DECREE 157/2015, of June 18, which approves the Regulation that regulates the use of semi-automatic and automatic external defibrillators by the first responders in the Autonomous Community of the Canary Islands.
Law 11/1994, of July 26, on Sanitary Regulation of the Canary Islands, attributes primary, specialized and emergency healthcare to the Canary Islands Health Service.
Among the situations that require urgent life-threatening health care, in which it is possible to reduce mortality with rapid and efficient treatment, due to its high incidence, it is worth highlighting cardiac arrest, which is generally related to ischemic heart disease. During an acute ischemic cardiac event, fatal arrhythmias can occur, such as ventricular fibrillation or pulseless ventricular tachycardia, for which it is scientifically recognized that the most effective treatment is early electrical defibrillation.
Aware of this reality in the area of the Autonomous Community of the Canary Islands, through Decree 225/2005, of December 13, the Regulation was approved by which the use of external semiautomatic defibrillators was regulated by the first responders in order to promote the safety in early defibrillation.
Subsequently, and within the National Quality Plan of the National Health System, an Ischemic Heart Disease Strategy was approved on June 28, 2006 by the Interterritorial Health Council, which includes the recommendation to establish a legal framework for the implementation and development of a program to promote the use of semiautomatic and automatic external defibrillators (hereinafter unified with the initials "DESA") in public places. Said legal framework is constituted today by Royal Decree 365/2009, of March 20, which establishes the conditions and minimum safety and quality requirements in the use of AEDs outside the health field, issued under the provisions of Article 149.1.16 of the Spanish Constitution.
In accordance with the basic state regulations and considering the accumulated experience with the use of AEDs in the Autonomous Community of the Canary Islands after the entry into force of the aforementioned Decree 225/2005, of December 13, the consensus among professionals and the high degree of With the awareness of society regarding the problem of sudden death, it has been considered necessary to modify certain aspects of its regulation in an attempt to remove unnecessary barriers and facilitate public access to defibrillation as a means to increase survival from cardiac arrest.
In addition, it is necessary that the different public and private entities assume the need to install AEDs in those places where the cost-benefit ratio is optimized in order to increase the survival of people who may suffer cardiac arrest, complying with what has already been provided in Royal Decree 365/2009, of March 20, regarding the promotion of the installation of AEDs and the recommendations of the Liaison Committee on Resuscitation (ILCOR).
ILCOR is an international committee that brings together global institutions with competencies in Cardiac Arrest care, its therapeutic approach, and critical care. It is made up of, among others, the American Heart Association (AHA), the European Resuscitation Council (ERC), the Resuscitation Council of Southern Africa (RCSA), the Australian Resuscitation Council, the Heart and Stroke Foundation of Canada (HSFC) and the Latin American Resuscitation Council. (CLAR). Prepares, with a four-year periodicity, protocols and treatment guidelines based on the consensus on the most relevant international scientific evidence in the field of emergency cardiac resuscitation.
In this sense, article 5 of the aforementioned Royal Decree 365/2009, of March 20, regarding the promotion of AEDs, determines that the Health Administrations of the Autonomous Communities will promote and recommend the installation of AEDs in accordance with the indications or recommendations from international organizations, in those places where a large number of people are concentrated or transit. Likewise, the health authorities of the Autonomous Communities will promote the appropriate coordination mechanisms with devices such as civil protection, firefighters, local police and others that may be necessary, to extend the installation and use of AEDs.
For this reason, and in view of the regulation contained in Royal Decree 365/2009, of March 20, cited, together with the accumulated experience with the use of DESAs in the Autonomous Community of the Canary Islands after the entry into force of the aforementioned Decree 225/2005, of December 13, considers it necessary to modify certain aspects of its regulation in an attempt to eliminate unnecessary barriers and facilitate public access to defibrillation as a means to increase survival from cardiac arrest.
This new legal framework provides that the health authorities of the Autonomous Communities must authorize their installation in accordance with the procedure established by them, considering as minimum requirements the notification and registration of the installation of AEDs, the need to signal them, the establishment of standards for their use that include the provision of devices for the immediate connection and activation of the emergency services available in the Autonomous Community, and the establishment of a system for subsequent notification of the event to the health authorities.
By virtue of this, after hearing the affected sectors, at the proposal of the acting Minister of Health, in accordance with the opinion of the Consultative Council of the Canary Islands and after deliberation by the acting Government at its meeting held on June 18, 2015,
Sole article.- Approval of the Regulations.
The Regulation regulating the use of semi-automatic and automatic external defibrillators (hereinafter AEDs), located outside health centers, by the first responders, in the Autonomous Community of the Canary Islands, is approved under the terms of the annex.
