Regulations on defibrillators in Galicia

Decree of the Xunta de Galícia on cardioprotection

Galician regulations on DEA defibrillators in Galicia

Galicia defibrillators regulations

 

DECRET 38/2017, of March 23, which regulates the installation and use of external defibrillators outside the healthcare environment, and its registry is created.

Article 43.1 of the Spanish Constitution recognizes the right to health protection, so that public powers have the constitutional obligation to protect or establish preventive measures and services necessary for health protection.

In accordance with article 149.1.16a of the Spanish Constitution, the Statute has exclusive competence in matters of foreign health, bases and general coordination of health, and legislation on pharmaceutical products. On the basis of this competence, approve Law 14/1986, of April 25, General Health. Així, no seu article 3 declares as an objective the health system that the mitjans and the actions of which will be oriented priority to the promotion of Saudi Arabia and the prevention of diseases. Així mateix, not article 6, establishes that the actions of the public health administrations will be oriented towards the promotion of Saudi Arabia and to guarantee that these health actions are carried out and are aimed at the prevention of diseases and not just at the cure, guarantee- health assistance is provided in all cases of loss of health.

Article 33.1 of the Statute of Autonomy of Galicia attributes the Autonomous Community 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 article establishes that the The Autonomous Community will be able to organize and administer for these purposes within its territory all the services related to the matters expressed above, and will exercise the guardianship of the institutions, entities and foundations in matters of health and social security; o Estat reserva per a si a high inspection conduent a l'accompliment de les functions i competències contingudes en article.

Article 32.3 of Law 8/2008, of July 10, of Saudi Arabia, includes the principle reiteration of the Public System of Saudi Arabia, a comprehensive conception of Saudi Arabia, which includes promotion of Saudi Arabia, protection against situations and circumstances that require health care, in particular protection against environmental hazards, prevention of illness and health care, as well as rehabilitation and social integration, from the perspective of health care. This sentence, in the aforementioned Law 8/2008, of July 10, in article 12.8, establishes that the persons holders of the right to the protection of Saudi Arabia and health care have right to the establishment of measures for the prevention of proven effective malaria. .

In Galicia, cardiovascular diseases constitute two of the most important Saudi problems. Of all emergency situations, cardiopulmonary resuscitation represents the paradigm in which early action and both adequate measures determine the prognosis in terms of recovery of life and minimization of possible consequences.

The most common causes of cardiorespiratory arrest in adults are ventricular fibrillation and ventricular tachycardia in general, and they have as a fundamental tract a dins cardiopulmonary resuscitation and the chain of survival to electrical defibrillation. These situations, at the immediate disposal of technical technicians, defibrillators, are essential to address both the success of resuscitation efforts, and to ensure continued healthcare assistance. According to the Recommendations for Resuscitation 2015 of the European Resuscitation Council, "the installation of AED in areas where a cardiac arrest can be expected every five years, is considered effective and comparable to other medical interventions."

In the autonomous community, the regulation of the matter must contain the current Decree 99/2005, of April 21, which regulates the training and use of external defibrillators by medical personnel. This regulatory standard included the conditions for out-of-hospital use of two external defibrillators, the authorization of the training entities and the training for the use of two external defibrillators, in accordance with the headings of the various chapters.

Dins of the National Quality Plan of the National Health System, approved on June 28, 2006 by the Interterritorial Consell of the National Health System

ischemic heart disease that included the recommendation to establish a legal framework for the implementation and development of a program to favor the use of two semi-automatic defibrillators in public buildings. The legal framework is currently constituted by Royal Decree 365/2009, of March 20, which establishes the conditions and minimum requirements of safety and quality for the use of automatic and semi-automatic external defibrillators outside the healthcare field, This is pursuant to Royal Decree 1591/2009, dated October 16, which regulates health products. These provisions have the condition of basic norms that are added to the article 149.1.16o of the Spanish Constitution.

