Decree 54/2016, of September 28, which regulates the installation and use of external defibrillators outside the health field, as well as the training and accreditation of training entities for this use.
Decree 24/2006, of March 15, regulated for the first time in the Autonomous Community of the Principality of Asturias the training and use of semi-automatic external defibrillators by non-medical personnel.
As then, cardiovascular diseases continue to be the most important health problem for the Asturian population and represent the main cause of death in our Autonomous Community. Most preventable deaths are due to coronary disease and occur in the out-of-hospital setting, with ventricular fibrillation being the initial cause of up to 85% of out-of-hospital cardiac arrests.
Unexpected cardiac arrest requires a series of actions, known as the chain of survival, with the aim of recovering life, trying to avoid sequelae. The most frequent causes are fibrillation and ventricular tachycardia, whose most appropriate treatment or health response is early defibrillation by applying an electric shock.
The current Decree 24/2006, of March 15, effectively addressed this problem in the past decade, but it has been overcome, not so much by the subsequent approval of the basic rule on the matter, Royal Decree 365/2009, of March, 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 well as the advancement of currently available technical means as well as the recommendations of different organizations international, regardless of non-negligent use, in extreme situations, by citizens in general.
The extent of the changes that should be introduced in the current regional regulations recommends the approval of a new decree. This norm is structured in nine articles, a transitory provision, an additional provision, a repealing provision and two final provisions, accompanied by six annexes.
Article 1 regulates the purpose of the standard, which excludes the health field.
Article 2 includes various definitions for the purposes of applying the decree, highlighting the one corresponding to the automated external defibrillator itself, to which the rest of the provision refers with the acronym DEA. Although Royal Decree 365/2009, of March 20, revolves around the concept of semiautomatic external defibrillator (DESA), there are no differences between the two provisions from a practical point of view, because the definition they contain for each type of equipment expressly includes the other. This decree chooses to take the AED as a reference, following the recommendations on this issue of the Spanish Cardiopulmonary Resuscitation Council and the European Resuscitation Council.
In accordance with the provisions of article 5 of the aforementioned Royal Decree 365/2009, of March 20, which states that the health administrations of the autonomous communities will promote the installation of this type of equipment in those places where a large number of people, article 3 lists the establishments and facilities required to have a DEA.
Article 4 establishes the obligations related to the installation of the DEA, beginning with the communication of the same to the Ministry competent in matters of health.
Article 5 contemplates various aspects related to the use of defibrillators, such as the persons authorized to do so and the obligation to notify the unit responsible for urgent and emergency care of the use of the equipment and the necessary data to ensure continuity of care. to the affected person. In any case, medical and nursing staff and Health Emergency Technicians, as well as those who have obtained certain professional certificates, are considered authorized to use the equipment.
Outside of this assumption, specific training is necessary for the management of AEDs, which is dealt with in articles 6 and 7, regulating the procedure to authorize training entities, the requirements to participate in the training program and the effects of the accreditation obtained.
With the purpose of guaranteeing an effective application of the decree, articles 8 and 9 contemplate respectively the administrative records and the powers of inspection and control of the Ministry competent in matters of health.
The sole additional provision contemplates other types of training for the use of AEDs other than the one generally provided for in the articles.
The single transitory provision provides that the authorization procedures of training entities initiated under the previous regulations continue to be processed in accordance with the same until their final resolution.
The single repeal provision expressly repeals Decree 24/2006, of March 15.
The first final provision authorizes the person in charge of the Ministry competent in matters of health to dictate the necessary provisions for the development and execution of the decree and to update the annexes, which include, among other issues, the models of documents that facilitate to the interested persons and entities compliance with the administrative procedures provided for in this standard.
In order to facilitate compliance with the obligation to have a DEA to the entities listed in article 3, the second final provision provides that the provisions of the aforementioned article will enter into force twelve months after the publication of the decree, as exception to the general term of twenty days established for the rest of the rule.
The Statute of Autonomy of the Principality of Asturias establishes in its article 11.2, among the powers of the Autonomous Community, the legislative development and the execution in matters of health and hygiene.
