DECREE 137/2008 of December 12, which regulates the use of semi-automatic external defibrillators in non-health centers in the Balearic Islands.
Article 43 of the Spanish Constitution recognizes the right to health protection and the competence of public powers to organize and protect public health. In development of this legal precept, Law 14/1986, of April 25, General Health was approved as an instrument of general regulation of all actions that allow the right to health protection to be made effective, in such a way that the actions of Public health administrations are oriented to guarantee health care in all cases of loss of health.
Within this legal framework, the Administration of the Autonomous Community is committed to responding to the mandate contained in article 15 of the Constitution, which recognizes the right to life, physical integrity and health of people through a public system that Ensure emergency/emergency management and immediate health care.
The Quality Plan for the National Health System includes, among others, the Ischemic Heart Disease Strategy, aimed at achieving care for patients with heart disease based on clinical excellence. Early defibrillation is an objective of this strategy, as a fundamental element of it, and it recommends establishing a legal framework for the implantation of semiautomatic external defibrillators (hereinafter DESA) in public places, under equal conditions throughout the national territory.
Article 30.48 of the Statute of Autonomy of the Balearic Islands, modified by Organic Law 1/2007, of February 28, attributes to the Autonomous Community of the Balearic Islands the power to promote health in all areas, within the framework of the bases and the general coordination of Health, and article 31.4, the competence of legislative development and execution in health and health matters, as well as specialized health training, and in article 31.11 in matters corresponding to the field of Civil Protection and emergencies.
The recommendations of scientific societies of recognized prestige are directed, at this point, to the orderly introduction of semiautomatic external defibrillators in those public or private places where a large number of people are concentrated or transit.
The effective response, in the face of a vital event that may require defibrillation, involves reducing the time between the occurrence of the problem, the early intervention of non-medical personnel, the defibrillation, the call to the emergency/emergency services 112/061 and its arrival to take charge of the situation, integrating non-medical personnel (emergency services, citizens...) into the so-called 'chain of survival'.
This Decree is intended to address a uniform regulation of the use of external semiautomatic defibrillators by non-health personnel, as well as the establishment of the accreditation procedure and minimum training program that trains for their use.
According to Law 5/2003, of April 4, on Health of the Balearic Islands, health care is carried out through comprehensive health care for the population through emergency care and health emergencies devices and, by At the same time, it obliges the Health Administration to continuously improve training in the health field, demanding intervention actions aimed at preventing risk situations.
Law 2/1998, of March 13, on the management of emergencies in the Balearic Islands established a public emergency management system in our autonomous community, inspired by the principles of diligence, speed, proportionality and efficiency, among others, which have been completed with the approval of law 3/2006, of March 30, on emergency management of the Balearic Islands, which confirms said commitment that ratifies the policy of prevention and comprehensive management of emergencies as a top priority, undertaking the regulation of some aspects of the so-called ordinary emergency, that is, situations that occur during the occurrence of an unexpected event that implies an alteration in the normal state of people..., with negative repercussions; a concept in which we must place, without a doubt, those cardiovascular accidents that sometimes lead to the so-called 'sudden death'.
For all these reasons, and at the proposal of the heads of the Ministry of Health and Consumption and the Ministry of the Interior, in accordance with the Advisory Council of the Autonomous Community of the Balearic Islands and having considered it the Governing Council, in the session of the day December 12, 2008
DECREE
Chapter I
General disposition
Article 1
Purpose and Scope
- The purpose of this Decree is:
- a) Regulate the minimum conditions and requirements for the use and maintenance of semi-automatic external defibrillators (hereinafter AEDs) outside the health field, by personnel who do not hold a Bachelor's degree in Medicine or a University Diploma in Nursing, in the territory of the Balearic Islands.
- b) Establish the minimum training program, as well as the accreditation procedure for the people and entities involved in the training and/or use processes of those.
- c) Create the following Records:
- The DESA Registry and establishments and facilities that have them.
- The Registry of Training Entities in the Use of DESA.
- This Decree is only applicable to defibrillators that are placed in places where there is a (fixed or temporary) presence of the public; Consequently, those intended for private use only are excluded.
Article 2
AED concept
For the purposes of what is established in this Decree, DESA is understood to mean the medical device intended to analyze the heart rhythm, identify fatal arrhythmias subject to defibrillation and administer an electric shock in order to restore a viable heart rhythm with high levels of security. This definition includes automated external defibrillators.
Article 3
Personnel trained in the use of a DESA
A DESA can be used, in addition to medical and nursing staff, by all those people who have passed initial theoretical and practical training in Basic Life Support and in the use of DESA and, where appropriate, have updated their knowledge through the corresponding ongoing training or recycling, in the manner established in this Decree.
