minimum size of ¼ of the upper box. Both designs must follow the conditions defined by ILCOR and established according to ESO 7010, 3864-3 and 9186-1 standards. The situation of the defibrillator should be properly identified by specifying its location, maps or informative maps of the place and the way to go to a possible user.
3 Individuals or legal entities that 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 reporting obligation will exist in the case of the removal of defibrillators.
4 External defibrillation devices shall have the minimum endowment indicated in Annex II.
Article 5. Responsible statement
1 The natural or legal persons referred to in section 3 of article 4 must notify the installation or removal of the defibrillators to the department responsible for health, as well as the variations that occur in the declared data, through the Foundation Public Health Emergencies of Galicia-061, making a responsible declaration.
2 The aforementioned responsible statements will preferably be submitted electronically through the standardized form included in Annex I, which will be available at the electronic headquarters of the Xunta de Galicia, https://sede.xunta.gal. Electronic submission will be mandatory for public administrations, legal persons, entities without legal personality, persons exercising a professional activity for which compulsory licensing is required for procedures and actions carried out with public administrations in the exercise of their professional activity, as well as for the people representing one of the above.
If any of the interested persons obliged to submit electronically presents their request in person, they will be required to submit it electronically. For these purposes, the filing date of the application will be considered as the date on which the correction was made. For the presentation of the applications, any of the identification and signature mechanisms admitted by the electronic headquarters of the Xunta de Galicia may be used, including the user and password system Chave365 (https://sede.xunta.gal/Chave365).
3 Interested persons not obliged to submit electronically, optionally, may present the declaration in person at any of the places and registries established in the regulations governing the common administrative procedure, using the standardized form available at the electronic headquarters of the Xunta de Galicia.
Article 6. Documentation
1 Along with the responsible statement, the following documentation will be presented:
a) Copy of the national identity document or equivalent identification document, only in the case of not denying your query.
b) Descriptive report of the location of the defibrillator and access roads.
c) Document identifying the personnel responsible for the defibrillator.
d) Document indicating the geolocation data of the device, if applicable.
2 It will not be necessary to provide the documents that have already been presented previously. For these purposes, the interested party must indicate at what time and before which administrative body the aforementioned documents were presented. It will be presumed that this consultation is authorized by the interested persons, except for the express opposition in the procedure.
In cases of material impossibility of obtaining the document, the competent body may require the interested person to present it, or, failing that, the accreditation by other means of the requirements to which the document refers.
Article 7. Additional documentation
1 The complementary documentation will preferably be submitted electronically. The interested persons will be responsible for the veracity of the documents that they present. Exceptionally, the Administration may require the display of the original document for the collation of the electronic copy presented.
2 The electronic submission will be mandatory for the subjects obliged to submit the declaration electronically. If any of the interested persons presents the complementary documentation in person, they will be required to submit it through their electronic submission. For these purposes, the filing date will be considered as the date on which the correction was made.
3 Those persons not obliged to the electronic submission, optionally, may present the complementary documentation in person at any of the places and registries established in the regulations governing the common administrative procedure.
Article 8. Registry of External Defibrillators of Galicia
1 The Registry of External Defibrillators of Galicia is created, managed by the Ministry responsible for health.
2 The installation of external defibrillators in the Autonomous Community of Galicia will be subject to registration on the registry, in accordance with the responsible statements presented. Likewise, all geographic and coordinates data on location, use and responsible personnel will be included, as well as all the variations that occur, so that the information is kept updated.
3 The department responsible for health will assign a registration number to each defibrillator, which must be visible together with the signage of the same.
4 The registry will be able to be consulted by means of the corresponding computer applications, with the purpose of increasing the accessibility to the defibrillation, by means of the elaboration of a defibrillator map in the Autonomous Community of Galicia. The defibrillators registered in said registry will be included in the map of resources available to the Coordination Center for Health Emergencies of Galicia-061 for attention to emergencies, in order to improve the accessibility to defibrillation and the prognosis of the cardiorespiratory arrest.
5 The communication of the removal of the defibrillator will lead to the cancellation of the registration.
CHAPTER III Titration, training and use of external defibrillators
Article 9. Titling
1 They will be able to use external defibrillation devices:
a) The personnel that is in possession of the following titles:
1º. Bachelor of Medicine and Surgery or degree of Medicine.