Article 5 of the Royal Decree 365/2009, dated March 20, establishes that the health administrations of the autonomous communities promote and recommend the installation of two external semi-automatic defibrillators according to the recommendations of two international organizations, in those countries. What is the focus on the transiti name of people, and promote the opportunistic coordination mechanisms with the devices such as civil protection, firefighters, local police and others that are necessary to ensure the installation and use of these devices.

Furthermore, article 4 of Royal Decree 365/2009, of March 20, provides that public or private entities, together with private persons who intend to install a semi-automatic defibrillator device, must notify the 'health authority of the autonomous community of lloc or do. Establishing what you want to do, make a responsible declaration that completes the requirements provided for in number 2 of this article.

This month, or on December 28, 2006, Directive 2006/123/EC of the European Parliament and the Consell, of December 12, 2006, relating to domestic market services, will come into force. According to the spirit of the aforementioned directive, a simple invocation of general interest does not serve to justify the a priori requirement of certain authorizations, since administrative control is possible during the term mitjançant the procedure of declaration responsible and the subsequent vixilància. The Statute transposed this regulation through Law 17/2009, of November 23, on the access to service activities and its exercise, to Law 25/2009, of December 22, modifying various laws per to the seva adaptation to the arrival on the lliure access to the activitats of services and to your exercise.

Law 20/2013, of December 9, guaranteeing the market unit, establishes in its article 3 that "cap is a general provision, administrative action or quality standard that refers to access or exercise." "Economic activities may not contain conditions or requirements that have a direct or indirect effect of discrimination based on the establishment or residence of the economic operator." Article 16 of the aforementioned law establishes the principle of free economic initiative, so that "access to economic activities and its exercise will be open throughout the national territory and may only be limited according to or established by the law. not provided for in the regulations of the Union. "European or international treaties and conventions." For this reason, not that I attend to the training entities, a new regulation dispenses with the previous authorizations for the training entities and the particular training activities, without preuíxo two controls a posteriori necessary.

In compliance with the provision of Decree 198/2010, of December 2, which regulates the development of the electronic Administration to the Xunta de Galícia and the entities of the dependents, the directive itself serves the regulations on access electronic two citizens for public services It is also easier to present the declarations responsible for telematic mitjans to the electronic address of the Xunta de Galícia.

Take into account the accumulated experience, or the development of two available technological resources, and the changes in normative operations, such as adapting to pre-existing regulations in this matter to the current requirements, seeking greater access to these resources to immediately address situations of cardiorespiratory arrest.

The decree is formatted by four capítols ens calis es recollin, respectively, a les disposició xerais; the requirements, installation, notification and re-existence of two external defibrillators; a qualification and precise training for the management of defibrillators and the conditions of their use; the provisions relating to inspection and sanctioning regime. This regulation is complete with two additional provisions, a transitional one, to adapt countries and serve, a derogatòria, and two decrees, referring to the development of regulations and entry into force.

The virtue, at the request of the competent minister in matters of health, was agreed by the Consultative Council, and logo of the deliberation of the Council of the Xunta de Galicia, at its meeting on March 3, 2000.

 

AVAILABLE

 

CAPITOL I

xerais provisions

 

Article 1

Object

 

Or aquest decret tingues per obxecte:

  • a) Establish the conditions and requirements for the installation, use and maintenance, health sector forum, of automatic and semi-automatic external defibrillators.
  • b) Determine the necessary quantities, it is recommended to have two dets defibrillators, or the requirement of notification of the installation and the correct signalling.
  • c) Establish the minimum requirements related to the training of two handlers.
  • d) Create or Reexist External Defibrillators of Galícia.

 

Article 2

Definitions

 

For the purposes of this decree, it will be understood as:

  • a) External semi-automatic defibrillator: a health product intended to analyze the cardiac rhythm, identify the fatal rhythms related to defibrillation and administer an electrical shock in order to finally restore the viable cardiac rhythm at high safety levels. This definition also includes the names of automatic external defibrillators.
  • b) External automatic defibrillator: a health product that is distinguished above in that, it is used to analyze the cardiac rhythm and identify fatal rhythms, carried out at the indication of administering an electrical shock.