By virtue, at the proposal of the Minister of Health and prior agreement of the Governing Council at its meeting on September 28, 2016,
The purpose of this decree is to regulate the conditions for the installation and use of health technology called automated external defibrillators in centers, services, establishments, entities or companies, public or private, outside the health field to attend to eventual cardiorespiratory arrests that may occur in their environment, as well as determining the training program and the accreditation procedure for the personnel that may make use of this technology and the training entities in this area.
For the purposes of the provisions of this decree, it is understood by:
- a) Automated external defibrillator (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) 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. .
- c) Sports facility: complex made up of one or more sports spaces and the auxiliary service spaces essential for its operation.
Establishments and facilities required to have a DEA
Public or private entities or individuals who 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) Individual and collective shopping centers that have a built-up area for exhibition and sale to the public of more than 2.500 square meters.
- b) Transportation facilities: airports and commercial ports; bus or railway stations in towns with more than 50.000 inhabitants, and train or bus stations with an average daily influx of 2.000 people or more.
- c) The establishments, premises and facilities in which public shows and recreational activities take place, with an authorized capacity of more than 750 people.
- d) Sports facilities in which the average daily influx of users is equal to or greater than 500 people.
Obligations related to the installation of the DEA
The subjects mentioned in the previous article, as well as any others who voluntarily decide to install a DEA for their use, must comply with the following obligations:
- a) Notify the Ministry responsible for health matters of said circumstance, indicating the identifying data of the defibrillator: manufacturer, name, model and serial number, the place of installation and the person or persons authorized to use it, as well as any modification that occurs, including deregistration of equipment. This communication will be accompanied by a responsible declaration according to the model included in annex I.
- b) Have the minimum material endowment determined in annex II.
- c) Mark, in a visible place, the location of the DEA and its rules of use.
- d) Provide the personnel in charge of managing the DEA with the training and updating of knowledge necessary for its use, as well as guarantee the availability of said personnel during the hours of operation of the corresponding center or entity.
- e) Be responsible for completing and submitting all data related to the registration provided for in art. 8.a).
- f) Carry out adequate inspection and maintenance of the AED, following the manufacturer's instructions, so that the defibrillator and its accessories are always in perfect condition for use.
- g) Comply with the guidelines and recommendations that are notified to them by the competent Department of Health.
- h) Notify the Health Product Surveillance System of adverse incidents detected in the operation of the DEA, as well as implement the corrective actions determined by the manufacturer or by the health authorities.
Use of defibrillators
- Medical and nursing personnel and Health Emergencies Technicians are authorized to use the DEA, as well as those who have obtained professional certificates in Health Care for multiple victims and catastrophes or in medical transport and those people who prove it through the corresponding tests. evaluation of the necessary knowledge and skills, in accordance with the provisions of this decree, without prejudice to non-negligent use in extreme situations by citizens in general.
- The use of the AED entails the obligation to immediately contact the coordinating center of the unit responsible for care for emergencies and medical emergencies (112) in order to guarantee continuity of care and medical control over the affected person.
- Notwithstanding the foregoing, the use of the AED will imply the obligation on the part of the personnel who use it to comply with the attendance sheet (Annex III) and its referral to the unit responsible for coordinating care for emergencies and health emergencies.
Authorization of training entities
- Training for the use of AEDs will be provided by authorized entities.
- The entity interested in providing the training will present the corresponding request for authorization according to the model established in annex IV, addressed to the Ministry competent in matters of health, together with the documentary justification of the following points:
- a) Certified copy of the document proving the identity of the applicant. In the case of being a legal person, a certified copy of its deed of incorporation, the NIF of the entity and the power of attorney will be provided.
- b) Certified copy of the qualification of the technical director of the training entity and of the training personnel made up of life support instructors, with appropriate qualifications and recognized by the European Resuscitation Council or by the American Heart Association or by the Spanish CPR Council ( CERP), as well as the documentation proving the instructor's relationship with the training entity.
- c) Report containing the place where the training will take place, the program that will be taught, in accordance with the minimum content determined in Annex V, and the list of material resources that will be used for teaching in accordance with Annex SAW.
- d) Deed of ownership or other documentation proving availability of the premises, with a plan of the same. In the event that the training is given at the premises of the person requesting the training, a responsible statement that they are properly equipped to carry out the training activity.
- The competent body to resolve authorization requests from training entities is the head of the Ministry responsible for health matters.
- The maximum term to resolve these requests and make the corresponding notification will be six months. If after said period the resolution has not been notified, it will be understood as granted.
