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Regulations for the use of external defibrillators in Navarra
Regional Decree of Navarre regulating the installation of automatic and semi-automatic external defibrillators and training for their use.
Standard that regulates the use of external automatic and semiautomatic defibrillators outside the health sector in the Autonomous Community of Navarra
The Navarre Regional Government's Decree aims to modify the 176 / 2011 Regional Decree of 31 of August, which regulates the use of automatic and semi-automatic external defibrillators outside the sanitary field, defining obligatory places for their installation, people whose training is considers key to the proper functioning and training, with necessary records for its use.
The General Technical Secretariat of the Department of Health and Service of Sanitary Citizenship, Assurance and Guarantees proposes to the citizens a proposal for the development of a norm that regulates and obliges the installation of cardioprotected spaces in Navarra.
Preamble of Navarra's regulations on external defibrillators
The Regional Law 10 / 1990, of 23 of November, of Health, includes among its informative principles the one of the integral conception of health and includes actions of the Sanitary Administrations oriented to the protection of the health, the prevention of the diseases and the health care
Currently, the main cause of death from sudden death that occurs outside the hospital is ventricular fibrillation suffered as a result of a coronary event. Achieving a significant improvement in the survival of people suffering from an episode of ventricular fibrillation has been a primary concern of professionals and health authorities.
The advantages of the use of automatic and semiautomatic defibrillators (DESA) by non-health personnel have been demonstrated, because immediate action can save lives of people in a situation of cardiorespiratory arrest. At the same time, the absence of risks for both patients and first responders has been proven.
In Navarre, the Regional Decree 105 / 2002, of 20 of May, which regulated the use of external semi-automatic defibrillators by non-medical personnel, was an initiative aimed at encouraging community participation in urgent healthcare in cooperation with health services. professionals from the Autonomous Community; This initiative was in tune with similar ones that were adopted in other Autonomous Communities at the same time.
More recently, the Ischemic Cardiopathy Strategy, approved by the Interterritorial Council of the National Health System, considered early defibrillation as a fundamental assistance element and gave rise, three years later, to the publication of Royal Decree 365 / 2009, of 20 de March, which establishes the conditions and minimum requirements for safety and quality in the use of automatic and semi-automatic external defibrillators outside the health field. This Royal Decree constitutes a basic rule, whose provisions have been observed in the drafting of this Regional Decree, which is issued by virtue of the powers of legislative development held by the Autonomous Community in matters of internal health and healthcare.
The experience accumulated since the publication of the aforementioned Regional Decree has highlighted the need to modify various aspects of that regulation. Along with some changes aimed at simplifying and clarifying requirements and administrative procedures, this Decree introduces major changes that should help to facilitate and extend training to a greater number of people, training them to use automatic and semi-automatic defibrillators.
Unlike the norm up to now in force, it includes the Graduates or Graduates in Nursing and the Technicians in Health Emergencies among the personnel to whom no additional training is required to be able to use the DESA. The reason is that the training regulated in this Regional Decree is already included in the teaching programs of these degrees.
The possibilities of forming part of the training teams are extended, including those professionals, Graduates or Graduates in Medicine and Graduates or Graduates in Nursing, who have the training course in Support or Advanced Life Support of entities accredited by the European Resucitation Council or by the American Heart Association.
The minimum time to teach the initial training course is reduced from twelve and a half to eight hours since, in addition to being sufficient to acquire the skills and knowledge required, it approaches the usual duration of a working day, which facilitates said training in the world of the company.
It is also established that continuous training is carried out every two years, after verifying that the frequency of one year required by the previous regulations was excessive and difficult to comply with.
Finally, collecting what was already a usual practice, it is mandatory to include the content of the initial training course established in this Regional Decree in the teaching program of transport auxiliaries in ambulance, regulated in the Regional Office of 7 of February of 1995, of the Minister of Health, as long as this training system continues. Likewise, said content is incorporated into the training course for lifeguarding in swimming pools foreseen in the Regional Decree 123 / 2003, of 19 of May, by which the technical-sanitary conditions of pools for collective use are established.
The Autonomous Community of Navarre is responsible for the exercise of regulatory powers in matters of internal health and healthcare, in accordance with the provisions of article 32 of the Regional Law 10 / 1990, of 23 of November, on Health.
