DECREE 9/2015, of January 27, which regulates the installation and use of automatic and semi-automatic external defibrillators and establishes the obligation of their installation in certain spaces for public use outside the health field.
The responsibility that corresponds to the public powers to organize and protect public health through preventive measures and the necessary benefits and services is established within the jurisdiction of the Autonomous Community of the Basque Country in article 18.1 of the Statute of Autonomy; article that includes internal health as one of the powers of legislative development and execution of the basic legislation of the State in matters of internal health.
Likewise, the state competence to establish bases and general coordination of health under article 149.1.16.a of the Constitution must be taken into account.
Within this jurisdictional framework, Law 8/1997, of June 26, on Health Organization of the Basque Country, provides in its article 14.1 development actions in protection, promotion of health and prevention of diseases; in general, in the different areas indicated by the basic legislation, and, specifically, as far as this norm is concerned, the exercise of the powers of public intervention recognized by the legal system in relation to individual and collective health. Thus, article 6.4 of Law 14/1986, of April 25, General Health establishes as one of the principles that public health administrations must act to guarantee health care in all cases of loss of health.
Proper care for cardiorespiratory arrest consists of the early application of a series of actions known as the chain of survival, made up of four interrelated links: recognition of the situation and immediate warning of a possible arrest, early initiation of basic cardiopulmonary resuscitation (CPR) by witnesses, early defibrillation and, finally, advanced life support in a few minutes.
The only effective treatment against ventricular fibrillation is early electrical defibrillation, so the participation of the first responder is essential. Technological advances have allowed the appearance of a series of defibrillators that, due to their characteristics and operation, and according to the available scientific evidence, make them suitable for use by personnel outside the health profession outside the health environment. They are called automatic and semiautomatic external defibrillators.
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, constitutes basic state regulations on the matter.
In the Autonomous Community of the Basque Country, after the publication of Decree 16/2005, of January 25, which regulated the use of automatic external defibrillators by non-medical personnel, and given that it had generated a series of practical difficulties in its application, it was Solved with the publication of Decree 8/2007, of January 23, on the use of automatic external defibrillators by non-health personnel.
After that, Directive 2006/123/EC of the European Parliament and of the Council, of December 12, 2006, regarding services in the internal market, more commonly known as the Services Directive, came to establish a series of general provisions considered necessary to facilitate the exercise of the freedom of establishment of service providers and the free movement of services, while maintaining a high level of quality in them.
The transposition of said Directive at the state level is undertaken mainly by Law 17/2009, of November 23, on free access to service activities and their exercise, and Law 25/2009, of December 22, modifying various Laws for its adaptation to the previous one, continuing through the approval of state norms of regulatory rank in the different spheres 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 on health matters to adapt them to the regulations for the transposition of the Services Directive.
As a consequence of the studies carried out and taking into account that the State also projected Royal Decree 109/2010, of February 5, of an omnibus nature in health matters, this Decree is proposed whose content supposes the modification of others from the reiterated perspective removal of barriers or obstacles related to access to service activities and their exercise.
Several similar cases are affected, in which restrictions that affect various service activities related to the preparation and delivery of training plans and programs will be eliminated, whose prior and conditioning supervision responded to the logic of guaranteeing greater security for certain activities. in its future development from the perspective of protecting public health, which is involved in all these activities, one of which is the non-professional use of automatic external defibrillators.
On the one hand, there is accumulated experience since the approval of the first regulations on the use of defibrillators. On the other hand, there is scientific evidence available in this regard.
Lastly, the high degree of social awareness of the problem of sudden death –which is revealed by the successive non-legal proposals of different political groups in the Basque Parliament– and the interest of the Department of Health of the Basque Government in promoting and to facilitate the use of defibrillators outside the health field -given the obvious possibility of improving survival expectations thanks to citizen solidarity-, they advise proceeding to the approval of a new norm that regulates, in the Autonomous Community of the Basque Country, the use of defibrillators automatic and semiautomatic external defibrillators and the obligation of their availability in certain spaces where there is a high concurrence of people and there is a greater probability of a cardiac arrest occurring.
By virtue of it, at the proposal of the Minister of Health, after the appropriate procedures, in accordance with the Euskadi Legal Advisory Commission, and after deliberation and approval by the Governing Council at its meeting held on January 27, 2015,
I HAVE
Article 1
Purpose
1.– The purpose of this Decree is to regulate the installation and use, outside the healthcare environment, of devices that can be used by personnel from outside the healthcare profession that make it possible to improve the survival expectations of those people who suffer cardiac arrest, through your immediate attention.
