Regulation of defibrillators C.Valenciana

DECREE 159/2017, of October 6, of the Consell, which regulates the installation and use of external automatic and semi-automatic defibrillators outside the health field, in the Valencian Community.

 

PREAMBLE

 

The Spanish Constitution in its article 43 recognizes the right of all citizens to the protection of health and the competence of the public powers to organize and protect public health.

Law 14/1986, of April 25, general health, has as its purpose the general regulation of all actions that allow the right to health protection to be made effective and establishes in its article 6.4 that the actions of public administrations Health care will be aimed at guaranteeing, among other things, health care in all cases of loss of health.

The Statute of Autonomy of the Valencian Community, establishes in its article 54 that the organization, administration and management of all public health institutions within the territory of the Valencian Community is the exclusive competence of the Generalitat.

Law 10/2014, of December 29, of the Generalitat, on health of the Valencian Community, establishes that promotion, information and education for the health of the population are basic activities of the Valencian Health System, among others. ; the prevention and control of risks to the health of the community; prevention and control of diseases and health emergency situations, and in article 36 it states that disease prevention is the set of actions and services aimed at reducing the incidence and prevalence of certain diseases, injuries and disabilities in the population and to mitigate or eliminate, as far as possible, its negative consequences through individual and collective actions.

Cardiovascular diseases are the first cause of death in the western world, highlighting among them sudden cardiac death, as a result of cardiac arrest secondary mainly to ventricular fibrillation. This chaotic heart rhythm represents between 75% and 80% of sudden deaths of cardiac origin and requires immediate attention, since for every minute that adequate treatment is delayed, the person's chance of survival is reduced by 10%. who suffers from it

Clinical and scientific evidence confirms that early defibrillation and quality basic cardiopulmonary resuscitation are the most appropriate response and specific treatment for ventricular fibrillation. The correct action in a situation of cardiorespiratory arrest must be part of a comprehensive action between the different participants in the chain of survival that guarantees continuity of care and that is made up of four links: recognition of the situation of a victim of cardiac arrest, activation immediately from the health emergency services, early initiation of cardiopulmonary resuscitation (CPR) and early defibrillation while specialized health services arrive to continue care and transfer the patient to a health center, if appropriate.

Royal Decree 365/2009, of March 20, establishes the minimum safety and quality conditions and requirements in the use of external automatic and semi-automatic defibrillators outside the health field (hereinafter DESA) and entrusts the health authorities of the Autonomous Communities , the establishment of the opportune control and inspection mechanisms, the notification process for the installation of AEDs, the necessary mechanisms to authorize the personnel for the use of AEDs, the promotion and recommendations for the installation of AEDs in accordance with the recommendations from international organizations and to promote appropriate coordination mechanisms with civil protection devices, firefighters, local police and others that are necessary to extend the installation of AEDs.

In the Valencian Community, the "use of external semiautomatic defibrillators by non-medical personnel" was regulated by Decree 220/2007, of November 2, of the Consell, repealed by Decree 157/2014, of October 3, of the Consell, by which establishes the health authorizations and updates, creates and organizes the health management records of the Department of Health.

This Decree 157/2014, established certain provisions referring to the use of automatic and semiautomatic external defibrillators outside the health field, determining in its article 7 that the use in the Valencian Community of external automatic and semiautomatic defibrillators outside the health field will be carried out in accordance with the provisions of Royal Decree 365/2009, of March 20, which establishes the conditions and minimum safety and quality requirements in the use of automatic and semi-automatic external defibrillators outside the health field, as well as the provisions of Royal Decree 1591/2009, of October 16, which regulates sanitary products. Likewise, this decree specifies that the department with competences in health matters may determine other requirements and conditions for the installation and use of automatic and semi-automatic external defibrillators outside the health field.

