Order SAN/82/2018, of October 1, which regulates the use of external defibrillators and establishes the obligation of their installation in certain spaces for public use outside the health field.
The main cause of sudden deaths that occur outside the hospital setting is ventricular fibrillation suffered as a consequence of a coronary event.
Achieving a significant improvement in the survival of people who suffer an episode of ventricular fibrillation has been the primary concern of professionals and health authorities, and early care, as close as possible to the moment it occurs, becomes the objective to improve the chances of success of the intervention and in the avoidance of deaths from this cause.
The best treatment for people suffering from cardiac arrest is the early application of a series of actions that medical scientific societies have called the chain of survival. This includes activation of the emergency medical system, performing basic cardiopulmonary resuscitation maneuvers, early defibrillation and specialized medical care.
Automatic and semiautomatic external defibrillators are simple and safe technical equipment, capable of analyzing the heart rhythm and identifying arrhythmias susceptible to defibrillation and then administering, automatically or semiautomatically, the required electric shock, without the need for professional intervention. qualified sanitary.
This has contributed to the scientific community promoting the use of these devices by the first responders outside the health field.
Enabling the use of automatic and semiautomatic defibrillators (DESA) by non-medical personnel in immediate action can save the lives of people in a situation of cardiorespiratory arrest without added risks for patients and first responders.
The Statute of Autonomy for Cantabria establishes in its article 25.3 that it corresponds to the Autonomous Community of Cantabria, within the framework of the basic legislation of the State and in the terms that it establishes, the legislative development and execution in matters of health and hygiene , promotion, prevention and restoration of health.
Order SAN1/2009, of January 7, which regulates the use of semiautomatic external defibrillators by first responders, regulated for the first time in the Autonomous Community of Cantabria the training and use of external defibrillators by first responders.
Subsequently, Royal Decree 365/2009, of March 20, which establishes the minimum safety and quality conditions and requirements for the use of automatic and semi-automatic external defibrillators outside the health field, as basic state regulations, established that the Health administrations of the autonomous communities will promote and recommend the installation of defibrillators following the recommendations of international organizations, in those places where a large number of people are concentrated or transit.
The high degree of awareness currently existing in society regarding the problem of sudden cardiac death allows for the obvious possibility of improving survival expectations thanks to citizen solidarity and community participation in health care in cooperation with professional services, advising to proceed to the approval of a norm that contributes to promote the creation of cardioprotected spaces through the installation of external defibrillators, regulating the installation, maintenance and use, as well as the obligatory nature of their availability in certain spaces of the Community of Cantabria where a high concurrence of people and there is a greater probability of a cardiac arrest occurring.
Within the exercise of the health authority attributed to the Ministry competent in matters of health by article 59. a) of the Law of Cantabria 7/2002, of December 10, of Health Regulation of Cantabria, this Order regulates the conditions of installation and use of external defibrillators in the territory of the Autonomous Community of Cantabria, establishes the places or conditions that require a mandatory installation, the training of personnel who will use them and the registration functions, with the ultimate aim of promoting safety in early defibrillation and immediate care.
In view of the foregoing, in accordance with article 33.f) of the Law of Cantabria 6/2002, of December 10, on the Legal Regime of the Government and the Administration of the Autonomous Community of Cantabria,
Purpose and Scope
The purpose of this Order is to regulate, within the scope of the Autonomous Community of Cantabria, the use of defibrillators outside the health field, to establish the obligatory nature of installation and its conditions in said field, promoting the creation of cardioprotected spaces equipped with defibrillators and personnel formed, and the organization of the administrative records necessary to fulfill the purposes pursued by this Order.
For the purposes of this Order, it is understood by:
- a) Automatic external defibrillator (hereinafter AED): the medical device capable of analyzing the heart rhythm, identifying fatal arrhythmias requiring defibrillation and administering an electric shock in order to restore a viable heart rhythm, with high levels of safety. This definition also includes the so-called semiautomatic external defibrillators (DESA).
- b) First responder: Who, due to their work or personal situation, is more likely to be the first person to contact the patient, identify the emergency situation, alert the extra-hospital emergency services and initiate resuscitation maneuvers at the scene of the event. (for the purposes of this Order, the first responders are not understood to be persons with the qualifications included in article 5 sections a) and b)).
- c) Public establishment: the premises where public shows and recreational activities take place, without prejudice to the fact that said shows and activities can be carried out in portable, removable facilities or on public roads.