2.– In order to meet the aforementioned purpose, this standard establishes the mandatory installation of automatic and semi-automatic external defibrillators (AED) in certain spaces for public use, outside the health field.
Article 2
Definitions
For the purposes of this Decree, it is understood by:
- a) Automatic external defibrillator, AED: the medical device intended to analyze the heart rhythm, identify fatal arrhythmias requiring defibrillation and administer, with the intervention of a person, an electric shock in order to restore a viable heart rhythm with high levels of security. This definition also includes the so-called semiautomatic external defibrillators.
- b) Large commercial establishment, individual or collective: any commercial establishment that has a built-up area of more than 700 square meters. Collective commercial establishment: the set of commercial establishments located in one or several connected buildings where commercial activities are carried out.
- c) Public establishment: any building, premises, enclosure or facility accessible to public attendance in which shows are offered or recreational activities are carried out.
- d) Educational center: educational center where non-university and university education is taught, of a public or private nature.
- e) Capacity: maximum occupancy granted or declared for each establishment in the municipal license or equivalent document issued or accepted by the corresponding municipal authority.
- f) Average daily influx: average number of people who go to a certain space or place daily, obtained by dividing the total annual influx of people in that specific space by the number of days that specific space has been available to the public that year. .
- g) Intervening person: the person who makes use of an AED outside the health field.
Article 3
Spaces required to have a DEA
The physical or legal persons responsible for the following spaces or places will be obliged to have a DEA in suitable operating conditions and ready for immediate use:
- a) Large commercial establishments, individual and collective.
- b) The following transportation facilities: airports and commercial ports. Bus or railway stations in towns with more than 50.000 inhabitants, and metro, train or bus stations with an average daily influx of 2.000 people or more.
- c) Public establishments, facilities, shows and recreational activities with authorized capacity greater than 700 persons.
- d) Educational centers with a capacity equal to or greater than 2.000 people.
Article 4
AED Technical Requirements
1.– The AEDs that must be installed in the places indicated by the previous article, must comply with the provisions of Royal Decree 1591/2009, of October 16, which regulates medical devices, they will bear the CE marking that guarantees their conformity with the essential requirements that apply to them, and their maintenance and conservation must be guaranteed at all times in conditions of use, in accordance with the instructions of the manufacturing company.
2.– The places where an AED is installed will have a visible and adequate space for its installation, and its location must be marked clearly and simply using the universal signage recommended by the International Resuscitation Coordination Committee (ILCOR). clearly showing the labeling corresponding to the emergency telephone number 112-Sos Deiak, according to its official logo. Said location must be duly identified in the plans or informative maps of the place, if any. Next to the DEA, the instructions for its use will be displayed, which must be written in Basque and Spanish.
Article 5
AED Facility Communication
1.- The individuals or legal entities that own both the spaces required to install an AED for use by non-health personnel, as well as the spaces in which said installation is not mandatory but want to do so voluntarily, must notify the competent department in advance. regarding health, indicating the place where it will be installed and its technical characteristics. The communication must be made using the model included in Annex I of this Decree.
2.- The withdrawal of an installed AED must also be communicated to the competent health department, using the model included in annex II of this Decree.
3.– The natural or legal persons who own the spaces where a DEA is installed will be responsible for guaranteeing its conservation and maintenance in accordance with the instructions of the manufacturing company.
Article 6
Use of AEDs
1.– Each action with an AED must be immediately preceded or followed by a call to the emergency telephone number 112-Sos Deiak, in order to urgently activate the entire chain of survival.
2.– After each use of the AED, the documentary record provided by the equipment itself must be sent to the Osakidetza-Basque Health Service Emergency Service, within a maximum period of 72 hours, accompanied by a report that the person who used it must draft according to the model included in annex III.
3.– The AEDs may be used by non-health personnel, taking into account that their use is included in the basic scheme of cardiopulmonary resuscitation with the support of the Osakidetza-Basque Health Service Emergency services, which will be contacted at the beginning of performances.
Article 7
AED registration
There will be attached to the department responsible for health matters a Registry of AEDs installed. Said registry will be managed by the competent Directorate for Planning of the Department of Health and will be maintained in connection with the Osakidetza Emergency Service-Basque Health Service.
Article 8
Promotion of the installation of AEDs outside the health field
The health administrations of the Autonomous Community of the Basque Country, within the scope of their powers, will promote and recommend the installation and use of AEDs outside the health field in places and spaces where, even though they are not obliged to do so, their installation can be considered appropriate. Likewise, training will be promoted with contents in basic life support and AED management.