In accordance with the basic state regulations, considering that there is accumulated experience in the use of AEDs in the Valencian Community, there being a high degree of social awareness of the problem of sudden death, the consensus among professionals and the interest of the health administration of the Generalitat to promote and facilitate the use of DESA, removing unnecessary barriers and facilitating public access to defibrillation to increase survival from cardiac arrest, it has been considered appropriate to proceed with the approval of a new standard that regulates the field of Community

Valenciana, the installation and use of the DESA. Thus, the general interest of this standard is justified; includes the necessary regulation to meet the needs covered, is issued under Royal Decree 365/2009, of March 20, establishes the conditions and minimum safety and quality requirements in the use of external automatic and semi-automatic defibrillators outside the health field; The procedures set forth in article 7 of Law 19/2013, of December 9, on transparency, access to public information and good governance have been complied with, publishing the procedures in the Official Gazette of the Generalitat Valenciana and on the website website of the Ministry of Universal Health and Public Health; and does not imply unnecessary administrative burdens in its application, the

minimal for its effectiveness. With all this, the adaptation of the decree to the principles of necessity, effectiveness, proportionality, legal certainty, transparency and efficiency included in article 129 of Law 39/2015, of October 1, on the common administrative procedure of public administrations is justified. .

This provision is included in the Regulatory Plan of the Administration of the Generalitat for 2017.

In the process of elaboration of this decree, the mandatory reports have been issued, the pertinent hearing procedures have been carried out and article 43 of Law 5/1983, of December 30, of the Generalitat, of the Consell has been complied with. .

For all these reasons, at the proposal of the Minister of Universal Health and Public Health, in accordance with the Consell Jurídic Consultiu of the Valencian Community and after deliberation by the Consell in its session on October 6, 2017,

 

DECREE

 

Article 1

Purpose and Scope

 

The object of this regular decree, in the territorial scope of the Valencian Community, is the installation and use outside the health field of automatic and semi-automatic external defibrillators (hereinafter DESA), by first responders outside the health profession, in a situation of cardiac arrest, as well as establishing the mandatory nature of its availability in certain spaces for public use.

 

Article 2

Definitions

 

1. For the purposes of this decree, it is understood as:

 

• a) Automatic or semi-automatic external defibrillator (DESA): the medical device intended to analyze the heart rhythm, identify fatal arrhythmias requiring defibrillation and administer an electric shock in order to restore a viable heart rhythm with high levels of safety. This definition also includes the so-called automated external defibrillators.
• b) Intervening person: the person who has initial contact with the patient, identifies the emergency situation, alerts the emergency services through a call to 112, initiates resuscitation maneuvers and makes use of an AED, outside the healthcare setting. .
• c) Personnel authorized for the use of a DESA: the personnel that accredits the overcoming of the initial and continuous training programs for the use of DESA.
• d) Capacity: the maximum authorized number of people that a venue intended for shows or other public events can admit.
• e) Average daily influx: the average number of people who daily go to a certain space or place. It is obtained by dividing the total annual influx of people in that specific space by the number of days that specific space has been available to the public that year.
• f) Establishment: that place in which a commercial, industrial or professional activity is carried out.

 

2. For the purposes of this decree, a public establishment is understood to be the premises where public shows and recreational activities take place, without prejudice to the fact that said shows and activities can be carried out in portable, removable facilities or on public roads; as defined in section c of point 1 of article 1, of Law 14/2010, of December 3 of the Generalitat, on shows, public, recreational activities and public establishments.

 

Article 3

Spaces required to have the DESA

 

The natural persons and legal entities responsible for the management or operation of the following spaces shall be obliged to dispose of the DESA, under suitable conditions of operation and ready for immediate use:

1. Transport facilities: airports and commercial ports, bus or railway stations or stops in towns with more than 50.000 inhabitants, and metro stations with an average daily influx of 2.000 people or more.
2. Sports facilities, centers or complexes in which the number of daily users, taking into account all its available sports spaces, is equal to or greater than 500.
3. Educational centers with a capacity equal to or greater than 1.500 people.
4. Public establishments with a capacity equal to or greater than 1.000 people.

Article 4

AED Installation and Location Requirements

 

1. The AEDs that are installed must comply with the provisions of Royal Decree 1591/2009, of October 16, which regulates medical devices, bearing the CE marking that guarantees their conformity with the essential requirements that apply to them.
2. AEDs will be installed in visible places and must be marked clearly and simply using the universal signage recommended by the International Resuscitation Coordination Committee (ILCOR). Said location must be duly identified in the plans or informative maps of the place, if any. Next to the defibrillator, the emergency telephone number 112 and the instructions for use of the DESA will be displayed clearly and with adequate visibility.

