Defibrillator regulations Castilla La Mancha

Decree 4/2018, of January 22, which regulates the use of automated external defibrillators outside the health field.

Decree 27/2015, of May 14, which regulates the organization and operation of the emergency care and coordination service 1-1-2 in Castilla-La Mancha, is intended to provide users with a quick, easy and free access to public emergency services, through the single European emergency telephone number, and to configure this service as a center for communications and coordination of actions in extraordinary emergency situations.

Among all the health emergency situations that involve vital risks and require an immediate response, cardiac arrest stands out. The most frequent causes of this situation in an adult, in the out-of-hospital environment, are ventricular fibrillation and pulseless ventricular tachycardia, and it is recognized that early electrical defibrillation is the most effective means to recover life, avoiding or minimizing the sequelae. .

The commercialization of automatic and semi-automatic external defibrillators, simple and safe technical equipment capable of analyzing the heart rhythm and identifying the arrhythmias susceptible to defibrillation and which then automatically or semi-automatically administer the required electrical discharge, without the need for intervention by a professional qualified health service, has contributed to the scientific community promoting the use of these devices by the first intervenors outside the sanitary field.

Decree 9 / 2009, of 10 of February, which regulates the use of external semiautomatic defibrillators outside the sanitary field, establishes in Castilla-La Mancha the requirements for the installation and use of external defibrillators outside of the health field, as well as for the accreditation of training entities to train non-health personnel to use them. He also created the necessary records for the management of this activity.

Royal Decree 365/2009, of March 20, which establishes the minimum conditions and requirements for safety and quality in the use of automatic and semi-automatic external defibrillators outside the health field, establishes

ce, as basic regulations, the conditions and minimum safety and quality requirements in the use of external automatic and semiautomatic defibrillators outside the health field and for their use and maintenance, as well as the essential contents of the training of those who are authorized to use them.

The accumulated experience in the time elapsed since the publication of Decree 9/2009, of February 10, the available scientific evidence and new recommendations about the importance of rapid intervention in the event of cardiac arrest in terms of survival rates, as well as the interest of the Health Administration of the Junta de Comunidades de Castilla-La Mancha in promoting and facilitating the use of this technology, makes it necessary to approve a new standard for the use of external, automatic or semi-automatic defibrillators, by the first responders, which are incorporated with this action to the chain of survival.

The purpose of this regulation is to update the requirements for the installation and use of automated defibrillators outside the health sector, as well as for the training of first responders and the accreditation of training entities for their training. Likewise, the procedures are adapted to current regulations on electronic administration and simplification.

This regulatory initiative is primarily related to the exercise of the powers defined in Article 32.3 of the Statute of Autonomy of Castilla-La Mancha, which attributes to the Community Board powers of legislative development and implementation of the basic legislation of the State in matters of health and hygiene, promotion, prevention and restoration of health.

By virtue of the foregoing, prior hearing of the Health Council of Castilla-La Mancha, in agreement with the Consultative Council of Castilla-La Mancha, at the proposal of the Minister of Health and prior deliberation of the Governing Council at its meeting of the 22 day of January of 2018,

 

I HAVE

 

Article 1

Purpose and Scope

 

1. The purpose of this decree is to regulate:

• a) The installation and use of automated external defibrillators (hereafter DEAs) outside of the health field.
• b) The initial and continuing training of personnel whose qualifications do not enable them to use AEDs.
• c) The accreditation of the training entities to train the personnel mentioned in the previous section of this article.
• d) The organization of the administrative records necessary to fulfill the purposes pursued by this decree.

2. The provisions of this provision will apply to all AEDs, automatic and semi-automatic that are installed in non-sanitary, public and private spaces in Castilla-La Mancha.

 

Article 2

Definitions

 

For the purposes of this decree, it shall be understood as:

 

1. a) Automated external defibrillator (AED): sanitary product, approved for use in accordance with current legislation, equipped with a computerized heart rhythm analysis system capable of identifying deadly defibrillation arrhythmias and administering an electric shock to restore the viable heart rate, with high levels of security. When this download is administered with the participation of the first intervener, who presses the connection button, the defibrillator is called semiautomatic (DESA). Unlike this one, in automatic defibrillators it is the device itself that administers the discharge after detecting the arrhythmia. For the purposes of this decree, the two types are included under the generic abbreviation of DEA.
2. b) First intervener: person who has initial contact with the patient outside the health area, identifies the situation of cardiac arrest, alerts the Emergency and Emergency Coordination Service and Coordination 1-1-2 of Castilla-La Mancha (hereinafter, Emergency Service 1-1-2), initiates the basic resuscitation maneuvers and uses an AED while emergency out-of-hospital emergency teams arrive.