First additional provision
The following records are created in relation to the activity regulated by this Decree:
- Registration of AED Installations located outside health centers, attached to the Directorate of the Canary Islands Health Service.
- Record of Training for the Use of AEDs, attached to the School of Health and Social Services of the Canary Islands (hereinafter ESSSCAN), which will be divided into two sections:
Training entities accredited to teach training courses
This Section will collect at least the identification data of the entity (name and address) and its owner, identification and qualification of the teacher or teachers, date of granting of the accreditation and, where appropriate, date of renewal of the same. .
Persons accredited to use DESA devices
It will contain the personal identification data, dates of issuance of individual training accreditations and their renewal dates.
Second additional provision
The Directorate of the Canary Islands Health Service will be in charge of managing and updating the data files that are necessary for the application of this regulation and that can be created by virtue of an order of the Ministry competent in matters of health.
Likewise, the necessary organizational and management technical measures will be adopted to guarantee the confidentiality, security and integrity of the data, in accordance with the provisions of current regulations on the protection of personal data.
Third additional provision
Qualifications exempt from accrediting training
- Graduates or Graduates in Medicine, Graduates or Graduates in Nursing and Technicians in Sanitary Emergencies may use the DESA without being required to prove the training provided for in this Decree.
Likewise, people from other Autonomous Communities or other member states of the European Union who have the necessary training recognized to perform similar functions in their place of origin are considered accredited for the use of the DESA, after the declaration of equivalence provided for in the Provision first transitory
- By means of an Order of the Ministry with competences in matters of health, other qualifications or professional certifications may be agreed which, due to the teachings included in their curriculum, enable them to use the DESA without specifying the training provided for in this Decree.
Fourth additional provision
In order to enable the quickest location of the DESA closest to the incident site, the geolocation of all devices in correct conditions of use will be promoted, creating a layer or map with their exact geopositioning, accessible to emergency services.
First transitory provision
For the purposes provided in articles 5, 6 and 7 of the Regulation, certifications or accreditations of having completed training courses in other Autonomous Communities or other EU member states in accordance with their specific regulations or regulations will be accepted, provided that the duration and content include the minimums established in the Regulations and that their equivalence can be demonstrated. Said evaluation of the equivalence in training will be carried out by the ESSSCAN.
Second transitory provision
Renewal of courses
In any case, the courses provided for in the above transitory provision must be renewed when their issue date is more than three years prior to the entry into force of this Decree.
Third transitory provision
Validity of accreditations
Accreditations already granted or issued in accordance with the provisions of Decree 225/2005, of December 13, will remain valid for the period set until their renewal, in which the new validity periods approved hereby will apply. Decree.
Unique derogatory provision
Upon the entry into force of this Decree, Decree 225/2005, of December 13, approving the Regulation regulating the use of external semi-automatic defibrillators by the first responders, and how many provisions of the same or lower rank oppose this Territorial Decree.
first final provision
The person in charge of the Ministry competent in matters of health is authorized to dictate as many provisions as are necessary for the development and execution of this Decree. Specifically, the update and modification of the courses provided in Annex 1, and the modification of the remaining annexes will be regulated by departmental Order.
Second final provision
Entry into force
This Decree will enter into force three months after its publication in the Official Gazette of the Canary Islands.
Given in Santa Cruz de Tenerife, on June 18, 2015.
OF THE GOVERNMENT,
Paulino Rivero Baute.
Brigida Mendoza Betancor.
REGULATION WHICH REGULATES THE USE OF DEFIBRILLATORS SE-
MIAUTOMATICS AND EXTERNAL AUTOMATICS BY THE FIRST RESPONDENTS IN THE AUTONOMOUS COMMUNITY OF THE CANARY ISLANDS.
Purpose and Scope
The purpose of this Regulation is to regulate the use, outside of health centers, of semi-automatic and automatic external defibrillators (hereinafter DESA) by the first responders, in the event of cardiac arrest in the Autonomous Community of the Canary Islands.
For the purposes of this Regulation, it is understood by:
Semiautomatic External Defibrillator (abbreviated as “DESA”): the medical device that complies with the applicable regulations, capable of analyzing the heart rhythm, identifying fatal arrhythmias and advising the operator to administer an electric shock, in order to try to restore a rhythm viable heart with high levels of safety.
Automatic external defibrillator: the medical device that complies with the applicable regulations and differs from the previous one in that, after analyzing the heart rhythm and identifying fatal arrhythmias, it is the device itself that makes the decision to administer an electric shock. For the purposes of this Regulation, they will also be included under the generic abbreviation "DESA", the provisions of this Regulation being applicable to them.
