Regulations on AED defibrillators in the Basque Country

DECRET 9/2015 Euskadi on cardioprotection

Legislation on defibrillators external to the Basque Country

Regulations on defibrillators in the Basque Country

 

DECRET 9/2015, of 27 Gen., which regulates the installation and use of automatic and semi-automatic external defibrillators and establishes the mandatory installation in certain public spaces external to the sanitary environment.

The responsibility that corresponds to the public powers to organize and protect public health through preventive measures and services and necessary services is competently established by the Autonomous Community of the Basque Country in article 18.1 of the Statute of the Basque Country. Autonomy; article that includes internal health as one of the powers of legislative development and implementation of the basic legislation of the State in matters of internal health.

Així mateix, to take into account the state competence of establishing bases and general coordination of health pursuant to article 149.1.16.a of the Constitution.

In this framework of competence, Law 8/1997, of June 26, of the sanitary order of the Basque Country, provides in article 14.1 for development actions in protection, promotion of health and prevention of diseases; In general, in the different areas that basic legislation establishes, and, specifically, in relation to this norm, the exercise of the powers of public intervention that recognize the legal order in relation to individual and collective health ·lective. Així, article 6.4 of Law 14/1986, of April 25, General de Sanitat establishes one of the principles that public health administrations must act to guarantee health assistance in all cases of loss of health.

Correct attention to cardiorespiratory arrest consists of the early application of a series of actions connected with a chain of survival, composed of four trunks, interrelated: the recognition of the situation and the immediate alert given by one possible stop, the early start of basic cardiopulmonary resuscitation (CPR) according to testimonies, the first defibrillation and, finally, the life support advances in a few minutes.

The only effective treatment against ventricular fibrillation is early electrical defibrillation, for which the participation of the first person intervening is fundamental. Technological advances have allowed the appearance of a series of defibrillators that, due to their six characteristics and their functioning, and according to the available scientific evidence, are ideal for use by personnel outside the healthcare profession. l'entorn sanitari. These are the names of automatic and semi-automatic external defibrillators.

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 healthcare field, constitutes basic state regulations on the matter.

To the Autonomous Community of the Basque Country after the publication of Decree 16/2005, of 25 Gen., which regulates the use of automatic external defibrillators by non-medical personnel, and at the same time that it has generated a series of practical difficulties in The new application will resolve the publication of Decree 8/2007, of 23rd Gen., on the use of automatic external defibrillators by non-healthcare personnel.

Following Directive 2006/123/EC of the European Parliament and of the Council, of 12 December 2006, relating to services in the internal market, more closely related to the Services Directive, a series of general provisions considered necessary will be established To facilitate the exercise of the freedom of establishment of the service providers and the freedom of circulation of the services, maintain at this time a high level of quality in these.

The transposition of this Directive to the state sphere is mainly carried out by Law 17/2009, of November 23, on the access to the activities of services and their exercise, and Law 25/2009, of December 22 , of modification of various laws to adapt them to the previous one, proceeds through the approval of state standards of regulatory range in the different areas and sectors.

In the area of ​​the Autonomous Community of the Basque Country, Decree 337/2010, of December 14, is published, which modifies various decrees in health matters to adapt them to the regulations transposing the Services Directive.

As a consequence of the studies carried out and it is clear that the State will also project the Royal Decree 109/2010, of February 5, of an omnibus nature in health matters, this Decree proposes the contingut of which the modification of others involves From the reiterated perspective of suppression of barriers or obstacles related to the activities of services and their exercise.

It focuses on various similar assumptions, in which restrictions that affect various service activities related to the development and delivery of training plans and programs will be eliminated, the prior supervision and conditioning of which responds to the logic of guaranteeing certain activities. better security in its future development from the perspective of public health protection, which is involved in all these activities, one of which is the non-professional use of automatic external defibrillators.

One band has accumulated experience since the approval of the first regulations on the use of defibrillators. Furthermore, there is scientific evidence available about this.

Finally, the high level of social awareness regarding the problem of unsubstantiated mortality – which is manifested by the successive propositions not of the law of different political groups of the Basque Parliament – ​​and the interest of the Health Department of the Basque Government promote and facilitate the use of defibrillators outside the health sector – given the obvious possibility of improving survival expectations thanks to citizen solidarity –, recommend approving a new norm that regulates the Autonomous Community of the Basque Country, The use of automatic and semi-automatic external defibrillators and the mandatory availability in certain countries coincides with a high number of people and has a greater probability of cardiac arrest.

In virtue of this, at the request of the Minister of Health, both the opportunistic procedures foreseen, agreed by the Legal Advisory Commission of Euskadi, and after deliberation and approval by the Governing Council in the session held on the 27th of January 2015,

DEVICE

 

Article 1

Purpose

 

1.– This Decree is intended to regulate the installation and use, outside the health environment, of devices susceptible to their use by personnel allied to the health profession that enables a million of the survival expectations of those People who experience cardiac arrest should receive immediate attention.