Article 9
Coordination and inspection
The department responsible for health planning and management of the department responsible for health will carry out the necessary coordination and inspection actions for the application of the measures contemplated in this Decree.
Article 10
Infractions
1.- Failure to comply with the obligations established in this Decree will be considered administrative offences, in accordance with the provisions of Law 8/1997 on health regulations in the Basque Country and article 35 of Law 14/1986, of April 25, General Health, and will give rise, after instruction of the appropriate procedure processed in accordance 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.- It will be considered a minor sanitary infraction, the fact of not having 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 sanitary risk produced is of minor importance.
3.- The following will be considered serious health infractions:
- a) Not having an adequate and correctly identified space for the installation of the defibrillator, in accordance with the provisions of article 4.2, when this entails serious damage to people's health.
- b) Failure to comply with the installation requirements of the defibrillators provided for in Royal Decree 1591/2009, of October 16, which regulates medical devices, in accordance with the provisions of article 4.1.
- c) Failure to notify the competent health department of the installation or removal of a defibrillator, or doing so without providing the necessary information in accordance with the provisions of article 5, when its installation is mandatory in accordance with the provisions of this decree.
- d) Failing to notify the Osakidetza-Basque Health Service Emergency Service of the use of a defibrillator outside the health area, within the established period of 72 hours after it, in accordance with the provisions of article 6.2.
- e) Not guaranteeing the maintenance and conservation in conditions of use of the defibrillators, as provided for in articles 3 and 4.1.
- f) The commission in a period of three months of two minor offenses provided for in section 2.
4.- They are very serious infractions:
- a) The conscious and deliberate breach of the obligations established in this decree when it produces serious damage to people.
- b) The absolute refusal to provide information or collaborate with the inspection activity.
- c) The commission in a period of five years of two serious offenses provided for in section 3.
Article 11
Sanctions
1.- Violations will be penalized with fines and other measures provided for in article 36, sections 1 and 2 of Law 14/1986, of April 25, General Health and in article 37 of Law 8/1997, of June 26, on health regulations in the Basque Country.
2.– The competent bodies for the imposition of the fines will be those that, according to the amount of the same, establishes article 39 of the Law 8/1997, of June 26, of Euskadi health management.
FIRST ADDITIONAL PROVISION
Processing by telematic means
The Department of Health, within a period not exceeding 12 months, will adopt the appropriate measures so that the communication of the installation of a defibrillator outside the health field, its withdrawal, as well as the communication of its use, can be carried out by telematic means, in the terms , with the requirements and guarantees provided for in current regulations on electronic processing.
SECOND ADDITIONAL PROVISION
Effectiveness of the Registry and creation of the file
The effective implementation of the Basque Registry of Automated External Defibrillators will entail the creation of the corresponding personal data file, which will be carried out by order of the person in charge of the competent health department, in accordance with the provisions of article 20.1 and 2. of Organic Law 15/1999, of December 13, on the protection of personal data.
THIRD ADDITIONAL PROVISION
Municipalities and Provincial Councils
The Town Halls and Provincial Councils in the establishments and facilities of their ownership or management may complete and expand the scope of application of this decree by virtue of the powers they have, either with Local Health Plans or other means.
TRANSITIONAL PROVISION
Adequacy of spaces
1.- The spaces, obliged to have a DEA, must prove compliance with the requirements set forth in this Decree within a period of twelve months from its entry into force.
2.– Within the period provided in the previous paragraph, the spaces that already have a DEA installed must comply with the requirements established in this decree.
REPEAL PROVISION
Decree 8/2007, of January 23, on the use of automatic external defibrillators by non-health 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 responsible for health is authorized to develop and execute this Decree and, in particular, to modify the content of its Annexes and to develop plans that complement it.
SECOND FINAL PROVISION
Entry into force
This Decree will enter into force the day after its publication in the Official Gazette of the Basque Country.
Given in Vitoria-Gasteiz, on January 27, 2015.
The Lehendakari,
IÑIGO URKULLU RENTERIA.
The Health Counselor,
JON DARPON SIERRA.
Download here the regulations on DEA DESA defibrillators in Euskadi
We are defibrillator installers and cardiac rescue points
Neosalus Euskadi we carry out AED defibrillator installations, we carry out equipment maintenance and training in BLS and use of the defibrillator with which to comply with the regulations on semi-automatic external defibrillators, comprehensive cardioprotection services in the Basque Country. Contact us in Euskadi for any installation, maintenance or repair of AED equipment that you may need, in facilities we certify cardioprotected spaces in Euskadi.
