Regulations on defibrillators in La Rioja

Decree of the Government of La Rioja on cardioprotection

Legislation on defibrillators external to La Rioja

Regulations for defibrillators in La Rioja

 

Decree 8/2019, of May 3, which regulates the installation and use of external semi-automatic defibrillators outside the healthcare environment in the Autonomous Community of La Rioja.

Article 9.5 of the Statute of Autonomy of La Rioja, in the current wording, attributes to the Autonomous Community of La Rioja the competence for legislative development and execution in matters of health and hygiene within the framework of the basic legislation of l'Estat.

It will be Law 14/1986, of April 25, General de Sanitat, as the backbone standard of the National Health System, which will regulate all the actions that allow the right to health protection to be effective and determine the General actions of public administrations to guarantee health care in all cases of health loss.

Likewise in La Rioja, you assume the functions and health services that will be transferred by Royal Decree 1473/2001, of December 27, Law 2/2002, of April 17, of Health of La Rioja, determines the various healthcare levels Among them, we can highlight the level of urgències and sanitary emergencies, a highly qualified level for the immediate response that the health system must provide in the event of an emergency to avoid a fatal outcome.

In the case of maximum urgency, cardiovascular diseases and especially cardiac arrest, due to their severe fatal consequences, require an immediate response.

From now on, scientific organizations recommend and encourage health policies aimed at early care in out-of-hospital cardiac arrest. This is the case of the International Liaison Committee on Resuscitation (ILCOR), a committee that brings together the main world scientific organizations in the field of prevention and assistance to cardiac arrest and death.

Among other recommendations, it includes the implementation and development of public access programs for automatic and semi-automatic external defibrillation in out-of-hospital settings.

The action leading to a cardiorespiratory arrest requires a comprehensive action between the different interveners in the chain of survival, with special relevance to the figure of the first intervener, who is the initial contact with the patient, identifies the situation. of cardiorespiratory arrest and use defibrillation immediately, as soon as the out-of-hospital urgent health care teams arrive.

The advance in the technological development of the semi-automatic external defibrillators allows these devices to be used outside the healthcare sector, by personnel allied to the healthcare profession with safety, in an initial attempt to provide, in the earliest possible way, the most Currently safe efficacy in the treatment of cases of cardiac death due to defibrillatable cardiac rhythm. Therefore, in order to pay attention, with the utmost safety, but also in the earliest possible way, to facilitate the distribution and use of the external semi-automatic defibrillators as best as possible and to the entire population, in order to 'above emergency health resources.

Tot això will be carried, considering the social, geographical and sanitary characteristics, to the publication of Decree 48/2008, of July 18, which regulates the use of external semi-automatic defibrillators by non-medical personnel in the Autonomous Community of La Rioja (BOR of August 4, 2008 and Correction of Errors BOR of October 15, 2008) was modified by Decree 140/2011, of October 28 (BOR of November 2, 2011) .

With a national character, this legal framework is going to be established by Royal Decree 365/2009, of March 20, which establishes the conditions and the minimum safety and quality requirements in the use of automatic and semi-automatic external defibrillators. of the health sector.

The prevention of death requires community participation in urgent health care in cooperation with emergency and emergency services professionals. For this reason, it is recommended that those entities, companies, establishments or public or private services in the region, in transit or in large groups of people, as recommended by national and international scientific organizations, adhere to this rule.

Així mateix, the assistance to the cardiac arrest is an emergency and as such it may imply the early arrival to the lloc of the agents of services of emergencies different from the sanitary with the firefighters, local policies and civil protection, for the What is considered convenient for these personnel to have defibrillators?

In accordance with the basic state regulations, considering that there has been accumulated experience in the use of automatic and semi-automatic external defibrillators, there is a high degree of social awareness regarding the problem of unsubstantiated death, the consensus between professionals and the interest of the health administration in promoting and facilitating the use of the external semi-automatic defibrillator (DESA) outside the health field, suppressing unnecessary barriers and facilitating public access to defibrillation to increase survival from cardiac arrest , it has been considered appropriate to approve a new norm that regulates the area of ​​the Community of La Rioja, the installation and use of the DESA outside the health area.