 

Article 3

Promotion of the installation and use of external defibrillators outside the healthcare environment

 

  1. To improve the survival expectations of people who experience cardiorespiratory arrest, we recommend installing external defibrillators, especially in the following countries:

 

  1. a) Large establishments and shopping centres, individuals and col·lectius.
  2. b) Airports.
  3. c) Commercial ports.
  4. d) Bus or railway stations and stations, intercanvi stations.
  5. e) Facilities, public establishments or open spaces in which recreational activities and public spectacles are carried out.
  6. f) Sports facilities or non-conventional public or sports spaces

private.

  1. g) Centers educatius.
  2. h) Llocs on hi hagi an elevated belt that is produeixi a cardiac arrest, cardiac rehabilitation centers, non urgent health transport vehicles, health establishments and clinics.
  3. i) Administrative dependencies of the General Administration of the autonomous community or

autonomous public sector of Galicia, the streets concentrate or transit a large number of people.

  1. j) Other countries that are considered of interest in relation to the activities carried out,

ou ens cales is concentri ou transiti a great name of people.

 

  1. The health administrations of the Autonomous Community of Galicia and the entities

instrumentais dependents, not the scope of the six competencies:

 

  1. a) They will promote training in basic life support continguts and defibrillator management.
  2. b) Promote opportunistic coordination mechanisms with devices and organizations

civil protection, firefighters, local police and others that are necessary to extend to

installation and use of external defibrillators.

 

  1. The General Administration gives the autonomous community or autonomous public sector of

Galicia will be responsible for and will evaluate the installation of external defibrillators in the tenders that are called for the construction or management of infrastructures or facilities, together with the public calls for the provision of public services under concessional regime with flux. important of people.

 

CAPITOL II

Requirements, installation, notification and reexistence of two devices

 

Article 4

Requirements

 

  1. Our external defibrillators refer to what this decree must comply with and establish in the Royal Decree 1591/2009, dated October 16, which regulates the products.

sanitaris, and will carry CE marking that guarantees their compliance with the essential requirements that result from their application.

 

External defibrillators must be used under the conditions specified by the manufacturer, and must be properly maintained so as to maintain the safety and performance provided during their period of use.

 

However, ensure that the equipment is equipped with a program that allows the extraction of these seveties, which will directly mitigate the necessary adaptations.

 

  1. Our defibrillation devices that are installed are signaled in a clear and simple manner:

 

  1. a) This situation must be specifically identified by the local information platforms or maps, so that people and emergency services can access it if necessary.

 

  1. b) Visibly explain the instructions for your use, so please contact us.

emergency services.

 

  1. c) The indication of the availability of a defibrillator must be clear and simple, and comply with the indication recommendations established by the International Liaison Committee on Resuscitation (ILCOR). For carrying out, you will use the standard RAL 6032 or equivalent: RGB:0-152-100.din 616421.7:6.5.4; Pantone 348C. Each of the signs must be placed in the recess on the part of the DESA, with a minimum measurement of 1⁄4 of the upper recess.

 

Both of the designs must follow the conditions defined by ILCOR and established according to the ISO 7010, 3864-3 and 9186-1 standards. In the situation of the defibrillator, it will take time to clearly identify its location on the computer's information boards or maps in order to contact a potential user.

 

  1. Natural or legal persons who install an external defibrillator will be required to notify in accordance with article 5 and will be responsible for ensuring its maintenance and conservation, in accordance with the manufacturer's instructions. Within a month of notification there will be no withdrawal of two defibrillators.

 

  1. Our external defibrillation devices have the minimum equipment that is indicated not

annex II.

 

Article 5

responsible statement

 

  1. The physical or legal persons referred to in number 3 of article 4 must notify the installation or removal of two defibrillators to the department competent in matters of health, in addition to the variations that are produced in the declared data. , through the Fundació Pública Urxències Sanitàries de Galícia-061, makes a responsible declaration.