Article 5

Communication of the installation and removal of the AED

 

1. Public or private entities obliged to install a DESA for use by non-health personnel, as well as public or private entities and individuals who, not being obliged to do so, want to do so voluntarily, prior to its installation, must notify the competent department in matters of sanitary order of the department responsible for health, for registration in the Autonomous Registry of External Automatic and Semiautomatic Defibrillators, in accordance with current regulations that develop the registration procedure in this registry.
2. The withdrawal of an installed AED must also be communicated to the competent department for health management of the department responsible for health for its removal from the Autonomous Registry of Automatic and Semiautomatic External Defibrillators.

 

Article 6

AED use

 

The use of a DESA entails the obligation to contact the Health Emergency Service (SES) of the department with competences in the field of health, through the emergency telephone number 112, in order to quickly activate the entire chain of survival and guarantee the continuity of care for the person affected.

 

Article 7

Notification of the use of the AED

 

After each use of a DESA and after completion of the intervention, the owner or natural or legal person responsible for the management or exploitation of those spaces or places where the DESA used is installed, must send to the Center for Information and Coordination of (CICU) dependent on the Health Emergencies Service, within a maximum period of 72 hours, the registration document that the DESA team itself provides, accompanied by the communication model that is available at the electronic headquarters or institutional portal of the Generalitat at internet, https://sede.gva.es, as well as on the website of the department with competences in health matters, www.san.gva.es.

 

Article 8

Personnel authorized to use the DESA

 

1. The following are authorized to use the DESA:

 

• a) People who are in possession of a degree in Medicine and Surgery or a degree in Medicine, a diploma in Nursing or a degree in Nursing, or Professional Training as a technician in Sanitary Emergencies.
• b) People who have completed official qualifications recognized in Spain whose program includes training in cardiopulmonary resuscitation, basic life support and use of DESA, with a content and duration that at least corresponds to that specified in the training programs.
• c) Persons from the member states of the European Union who have completed the courses or programs required for this purpose in their countries, prior approval by the administrative unit with competence in training and teaching in health matters, if it is found that there is equivalence in content. and duration with the initial and continuing training programs for the use of AEDs. The homologation will be valid for two years from the date of completion of the course.
• d) And all those people who have passed the initial and ongoing training programs for the use of DESA.

2. Exceptionally, in those cases in which no person accredited to use the DESA is present, when the circumstance occurs and in order to increase the chances of survival, any person who is present at the DESA may use the DESA. the place of cardiac arrest and whenever you are in communication with the Emergency Information and Coordination Center (CICU) through the emergency telephone number 112.

 

Article 9

Training programs for the use of the AED

 

1. The initial training and ongoing training programs for the use of the AED by non-health personnel will be established by resolution of the person in charge of the general directorate with powers in matters of health care of the Ministry with powers in matters of health and will be published in the Official Gazette of the Generalitat Valenciana.
2. The owner or natural or legal person who has a DESA installed in his premises due to being obliged to do so or doing so voluntarily, will have to guarantee, in any case, the training of the personnel foreseen for the use of the DESA.
3. People who have passed the initial training program have to update their training at least every two years, by passing the continuing training program.
4. The training programs will be taught by natural or legal persons, public or private, that are accredited as training centers for the implementation of training programs for non-health personnel for the use of external automatic and semi-automatic defibrillators by the competent administrative unit. in matters of training and teaching of the department responsible for health.
5. The accredited training centers will be the ones that must issue the individual certificates to the students who pass the programmes, which include at least: the accreditation resolution of the training center by the competent body, the name of the center or entity that has taught, name of the program carried out (initial or continuing training), duration, place, date of completion and period of validity of the certificate, and name of the person signing said certificate. Likewise, the accredited center must register and keep the documentation of each of the programs carried out (teaching materials and minutes with the list of students entitled to a certificate) for a minimum period of five years.
6. The initial training program must be carried out in person.