2º. University degree in Nursing or Nursing degree.
3º. Professional training of technician in health emergencies or certificate of equivalent professionalism.
4º. Official qualifications equivalent to the previous ones, issued by a Member State of the European Union.
b) Those of legal age who demonstrate passing the basic training program with official accreditation in the area of cardiopulmonary resuscitation, basic life support and the use of external defibrillators.
2 In the case of an exceptional situation in which it is not possible at that moment to have a person with the necessary training or qualifications for the use of the defibrillator, the Health Emergency Management Center of Galicia-061 may authorize any other person to the handling of the defibrillator, keeping the Central of the process at all times.
Article 10. Training institutions use defibrillators
The training of personnel who do not have the qualification indicated in section a) of number 1 of the previous article, may be taught by training units of the health centers of the public health system of Galicia, by the Public Foundation of Health Emergencies of Galicia- 061, by occupational risk prevention centers dependent on any public administration, by mutuals for work accidents and occupational diseases, by entities or institutions that are part of the Spanish Council for Cardiopulmonary Resuscitation or by individuals or legal entities that are recognized as instructors by any of the institutions or entities that form said council.
Article 11. Contents and minimum skills of the training activities
The training will have, as a minimum, the content established in Annex III, so that upon completion the students have demonstrated skills to:
a) Start the chain of survival, including a suitable interaction with the emergency system.
b) Recognize quickly a cardiorespiratory arrest.
c) Apply permeabilization techniques of the airway, including the initial measures before obstruction by a foreign body (choking).
d) Perform a high quality cardiopulmonary resuscitation.
e) Use the defibrillator in an effective and safe way.
Article 12. Accreditation of training
1 The training of the personnel referred to in section b) of the 1 number of the 9 article will be accredited through the corresponding individual certification, which must be recognized by the Spanish Council of Cardiopulmonary Resuscitation (CERCP) through the Public Foundation of Health Emergencies of Galicia -061, or of another equivalent entity in the case of personnel trained in another autonomous community or in another state.
The training obtained outside the Autonomous Community of Galicia will be recognized if it complies with the conditions established in the previous paragraph or if it is recognized according to the specific regulations of the autonomous community in which the training was carried out and the degree was obtained.
The same criteria will be applicable for the degrees obtained in the member countries of the European Union according to their regulations.
2 The original or duly certified copy of said certificates must be submitted at the request of the health authority, both for its verification and to validate the effectiveness of the same for its use in any functionality or registration that requires it within the Autonomous Community.
3 The individual certifications will have a validity of two years, counted as of their expedition.
4 The training entities will maintain an updated record of the issued certificates and the validity thereof.
Article 13. Use of defibrillation and assistance coordination devices
1 Every act of using the external defibrillator entails, in any case, the duty to immediately contact the Coordination Center for Health Emergencies of Galicia-061, by telephone call, or through the connection devices that may have installed the device, with the object of guaranteeing the proper continuity of care and medical follow-up of the affected person.
2 Once used, the personnel who carried out the defibrillation or the person responsible for the device, must complete the sheet of assistance provided, which is included as Annex IV, and send it to the competent department for health within the following 72 hours , together with the electronic information of the event collected in the data system of the external defibrillator. This information will be incorporated into the Registry of Cardiopulmonary Resuscitation of the Public Health Emergency Foundation of Galicia-061, in order to monitor and evaluate the use of the devices outside the health field, detecting the need to promote the installation in certain places and propose improvement actions in the use procedures, as well as promoting training and research in basic life support and in the use of defibrillators.
3 The transmission of the data will respect, in any case, what is established in the regulations for the protection of personal data.
Inspection and penalty system breach the standard on external defibrillators
Article 14. Defibrillator inspection and control
The consellería with competences in matter of health, through the services of sanitary inspection, will be able to inspect the activities and facilities foreseen in this decree, in order to verify the adequacy of the same ones and the defibrillators, as well as the formation of the personnel responsible for its management, to the provisions contained in this decree.