 

  1. These responsible declarations will preferably be submitted electronically through the standard form included in Annex I, which will be available at the electronic address of the Xunta de Galícia. https://sede.xunta.gal

 

The electronic presentation will be obligatory for public administrations, legal persons, legal entities, persons who exercise a professional activity for the need of the association, obligatory for the procedures and actions carried out by public administrations not exercised. . Please contact the representatives of previous days.

 

For some interested parties, please refer to the electronic presentation.

This application will be required in person, but will also require electronic submission. For these purposes, it is considered as presentation date

sol·liciteu that in which the amendment was made. For the presentation of the applications

You will be able to purchase two identification and location mechanisms allowed by the electronic address of the Xunta de Galícia, including the user system and Chave365 code (https://sede.xunta.gal/chave365).

 

  1. Those interested persons not eligible for electronic submission may optionally submit the responsible declaration in person at the local council if there are established regulations for the common administrative procedure, using the standard form available on the electronic website of the Xunta de Galícia.

 

Article 6

documentation

 

  1. Once the responsible declaration is made, you will present the following documentation:

 

  1. a) Copy of the national identity document or equivalent identification document,

It is not necessary to deny the serious consultation.

  1. b) Descriptive memory of the location of the defibrillator and vies daccés.
  2. c) Document not necessary to identify the personnel responsible for the defibrillator.
  3. d) Document not necessary indicating the geolocation data of the device, if it is escaping.

 

  1. It will not be necessary to refute documents that have not been previously presented.

 

For these purposes, the interested person will have to indicate at what time and when

guany administratiu presented the cited documents. We will assume that this consultation is authorized by the interested parties, meaning that it constitutes no procedure for express opposition.

 

In cases where it is impossible to obtain material or document, or competent body

You may request it from an interested person upon presentation, or, if necessary, upon credit.

For others there are two requirements as to what is refereixi or document.

 

Article 7

complementary documentation

 

  1. Complementary documentation will preferably be submitted electronically.

 

Interested persons are responsible for verifying the two documents presented. Exceptionally, the Administration may require the exhibition of the original document in conjunction with the electronic copy presented.

 

  1. Electronic filing will be mandatory for all suxeits obrigats to electronic filing of the declaration. If any interested persons present complementary documentation in person, they will be required to do so through electronic submission. For these purposes, the presentation date is considered to be the date in which the amendment was made.

 

  1. Those people not open to electronic presentation, optionally, may

present complementary documentation in person to calquera dos llocs i

registries establish the regulations governing the common administrative procedure.

 

Article 8

Reexistre de Defibril·ladors Externs de Galícia

 

  1. Creeu-vos or Record of External Defibrillators of Galícia, xestionat by the department

competent in health matters.

 

  1. It is the object of non-existent official registration, in accordance with the responsible declarations presented, to the installation of defibrillators external to the Autonomous Community of Galicia. In addition, all the graphical information and location coordinates are included, as well as the responsible personnel, along with all the variations that are produced, so that the information is kept up to date.

 

  1. The department competent in health matters will assign a registration name to

each defibrillator, which must be visible along with its signal.

 

  1. The record is you can consult with the corresponding computer applications,

in order to increase the accessibility to defibrillation, mitjançant the elaboration of a map

of defibrillators to the Autonomous Community of Galícia. Us registered defibrillators do not

esdevingut registration will be incorporated into the resource map that complies with Central

Coordination of Urxències Sanitàries de Galícia-061 for attention to emergencies, with the goal of increasing access to defibrillation and the prognosis of cardiorespiratory arrest.

 

  1. The communication of the removal of the defibrillator will lead to the cancellation of the registration.

 

CAPITOL III

Qualification, training and uses

 

Article 9

qualification

 

  1. They may use external defibrillation devices:

 

  1. a) Or personnel who are in possession of two following titles:

1st. Bachelor's degree in Medicine and Surgery or degree in Medicine.