The decree regulates the communication of the installation of external semi-automatic defibrillators outside the healthcare environment to the Autonomous Community of La Rioja, the procedures for accreditation for their use by non-healthcare personnel and for imparting training for the proper use and treatment of personal data in relation to these procedures in accordance with Regulation (EU) 2016/679 of the European Parliament and the Council, of April 27, 2016, relating to the protection of persons Physics for the processing of personal data and the free circulation of these and which repeals Directive 94/46/EC and the rest of the regulations in force in this matter that are applicable.

It also regulates the Registry of external semi-automatic defibrillators of La Rioja and the six sections with an instrument that allows the defibrillators to be installed outside the healthcare environment and the persons accredited for its use and for providing training. for its use in the territorial scope of our Autonomous Community, in addition to contributing to guaranteeing the adequate exercise of the function of attention to health emergencies and emergencies. In this case, it is possible to prepare a complete geographical map of the deployment of the defibrillators installed and to publish it in order to improve the effectiveness and efficiency of the care response in the event of a cardiac arrest.

Per tot, the Governing Council, at the request of the Health Minister, in accordance with the Consultative Council of La Rioja and prior deliberation of its members, at the meeting held on May 3, 2019, agrees to approve the following

 

Article 1

Object

 

This decree per object:

 

DECRET CAPITOL I

general provisions

 

  • a) Regulate the installation and use, outside of health centers or environments, of external semi-automatic defibrillators, giving rise to a situation of cardiac arrest in the Autonomous Community of La Rioja, in order to provide immediate attention.
  • b) Establish the training requirements, and the contingency, for the use of external semi-automatic defibrillators by non-health personnel, along with the requirements of the training persons or entities.

 

Article 2

Scope

 

  1. This decree is applicable to all natural or legal persons outside the health sector located in the Autonomous Community of La Rioja, who must install one or more external semi-automatic defibrillators, who must install or use them. provide training to use them.
  2. They are exempt from the application of this decree of the centres, services and health establishments subject to administrative authorisation.

 

Article 3

Definitions

 

For the purposes of this decree, please note:

 

  • a) External semi-automatic defibrillator, DESA: a health product that complies with the applicable regulations, capable of analyzing the cardiac rhythm, identifying the fatal rhythms related to defibrillation, and administering, with the intervention of a person, an electrical shock. the goal of establishing a viable heart rate at high safety levels. For the purposes of this standard, the AED term is equivalent to both AED (automatic external defibrillator).
  • b) Healthcare personnel: every person in the qualified healthcare profession who is regulated by Law 44/2003, of November 21, regulating healthcare professions. These personnel will not require accreditation to use the DESA.
  • c) First responder: person who makes initial contact with the patient, who identifies the situation of cardiorespiratory arrest, alerts SOS Rioja through 112 and provides the health response and initiates the basic resuscitation maneuvers at the succes level.

 

CAPITOL II

Installation and requirements

 

Article 4

Installation and registration

 

  1. Any natural or legal person may install one or more semi-automatic defibrillators external to the six dependencies.
  2. Those interested in installing an AED will present, as provided in Article 9, prior to its installation, a responsible declaration submitted to the General Directorate competent in matters of authorization of health centers, which includes:

 

  • a) Identification details of the owner: name, NIF and address of the responsible natural or legal person and their representative.
  • b) Location and description of the land where the DESA is located.
  • c) Identification details of the AED: brand, model and serial number of the defibrillator.
  • d) Identification of the persons accredited for the use of the DESA: name and DNI.
  • e) The availability of communication telephone number 112 and the subtraction of the minimum amount collected in Annex I.
  • f) Compliance with the instructions of the DESA manufacturer regarding maintenance and conservation and the functional requirements demanded by this decree.
  1. The responsible declaration model is found in annex II and will be available as indicated in article 9.
  2. The responsible declaration will allow the holder to install the DESA at the indicated level from the day of its presentation, without prejudice to the powers of verification, control and inspection that are attributed to you by the Ministry competent in matters of health.
  3. The competent general directorate may require at any time the owner of the DESA facility to provide documentation accrediting compliance with the requirements demanded in this decree.
  4. The inaccuracy, falsification or omission, of an essential nature, of any given or information that is incorporated into the responsible declaration along with the failure to present to the competent General Directorate of the responsible declaration or supporting documentation, will determine the impossibility of disposing of the DESA from the moment in which there is no evidence of these fets, without prejudice to the criminal, civil or administrative responsibilities to which it falls.
  5. Any variation of the details that appear in the responsible declaration, together with the withdrawal of the DESA, will be communicated to the competent General Directorate within one month from when it is produced.
  6. The competent General Directorate will register the owner responsible for the AED installed for the use by non-medical personnel in the Registry of external semi-automatic defibrillators of La Rioja, to the Section of semi-automatic external defibrillators installed by the seva utilització by non-health personnel, in accordance with that provided by Chapter VII.
  7. The owner of the DESA installation will have to guarantee at all times that he has accredited personnel to use it.