 

Article 10

Accreditation of training centers

 

1. Individuals or legal entities, public or private, who are interested in being accredited centers to carry out training programs for non-health personnel for the use of automatic and semi-automatic external defibrillators, must submit an application, which is available at the electronic office o Institutional portal of the Generalitat on the Internet, https://sede.gva.es, as well as on the website of the department with competences in matters of health, www.san.gva.es, in the registry of the administrative unit with competence in training and teaching matters of the department responsible for health, or in any of the ways provided for in the legislation regulating the common administrative procedure of public administrations, together with the following documentation:

• a) Document accrediting the personality of the applicant person or entity and, where appropriate, the representation it holds.
• b) In the case of private individuals or legal entities, a certified copy of the receipt proving that they have been registered with the Tax on Economic Activities (IAE).
• c) Justification report that will include a responsible statement on compliance with the requirements that training centers must observe and that are included in the following article of this decree, without prejudice to the documentation that will have to be provided and that is specified in that same article.

2. The administrative unit with competence in matters of training and teaching of the Ministry competent in matters of health, will initiate the corresponding file, will study the application and documentation presented, and will verify compliance with the requirements demanded by the regulations, and may request its correction in accordance with the provisions of the legislation regulating the common administrative procedure of public administrations.
3. In view of the complete file and the proposed resolution of the administrative unit with competence in training and teaching matters, the person in charge of the management center competent in training and teaching matters of the Ministry competent in matters of health, will issue and notify a resolution of accreditation or denial of the same within a maximum period of four months from the submission of the application. This resolution puts an end to the administrative procedure. Once the period indicated in the previous paragraph has elapsed for issuing an accreditation resolution, without notification of the express resolution, the accreditation request will be deemed to have been accepted.
4. The accreditation of training centers will be valid for three years, counting from the date specified in the resolution.
5. The renewal of the accreditation must be requested within the three months prior to the end of the validity period, at the request of the person or entity that owns the accredited training center, presenting a brief report of the programs carried out and specifically indicating whether it has been there has been some change in the conditions of its center expressed in the initial memory. The verification and fulfillment of the conditions and requirements for the maintenance of the accreditation of the center, will imply after the appropriate file, the corresponding resolution of renewal of the accreditation, of the person in charge of the management center competent in training and teaching matters of the competent department in terms of health. The lack of renewal within the term, will determine the loss of the accreditation for the delivery of the training referred to in this decree. In these cases, to request a new accreditation as a training center, the person or entity must initiate a new procedure.
6. The accreditation of a center will be without effect and may be revoked ex officio by the Administration, after processing the corresponding procedure with a hearing of the person or entity concerned, without the right to any compensation, if it is verified that the requirements have been no longer met. established that motivated its granting. The maximum period to decide on the revocation will be three months, counting from the date of adoption of the agreement to initiate the revocation procedure. Once the indicated period has elapsed without the interested party being notified of the express resolution, this procedure will be understood to have expired.
7. Any modification of the teaching team after the accreditation of the center must be notified to the administrative unit with competence in training and teaching matters of the Ministry competent in health matters and must be authorized by the head of the management center competent in training and teaching matters of the department responsible for health, without this implying a change in the validity of the accreditation granted in the resolution.

 

Article 11

Training center requirements

 

Non-health personnel training centers for the use of external automatic and semiautomatic defibrillators must comply with the following requirements:

 

a) Have a training program whose minimum content conforms to the subjects and contents described in the initial and ongoing training programs for the use of DESA. It will be accredited in the report referred to in article 10, point 1, section c, by presenting the program.

b) Have a minimum endowment of personnel resources, which will be one teacher for each group of ten students.

 

The teaching team of the training center may be made up of:

• Health professionals with the life support instructor course or with the life support monitor course, with a valid certificate issued by the State health administrations and health entities whose statutory purposes are of a scientific nature and related to the matter regulated by this decree. .
• Health professionals from the hospital emergency services and the health emergency services (SES), of the department responsible for health in the Valencian Community.
• Health professionals from the occupational risk prevention services of the Generalitat bodies that exercise competencies in matters of safety and health at work.

All the personnel referred to in the preceding paragraphs, in the case of personnel at the service of public administrations, must comply with the provisions of the legislation on incompatibilities at the service of public administrations.