Chapter II
Requirements and obligations for the use, installation and maintenance of DESAs
Article 4
Installation and maintenance of AEDs
- Individuals or legal entities, public or private, who wish to install one or more DESAs in their premises must submit, in advance, to the General Directorate for Evaluation and Accreditation an application for registration in the DESA Registry created for this purpose. in this Decree. This Registry and its modifications will be accessible at all times by the General Directorate of Emergencies for its integration into the Emergency Service of the Balearic Islands, 112. Likewise, the information will be available to the Health Service of the Balearic Islands, at through 061.
- Along with the application, interested persons or entities must provide the following documentation:
- a) DNI/NIF of the physical or legal person who owns the entity, company, establishment or service that intends to dispose of the DESA. In the case of legal persons, the name of the person holding the legal representation and documentation that proves this condition.
- b) Brand, model and serial number of the defibrillator to be installed, as well as the certificate from the manufacturer that it complies with all applicable regulations and the number of the organization that has granted the CE marking.
- c) Specific physical space where the defibrillator will be located and access routes to it.
- Any variation of the information contained in the documentation provided in accordance with the provisions of the previous section, must be communicated to the General Directorate of Evaluation and Accreditation within fifteen days from when it occurs and, especially, the removal of the defibrillator. .
- The organizations, institutions and public or private companies or individuals registered in the Registry referred to in this article will place, in a visible place and facing the public, a sign indicating the existence and location of one or more defibrillators, in which must state the rules of use, with the following message: 'Attention. Establishment equipped with an external semiautomatic defibrillator', which must also include a green square sign with a white cross in the upper right corner and a white heart crossed by an image of a green ray indicative of emergency services, as as listed in Annex VI.
- The DESA should preferably be installed next to a telephone that allows immediate communication with 112/061.
- Individuals or legal entities, organizations, institutions and companies, public or private, that install a DESA in their premises will be responsible for guaranteeing its maintenance and upkeep, in accordance with the equipment manufacturer's instructions.
Article 5
AED use
- The use of a DESA must be communicated without delay to number 112/061, in order to guarantee continuity of care and medical control over the affected person.
- In addition, the use of a DESA must be reported to the General Directorate of Evaluation and Accreditation through the document that appears as Annex IV of this Decree, which must be sent within three days by the person responsible for the place or establishment. where the event occurred.
- The document referred to in the previous section may also be delivered to the person in charge of the acting emergency/urgency service.
Chapter III
Training, accreditation and control
Article 6
Training program
- The training program aims to train recipients in Cardiopulmonary Resuscitation (CPR) techniques, achieve better results in the treatment of cardiorespiratory arrest (CPA), and specifically acquire knowledge and mastery of AEDs and integrate them into algorithms. of CPR in the chain of survival.
- The minimum training program for the use of DESA will conform to the program established in Annex I of this Decree.
- The Training Program for the use of AEDs is aimed at non-health professionals, and all those people interested in being able to use an AED in case of need, acquiring the minimum necessary knowledge about the specific operation of this type of device and the actions to be taken. perform in urgent and emergency situations.
- The minimum age to access the training subject to regulation of this Decree will be 18 years, you must have at least a school graduate degree or equivalent and have completed a basic life support module.
- The training program must be carried out in its entirety to obtain the certificate that enables the use of the DESA.
Article 7
Accreditation of training entities
- Public or private entities or natural persons interested in imparting the training activities regulated in this Decree must request the corresponding accreditation from the General Directorate of Evaluation and Accreditation.
- To this end, they must submit a standardized application form to the aforementioned General Directorate, accompanied by the following documentation:
- a) Identification data of the Entity, accompanied by a copy of the DNI if it is a natural person or public deed of incorporation in the case of a legal person or Bylaws or Creation Agreement if it is a public entity.
- b) Report justifying the activities to be carried out, specifying the course program, which must include theoretical and practical classes, stating the number of hours that will be dedicated to each of the modules.
- c) List of professors accompanied by their qualifications, who must be in possession of a Bachelor's degree in Medicine, a Diploma BOIB No. 178 20-12-2008 345 University in Nursing or basic life support instructors accredited by the scientific societies American Heart Association or by the European Resuscitation Council.
- d) Center or centers where the teaching activity will be taught, as well as the way and place in which the practical modules will be taught.
- e) Registration conditions and number of places offered (not more than 25).
- f) Director of the course, with a degree in Medicine or a University Diploma in Nursing.
- g) Material available to carry out the training activities, which will comply with the provisions of Annex II.
- The General Director of Evaluation and Accreditation will issue a reasoned resolution granting or denying accreditation. This resolution does not exhaust the administrative route and, therefore, can be filed against appeal before the Minister of Health and Consumption.
- The Resolution by which it is agreed to grant the accreditation will be valid for five years, and the training entity must notify the General Directorate of Evaluation and Accreditation of any variation that has occurred in the program of the accredited course.
- The Accreditation Resolution may be revoked, prior to the initiation of the corresponding administrative file when the holder incurs in any of the following causes:
- a) False information in the application to provide training.
- b) Falsehood regarding the people who teach training courses.