 

Article 5

Homologation, maintenance, signaling and information

 

  1. The external semi-automatic defibrillators that are still installed must comply with the one established by Royal Decree 1591/2009, of October 16, which regulates health products, with the CE marking that guarantees compliance with both essential requirements that result from application.
  2. The owner responsible for installing the DESA must guarantee maintenance and conservation in accordance with the instructions of the equipment manufacturer.
  3. Individuals, organizations or companies will install the DESA in a space visible to the public, and the location must be signaled clearly and simply using the universal signaling recommended by the International Coordination Committee on Ressuscitation (ILCOR). This location must be clearly identified on the information boards or maps of the lloc, both in the area where the DESA is located and on the exterior of the premises. At the expense of DESA, the emergency telephone number 112 and instructions for using it will be shown clearly and adequately visible.

 

CAPITOL III

Use of the DESA and accreditation

 

Article 6

Use of the DESA

 

  1. The external semi-automatic defibrillators can be used by healthcare personnel and by people who have the accreditation certificate of the training regulated by this decree.
  2. In those cases in which there is no other person accredited for the use of the AED, and exceptionally, you may use it for both therapeutic purposes in order to increase the possibilities of survival, whichever person is present, always beforehand. has been authorized by the Center Coordinator d'Urgències i Emergències Sanitàries through the call to the single emergency telephone number 112, maintaining at all times the supervision of the process by medical personnel.
  3. All actions by sanitary or non-sanitary personnel within DESA entail the obligation to contact the person in advance, or if escau, gives rise to the impossibility of fer-ho for not being present more than one person, immediately, at the Coordinating Center for Urgències and Emergències Sanitàries through the telephone number 112, in order to guarantee the medical control of the lactation and the continuity of care of the affected person.
  4. The person who uses the DESA will fill out a full DESA usage record, the model of which (Utstein model) is collected in annex III, which will be available as indicated in article 9.
  5. The head of the DESA will send to the General Directorate competent in Authorization of health centers, as provided in article 9, and to the Coordinating Center for Sanitary Emergencies and Urgències in the 24 hours following the use, a copy of the full DESA utilitization record, both independence that another copy must be sent to the health care team that intervenes in the lloc.

 

Article 7

Accreditation of non-medical personnel for the use of external semi-automatic defibrillators

 

  1. Persons who have completed a training course in accordance with the program defined in Annex IV, and taught by a person or entity accredited in accordance with the provisions of Article 8, will submit an application for accreditation for the use DESA gives the General Directorate competent to Authorize health centers in accordance with article 9.
  2. The application form is found in annex V and will be available as indicated in article 9.
  3. The competent General Directorate, after verifying the documentation attached to the application and course record provided by the training person or entity, will accredit for the use of the DESA the people who complete both the requirements established in this standard for the expedition of the course. certified in the maximum term of three months, which will be notified according to article 9.2. The expiration of this term ends without having notified the certificate, legitimate interest to understand the application is considered.
  4. The competent General Directorate will register the accredited persons in the Registry of external semi-automatic defibrillators of La Rioja, in the Section of persons accredited for the use of external semi-automatic defibrillators, in accordance with the provisions of Chapter VII.
  5. The credit for the use of the DESA will remain valid indefinitely.

