Defibrillator regulations Castilla - La Mancha

Regulations on the use of external defibrillators in Castilla La Mancha

Regulations on the use, installation and training on defibrillators for cardio protected spaces in the Community of Castilla La Mancha.

Castilian Mancha standard on external defibrillators - Regulation of the Autonomous Community of Castilla La Mancha


Decree 4 / 2018, of 22 of January, by which the use of automated external defibrillators is regulated outside the sanitary field. [2018 / 1227]
Decree 27 / 2015, of 14 of May, by which regulates the organization and operation of the service of attention and coordination of emergencies and emergencies 1-1-2 of Castilla-La Mancha, has the purpose of providing users with a quick, easy and free access to public emergency services, through the European single emergency telephone number, and to configure this service as a communications center and coordination of actions in emergency situations. Among all situations of health emergency that involve life risks and require a
immediate response, cardiac arrest stands out. The most frequent causes of this situation in an adult, in the extra hospital environment, are ventricular fibrillation and ventricular tachycardia without a pulse and it is recognized that early electrical defibrillation is the most effective means to recover life, avoiding or minimizing aftermath.

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.

The Royal Decree 365 / 2009, of March 20, which establishes the conditions and minimum requirements for safety and quality in the use of external automatic and semi-automatic defibrillators outside the sanitary field, establishes, as a basic regulation, the conditions and minimum requirements of safety and quality in the use of automatic and semi-automatic external defibrillators outside of 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 experience accumulated in the time since the publication of Decree 9 / 2009, of 10 in February, the available scientific evidence and new recommendations about the importance of rapid intervention in the face of cardiac arrest in survival rates, as well as interest of the Health Administration of the Board of Communities of Castilla-La Mancha to promote and facilitate the use of this technology, it is necessary to approve a new standard for the use of external defibrillators, automatic or semiautomatic, by the first intervening, which
they incorporate 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:

YEAR XXXVII Num. 24 2 of February of 2018 2854

Article 1. Object and scope of application.

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 shall apply to all AEDs, automatic and semiautomatic that are installed in non-sanitary, public and private spaces of Castilla-La Mancha.

Article 2. Definitions.

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

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.
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 AEDs in spaces or places outside the sanitary area, the requirements established in the basic state regulations, in this decree and in subsequent regulations that replace or develop them will apply.
2 The public or private entities that proceed to the installation of an AED in their dependencies must:
a) Have an accessible and adequate space for its installation, signaling the existence of the DEA through an indicative sign placed in a visible place. This location will appear on the maps 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 in relation to the installation of defibrillators.

1 Individuals or legal entities responsible for entities, public or private, wishing to install an AED must submit a responsible statement to the Provincial Directorates of the Ministry responsible for health according to the model enabled for that purpose in the electronic headquarters of the Board of Communities of Castilla-La Mancha (www.jccm.es).
2 The persons required to interact electronically with the Administration, in accordance with the provisions of article 14.2 of the 39 / 2015 Law, of 1 of October, of the Common Administrative Procedure of the Public Administrations, must present the responsible declaration electronically with signature electronic through the electronic headquarters of the Administration of the Board of Communities of Castilla-La Mancha (https://www.jccm.es). The remaining individuals may also present it in the places provided in article 16.4 of the 39 / 2015 Law,
of 1 for October.
3 This responsible statement shall 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.
4 Along with the responsible statement, you must provide the following documentation:
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 responsible for health matters; 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 in the electronic headquarters of the Regional Government of Castilla-La Mancha (www.jccm.es), within the deadline
maximum one month from when these situations occur.
6 Once notified of the installation of the DEA and prior to its use, the General Directorate responsible for ordination, through its Provincial Directorates, will instruct the entity in the registry of non-sanitary entities with Automated External Defibrillators to which it refers. Article 13.

Article 5. Authorized persons for the use of defibrillators outside the health field.