First responder: the person who, during the exercise of a professional activity, voluntary occupation, or accidentally, has initial contact with the patient, identifies the emergency situation, alerts the extra-hospital emergency services, and initiates recovery maneuvers. on-scene resuscitation including cardiopulmonary resuscitation and electrical defibrillation.
Capacity: maximum public occupancy allowed by current regulations in establishments intended for the celebration or practice of public shows or recreational activities.
Average daily influx: average number of people who go to a specific space or place daily, 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.
- The AEDs that are installed in accordance with the provisions of this Regulation must meet the requirements established at all times by current legislation on medical devices.
- AEDs must be installed and maintained under the conditions specified by their manufacturer, in such a way that they maintain the safety and benefits provided for throughout their period of use.
Use of semiautomatic and automatic external defibrillators
- The DESA, within the framework of this Decree, will be used by all those who are in possession of the corresponding accreditation included in this Regulation.
- The use of AEDs entails, in any case, the obligation to immediately contact the extra-hospital medical emergency service (Servicio de Urgencias Canario-SUC) through the single emergency telephone number 1-1-2, in order to guarantee continuity of care and medical control over the affected person.
- In those cases in which no person accredited to use the DESA is present, and exceptionally, any person who is present may use it for therapeutic purposes and in order to increase the chances of survival, provided that they have previously been authorized by the extra-hospital medical emergency service (Servicio de Urgencias Canario-SUC) through the single emergency telephone number 1-1-2.
Communication, by means of a responsible declaration, of the installation of
semiautomatic and automatic external defibrillators
- Individuals or legal entities who wish to install a DESA in places of public attendance or in their own residence must notify the Directorate of the Canary Islands Health Service, by means of a responsible declaration (which commits the signatory to the veracity of the data contained in the document) that includes:
* IDENTIFICATION OF THE HOLDER.
* EXACT LOCATION OF THE DESA.
* DESA IDENTIFICATION DATA including brand, model, serial number, manufacturer's Declaration of Conformity and Notified Body Certificate (expressed through their corresponding registration, report and certificate numbers) accrediting compliance with all applicable regulations.
* IDENTIFICATION OF ACCREDITED PERSONNEL FOR ITS USE [NIF and dated reference]
cient of the training accreditation issued or endorsed by the ESSSCAN (or entity with similar functions in other Autonomous Communities)].
* In the case of private homes, regarding the OPTIONAL REPORT, the date of
its issuance and the no of the collegiate that signs it.
* The availability of the device for immediate connection and activation of the Services
emergencies of the Autonomous Community of the Canary Islands as well as the notification system
after the episode occurred to the health authorities.
* Commitment to comply with the requirements demanded for the correct maintenance of the DESA according to the manufacturer's recommendation as well as those required in terms of the accreditations of its users.
- The "Responsible Declaration" model is included as Annex 2, and is available at the Electronic Headquarters of the Government of the Canary Islands.
- Any change in the data contained in the above documentation must be communicated to the Directorate of the Canary Islands Health Service within a month from when it occurs and, especially, the will to suspend the use of a certain AED, as well as the expiration date. of the training accreditations of the personnel responsible for its use within the periods recommended by the manufacturer. The omission of the communication of these circumstances will entail the holder the pertinent responsibilities.
- In the case of holders of more than one DESA, their participants may join all of them jointly or indistinctly.
Installation, use and maintenance of semiautomatic and automatic external defibrillators
The installation and maintenance of DESAs must also comply with the following standards:
- The natural or legal persons responsible for the management or exploitation of the following spaces or places will be obliged to have a DESA in suitable operating conditions and ready for immediate use:
* Land transport stations and interchanges in towns with more than 50.000 inhabitants.
* All airports.
* All commercial ports.
* Hotels with more than 1.000 beds.
* Facilities, centers, public sports complexes in towns with more than 50.000 inhabitants and with an average daily influx of more than 1.000 users, taking into account all their available spaces and those with less occupancy that carry out rehabilitation therapies. Facilities for private use are excluded.
* Establishments dependent on the public administrations of towns with more than 50.000 inhabitants and with an average daily influx of more than 1.000 users, taking into account all their available spaces.
* Municipal theatres, auditoriums and conference rooms with a capacity of more than 1.000 people.
* Large commercial establishments and shopping centers.
- The recommendation is established to have a DESA in the following places:
* Land transport stations and interchanges in towns with more than 20.000 inhabitants.
* Facilities, centers, public or private sports complexes with an average daily influx of more than 500 people.
* Hotels with between 700 and 1.000 beds.
* Ships and passenger planes that operate inter-island lines.
* Non-health emergency services that can be first responders such as firefighters, local police and civil protection in towns with more than 20.000 inhabitants.
* Educational centers with an average daily influx of more than 2.000 people.