 

CAPITOL IV

Accreditation to provide training for the use of the DESA

 

Article 8

Accreditation of training persons or entities

 

  1. The training programs aimed at people for the use of external semi-automatic defibrillators may be taught by persons or entities dependent on the Department competent in matters of health and by physical or legal persons accredited by the Department. This training takes time to always be taught in person.
  2. Physical or legal persons interested in providing training programs to people for the use of external semi-automatic defibrillators must have prior accreditation. Therefore, they will present a specific application to the General Directorate competent for Authorization of health centers together with a supporting report, as provided in article 9, and state that they have the following mitjans:
  • a) A program of the course with the minimum contingut which is adapted to the subjects and thematic blocks described in Annex IV.
  • b) A teaching team integrated by life support monitors and instructors with current training certificates issued by entities and scientific societies to recognize national and international prestige and competence in this matter, such as the American Society of Health (AHA) and the European Ressuscitation Council (ERC).
  • c) The teaching, bibliographic and audiovisual material, appropriated.
  • d) Adequate premises, well ventilated and sufficiently illuminated, and which maintain a reasonable proportion between the available space and the number of students.
  1. The application form is included in annex VI and will be available as indicated in article 9.
  2. Upon receipt of the documentation presented, and confirmation of compliance with the required requirements, the competent General Directorate will issue the resolution of accreditation to provide training for the use of external semi-automatic defibrillators within a maximum period of three months, and will notify it as indicated in article 9.2. The expiration date of the request terminates without having been notified of the express resolution, which legitimates the interested parties to understand that the application has been approved.
  3. Within 15 days after the end of each course, the physical or legal persons who teach training courses will send to the competent General Directorate the list of persons who have passed the assessment tests for the issuance of the corresponding certificate.
  4. The accreditation of the training person or entity will be valid indefinitely, without maintaining the requirements required for accreditation and immediately notifying any modification that may occur. The competent general management may exercise at any time the functions of inspection and control to verify the fulfillment of the requirements expressed in part 2.
  5. The accreditation of the training person or entity will remain in effect and may be revoked officially by the Administration, after processing the corresponding procedure with the hearing of the person or entity concerned, without compensation, if it is established that they have deixat to comply with the requirements established in this standard.
  6. The competent General Directorate will register the training persons or entities accredited to the Registry of external semi-automatic defibrillators of La Rioja, to the Section of persons or entities accredited to provide training for the use of external semi-automatic defibrillators, in accordance with that provided by the Chapter VII.

 

CAPITOL V

Presentation of documentation and notifications

 

Article 9

Presentation of documentation and notifications

 

  1. The declaration responsible for the installation of the DESA, the full registration of its use and the requests for accreditation for its use and for providing training for its use:

 

  • a) They will be available to the General Directorate competent in Authorization of health centers, to the City Service or to the electronic address of the Government of La Rioja (larioja.org), to the Electronic Office apartment, to the Health thematic area.
  • b) They will present:

 

  1. In the case of persons obliged to interact electronically with the Administration in accordance with article 14.2 of Law 39/2015, of October 1, of the Common Administrative Procedure of Public Administrations, through the electronic address of the Government of La Rioja, The electronic office apartment, in the Health thematic area.
  2. In the case of persons not obliged to interact electronically with the Administration according to article 14.2 of Law 39/2015, from October 1, be in person to the General Directorate competent in Authorization of health centers or to qualsevol dels llocs assenyalats to article 6 of Decree 58/2004, of October 29, which regulates the Registry in the area of ​​the General Administration of the Autonomous Community of La Rioja and its six Autonomous Organizations. Article 16.4 of Law 39/2015, of October 1.
  3. Notifications of interest will be carried out in accordance with the provisions of articles 40 to 44 of Law 39/2015, dated October 1.