2n. University Diploma in Nursing or Nursing Degree.

 

3rd. Professional training as a technician in health emergencies or certification of health

equivalent professionalism.

 

4t. Official qualifications equivalent to previous ones, issued by a Member State of the European Union.

 

  1. a) Senior persons who demonstrate success in the training program

basic with official accreditation in matters of cardiopulmonary resuscitation, vital support

basic and use of external defibrillators.

 

  1. In case of an exceptional situation in which it is not possible to provide at the time a person or training or qualification necessary for the use of the defibrillator, the Central de Coordinació d'Urxències Sanitàries de Galícia-061 may authorize labels another person to manage the defibrillator, the Central will maintain, at all times, the supervision of the process.

 

Article 10

Training entities

 

Training of personnel who do not have the qualification indicated in line a) of number 1

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 Urxencias of Galicia-061, by risk prevention centers at work dependent on public administration, for mutual accidents. of treball and malalties professionals, for entities or institutions that form part of the Consell Español de Ressuscitació Cardiopulmonar per persones físiques o jurídiques que estiguin collídes com a instrutores per quaquera de les institucions o entitats que formamin o dit consell.

 

Article 11

Continguts and minimum qualifications for training activities

 

A formació terà, with a minimum, or contingut establishes in annex III, so that it does not

moment of completion or students demonstrate qualifications for:

 

  1. a) Start the chain of survival, including an adequate interaction with the survival system.

emergencies.

  1. b) Quickly recognize cardiorespiratory arrest.
  2. c) Apply the airway permeability techniques, including the initial measures

davant obstrució por un cos extrany (atragament).

  1. d) Perform high-quality cardiopulmonary resuscitation.
  2. i) Use the defibrillator in an effective and safe manner.

 

Article 12

Training accreditation

 

  1. The training of personnel to which reference is made to line b) of number 1 of art. or two equivalent entities in no case of personal format, noutra communitate autònoma or noutro estat.

 

The training obtained outside of the Autonomous Community of Galicia will be recognized and compleixi with the conditions established in the previous paragraph or if it is recognized in accordance with the specific regulations of the autonomous community of Galicia and will last for the duration of the training and is obtained at titling

 

The same criteria will be applied to the qualifications obtained in the member countries.

bros donates to the European Union according to its regulations.

 

  1. The original or authenticated copy of two certified certificates must be presented.

assegut per requirement of the sanitary authority, both for the verification and to validate the effectiveness of its commitment in functional or re-existing calquera that is required by the Autonomous Community.

 

  1. Aix individual certifications have a validity of two years, comptats from

expedition.

 

  1. Training entities will maintain a current record and two expedited certificates.

dues e dona sua vixència.

 

Article 13

Use of two devices and coordination of assistance

 

  1. Each act of using the external defibrillator entails, in all cases, the obligation to immediately contact the Galicia-O61 Sanitary Emergency Coordination Center, using a telephone call, or using the connection devices that can be installed. The device is intended to guarantee continuous care and medical follow-up for the affected person.

 

  1. A co-worker, the personnel involved during the defibrillation or the person responsible for the device, must pay for the assistance provided, which is collected according to CVE-DOG: annex IV, and sent to the competent department. in terms of health within the following 72 hours, together with electronic information from the subsequent collection of the data system of the external defibrillator.

 

This information will be incorporated into the Cardiopulmonary Resuscitation Registry of Fun-

dació Pública Urxències Sanitàries de Galícia-061, in order to carry out follow-up and endorse the two devices outside the sanitary environment, detect needs to promote the installation in certain areas and propose better actions in procedures of its, així to promote training and research in basic life support and not the use of defibrillators.

 

  1. The transmission of data will respect, in all cases, or establish the regulations for the protection of personal data.