You can also request the appropriate reports to the Galician Urgency Health Foundation-061, in order to maintain a constant and updated knowledge of the location and status of the defibrillators, as well as for the detection of non-communicated discharges.
Article 15. Penalties system Defibrillator regulations
Without prejudice to other regulations that may be applicable, infractions committed against the provisions of this decree shall be considered infringements in matters of health, and the corresponding liability shall be required as provided in Chapter IV of Title II of the 8 Law / 2008, of 10 of July, of health of Galicia; in chapter VI of title I of Law 14 / 1986, of 25 of April, general of health; prior processing of the corresponding file in accordance with the provisions of the 39 / 2015 Law, of 1 of October, and of the 40 / 2015 Law, of 1 of October, of the legal regime of the public sector.
First additional provision. Personal data protection
The treatment of the data referred to in this decree will be adjusted, in any case, to what is determined by the applicable legislation on the protection of personal data.
In accordance with the Organic Law 15 / 1999, of 13 December, for the protection of personal data, the personal data collected, whose processing and publication are authorized by the interested persons through the presentation of the responsible declarations, will be included in a file called « users and professionals of the health system ", in order to manage the present procedure, as well as to inform interested persons about its 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 a communication to the following address: Consellería de Sanidad, Administrative Building San Lázaro, s / n, 15703 Santiago de Compostela, or through an electronic communication.
Second additional provision. Updating the responsible declaration form
For the presentation of the responsible declarations regulated in this decree, it will be necessary to use the standardized form, available at the electronic headquarters of the Xunta de Galicia, where it will be permanently updated and accessible to interested persons.
In order to keep it adapted to current regulations, 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 or of the content of the declarations provided in this decree.
The updating of the form must be approved by resolution of the person in charge of the consellería with competences in matters of health, without prejudice to its publicity through the electronic headquarters of the Xunta de Galicia.
Sole transitory provision. Adaptation of spaces and devices
The organizations, companies and entities that have external defibrillation devices will have a period of six months, counted from the date of entry into force of this decree, to adapt to the provisions contained therein. Once this period has elapsed, the Ministry with powers in matters of health may make use of its powers of inspection and control, in the manner indicated in chapter IV of this decree.
Single derogatory provision. Normative repeal
Decree 99 / 2005, of 21 of April, which regulates the training and use of external defibrillators by non-medical personnel, and the provisions of equal or lower rank that oppose the provisions of this decree is repealed.
First final provision. Regulatory development
The person in charge of the consellería with powers in matters of health, within the scope of the organization and matters specific to his department, is authorized to dictate the necessary provisions for the development of the provisions of this decree.
Second final provision
Entry into force This decree will come into force twenty days after its publication in the Official Gazette of Galicia.
Santiago de Compostela, March twenty-third, two thousand and seventeen
Alberto Núñez Feijóo President
Jesús Vázquez Almuiña Conselleiro de Sanidade
Company specialized in the training, installation and maintenance of defibrillators in La Coruña, Pontevedra, Orense and Lugo
Our company offers services of installation and maintenance of external defibrillators, approved facilities according to Galician regulations, comprehensive management service for external defibrillators with advice, installation, training, maintenance and repair of defibrillators to comply with the rule of the autonomous community.
In the province of La Coruña We offer services of sale and installation of external defibrillators in La Coruña city, Santiago de Compostela, Ferrol, Finisterre, Betanzos, Mugía, Padrón, Noia and Muros, we are a defibrillator maintenance company and approved training on the use of external defibrillators.
In the province of Pontevedra We offer services of sale and installation of external defibrillators in Pontevedra city, Vigo, Porriño, Baiona, Tui, La Guardia, Redondela and Moaña, we are a defibrillator maintenance company and approved training on the use of external defibrillators.
In the province of Orense We offer services of sale and installation of external defibrillators in Orense city, Verín, Allariz, Ribadavia, Carballino, Ginzo de Limia and Oímbra, we are a defibrillator maintenance company and approved training on the use of external defibrillators.
In the province of Lugo We offer services of sale and installation of external defibrillators in Lugo city, Villalba, Monforte de Lemos, Vivero, Burela, Ribadeo, Fonsagrada, Chantada and Sarria, we are a defibrillator maintenance company and approved training on the use of external defibrillators.
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