 

CAPITOL VI

Treatment of personal data

 

Article 10

Treatment of personal data

 

  1. The Department responsible for health, through the General Directorate with functions in the Authorization of health centres, will adopt the necessary measures for the protection of personal data in accordance with the provisions of Regulation (EU) 2016/679 of the European Parliament and of the Consell, of April 27, 2016, relating to the protection of natural persons for the processing of personal data in the free circulation of these and for which Directive 95/46/EC and the rest of the regulations that treat this matter and in the current state regulations regarding data protection.
  2. The processing of personal data of persons who have an installed external semi-automatic defibrillator or who are accredited for its use or for providing training for its use is lasting through the Defibrillator Registry. semi-automatic external ladors from La Rioja, which regulates Chapter VII.
  3. The personal data collected from interested persons will be kept for the time necessary to comply with the finality that is required for the purposes of the communication or resolution of withdrawal from the DESA, the communication of the cessation of training activities or the resolution of revocation of accreditation to provide training, if necessary. However, the time necessary to determine the possible responsibilities that may be derived will be kept, and the provisions of the regional regulations for documentary archives and heritage will be applicable.

 

CHAPTER VII

Registry of Semiautomatic External Defibrillators of La Rioja

 

Article 11

Natural and final

 

  1. The Registry of external semi-automatic defibrillators of La Rioja (REDESA) is created, of an administrative nature, assigned to the Ministry of Health, to the General Directorate competent in Authorization of health centers, which will be responsible for the safekeeping, management and update
  2. The data that is registered with REDESA will be obtained from the declaration responsible for installing the DESA and from the requests for accreditation to use them or to provide training to use them and from the corresponding accreditations.

 

Article 12

Object and structure

 

  1. The REDESA is divided into the following sections: Section of semi-automatic external defibrillators installed for use by non-health personnel, Section of persons accredited for the use of external semi-automatic defibrillators and Section of persons accredited to teach Training for the use of external semi-automatic defibrillators.
  2. The Section of semi-automatic external defibrillators installed for their use by non-health personnel is registered with the physical and legal persons who have declared to the General Directorate competent in Authorization of health centers the installation of a defibrillator for use by non-health personnel in La Rioja.
  3. The Section of persons accredited for the use of external semi-automatic defibrillators will register the physical persons accredited by the General Directorate competent for the use of semi-automatic defibrillators external to La Rioja.
  4. To the Section of persons or entities accredited to provide training for the use of external semi-automatic defibrillators, register the physical and legal persons accredited by the General Directorate competent to provide training for the use of external semi-automatic defibrillators. The Rioja.

 

Article 13

Contingut and access

 

  1. Registration at REDESA will continue:
  • a) Identification details: DNI or NIF. Nom i cognoms. Social raó. Adreça. Telefon.
  • b) Data related to credit: Data issued by the General Directorate competent in Authorization of health centers.
  • c) An other type of data: academics and professionals.
  • d) Tract system: Mixt.
  1. The right of access to the registry will be exercised in accordance with that provided for by Law 3/2014, of September 11, on transparency and good governance of La Rioja.

 

Article 14

Cessió de dades

 

  1. The General Directorate competent in the Authorization of health centers will transfer to the Center Coordinator d'Urgències i Emergències Sanitàries of the Servei Riojano de Salut the following data:
  • a) Name, location and telephone number of the owner of the facilities in La Rioja that have declared that they have external semi-automatic defibrillators for use by non-medical personnel.
  • b) Name, ID and ID of the persons accredited to La Rioja for the use of external semi-automatic defibrillators and expiration date of the accreditation.
  1. The competent General Directorate will assign to the Rioja Health Service, for the publication on the agency's website, the data relating to the location of the external semi-automatic defibrillators in La Rioja.
  2. The competent general directorate will inform the population about who are the natural or legal persons accredited to provide training courses for the use of external semi-automatic defibrillators for non-medical personnel.

 

Article 15

Validity, modification and cancellation

 

  1. Registration at REDESA will be indefinite as long as it maintains the conditions that will be donated.
  2. The holder of the DESA installation will communicate the modifications of the data registered in the corresponding section of the REDESA to the General Directorate competent in Authorization of health centers in the term provided for in article 4.7.

The person accredited to provide training for the use of the DESA will communicate the modifications immediately in accordance with article 8.6.

  1. The cancellation of the registration is produced by the resolution of the competent authority in the authorization of health centers:
  • a) Official: when the responsible holder of the DESA installs or the person accredited to provide training to use the deixin to comply with the requirements established in this decree.
  • b) At the request of the party: prior communication of the withdrawal of the DESA by the holder or the cessation of training activities by the accredited person.