- d) Capacity: the maximum authorized number of people that a venue intended for shows or other public events can admit.
- e) Average daily influx: the average number of people who daily go to a certain space or place. It is obtained by dividing the total annual influx of people in that specific space by the number of days that specific space has been available to the public that year.
Establishments and facilities required to have a DEA
Public or private entities or individuals that own or enjoy the right to operate the following establishments and facilities will be required to have a DEA in suitable operating conditions and ready for immediate use:
- a) Transport facilities, airport and commercial port and bus and railway stations in towns with more than 20.000 inhabitants.
- b) Individual and collective shopping centers, defined as the establishment in which retail business activity is carried out and which has a built-up area of more than 500 m2 (adding one more for every 1.000 m2).
- c) Public and private establishments, with an average daily influx of 500 people.
- d) Sports facilities in which the number of daily users is equal to or greater than 350 people.
- e) Educational centers with a capacity of more than 1.500 people.
Requirements and obligations related to the installation and maintenance of the AED
The AEDs referred to in this Order will comply with the requirements set forth in Royal Decree 365/2009, of March 20, which establishes the minimum safety and quality conditions and requirements in the use of automatic and semi-automatic defibrillators. outside the health field, as well as current regulations on medical devices, and must:
- a) Be installed in a suitable, accessible and signposted place in accordance with universal signage and its rules of use, including the 061 health emergency telephone number.
- b) Have automatic connection devices with 061 for the activation of urgent health care services, in order to improve health coordination. Defibrillators already installed will be exempt from this obligation, or when there are technical situations that do not allow the installation of this type of device.
- c) Hold the CE mark that guarantees compliance with the essential requirements that apply to them.
- d) Have the following minimum material endowment:
1st- Two sets of defibrillation patches for adults, it being advisable to include a set of patches for pediatric defibrillation, or an adaptation system for pediatric use.
2nd- Computerized registration system of events.
4th- Gauze to guarantee the correct use of the external defibrillator.
5th- Clothes-cutting scissors.
- Those responsible for the entities that have a DEA must comply with the following obligations:
- a) Communicate through a responsible declaration, in the terms provided in article 69 of Law 39/2015 of October 1, of the Common Administrative Procedure of Public Administrations, the installation, the change of location or ownership, and the withdrawal of an AED, according to the model included in Annex I, to the Primary Care Management of the Cantabrian Health Service, sending all the data collected therein. Subsequently, said information must be sent by the Primary Care Management of the Cantabrian Health Service to the Ministry responsible for health, for the maintenance of an updated record with these data.
- b) Be responsible for the proper review and maintenance of the AED, following the manufacturer's instructions, so that the defibrillator and its accessories are always in perfect condition for use.
- c) Provide the personnel in charge of managing the DEA with the training and updating of knowledge necessary for its use.
- d) Guarantee the availability of trained personnel during the hours of operation of the corresponding center or entity.
Persons authorized for the use of AED outside the health field
Those people who have knowledge of cardiopulmonary resuscitation, basic life support and the use of a defibrillator may use an AED, outside the health field, to provide the necessary care for cardiac arrest until the arrival of health teams. specialized; specific:
- a) Graduates in Medicine and Surgery or Graduates in Medicine, Graduates or Graduates in Nursing, as well as other health professionals of those academic levels that include training in basic life support and defibrillator management within their training curriculum.
- b) Graduates of Technical Degree in Health Emergencies.
- c) Those persons who have passed the initial training and continuing education programs whose contents and duration are set out in Annex VI of this Order.
- d) Persons who accredit documentary evidence of having taken training courses for the use of DEA recognized by the Spanish Council of Cardiopulmonary Resuscitation (hereinafter CERCP) or by any of the entities that comprise it, as well as recognized by the competent authorities of other Communities Autonomous and other Member States of the European Union in the last 3 years, provided that its content and duration includes the minimums established in this Order and prior recognition before the Ministry responsible for health and registration in the Register of training for the use of DEA regulated in article 11 of the present Order, in its corresponding section.
- e) Anyone can use the AED, after communicating with the 061 health emergencies service, if the person or specific persons authorized for its use are not present in the place.
Coordination and continuity of care
- The Primary Care Management of the Cantabrian Health Service, as the body for the direction and management of resources and centers for the care of urgent situations, emergencies and health catastrophes, will have the following functions:
- a) Coordination of all healthcare activities related to the use of AEDs in the Autonomous Community of Cantabria, ensuring the operation of the chain of survival.