- In organizations, institutions, public or private companies and communities of owners, a sign indicating the existence and location of a DESA will be placed in a visible place and facing the public, and sufficient signage will be available to indicate its precise location and direct a potential user to it. To this end, the signaling models specified in Annex 3 of this Regulation must be used.
In the place where the DESA is located, its rules of use must be installed in a visible way.
- After each use of the DESA, the person in charge of the installation must provide the data sheet (Annex 24 model) and the electrical record generated by the DESA in pdf format within the following 4 hours. To do this, you must send them to the Canary Islands Emergency Service (SUC), at the following email address:
- The people, organizations, institutions, public or private companies that install a DESA in their home or center, will be in charge of guaranteeing the maintenance and conservation of the equipment (according to the manufacturer's instructions) and the accompanying signage to guarantee its location and use; as well as to keep in force the accreditation certificates of the registered users and the software of the equipment, updated according to the recommendations in force at the time of its use.
- The responsibility for compliance with the provisions of the preceding sections corresponds to the owner of the entity, company, establishment or service that has a DESA or to the person at whose address it has been installed.
Accreditation for the use of semiautomatic defibrillators and
- The competent Department of Health, through the ESSSCAN, will accredit people who have completed the initial training courses in basic life support and semiautomatic external defibrillation provided for in these Regulations to use the AED. For this, Annex 5 must be completed.
- The accreditation will be valid for three years, and must be renewed before its expiration by passing the continuous training provided in Annex 1 of these Regulations.
- Failure to pass or not participate in this continuing education course, in each corresponding three-year period, will result in the loss of accreditation.
- Only public or private entities accredited by the ESSSCAN may give the training courses, which will have the duration and content provided in Annex 1 of this Regulation.
Entities that provide defibrillation training will have to include in their Statutes their dedication to preferably health training.
Any Center or Institution interested in teaching initial and continuing training courses may request accreditation from the ESSSCAN, accrediting compliance with the following requirements:
- a) Have a minimum supply of educational material in each center, for each group of eight students, which must be made up of at least:
- A teacher.
- Two simulation mannequins that allow the practice of basic life support maneuvers, including opening the airway, artificial ventilation (mouth-to-mouth, mouth-to-nose or mouth-to-mask) and intermittent chest compression (called "external cardiac massage"). ”), as well as the use of the semiautomatic external defibrillator.
- A pediatric simulation manikin.
- Two masks for artificial ventilation.
- A duly approved semiautomatic external defibrillator for training.
- b) Have teachers accredited by the ESSSCAN.
- c) Request to the ESSSCAN two months in advance with respect to its start, the Recognition of Officiality of the courses that it intends to teach in this matter, in accordance with its regulations.
- The ESSSCAN may sign collaboration agreements with entities and scientific societies dedicated to this matter that are members of the Spanish Resuscitation Council, or with their regional representatives in the Canary Islands in order to train teachers.
- The accreditation of the Training Centers will be valid for three years, and must be renewed within said period by complying with the requirements set forth in the previous sections. The lack of renewal within the term will determine the loss of the accreditation for the delivery of the training and recycling courses referred to in this Regulation.
To request the accreditation of centers, Annex 6 must be completed.
Commission for monitoring the use of defibrillators
The monitoring of the use of semi-automatic and automatic external defibrillators by non-medical first responders will be carried out through a specific working group, whose designation and composition will correspond to the Directorate of the Canary Islands Health Service, and must include the following functions:
- a) Monitoring and evaluation of the use of semiautomatic external defibrillators by the first responders, for which they may request information on the records of the actions carried out for their subsequent analysis, communicating any indication or deviation that may lead to suspicion of the existence of irregularities or incorrect operation. of one or more devices, including their disappearance or loss of requirements.
- b) Elaboration of strategic lines and priorities for the use of semiautomatic external defibrillators according to scientific advances on the matter.
- c) Any other functions entrusted to them in relation to the purpose of these Regulations.
Inspection and control
The Ministry responsible for health matters will inspect the AEDs installed to ensure correct communication to the health authority and the maintenance of the conditions that gave rise to their registration, as well as to accredited training entities, in order to verify their adequacy. of the same to the provisions contained in this Decree.
Infringements and sanctions
Failure to comply with the provisions of this Regulation will give rise to the corresponding administrative responsibility in the terms contemplated in Law 14/1986, of April 25, General Health, and Law 11/1994, of July 26, of Ordination Sanitaria de Canarias, giving rise to the initiation of the corresponding disciplinary procedure, which will be processed in accordance with the general principles established in Law 30/1992, of November 26, on the Legal Regime of Public Administrations and Common Administrative Procedure, and others rules applicable to the penalty system.
Download here the regulations on DEA DESA defibrillators in the Canary Islands
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