 

Article 3.

Requirements for the installation and use of automated external defibrillators.

 

1. For the installation and use of DEAs in spaces or places outside the health field, the requirements established in the basic state regulations, in this decree and in subsequent regulations that replace or develop them will apply.
2. Public or private entities that proceed to install a DEA in their premises must:

• a) Have an accessible and adequate space for its installation, signaling the existence of the DEA by means of an indicative sign placed in a visible place. Said location will appear on the plans and informative maps of the place. The universal signaling recommended by the Spanish Cardiopulmonary Resuscitation Council (hereinafter CERCP) will be used, according to the model that appears as Annex I of this decree.
• b) Have the minimum material endowment with the DEA that is included in Annex II of this decree.
• c) Have authorized personnel for the use of AEDs during the time that the place where it is installed is open to the public and provide its personnel with initial and ongoing training for said use, in accordance with the provisions of this decree.
• d) Have a telephony service, integrated or not in the AED, for immediate communication with the Emergency Service 1-1-2. If it is not integrated, it must have a hands-free system with external loudspeaker that will travel with the DEA itself.
• e) Guarantee the conservation and maintenance of the AEDs according to the instructions of the manufacturer of the equipment, so that the defibrillator and its accessories are in perfect use.

Maintenance reports will be available to health inspectors of the Ministry responsible for health.

 

Article 4

Communications regarding the installation of defibrillators

 

1. The natural or legal persons responsible for entities, public or private, who wish to install a DEA must submit a responsible declaration to the Provincial Directorates of the Ministry competent in matters of health according to the model enabled for this purpose in the electronic headquarters of the Community Board. from Castile-La Mancha (www.jccm.es).
2. The persons obliged to interact electronically with the Administration, in accordance with the provisions of article 14.2 of Law 39/2015, of October 1, on the Common Administrative Procedure of Public Administrations, must present the responsible declaration electronically with signature electronically through the electronic headquarters of the Administration of the Junta de Comunidades de Castilla-La Mancha (https://www.jccm.es). The remaining natural persons may also present it in the places provided for in article 16.4 of Law 39/2015, of October 1.
3. This responsible statement must specify:

• a) The name and address of the place where the defibrillator is to be installed, as well as the description of the specific physical space where it will be located.
• b) The brand, model, serial number of the defibrillator and name of the manufacturer or distributor.
• c) The reference to the available devices for immediate communication with the Emergency Service 1-1-2, associated or not with the DEA.
• d) That it complies with the applicable regulations, state and regional, for the installation and use of the AEDs and the requirements for said installation and use, included in article 3 of this decree.
• Along with the responsible declaration, the following documentation must be provided:
• a) Documentation accrediting the identity of the owner of the entity that communicates the installation of an AED, provided that it does not authorize the Ministry responsible for health matters to proceed with the verification and verification of said data.
• b) Deed or document of incorporation of the company, in the case of legal persons.
• c) List of persons authorized to use the AED, including information on their identity, qualification or accreditation for use, and the dates on which these persons performed the initial and continuing training, in accordance with the provisions of article 5 of this decree.

5. It will be the responsibility of the owners of the entities, whether public or private, to send the documentation and information referred to in this article to the Provincial Directorate of the Ministry competent in matters of health; as well as the communication of any modification of the data communicated or the will to suspend or cease the use of the DEA in question. These communications must be made through the model enabled for this purpose at the electronic headquarters of the Junta de Comunidades de Castilla-La Mancha (www.jccm.es), within a maximum period of one month from when these situations occur.
6. Once the installation of the AED has been notified and prior to its use, the General Directorate responsible for management, through its Provincial Directorates, will automatically register the entity in the Register of non-health entities with Automated External Defibrillators to which it refers. article 13.