- The authorizations of the training entities will have to be renewed every 3 years.
- Prior instruction of the corresponding procedure, the authorization for training may be revoked both for non-compliance with the requirements on which the granting of the authorization was based and for non-compliance with any other of those required in this decree.
- The courses to be taught will be communicated, with a minimum of 15 days in advance, indicating: date, time, place, number of students and program, as well as a list of the instructors and monitors who will teach them.
- Entities already authorized or authorized by another autonomous community or member state of the European Union may give training courses in Asturias, accompanying the communication provided for in the previous section with a responsible statement stating that they have the material resources required in annex VI. and have been authorized or authorized to provide the training by another autonomous community or member state of the European Union, identifying the authority that granted or recognized it and committing to make the corresponding supporting documentation available to the Administration of the Principality of Asturias when required. required.
- The necessary requirements to participate in the training program provided for in this decree will be to be of legal age and have the title in Compulsory Secondary Education, School Graduate or equivalent.
- The basic training program will be the one included in Annex V, with at least 80% of it being of a practical nature.
- 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.
- Once the training process has been completed and the evaluation tests have been passed, each student will receive a certificate attesting to their training in the use of AEDs.
- This accreditation must expressly contain the period of its validity, which will be three years, and will be renewed according to the training program established in annex V.
- The authorized entity will notify the Ministry responsible for health matters of the list of persons to whom the accreditation certificate has been issued, as well as its periodic renewals, within one month from the issuance of the corresponding certificates.
The Ministry responsible for health matters will keep three records:
- a) Registration of centers, services, establishments, entities or companies with AED installed for use by authorized personnel.
- b) Register of authorized training entities.
- c) Register of people with training to manage the DEA.
Inspection and control
- The Ministry competent in matters of health may inspect the authorized training entities, as well as the facilities of the entities that have defibrillators, in order to verify their adequacy to the provisions contained in this decree.
- The responsibility for non-compliance with the provisions of this decree will be required in accordance with the provisions of Chapter VI, Title I, of Law 14/1986, of April 25, General Health.
Unique additional provision
Other cases of qualification for the management of AEDs
Persons who provide documentary evidence to the Ministry responsible for health matters who have completed and passed courses recognized by the competent authorities of other Autonomous Communities, whose content is at least that included in Annex V, will be authorized to use the DEA, without prejudice to its renewal in accordance with the provisions of article 7.
Likewise, any person who has obtained a diploma or certificate issued by any of the institutions or entities that make up the Spanish Council for Cardiopulmonary Resuscitation (CERCP) will be considered authorized for its use.
Those who have obtained the certification of passing the training unit "Basic life support" (UF0677) of the Modular Catalog of Vocational Training, or who are in possession of the professional qualification of driver for assistance and non-assistance ambulances under the conditions defined by the second transitory provision of Royal Decree 836/2012, of May 25, which establishes the technical characteristics, sanitary equipment and staffing of medical road transport vehicles, and by Decree 47/2013, of June 26, which regulates the process of adaptation to the new training requirements for health transport personnel in the territorial scope of the Principality of Asturias, or the corresponding regulations of other Autonomous Communities.
Single transitional provision
Procedures already started
The authorization procedures of training entities initiated under Decree 24/2006, of March 15, which regulates the training and use of semiautomatic external defibrillators by non-medical personnel, will continue to be processed in accordance with it 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.
Unique derogatory provision
Decree 24/2006, of March 15, which regulates the training and use of semi-automatic external defibrillators by non-medical personnel, is repealed.
Likewise, upon the entry into force of this decree, regulations of equal or lower rank emanating from the bodies of the Autonomous Community that oppose the provisions of the same are repealed.
first final provision
The person in charge of the Ministry competent in matters of health is empowered to issue the necessary provisions for the development and execution of this decree and to update the annexes.
Second final provision
Entry into force
This decree will enter into force twenty days after its publication in the Official Gazette of the Principality of Asturias, with the exception of the provisions of article 3, which will do so twelve months after said publication.
Given in Oviedo, on September XNUMX, two thousand and sixteen.
The President of the Principality of Asturias, Javier Fernández Fernández.
The Minister of Health, Francisco del Busto de Prado.
Download here the regulations on DEA DESA defibrillators in Asturias
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