Consequently, at the proposal of the Minister of Health, in agreement with the Council of Navarre and in accordance with the decision adopted by the Government of Navarra in a meeting held on August thirty-first of two thousand and eleven, decree:
Article 1. Object.
The purpose of this Provincial Decree is to regulate the use of external automatic and semi-automatic defibrillators outside the health area, as well as the initial and continuing training of authorized personnel for use in the Autonomous Community of Navarra.
Article 2. Definition of external semiautomatic defibrillator.
An external semi-automatic defibrillator (DESA) is the medical device capable of analyzing the heart rhythm, identifying deadly arrhythmias and administering an electric shock that restores a viable heart rhythm, with high levels of safety. In this definition, external automatic defibrillators must be understood.
Article 3. Installation, maintenance and use of defibrillators.
1 The persons or entities that install a DESA must notify the Department of Health by submitting a declaration responsible that they meet the requirements of this article. In this declaration, together with the identification data of the natural or legal person who makes the notification, the place where the device will be installed, its technical characteristics and the authorized persons who will be able to use it will be specified.
2 The persons or entities that install the DESA will be responsible for its conservation and maintenance in accordance with the instructions of its manufacturer.
3 The DESA will be located in a visible and accessible place and will be duly signposted. In the same location, the rules of use will be displayed in a visible way.
4 The connection system with the 112 Coordination Center must be foreseen and indicated, for its immediate use whenever the DESA is used, in order to urgently activate the survival chain.
5 After each use, the persons or entities that have installed a DESA will send to the Department of Health the documentary record that provides the equipment, accompanied by a report that includes the day, time, circumstances of the action and identification of the person who used the DESA and from which it was attended.
Article 4. Authorized personnel for the use of the DESA.
1 They will be authorized for the use of external semiautomatic defibrillators:
a) The persons who accredit having carried out the initial training course whose content is included in Annex 1, given by centers authorized by the Department of Health.
b) Persons who prove that they have taken training courses recognized by the competent authorities of other Autonomous Communities or of other Member States of the European Union and that, after the appropriate verifications, are included by the Department of Health in the registry established in the Article 7.1.
2 In order to maintain the validity of the accreditation obtained, authorized persons must complete the continuing education course every two years, the content of which is included in Annex 2.
Article 5. Authorization of entities to provide training courses.
1 The training courses whose content is included in the Annexes 1 and 2 will be taught by people or public or private entities, authorized by the Department of Health.
2 To obtain the authorization to teach the indicated courses, the persons or entities must request it from the Department of Health, attaching the following documentation:
a) Accreditation of the personality of the applicant and, where appropriate, of the representation he holds.
b) If it is a legal person, bylaws of the entity.
c) Description of the facilities available to carry out the courses.
d) Available teaching material, including sanitary materials, mannequins and defibrillators.
e) Teaching program of the courses that will contain, as a minimum, the one that appears in the annexes of this Regional Decree.
f) Teaching team made up of Graduates or Graduates in Medicine and / or Graduates or Graduates in Nursing, who have completed the Support or Advanced Life Support course, given by entities recognized by the European Resucitation Council or by the American Heart Association.
g) Designation, among the teaching staff, of a responsible coordinator who will organize and supervise the development of the courses, who must possess the Instructor Certificate in Support or Advanced Life Support, issued by entities recognized by the European Resucitation Council or by the American Heart Association.
It will not be necessary to provide the documentation previously recorded in the Health Department, unless there have been modifications in the required documents.
3 Once the documentation presented has been examined, the Department of Health will grant or deny the requested authorization.
4 The period of validity of the authorizations will be two years.
Article 6. Certificates of personal accreditation.
1 After the completion of each initial or continuing training course, the coordinator will send to the Health Department a record that contains a list of the teaching staff that has taught it, and of the students who have completed it and who have passed the tests. corresponding evaluation, proposing the issuance of the corresponding certificates of accreditation.
2 Persons who accredit having conducted training courses recognized by the competent authorities of other Autonomous Communities or other member states of the European Union and whose content is similar to that established in this Regional Decree, may request a certificate accrediting the use of defibrillators semiautomatic in Navarra.
3 The Department of Health will issue the personal accreditation certificates that authorize the use of external semiautomatic defibrillators, which will indicate their period of validity. Likewise, it will register in the Registry established in section 1 of article 7 the people who have valid accreditation for the use of the DESA in Navarra.