 

Article 5

Persons authorized to use defibrillators outside of the healthcare environment

 

1. Those people who have basic 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 specialized health teams. ; 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) Technicians in Health Emergencies or any person who is in possession of an official academic certificate that certifies that they have passed the vocational training unit called "Basic Life Support" (UF0677) or that they have passed a professional module that includes said unity; or a person who holds a certificate of professionalism, training program or specialization course, in which the aforementioned unit is included.
• c) Those persons who have passed the initial training and continuing education courses whose content and duration are set out in Annex III of this decree.
• d) Persons who prove documentary evidence of having taken training courses for the use of DEAs recognized by the competent authorities of other Autonomous Communities and other Member States of the European Union in the last 2 years, provided that their content and duration includes the minimum established in this decree and prior recognition before the Ministry responsible for health and registration in the Training Registry for the use of Automated External Defibrillators, regulated in Article 12 of this decree, in its corresponding section. For the purposes of possible validations to make use of the AEDs in the terms provided by this rule, the person holding the General Directorate responsible for training the Ministry responsible for health, at the proposal of the Institute of Health Sciences (hereinafter ICS), will determine the equivalences between the initial and continuing education programs established in this decree and the contents of the curricula that may be presented by the interested parties.

2. Exceptionally, in the event that the specific person or persons authorized for its use are not present at the time the cardiac arrest occurs, any person may use the AED as long as they contact a person with a degree in Medicine and Surgery. , Graduated in Medicine or Diploma or Graduated in Nursing from the Emergency Service 1-1-2.

 

Article 6

Maintenance of the authorization for the use of defibrillators outside the health field

 

1. The maintenance of the authorization for the use of AEDs of the persons included in points c) and d) of section 1 of the previous article will be conditioned to the completion, on a biennial basis, of the continuing education courses provided for in Annex III of this decree.
2. Failure to pass or participate in these continuing education courses, in each corresponding biennial period, will result in the expiration of the authorization automatically and the cancellation of your registration in the Training Registry for the use of Automated External Defibrillators.

 

Article 7

Use of defibrillators

 

1. The DEAs referred to in this decree may only be used by persons authorized to do so in the manner provided therein.
2. The use of AEDs entails, in any case, the obligation to immediately contact the 1-1-2 Emergency Service, in order to urgently activate the chain of survival.
3. After each use of the defibrillator, it will be the responsibility of the entity that installed it to send, within a maximum period of 7 days, a report written by the person who used it, as well as the records of the electrical activity of the defibrillator when using it that the defibrillator himself appliance provides. This communication will be made to the Emergency, Emergency and Sanitary Transport Management (hereinafter Guets), according to the model enabled for this purpose in the electronic headquarters of the Junta de Comunidades de Castilla-La Mancha (www.jccm.es). The communication will be presented in accordance with the provisions of article 4.2. The Guets will send a copy of the report to the Registry of non-health entities with Automated External Defibrillators, regulated in article 13 of this decree. The entity will be exempt from this communication when the assumption contained in section 2 of article 5 occurs, but it must send the Guets the record of the electrical activity of the AED used.

 

Article 8

Training of first responders

 

1. The objective of the training programs for first responders is that they obtain the necessary knowledge and skills to identify the situation of cardiac arrest, alert the 1-1-2 Emergency Service, initiate basic resuscitation maneuvers and use an automated external defibrillator. while extrahospital emergency teams arrive.
2. The minimum contents, the duration of the initial training program and continuous training and the minimum requirements of the teaching staff are described in Annex III of this decree.
3. The teaching team will be made up of people with the qualifications that are included in points a) and b) of section 1 of article 5 of this decree.

Within the same, there will be a coordinator who will deal with the general tasks of organization and development of the course, which must have the status of Bachelor of Medicine and Surgery or Graduate in Medicine or Diploma or Graduate in Nursing, and gather at least one of the following conditions:

1- Minimum experience of 18 months in hospital emergencies, assisted transport, resuscitation or critical care.

2- Minimum training of 500 theoretical-practical hours in emergencies and health emergencies, with at least 25% of face-to-face practices.

3- Possess the specialty of Intensive Medicine, Anesthesiology and Resuscitation or Cardiology.

Public or private entities accredited by the competent Department of Health, the competent units in training and occupational risk prevention centers dependent on the Ministry of Health, may organize and teach these courses, provided they meet the requirements of this decree. board of

Communities of Castilla-La Mancha, the Guets, the Mutual Collaborators with the Social Security and other entities or institutions that are part of the CERCP.