- b) Monitoring and control of the use of AEDs in the Autonomous Community of Cantabria.
- The use of the DEA by first responders must always be immediately preceded or accompanied by communication to the Emergency Coordination Center (CCU) of the 061 Emergency Service (Telephone 061), in order to urgently activate the entire chain of survival, to guarantee the continuity of care and the medical follow-up of the affected person.
- The person in charge of the entity in which the DEA has been used must send to the Primary Care Management of the Cantabrian Health Service within 48 hours (except in cases of force majeure) of the use of the DEA:
- a) The care sheet provided to the patient who has presented cardiorespiratory arrest, according to the Utstein model provided in Annex III.
- b) The computerized record of the event stored in the defibrillator's memory system.
Characteristics of the formation.
- The necessary requirements to participate in the training programs provided for in this Order will be to be of legal age, and to have, at least, a compulsory secondary education title, a school graduate or equivalent.
- The training programs described in Annex VI of this Order are aimed at enabling the acquisition of the necessary knowledge and skills, to make proper use of AEDs in situations of cardiorespiratory arrest that occur in the field of action of the first responders. .
- The first responders will receive the initial training program lasting a minimum of six hours. In subsequent recycling, they must complete the continuous training program, lasting at least three hours, to continue fulfilling the necessary requirements for the use of the DEA. All this must be done before three calendar years have elapsed since the previous certification or renewal. Otherwise said person will lose the accreditation.
- The number of students will be a maximum of 24 per instructor in the theoretical part, and 8 students per instructor in the practical part.
- The training of first responders for the use of the external defibrillators referred to in this Order may be given by training units of the health centers of the Cantabrian Health Service, by the Primary Care Management of the Cantabrian Health Service, by Occupational risk prevention centers dependent on any public Administration, by mutual insurance companies for accidents at work and occupational diseases, by entities or institutions that are part of the CERCP or by natural or legal persons that are recognized as instructors by any of the institutions or entities that form said council, having to meet the following requirements:
- a) Provide a training program whose minimum content is determined in Annex VI of this Order.
- b) Have a minimum teaching team of one teacher for each group of eight students.
- c) There must be a person responsible for the direction, coordination and development of the training activity, with one of the qualifications included in article 5 sections a) and b).
- d) The teaching team may be made up of:
1st - Health professionals with the life support instructor course with a valid certificate issued by the CERCP or by any of the entities that comprise it.
2nd - Health professionals from emergency services and health emergencies.
3rd - Health professionals from the occupational risk prevention services of the Government of Cantabria agencies that exercise competencies in matters of safety and health at work.
- e) Have appropriate teaching material for the courses to be taught, both bibliographic and audiovisual material, as well as equipment for practices (mannequins, defibrillators, medical supplies), as set out in Annex VI.
- f) Guarantee the availability of adequate facilities to provide training, through a responsible statement.
- All personnel referred to in the preceding paragraph, in the case of personnel at the service of public administrations, must comply with the provisions of the legislation on incompatibilities at the service of public administrations.
- Entities interested in providing the training will submit the corresponding application for authorization, according to the model established in Annex IV, addressed to the General Directorate responsible for health management together with the corresponding supporting documentation required.
- Requests for authorization from training entities will be resolved by the head of the General Directorate responsible for health management. Faced with the resolution granting or denying the authorization, an appeal may be filed before the head of the Ministry competent in matters of health.
- The validity of the authorization of training entities will be three years. Interested parties may request the renewal according to the model in Annex V, addressed to the General Directorate responsible for health management.
- Once compliance with the requirements has been verified, authorization and registration in the registry provided for in article 11 of this Order will proceed. The additions and withdrawals of teaching staff and any other modification that affects the requirements of the courses, as well as the cessation of the activity, must be the subject of a responsible declaration within 15 days of their occurrence.
- Likewise, the training center must register and keep the documentation of each of the programs carried out (teaching materials and minutes with the list of students in the corresponding program) for a minimum period of five years.
The authorized training entities will send to the General Directorate responsible for health management, for each organized training activity:
- a) Communication by email, with a minimum of 7 days in advance, of the courses to be taught, indicating: date, time, place, number of students and program, as well as the list of instructors who will teach them , attaching the corresponding update of your life support instructor training and the responsible statement that the classroom has been reviewed and meets the appropriate requirements for teaching.