2.– To meet the stated finality, this standard establishes the mandatory installation of automatic and semi-automatic external defibrillators (AED) in certain public countries, external to the healthcare environment.

 

Article 2

Definitions

 

For the purposes of this Decree, it is understood that:

  • a) Automatic external defibrillator, AED: the health product intended to analyze the cardiac rhythm, identify the fatal rhythms related to defibrillation and administer, with the intervention of a person, an electrical shock with the aim of restoring the cardiac rhythm viable with high security levels. This definition also includes the names of semi-automatic external defibrillators.
  • b) Large commercial establishment, individual or collective: all commercial establishments that have a built surface greater than 700 square meters. Collective commercial establishment: the set of commercial establishments located in one or several buildings connected by these commercial activities.
  • c) Public establishment: any building, premises, enclosure or installation accessible to the public in which shows are offered or recreational activities are carried out.
  • d) Center educatiu: teaching center on teaching non-university and university education, public or private.
  • e) Capacity: maximum occupancy granted or declared by each establishment to the municipal license or equivalent document emès or accepted by the corresponding municipal authority.
  • f) Average daily influx: the name of the number of people who daily go to a given space or location, with the aim of dividing the total annual influx of people into this determined space by the name of the days that any one determined space is available to the public.
  • g) Intervening person: the person who uses the AED outside the sanitary environment.

 

Article 3

Countries required to have an AED

 

The natural or legal persons responsible for the following countries or entities will be obliged to have an AED in fully operational conditions:

 

  • a) The large commercial establishments, individuals and col·lectius.
  • b) The following transport facilities: airports and commercial ports. Bus or railway stations in populations of more than 50.000 inhabitants and metro, train or bus stations with a daily mid-day traffic equal to or greater than 2.000 people.
  • c) Public establishments, installations, shows and recreational activities with authorized capacity exceeding 700 people.
  • d) The educational centers have a capacity equal to or greater than 2.000 people.

 

Article 4

DEA technical requirements

 

1.– The DEA that must be installed in the llocs assenyalats per the previous article, must comply with the one established by Royal Decree 1591/2009, of October 16, which regulates health products, will display The CE marking that guarantees conformity with the essential requirements that still apply, and must guarantee, at all times, the maintenance and conservation in the conditions of these, in accordance with the instructions of the 'manufacturing company.

2.– Those who install an AED will have a visible and adequate space to install them, and their location will be signaled in a clear and simple manner using the universal signaling recommended by the International Committee. Coordination on Responses (ILCOR) visibly maintains the report corresponding to the emergency telephone number 112-Sos Deiak, in accordance with the official logo. This location must be clearly identified on the computer's information boards or maps. At the expense of the DEA, the instructions for its use will be visible, which must be written in Spanish and Spanish.

 

Article 5

Communication of the DEA installation

 

1.– The physical or legal persons who own both the countries obligated to install an AED for their own use by non-health personnel, as well as the countries in which this installation is not obligatory but only voluntarily, however To communicate in advance to the competent department in matters of health, indicating that the lock will be installed and the six technical characteristics. Communication has been based on the model that is incorporated into Annex I of this Decree.

2.– The withdrawal of an installed AED will also have to be communicated to the competent department in health matters, using the model that is incorporated into Annex II of this Decree.

3. The natural or legal persons who own the countries where an AED is installed will be responsible for guaranteeing its conservation and maintenance in accordance with the instructions of the manufacturing company.

 

Article 6

Using the AED

 

1. Each action with an AED must be immediately preceded or followed by communication to the emergency telephone number 112-Sos Deiak, in order to urgently activate the entire chain of survival.

2.– After each AED user must be sent to the Osakidetza-Basic Health Service, within a maximum period of 72 hours, the documentary record that the team provides is accompanied by a report that the person who has used it to write according to the model that contains Annex III.

3.– The AED may be used by non-medical personnel, keeping in mind that the patient is included in the basic cardiopulmonary resuscitation scheme with the support of the Osakidetza-Basic Health Service's Emergency Services, as well as those that are will contact the initial actions.

 

Article 7

DEA Registration

 

A record of the AED installations has been assigned to the department responsible for health matters. This record will be managed by the competent planning management of the Health Department and will be maintained in connection with the Osakidetza-Basic Health Service.

 

Article 8

Promotion of the installation of AEDs outside the healthcare environment

 

The health administrations of the Autonomous Community of Euskadi in the area of ​​​​the six competencies must promote and recommend the installation and use of the DEA outside the health area in all countries and countries, all and not. hi obligats, if the installation can be considered pertinent. Likewise, training will be promoted along with continguts in basic vital support and management of the AED.

 

Article 9

Coordination and inspection

 

The direction competent in matters of planning and sanitary order of the department competent in matters of health will last until the end of the coordination and inspection actions necessary for the application of the measures provided for in this Decree.