1 An AED may be used outside of the healthcare setting by people who have basic knowledge of cardiopulmonary resuscitation, basic life support and the use of a defibrillator, 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 who include training in basic life support and defibrillation 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 person or specific persons authorized for its use at the moment of the cardiac arrest are not present in the place, any person may use the AED whenever he or she contacts a person with a degree in Medicine and Surgery , Graduated in Medicine or Diplomada 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 accomplishment, on a biennial basis, of the continuing education courses foreseen in Annex III of this decree.
2 The non-completion or non-participation in these continuing education courses, in each corresponding biennial period, will result in the expiration of the authorization automatically and the cancellation of their enrollment in the Training Registry for the use of Automated External Defibrillators.

Article 7. Use of defibrillators.

1 Only the persons authorized to do so may use the DEAs referred to in this decree in the manner provided therein.
2 The use of the AEDs entails, in any case, the obligation to immediately contact the 112 Emergency Service, in order to urgently activate the survival chain.
3 After each use of the defibrillator, it will be the responsibility of the entity that has 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. apparatus provides. This communication will be made to the Emergency Management, Emergencies and Health Transport (hereinafter Guets), according to the model enabled for that 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. La Guets will send a copy of the report to the registry of non-sanitary entities with Automated External Defibrillators, regulated in article 13 of this decree. The entity will be exempt from this communication when the assumption set out in section 2 of article 5 is given, but it must send to the Guets the record of the electrical activity of the DEA 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 112 Emergency Service, initiate the basic resuscitation maneuvers and use an automated external defibrillator while the equipment arrives. of extrahospital emergencies.
2 The minimum contents, the duration of the initial training and continuous training program and the minimum requirements of the teaching staff are described in Annex III of this decree.
3 The teaching team will be composed of people with the degree that is 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:

1º Minimum experience of 18 months in hospital emergencies, assisted transport, resuscitation or critical care.
2º Minimum training of 500 theoretical-practical hours in emergencies and health emergencies, with at least the 25% of face-to-face practices.
3º Possess the specialty of Intensive Medicine, Anesthesiology and Resuscitation or Cardiology.
4 They can organize and deliver these courses, provided they meet the requirements of this decree, public or private entities accredited by the Ministry responsible for health, the units responsible for training and occupational risk prevention centers dependent on the Board of Communities of Castilla-La Mancha, the Guets, Mutual Collaborating with Social Security and other entities or institutions that are part of the CERCP.

Article 9. Accreditation of training entities.

1 The entities interested in imparting the training referred to in this decree should request the corresponding accreditation from the General Directorate responsible for training the competent Ministry.
in the field of health.
2 To be accredited as a training entity, the center or institution must submit the following documentation and information:
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.
b) Along with the information contained in the application form mentioned in this article, the following documentation must be provided:
1º Documentation accrediting the identity of the owner of the requesting entity, provided that it does not authorize the Ministry responsible for health matters to proceed with the verification and verification of said data.
2º Deed or document of incorporation of the company, in case it is a legal entity.
3º List of the people who make up the teaching team, including information about their identity, degree or accreditation to teach the initial or continuing education courses, in accordance with the provisions of article 8 and Annex III of this decree.
3 The technical services of the ICS will determine if the application and documentation presented meet the requirements indicated in the previous section. In the event that there are faults or omissions in them, the interested party will be required to correct the lack or provide the required documents within a period of ten days.
4 The technical services will study the submitted documentation and issue a report with their proposal of accreditation or denial to the General Directorate responsible for training of the Ministry responsible for health. The titular person of the General Direction, in view of this report, will resolve granting or denying 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, accreditation shall be understood as granted.
5 Once the training entity has been accredited, a copy of the accreditation will be sent to the ICS, which will 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.
6 The accreditation of the 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 term of validity, the interested parties may request its renewal, following the same procedure as for the initial accreditation.
If in this period no renewal application has been submitted, the accreditation will be considered expired.
7 Accredited training entities must inform the General Directorate competent in matters of training of the Ministry responsible for health matters of any modification of the accreditation conditions.
8 The procedure for communicating 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 complied with, the holder of the General Directorate may revoke said accreditation.