- b) The communication, within a period of 30 days after the completion of the training, of the minutes or report of the course with the following information: date, time, place, number of students who have passed the course, as well as a list of the instructors who They have given the training and the list of people who have been issued the corresponding accreditation certificate that authorizes them to use external defibrillators, as well as the periodic renewals of said certifications, with the following information: name, surname, ID with letter, and date of validity of the accreditation, within a month from the issuance of the corresponding certificates.
Accreditation of training
- It will be the authorized training centers that must issue an individual certification accrediting the completion and passing of the training course.
- In the individual accrediting certification, the following will count as a minimum:
- a) The name of the center or entity that has taught it.
- b) Name of the program completed (initial or continuing education).
- c) Duration in hours.
- d) Place.
- e) Date of completion.
- f) Period of validity of the certificate.
- g) Name of the person signing said certificate.
- Said certification will be recognized by the Ministry responsible for health matters to accredit their training for the use of the DEA in the Autonomous Community of Cantabria.
- The accreditation will be valid for three years from its issuance or renewal. It will be renewed according to the training program established in Annex VI.
The Ministry competent in matters of health, in relation to the activity regulated by this Order, will keep the following administrative records attached to the General Directorate competent in matters of health management:
- a) Registration of persons accredited for the use of AEDs. It will contain, at least, personal identification data (full name and ID), date of issuance of the accreditation certificates, as well as renewal dates received with the minutes of each course carried out in Cantabria.
- b) Registration of people, organizations, institutions, companies, or establishments that install an AED at their home or center for use outside the health field, whose availability has been communicated to the Primary Care Management of the Cantabrian Health Service in the model included in Annex I of this Order.
- c) Register of entities authorized in Cantabria to teach the programs described in this Order, with the list of instructors, which will collect the instructor's personal and qualification data with the date of accreditation or update.
Inspection and control
The Ministry competent in matters of health may inspect the training activities, as well as the facilities of the entities that have defibrillators, in order to verify their adequacy to the provisions contained in this Order.
Infringements and sanctions
The penalty regime for non-compliance with the obligations established in this Order is that provided for in Cantabria Law 7/2002, of December 10, on Cantabria Health Regulations and other applicable regulations in this matter.
FIRST ADDITIONAL PROVISION
Treatment of personal data
The treatment of the data referred to in this Order will be adjusted in any case to what is determined by the applicable legislation regarding the protection of personal data.
SECOND ADDITIONAL PROVISION
Collaboration for compliance with this Order
The Government of Cantabria will collaborate with local entities and institutions so that the natural or legal persons responsible for the aforementioned public spaces install the defibrillators and put them into operation and comply with the obligation to train the personnel responsible for said facilities.
FIRST TRANSITIONAL PROVISION
The training entities authorized under Order SAN/1/2009, of January 7, which regulates the training and use of external defibrillators by first responders, will continue to be authorized during the validity period established in its resolution.
Once said period has elapsed, they must proceed in accordance with the provisions of this Order. In the case of authorization procedures for training entities initiated prior to the entry into force of this Order, they will continue to be processed in accordance with Order SAN/1/2009, of January 7, until its final resolution. For these purposes, it will be understood that the procedure has been initiated on the date on which the application has been entered in the registry of the Ministry competent in matters of health.
SECOND TRANSITORY PROVISION
Defibrillators already installed
Natural or legal persons who, on the date of entry into force of this Order, already have external defibrillator devices in their facilities will have a period of six months, counted from the date of entry into force of this Order, to adapt to the provisions contained therein.
SOLE REPEALING PROVISION
Order SAN/1/2009, of January 7, which regulates the use of semi-automatic external defibrillators by first responders, is hereby repealed.
Likewise, upon the entry into force of this Order, regulations of equal or lower rank emanating from the bodies of the Autonomous Community that oppose the provisions of the Order are repealed.
FIRST FINAL PROVISION
The General Directorate responsible for health management is empowered to issue the necessary measures for the development and execution of this Order and to update the annexes.
SECOND FINAL PROVISION
Entry into force
This Order will enter into force the day after its publication in the Official Gazette of Cantabria, with the exception of the provisions of article 3, which will do so twelve months after said publication.
Santander, October 1, 2018.
The Minister of Health,
Maria Luisa Real Gonzalez.
Download here the regulations on DEA DESA defibrillators in Cantabria
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