- c) Failure to comply with any of the conditions that led to the granting of accreditation.
- Once the course is finished, the training entity will notify the General Directorate of the list of people who have passed it.
Article 8
Accreditation of training courses
The accredited training entities must issue to the students who have passed the courses a certificate according to the models that appear in Annex V of this Decree. This certificate will be valid for a period of three years.
Article 9
Renewal of accreditations
- The certificate accrediting the completion of the training course must be renewed, before the expiration of the three-year period, by completing the corresponding refresher course and passing the tests established in Annex III.
- The renewal thus obtained is valid for a new period of three years from the date of issuance of the certificate certifying said renewal.
Article 10
Homologation of training courses
- The General Directorate of Evaluation and Accreditation may approve the courses taken in the subjects contained in Annex I of this Decree, as well as the training activities carried out within other regulated training plans and specifically:
- a) Training activities carried out by the EBAP before the entry into force of this Decree that comply with the minimum content established in its Annex I.
- b) Training activities carried out in other autonomous communities as long as their content basically coincides with the criteria set out in this Decree, following a favorable report from the Training and Research Service of the General Directorate of Evaluation and Accreditation.
- The approval request must be accompanied by:
- a) Documentation accrediting having passed the course for which approval is requested.
- b) Program of the course, which must basically coincide with the minimum content established in Annex I of this Decree.
- The homologation file will end by Resolution of the person in charge of the General Directorate of Evaluation and Accreditation, granting or denying the homologation.
Article 11
Inspection and control
The General Directorate of Evaluation and Accreditation may at any time carry out audits and inspections of accredited training entities in order to verify that they continue to meet the requirements for which accreditation was granted.
Chapter IV
Records!
Article 12
Information management. Entity registration
The following Registries dependent on the General Directorate of Evaluation and Accreditation are created:
- a) Registration of Semiautomatic External Defibrillators and establishments or institutions that have them installed in the Autonomous Community of the Balearic Islands.
- b) Registration of Training Entities that provide training courses in the use of semiautomatic external defibrillators.
Article 13
Data that will access the Registry
- The data that will access the Registry of Semiautomatic External Defibrillators and establishments and institutions that have them installed in the Autonomous Community of the Balea Islands, are those listed in article 4.2 of this Decree, as well as those referring to the communication of incidents of use of DESA referred to in art. 5.2.
- The data that will access the Register of Training Entities that provide training courses in the use of semiautomatic external defibrillators are the following:
- a) Training entities accredited in accordance with the procedure established in this Decree.
- b) Accredited courses within the training programs regulated in Chapter II of this Decree.
- c) List of people who have passed the courses.
Article 14
Protection of personal data
- The Ministry of Health and Consumption, as the person responsible for the automated processing of personal data contained in the Registries created by this Decree, will adopt the necessary technical, management and organizational measures to guarantee the confidentiality, security and integrity of the data. , in accordance with the provisions of Organic Law 15/1999, of December 13, Protection of Personal Data.
- Access to the Records is subject to the provisions of Organic Law 15/1999 and to the provisions of article 37 of Law 30/1992, of November 26, on the Legal Regime of Public Administrations and Common Administrative Procedure.
Chapter V
Infringements and sanctions
Article 15
Infringements and sanctions
- In accordance with the provisions of articles 32 to 37 of Law 14/1986, of April 25, General Health, and articles 54 and following of Law 5/2003, of April 4, Health of the Islands Balearic Islands, failure to comply with the obligations arising from this Decree is considered a sanitary infraction.
- Notwithstanding the foregoing, in the absence of accredited personnel, in the event of a vital event that may require defibrillation, the use of a semiautomatic external defibrillator by a person who does not have the training regulated in this Decree will be exempt from liability, as long as contact is established immediately with 112/061.
First additional provision
From the entry into force of this Decree, the obligation is established for the emergency services of the Balearic Islands to have DESA teams in their vehicles for immediate intervention.
Second additional provision
The Balearic School of Public Administration (EBAP) may develop training programs regarding the use of DESA, adapted to the minimum content of the program that appears in Annex I of this Decree without requiring the accreditation of the General Directorate of Evaluation and Accreditation as an entity. trainer, in the manner provided in article 7 of this Decree.
Single transitional provision
Individuals or legal entities, public or private, who have a DESA installed upon the entry into force of this Decree, have a maximum period of six months to comply with the provisions of the Decree.
first final provision
The holders of the Ministry of Health and Consumption, and the Ministry of the Interior, are empowered to dictate the necessary development provisions for the application of this Decree, within the scope of their respective powers.
Second final provision
This Decree will enter into force the day after its publication in the Official Gazette of the Balearic Islands.
Palma, December 12, 2008
El Presidente
Francesc Antich i Oliver
The Minister of Health and Consumption
Vicenç Thomas Mulet
The Minister of the Interior
Maria Angeles Lecinena Esteban
Download here the regulations on DEA DESA defibrillators in the Balearic Islands
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