 

Article 10

violations

 

1. Failure to comply with the obligations established in this Decree will be considered administrative infractions, in accordance with the provisions of Law 8/1997 of the Sanitary Ordinance of the Basque Country and article 35 of Law 14/1986, of 25 April, General of Health, and will donate lloc, prior instruction of the appropriate procedure of agreement with Law 2/1998 of the sanctioning power of the public administrations of the Basque Country, to the imposition of the corresponding administrative sanctions.

2.– The failure to have an adequate and correctly identified space for the installation of the defibrillator, in accordance with the provisions of article 4.2, when the alteration or the risk sanitari produït followed d'escassa entitat.

3.– Consideration of gross sanitary infractions:

  • a) Not having an adequate and correctly identified space for the installation of the defibrillator, in accordance with what is provided for in article 4.2, which then represented a great harm to people's health.
  • b) Failure to comply with the installation requirements of defibrillators provided for in Royal Decree 1591/2009, of October 16, which regulates health products, in accordance with the one established in article 4.1.
  • c) Failure to communicate to the competent health department the installation or removal of a defibrillator, or otherwise provide the necessary information according to the one who provides article 5, when the installation is still obligatory. in accordance with the provisions of this decree.
  • d) Do not communicate to the Osakidetza-Basic Health Service the use of a defibrillator outside the healthcare environment, within a period of 72 hours after this, in accordance with what is foreseen. l'article 6.2.
  • e) Not guaranteeing the maintenance and conservation of the defibrillators in the correct conditions, as provided for in articles 3 and 4.1.
  • f) The commission will within a period of three months of any violations foreseen in section 2.

 

4.– These are serious infractions:

  • a) The conscious and deliberate non-compliance of the obligations established in this decree that produces great harm to people.
  • b) The absolute refusal to provide information or provide collaboration to the inspectorate.
  • c) The commission in a period of five years for any serious infractions provided for in section 3.

 

Article 11

Sanctions

 

1.– Infractions will be sanctioned with fines and other measures provided for in article 36, paragraphs 1 and 2 of Law 14/1986, of April 25, General de Sanitat and article 37 of Law 8/ 1997, on June 26, Euskadi sanitària decree was issued.

2.– The bodies competent to impose fines will be those that, taking into account the import, establish article 39 of Law 8/1997, of June 26, of the health order of the Basque Country.

 

FIRST ADDITIONAL PROVISION

Processing by mitjans telemàtics

 

The Department of Health, in a term not exceeding 12 months, will adopt the appropriate measures because the communication of the installation of a defibrillator outside the healthcare environment, the removal, together with the communication of its use, is puguin fer per mitjans telemàtics, in the terms, with the requirements and guarantees provided for in current regulations regarding electronic processing.

 

ADDITIONAL PROVISION SEGONA

Effectiveness of the Registry and creation of the fitxer

 

The effective implementation of the Basc Registry of Automated External Defibrillators will entail the creation of the corresponding adjuster of data of a personal nature, which will be carried out by order of the person in charge of the department competent in matters of health, in accordance with both establishments therein. Article 20.1 and 2 of Organic Law 15/1999, of December 13, on the protection of personal data.

 

Third additional provision

Ajuntaments and Provincial Councils

 

The councils and the provincial councils in the establishments and the installations of the seva ownership or management can complete and expand the areas of application of this decree in virtue of the competencies that they dispose, bé amb local health plans or both mitjans.

 

TRANSITIONAL PROVISION

Adequacy of the countries

 

1.– The countries, obliged to have a DEA, must prove compliance with the requirements provided for in this Decree within a period of two months from the date of its entry into force.

2.– In the terms provided in the previous paragraph, the countries that have an installed AED available must adapt to the requirements established in this decree.

 

DEROGATION PROVISION

 

Decree 8/2007, of 23 Gen., on the use of automatic external defibrillators by non-medical personnel and any other provision in this matter that opposes this decree is hereby repealed.

 

FIRST FINAL PROVISION

Development and execution

 

The head of the department competent in matters of health is empowered to develop and execute this Decree and, in particular, to modify the contingency of its six annexes and to develop plans that complement it.

 

FINAL PROVISION SEGONA

Entry into force

 

This Decree will come into force at the end of the publication in the «Official Bulletin of the Basque Country».

 

Donate to Vitòria-Gasteiz, on January 27, 2015.

 

The Lehendakari,

INJIG URKULLU RENTERIA.

 

The Health Minister,

JON DARPON SERRA.

 

Download here regulations on defibrillators DEA DESA to Euskadi

 

We are defibrillators and cardiac rescue installers

 

Neosalus Euskadi carries out installations of AED defibrillators, carries out equipment maintenance and BLS training and the use of the defibrillator in order to comply with the regulations for semi-automatic external defibrillators, providing comprehensive cardioprotection to Euskadi. Contact us in Euskadi for any installation, maintenance or repair of AED equipment that you may need, for installations by certifiers of cardioprotect countries in Euskadi.