Article 7. Administrative records.
The following records will be kept attached to the Department of Health:
1 Registration of people who have valid accreditation for the use of DESA in Navarra.
2 Registration of persons or entities that have authorization to provide training courses for the use of DESA in Navarra.
3 Registration of natural or legal persons that have communicated the installation of a DESA for use outside the sanitary field in Navarra.
4 Registration of data on the use of the DESA communicated to the Department of Health.
Article 8. Data Protection.
The treatment of the data referred to in this Regional Decree will be adjusted to what is determined by the applicable legislation on the protection of personal data.
First Additional Provision. Qualifications exempt from accrediting training.
The Graduates or Graduates in Medicine, the Graduates or Graduates in Nursing and the Technicians in Health Emergencies will be able to use the DESA without it being required to accredit the training foreseen in this Regional Decree.
By means of a Regional Order of the Health Counselor, other professional qualifications or certifications may be agreed upon which, based on the teachings included in its curriculum, enable the use of the DESA without specifying the training provided for in this Regional Decree.
Second Additional Provision. Gender equality.
In the cases in which this Foral Decree uses masculine grammatical gender nouns to refer to technicians, health professionals or positions of responsibility, it must be understood that it is done by mere economy of expression, whether men or women occupy it, with equality in terms of legal effects.
Third Additional Provision. First aid courses in swimming pools and auxiliary ambulance transport personnel.
The contents of the initial training course established in this Regional Decree must be included in the program of the first-aid training course in swimming pools foreseen in the Regional Decree 123 / 2003, of 19 of May, which establishes the technical-sanitary conditions of the pools for collective use.
Similarly, these contents should also be included in the course of training of ambulance transport assistant established in the 7 Foral Order of February of 1995, of the Health Counselor, which regulates the procedure of accreditation of centers to impart training courses for auxiliary ambulance transport personnel, as well as the teaching program of said courses.
In both cases, the persons who have completed said courses will obtain the personal accreditation certificate mentioned in article 6, and they will be registered in the Registry provided in article 7.1. In order to maintain the validity of the accreditation obtained, they must complete the continuing education courses whose content is included in Annex 2.
Sole Transitory Provision. Accreditation of the training for the use of semiautomatic defibrillators.
Rescuers who have completed their training courses prior to the inclusion of the contents of the initial training course established in this Foral Decree in the program of the first-aid training course in swimming pools, must prove that they have passed the training course for the use of semiautomatic defibrillators taught in authorized centers, within a maximum period of three years from the entry into force of this Regional Decree.
In accordance with the provisions of the Second Transitory Provision of the Regional Decree 8 / 2011, of 7 of February, which regulates the sanitary transport by road of Navarra, ambulance transport assistants must prove having carried out the training course for the use of semiautomatic defibrillators taught in authorized centers, at the latest as of the 2 date of June of 2014.
Single Derogatory Provision. Normative repeal.
The Regional Decree 105 / 2002, of 20 of May, which regulates the use of external semiautomatic defibrillators by non-medical personnel, and any provisions of equal or lower rank that are contrary to this Regional Decree are hereby repealed.
First Final Provision. Regulatory authorization.
The Health Counselor is authorized to dictate as many provisions as he deems appropriate for the execution and development of this Regional Decree.
Second Final Provision . Entry into force
The present Regional Decree will come into force two months after its publication in the Official Gazette of Navarre.
Initial training course
Minimum duration: 8 hours.
Maximum number of students per teacher: 8.
Approximate distribution of times: 25% for the theoretical part and 75% for the practical part and evaluation.
1 Theoretical part.
- Acting before an unconscious person.
- Cardiorespiratory arrest.
- Basic cardiopulmonary resuscitation.
- Semi-automatic external defibrillator. Operation and maintenance.
- Legislation. Data Collect.
2 Practical part.
- Basic cardiopulmonary resuscitation practices.
- Semi-automatic external defibrillation practices.
- Simulation of cardiorespiratory arrest and corresponding action.
Continuing education course
Minimum duration: 4 hours.
Maximum number of students per teacher: 8.
- Basic cardiopulmonary resuscitation practices.
- Semi-automatic external defibrillation practices.