 

CAPITOL IV

Inspection and sanctioning regime

 

Article 14

Inspection and control

 

A department with competencies in matters of health, through two services d'ins-

The health department will be able to inspect the activities and installations provided for in this decree, with the objective 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. decreed

 

You will also be able to request the appropriate reports from the Public Foundation of Sanitary Urxencies of Galicia-061, with the objective of maintaining a constant and updated set of the location and status of two defibrillators, in order to ensure the detection of 'altes or baixes not communicated.

 

Article 15

Sanctioning regime

 

According to the provisions of the regulations that may result from application, the infractions committed against or provided for in this decree will be considered as infractions in matters of health, the corresponding responsibility will be required according to or provided for in Chapter IV of Title II of Law 8/ 2008, June 10, from Saudi Arabia; Chapter VI of Title I gives Law 14/1986, April 25, General of Health; logo of the processing of the corresponding file to comply with the provisions of Law 39/2015, of the 1st of October, of the Law 40/2015, of the 1st of October, of legal rèxim of the public sector.

 

First additional provision

Protection of personal data

 

O treats the data to which this decree refers in all cases or that determines the applicable legislation regarding the protection of personal data.

 

In accordance with Organic Law 15/1999, of December 13, protection of data,

personal nature, the personal information collected, the processing and publication of the authorizations of the persons interested in the presentation of the responsible declarations, will be included in a file called "users and professionals of the health system", for the purpose of managing the present procedure, here I want to inform you. people interested in the procedure. The body responsible for this fitxer is the General Technical Secretary. Our rights of access, rectification, cancellation and opposition can be exercised by the body responsible for the fitxer, mitjançant or sending a communication to the following address: Conselleria de Sanidade, Edifici Administratiu San Lázaro, s/n, 15703 Santiago de Compostel·la, or through electronic communication.

 

Second additional provision

Update of the responsible declaration form

 

For the presentation of the responsible declarations regulated in this decree it will be necessary

Please use the normalized form, available on the electronic address of the Xunta de Galícia, which will be permanently updated and accessible to interested persons.

 

The object of this document adapted to the current regulations, or formulated even with annex I, may be updated on the electronic website of the Xunta de Galícia, without the need to publish the new document in the Official Gazette of Galicia, provided that a modification or The update did not imply a substantial modification of this document nor any of the declarations provided for in this decree.

 

The updating of the form must be approved by the resolution of the person in charge of the Ministry of Competencies in Health Matters, without the need for publicity through the electronic address of the Xunta de Galícia.

 

Unique transitional provision

Adaptation of countries and devices

 

Us organizations, companies and entities that have defibrillation devices

external services will have a portion of six months, compiled from the date of

entry into force of this decree, in order to adapt to the provisions contained therein.

 

Transcorregut this period, to the department with competencies in matters of health

must exercise the facultats d'inspecció i control, in the manner indicated not capí-

tol IV daquest decree.

 

Unique derogatory provision

Regulatory repeal

 

Decree 99/2005, of April 21, which regulates training, is hereby repealed.

or use of external defibrillators by non-medical personnel, the provisions of the same or

lower rank that s'opposen to the disposat did not present decree.

 

First draft provision

Normative development

 

Empower the person who holds the department with competencies in matters of health, not

The scope of organization and materials of your department, to donate the necessary provisions for the development of the device, does not present a decree.

 

Disposició derradeira segona

Entry into force

 

This decree will come into force on the vint days of publication in the Official Gazette of Galicia.

 

Santiago de Compostel·la, vint i 3 de març de dos mildesset

 

Alberto Nunez Feijoo

President

 

Jesus Vazquez Almuina

Minister of Health

 

Download here regulations on defibrillators DEA DESA to Galícia

 

We are defibrillators and cardiac rescue installers

 

Neosalus Galicia carries out installations of AED defibrillators, carries out equipment maintenance and BLS training and uses of the defibrillator in order to comply with the regulations for semi-automatic external defibrillators, providing comprehensive cardioprotection to Galicia. Contact us in Galicia for any installation, maintenance or repair of AED equipment that you may need, for installations by certifiers of cardioprotect countries in Galicia.