Article 10. Organization of the courses.

1 Once the teaching activity is completed, within a period of 15 days, the organizing entity will provide a report to the ICS, using the model enabled for that purpose in the electronic headquarters of the Regional Government of 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 report shall state:
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.
b) The name of the person who coordinated the activity.
c) The place where the theoretical and practical training was given, with expression of the furniture and equipment.
d) The content, duration and organization of the activity.
e) The relationship of the teaching team.
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.
3 The person in charge of the Management Office of the ICS will issue the corresponding individual authorization certificates for the use of DEA to the students who have passed the evaluation, both of the initial training and of the continuing education 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 Semi-Automatic Defibrillators, created by Decree 9 / 2009, of 10 of February, regulating the use of external semiautomatic defibrillators outside the sanitary field, is now called the Training Registry for Use. of Automated External Defibrillators (hereinafter, RFDEA) and integrates all the data from the previous registry.
2 The purpose of the RFDEA is to carry out the necessary follow-up and control of the persons authorized to make use of the DEAs and accredited training entities to provide the training provided in Annex III of this decree. This registry depends on the General Directorate responsible for training the Ministry responsible for health.
3 The Registry is structured in the following two sections:
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.
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.
4 The inscription will be done ex officio by the ICS once the evaluation of the training courses has been completed and, in the case of the training entities, once the entity has been accredited.
5 In order to facilitate administrative transparency and access to training of the first respondents, the General Directorate responsible for the RFDEA will make public the data of the accredited training centers through the website of the Regional Government of Castilla-La Mancha.

Article 13. Registration of non-sanitary entities with Automated External Defibrillators.

1 The Registry of non-sanitary entities with External Semiautomatic Defibrillators, created by Decree 9 / 2009, of 10 of February, is renamed the Registry of non-sanitary entities with Automated External Defibrillators (hereinafter, RDEA) and integrates all data from the previous registry .
2 The purpose of the RDEA is to provide information on the location of the AEDs, both to the 112 Emergency Service and to citizen protection institutions, such as the State Security Forces and Corps or civil protection services.
3 This register is attached to the General Directorate responsible for health management and must register the entities and institutions that have installed an AED and individuals who voluntarily request it; in this record all the data collected in the model of responsible declaration described in article 4 of this decree will be recorded.
4 Registration in the Registry is mandatory for entities that have an AED installed prior to the start of its use. Compliance with this obligation corresponds to the person holding the entity or company that holds the DEA.
5 The Directorate General responsible for health management, responsible for the RDEA, will inform the Emergency Service 1-1-2, the number, characteristics and location of the existing AEDs in non-healthcare spaces. Likewise, it will make this information available to citizens, professionals and institutions through the website of the Regional Government of 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 sanctioned according to the provisions of Section 4ª of Chapter III of Title V of the Law 8 / 2000, of 30 of November, of Sanitary Regulation of Castilla-La Mancha, as well as in the Chapter VI of Title I of the Law 14 / 1986, of 25 of April, General of Health.

First transitory provision. Authorizations and accreditations in force.
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 disposition. Adequacy to the required requirements.
1 Public and private spaces that already have a registered defibrillator must comply with the requirements of this decree within twelve months of its entry into force.
2 The physical or legal persons responsible for the management or exploitation of those spaces or places, that upon the entry into force of this decree already have an installed defibrillator, but not registered, must communicate this facility to the registry of non-sanitary entities with External Defibrillators Automated, in the terms provided in Article 4, within six months from the entry into force of this decree.


Single derogatory provision. Normative 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. Treatments 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 the current regulations.
2 For the purposes of this decree and in all that applies to it, the data of the current registries, created in accordance with articles 10 and 11 of Decree 9 / 2009, of 10 of February, by which the use of defibrillators is regulated external semiautomatics outside the sanitary field, they are also considered part of the RFDEA and the 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
YEAR XXXVII Num. 24 2 of February of 2018

DOWNLOAD REGULATIONS that regulate the use of automated external defibrillators in Castilla La Mancha


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