 

CAPITOL VIII

Subjects responsible for the use of external semi-automatic defibrillators, inspection and control

 

Article 16

Responsible subjects

 

Responsibility for the location, correct operation and training of the people who use the external semi-automatic defibrillators will be the responsibility of the owner indicated in article 4.2 a).

 

Article 17

Inspection and control

 

The general directorate competent in the authorization of health centers exercises the functions of inspection and control of all installations and activities that are related to the application of this decree. In particular, the following will be subject to inspection and control:

  • a) That the physical and legal persons who have installed any DESA compleixen both the obligations and requirements established in this standard.
  • b) That the persons and entities accredited to provide training for the use of external semi-automatic defibrillators complete the requirements demanded in this standard.

 

Article 18

Sanctioning regime

 

  1. Conduct contrary to what is established by this rule is considered an infraction in matters of health, as provided for in Title , Chapter VI, article 2 and following of Law 2002/17, of April 32, General de Sanitat.
  2. In the event of false notices and inadequate mobilization of services, the sanctioning regime established by Law 1/2011, of February 7, on Civil Protection and Emergency Assistance of La Rioja, will be applied.

 

First additional provision

Promoted the installation of external semi-automatic defibrillators

 

  1. The Department responsible for health will recommend the installation in the Autonomous Community of La Rioja of, Almenys, an external semi-automatic defibrillator to all establishments in the area, transit or romanguin large concentrations of people, such as:
  • a) Airport, railway and bus stations.
  • b) Large commercial establishments and shopping centers.
  • c) The stadiums, the sports centers, the performance venues, the conference halls, the events or the exhibitions, the gymnasiums, the educational centers and the companies.
  • d) Hotels.
  • e) Institutions and public organizations.
  1. It will also be recommended that emergency services, such as firefighters, local police and Civil Protection, may have DESA to be used by non-emergency health personnel.

 

Second additional provision

Authorizations of other public administration

 

In the area of ​​the Autonomous Community of La Rioja, all those who accredit having been authorized by another Public Administration have the status of persons accredited for the use of external semi-automatic defibrillators. In these cases, registration with REDESA, the Section of persons accredited for the use of external semi-automatic defibrillators, is carried out at any time at the request of the interested party.

 

Third additional provision

Standard application models

 

The Department responsible for health may establish normalized models of requests that include the name of procedures that are initiated in application of this standard.

 

Fourth additional provision

Existing administrative records

 

The annotations of each of the records created by Decree 48/2008, of July 18, which regulates the use of external semi-automatic defibrillators by non-medical personnel in the Autonomous Community of La Rioja, are constituted officially in annotations of the corresponding sections of REDESA created in this decree.

Unique transitional provision. Regularization of expedients.

  1. The authorizations granted pursuant to Decree 48/2008, of July 18, which regulates the use of external semi-automatic defibrillators by non-medical personnel in the Autonomous Community of La Rioja, will retain their validity for the purposes of that foresee this decree.
  2. The procedures initiated have just come into force and this regulation will govern and resolve in accordance with the regulations in force at the time of its initiation.

However, once this decree comes into force, if the provisions are more favorable to the interest, these will apply.

 

Unique derogatory provision

Regulatory repeal

 

Decree 48/2008, of July 18, which regulates the use of external semi-automatic defibrillators by non-medical personnel in the Autonomous Community of La Rioja, is hereby repealed.

 

First final provision

Regulatory authorization

 

The head of the Ministry responsible for health may dictate all the provisions that are necessary for the deployment and execution of this decree as well as the necessary provisions for the adequacy of the contingut of the annexes.

 

Second final provision

Entry into force

 

This decree comes into force in addition to publication in the "Butlletí Official de la Rioja".

Achieved on May 5, 2019.

 

The President, José Ignacio Ceniceros González.

 

The Minister of Health, María Martín Díez de Baldeón.

 

Download here regulations on defibrillators DEA DESA to La Rioja

 

We are defibrillators and cardiac rescue installers

 

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