The capacity for teaching will be accredited in the supporting report that is submitted together with the application, providing authenticated copies of the corresponding valid accrediting certificates.

c) Have a minimum endowment of material resources, which will be the following for each group of ten students:

• 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 DESA.
• A pediatric simulation manikin.
• Two masks for artificial ventilation.
• A training DESA, duly approved.

d) Have premises that comply with the regulations on habitability of the Valencian Community, and must have a minimum space of 40 m2 that allows adequate training practice.

 

Article 12

Inspection and control

 

Without prejudice to the powers of other bodies due to the matter, it will be the competent management center for inspection

of the department responsible for health, who will carry out the inspection and control of compliance with the provisions of this

Decree, in accordance with the provisions of Royal Decree 1591/2009, of October 16.

 

Article 13

Infringements and sanctions

 

1. Failure to comply with the provisions of this decree will give rise to the corresponding administrative responsibility in the terms contemplated in Law 14/1986, of April 25, general health, and in Law 10/2014, of December 29, of the Generalitat, of health of the Valencian Community.
2. Violations will be penalized in accordance with the provisions of Law 14/1986, of April 25, general health, and Law 10/2014, of December 29, of the Generalitat, health of the Valencian Community.

 

ADDITIONAL PROVISIONS

 

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educational content

 

The Administration of the Generalitat, through the department responsible for education, will promote the introduction in the educational contents of Compulsory Secondary Education (ESO) and in the stage of the same that is considered most appropriate, of knowledge in first aid and basic life support that includes, at least, requesting help from the 112 emergency telephone number, basic cardiopulmonary resuscitation (CPR) and the use of a DESA.

 

Away

local entities

 

Local entities may install DESAs in addition to those provided for in article 3 of this decree in establishments or services under their ownership or management.

 

Third

Fees

 

The Administration of the Generalitat may demand the payment of a fee for the provision of training center accreditation services provided for in this decree, in the terms established in the legislation on fees of the Generalitat.

 

Quarter

budget impact

 

The implementation and development of this decree may not have any impact on the endowment of the spending chapters assigned to the department with competences in health matters and, in any case, it must be attended with the personal and material means of the aforementioned department.

 

TRANSITORY DISPOSITIONS

 

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Adequacy of spaces and communication

 

1. Natural persons and legal persons responsible for the management or exploitation of spaces obliged to have a DESA, must comply with the requirements set forth in this decree within a period of twelve months from its entry into force.
2. Individuals and legal entities responsible for the management or operation of spaces that already have one or more DESAs installed must comply with the requirements established in this decree, within a period of twelve months from its entry into force.

 

Away

Approval

 

Those people who have completed training programs or courses for the use of DESA in training centers of the Valencian Community after the repeal of Decree 220/2007, of November 2, of the Consell, as established by Decree 157/2014, of October 3, of the Consell, until the entry into force of this decree, may request the approval of the training to the administrative unit with competence in training and teaching matters of the competent department in health matters, which will grant it only if it is verified that there is equivalence in content and duration with the initial and continuing training programs for the use of DESA. In any case, the homologation will be valid for two years from the date of completion of the course.

 

REPEAL PROVISION

 

One size fits all

Repeal

 

Any provisions of equal or lower rank that oppose the provisions of this decree are hereby repealed.

 

FINAL PROVISIONS

 

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Performance

 

The person in charge of the ministry with powers in the field of health is empowered to issue the necessary provisions for the development and application of the provisions of this decree.

 

Away

Entry into force

 

This decree will enter into force the day after its publication in the Official Gazette of the Generalitat Valenciana.

 

Valencia, October 6, 2017

 

The President of the Generalitat,

XIMO PUIG I FERRER

 

The Minister of Universal Health and Public Health,

CARMEN MONTON GIMENEZ

 

Download here the regulations on DEA DESA defibrillators in the Valencian Community

 

We are defibrillator installers and cardiac rescue points

 

Neosalus Comunitat Valenciana we carry out DEA defibrillator installations, we carry out equipment maintenance and training in SVB and use of the defibrillator with which to comply with the regulations on semi-automatic external defibrillators, comprehensive cardioprotection services in the Valencian Community. Contact us in Comunitat Valenciana for any installation, maintenance or repair of AED equipment that you may need, in facilities we are certifiers of cardioprotected spaces in Comunitat Valenciana.