 

Article 9

Accreditation of training entities

 

1. Entities interested in providing the training referred to in this decree must request the corresponding accreditation from the General Directorate responsible for training of the Ministry responsible for health.
2. To be accredited as a training entity, the center or institution must present the following documentation and information:

 

4. a) Application for accreditation addressed to the ICS, in the model provided for that purpose in the electronic headquarters of the Regional Government of Castilla-La Mancha (www.jccm.es). The presentation of the application will be made according to the provisions of article 4.2. This request must contain the responsible statement of the owner of the requesting entity that has the bibliographic, audiovisual material and, at least, the pedagogical material provided in Annex III; and compliance with the other requirements and conditions contained in this decree.
5. b) Along with the information contained in the application form mentioned in this article, the following documentation must be provided:

 

1. Documentation accrediting the identity of the owner of the requesting entity, provided that it does not authorize the Ministry competent in matters of health to proceed to the verification and verification of said data.
2. Deed or document of incorporation of the company, in the case of legal entities.
3. List of the people who make up the teaching team, including information on their identity, qualifications or accreditation to teach initial or continuing training courses, in accordance with the provisions of article 8 and Annex III of this decree.
4. The ICS technical services will determine if the application and documentation submitted meet the requirements indicated in the previous section. In the event that faults or omissions are observed in them, the interested party will be required to correct the fault or provide the required documents within a period of ten days.
5. The technical services will study the documentation submitted and will issue a report with their proposal for accreditation or refusal to the General Directorate responsible for training of the Ministry responsible for health. The person in charge of the General Directorate, in view of this report, will decide whether to grant or deny the requested accreditation. The deadline for issuing and notifying the accreditation resolution will be three months. Once said period has elapsed without an express resolution, the accreditation shall be understood to have been granted.
6. Once the training entity is accredited, a copy of the accreditation will be sent to the ICS, which will automatically register the center in the corresponding section of the Training Registry for the use of Automated External Defibrillators, regulated in article 12 of this decree.
7. The accreditation of training centers will be valid for five years from the date of the accreditation resolution. Within the three months prior to the expiration of the validity period, interested parties may request its renewal, following the same procedure as for the initial accreditation. If no application for renewal has been submitted within this period, the accreditation will be considered to have expired.
8. The accredited training entities must notify the General Directorate responsible for training of the Ministry responsible for health of any modification of the accreditation conditions.
9. The procedure for communication of modifications will be the same as for the initial accreditation. If the modifications affect the conditions that made the accreditation possible and it is verified that the requirements that served as the basis for its granting are not met, the person in charge of the General Directorate may revoke said accreditation.

 

Article 10

Organization of the courses

 

1. Once the teaching activity is finished, within a period of 15 days, the organizing entity will provide a report to the ICS, using the model enabled for this purpose in the electronic headquarters of the Junta de Comunidades de Castilla-La Mancha (www.jccm.es) . The presentation of the report will be made in accordance with the provisions of article 4.2.
2. The memory shall state:
3. a) The name of the accredited training institution or, where applicable, the unit responsible for training from among those included in section 4 of article 8.
4. b) The name of the person who coordinated the activity.
5. c) The place where the theoretical and practical training was given, with expression of the furniture and equipment.
6. d) The content, duration and organization of the activity.
7. e) The relationship of the teaching team.
8. f) The list of students who have passed the course evaluation. These will be registered, ex officio, in the corresponding section of the Training Registry for the use of Automated External Defibrillators.
9. The person in charge of the ICS Management Department will issue the corresponding individual authorization accreditations for the use of DEA to the students who have passed the evaluation, both of the initial training and of the continuing training courses.

 

Article 11

Accreditation of entities based in other Autonomous Communities

 

In the case of an entity that has its headquarters in another Autonomous Community, it may also request accreditation, following the procedure established in article 9 of this decree, or, if the entity is already accredited in another Autonomous Community, communicate said accreditation to the General Directorate responsible for the training of the Ministry responsible for health, in the model provided for this purpose in the electronic headquarters of the Regional Government of Castilla-La Mancha (www.jccm.es). The presentation of the communication will be made according to the provisions of article 4.2. Once the teaching activity is finished, they will provide information and documentation about it to the ICS in the terms established by article 10 of this decree.

 

Article 12

Training record for the use of Automated External Defibrillators

 

