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.
Article 43 of the Spanish Constitution recognizes the right to health protection, and declares that it is the responsibility of the public powers to organize and protect public health through preventive measures and the necessary benefits and services.
Law 14/1986, of April 25, General Health, has as its purpose the general regulation of all actions that make it possible to make effective this right to health protection, and determines among its general principles that the actions of the administrations Public authorities will guarantee health care in all cases of loss of health. In its article 3, this law declares as an objective of the health system that the means and actions of the same will be oriented primarily to the promotion of health and the prevention of diseases. Likewise, in its article 6, it establishes that the
The actions of the public health administrations will be aimed at promoting health and guaranteeing that all health actions carried out are aimed at preventing diseases and not only curing them, guaranteeing health care in all cases of loss. Of the health.
For its part, Law 16/2003, of May 28, on the cohesion and quality of the National Health System includes in its article 2, among the general principles that inform it, the provision of comprehensive health care, comprehensive both its promotion as well as disease prevention, assistance and rehabilitation, seeking a high level of quality.
In our country, cardiovascular diseases constitute one of the most important health problems for the population. Most of the preventable deaths are due to coronary diseases, and they occur in the extrahospital environment. It is estimated that each year more than 24.500 cardiac arrests occur in Spain, which is equivalent to an average of one every 20 minutes, causing four times more deaths than traffic accidents, and ventricular fibrillation is initially responsible for up to 85 percent of out-of-hospital cardiac arrests.
To combat this problem, various scientific research studies have demonstrated the effectiveness, usefulness, and zero risk of using semiautomatic defibrillators in immediate care programs carried out by non-health personnel in public spaces, and support that such use can save life. life to people suffering from ventricular fibrillation.
Thus, within the Quality Plan, the Ischemic Cardiopathy Strategy, approved by the Interterritorial Council of the National Health System on June 28, 2006, contemplates early defibrillation as a fundamental element in the care aspect, in line with what has been stated by a large number of international medical bodies. To this end, objective 6 of this Strategy includes a recommendation consisting of the need to establish a legal framework for the implementation and development of a semi-automatic defibrillator program in public places, as is already provided for in the legislation of a significant number of autonomous communities that, in the exercise of their powers of organization and administration of their services, have regulated the use of external defibrillators by non-health personnel with specific regulations, through which they incorporate these actions into the care chain and the emergency system of the different autonomous communities.
Although the most widely used external defibrillator model in immediate care programs carried out by non-medical personnel in public spaces is the so-called semiautomatic, this standard also regulates the devices generally known as automatic external defibrillators.
For all of the above, it is appropriate to address through this royal decree the regulation of the use of semiautomatic defibrillators outside the health field by establishing the minimum safety and quality requirements in their use throughout the territory, giving effective and broad coverage to the requirements for the use of these devices in emergency situations that require early defibrillation, favoring their availability in the greatest number of places where a large number of people are concentrated and establishing the essential contents of the training of those who are authorized to use them.
This royal decree, during the preparation of which the affected sectors have been heard and the Interterritorial Council of the National Health System has reported, is issued under the provisions of article 149.1.16.a of the Spanish Constitution.
By virtue, at the proposal of the Minister of Health and Consumption, in accordance with the Council of State and after deliberation by the Council of Ministers, at its meeting on March 20, 2009,
The purpose of this royal decree is to regulate the conditions and minimum requirements for the use and maintenance of external semiautomatic defibrillators outside the health field.
All the regulations established in this royal decree for external semiautomatic defibrillators will also be applicable to external automatic defibrillators.
For the purposes of this royal decree, a semiautomatic external defibrillator (DESA) is understood to be the medical device intended to analyze the heart rhythm, identify fatal arrhythmias subject to defibrillation and administer an electric shock in order to restore a viable heart rhythm with high levels. of security. This definition also includes the so-called automated external defibrillators.
Performance requirements for semiautomatic external defibrillators
- The AEDs that are installed in accordance with the provisions of the following articles, must comply with the provisions of Royal Decree 414/1996, of March 1, which regulates medical devices, bearing the CE marking that guarantees their conformity with the essential requirements that apply to them.
- AEDs must be used under the conditions specified by their manufacturer and be adequately maintained, so that they maintain the safety and benefits provided during their period of use.
- The health authorities of the autonomous communities will establish the appropriate control and inspection mechanisms, in accordance with the provisions of article 24 and concordant Royal Decree 414/1996, of March 1.
Notification regime for installation
- For its installation, public or private entities, as well as individuals who intend to install a DESA, must notify the health authority of the autonomous community of the place or establishment where it is to be installed, making a responsible declaration that they comply with the requirements set forth in section 2 of this article.
- The autonomous communities will establish the appropriate notification procedure, in accordance with their powers. In any case, the notification procedure must ensure that the following minimum requirements are met:
- a) Notification and registration of the DESA installation.
- b) The need to signpost its installation and the rules of use in a visible place.
- c) The provision of devices for immediate connection and activation of the emergency services of the corresponding autonomous community.
- d) The subsequent notification system of the event to the health authorities.
Promotion of the installation of AEDs
The health administrations of the autonomous communities will promote and recommend the installation of AEDs, in accordance with the indications or recommendations of international organizations, in those places where a large number of people are concentrated or transit.
Likewise, the health authorities of the autonomous communities will promote the appropriate coordination mechanisms with devices such as civil protection, firefighters, local police and others that may be necessary, to extend the installation and use of AEDs.
Authorized personnel for the use of AEDs
- The autonomous communities will establish the necessary mechanisms to authorize the use of AEDs to all those people who are in possession of the minimum and basic knowledge necessary for it.
- The training programs, both initial and continuous, for non-health personnel, will be organized both by the autonomous communities and by public or private entities duly authorized to do so.
The training program must, at least, develop the following contents:
- a) Identification of situations susceptible to the use of defibrillators.
- b) Use of the external semiautomatic defibrillator.
- The public and private organizations, companies and institutions that install a DESA will be responsible for guaranteeing its maintenance and upkeep, in accordance with the manufacturer's instructions.
- The autonomous communities will establish, in accordance with their powers, the appropriate inspection and control mechanisms to ensure compliance with the provisions of this Royal Decree.
Without prejudice to other regulations that may be applicable, infringements committed against the provisions of this Royal Decree and its implementing provisions will be considered as infringements in the field of health, as provided for in Chapter VI of Title I of Law 14. /1986, of April 25, General Health, and in the other provisions that are applicable.
first final provision
This royal decree is issued under the provisions of article 149.1.16.a of the Spanish Constitution, which attributes exclusive competence to the State in terms of bases and general coordination of health.
Second final provision
Entry into force
This Royal Decree shall enter into force the day after its publication in the "Official State Gazette".
Given in Madrid, on March 20, 2009.
JOHN CARLOS R.
The Minister of Health and Consumption,
BERNAT SORIA ESCOMS
Download here the regulations on DEA DESA defibrillators in Melilla
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