1. The Training Registry for the Use of External Semiautomatic Defibrillators, created by Decree 9/2009, of February 10, which regulates the use of external semiautomatic defibrillators outside the health field, is renamed the Training Registry for the Use of Automated External Defibrillators (hereinafter, RFDEA) and integrates all the data from the previous registry.
2. The purpose of the RFDEA is to be able to carry out the necessary monitoring and control of the persons authorized to make use of the DEAs and of the accredited training entities to provide the training provided for in Annex III of this decree. This registry depends on the General Directorate responsible for training of the Ministry responsible for health.
3. The Registry is structured in the following two sections:
4. a) Section I. Accredited training entities to provide training courses. This section will collect, as a minimum, the identification data of the entity (name and address) and its owner; identification and certification of the coordinator; date of granting the accreditation and, if applicable, date of renewal thereof.
5. b) Section II. Persons authorized to make use of the AEDs. It will contain, as a minimum, the personal identification data, dates of issuance of individual authorization credentials and renewal dates thereof.
6. Registration will be carried out ex officio by the ICS once the evaluation of the training courses has been passed and, in the case of training entities, once the entity has been accredited.
7. In order to facilitate administrative transparency and access to training for the first responders, the General Directorate responsible for the RFDEA will make public the data of the accredited training centers through the Web page of the Junta de Comunidades de Castilla-La Mancha.

 

Article 13

Registration of non-health entities with Automated External Defibrillators

 

1. The Registry of non-health entities with External Semiautomatic Defibrillators, created by Decree 9/2009, of February 10, is renamed the Registry of non-health entities with Automated External Defibrillators (hereinafter, RDEA) and integrates all the data from the previous registry .
2. The purpose of the RDEA is to provide information on the location of the AEDs, both to the 1-1-2 Emergency Service, and to citizen protection institutions, such as the State Security Corps and Forces or civil protection services.
3. This registry is attached to the General Directorate responsible for health management and entities and institutions that have a DEA installed and individuals who voluntarily request it must register in it; This registry will contain all the data collected in the responsible declaration model described in article 4 of this decree.
4. Registration in the Registry is mandatory for entities that have installed an AED prior to starting to use it. Compliance with this obligation corresponds to the owner of the entity or company that has the DEA.
5. The General Directorate responsible for health management, responsible for the RDEA, will notify the 1-1-2 Emergency Service of the number, characteristics and location of the existing AEDs in non-sanitary spaces. Likewise, it will make this information available to citizens, professionals and institutions through the website of the Junta de Comunidades de Castilla-La Mancha.

 

Article 14

Inspection and control

 

The Ministry responsible for health will carry out the necessary actions to supervise and control compliance with the obligations established in this decree.

 

Article 15

Sanctions regime

 

Violations of the provisions of this decree will be penalized in accordance with the provisions of Section 4a of Chapter III of Title V of Law 8/2000, of November 30, on Sanitary Regulation of Castilla-La Mancha, as well as in the Chapter VI of Title I of Law 14/1986, of April 25, General Health.

 

First transitory provision

Current authorizations and accreditations

 

The authorizations for the installation and use of DEAs and the accreditations of training entities for their use granted under the 9 / 2009 Decree of 10 of February, will remain in force until the date of their renewal.

 

Second transitory provision

Adaptation to the demanded requirements

 

1. Public and private spaces that already have a registered defibrillator must adapt to the requirements set forth in this decree within twelve months from its entry into force.
2. The natural or legal persons responsible for the management or exploitation of those spaces or places, which at the entry into force of this decree already have a defibrillator installed, but not registered, must notify said installation to the Registry of non-health entities with External Defibrillators. Automated, under the terms provided in article 4, within six months from the entry into force of this decree.

Unique derogatory provision

Regulatory repeal

 

Decree 9 / 2009, of 10 of February, which regulates the use of external semiautomatic defibrillators outside the sanitary field, and any provisions of equal or lower rank that are contrary to the provisions of this decree, is repealed.

 

first final provision

Processing of personal data

 

1. Within a month, counted from the day following the publication of this decree in the Official Gazette of Castilla-La Mancha, the Ministry responsible for data protection will modify the corresponding files, in accordance with the provisions of current regulations.
2. For the purposes of this decree and in everything that is applicable to it, the data of the current records, created in accordance with articles 10 and 11 of Decree 9/2009, of February 10, which regulates the use of defibrillators External semiautomatic devices outside the healthcare field are also considered part of the RFDEA and RDEA.

 

Second final provision

Development and execution

 

The person in charge of the Ministry responsible for health matters is authorized to modify the contents of the annexes of this decree, as well as to dictate the provisions that are necessary for the development and execution thereof.

 

Third final provision

Entry into force

 

This Decree will come into force one month after its publication in the Official Gazette of Castilla-La Mancha.

 

Given in Toledo, the 22 of January of 2018

 

El Presidente

EMILIANO GARCÍA-PAGE SÁNCHEZ

 

The Health Counselor

JESÚS FERNÁNDEZ SANZ

 

Download here the regulations on DEA DESA defibrillators in Castilla-La Mancha

 

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