PROVISIONAL DECREE 6/2019, of January 30, which regulates the installation of automated external defibrillators and training for their use.
STATEMENT OF MOTIVES
Through Provincial Decree 176/2011, of August 31, the use of external automatic and semiautomatic defibrillators was regulated outside the health field in the Comunidad Foral de Navarra.
Said foral decree was issued in development of the provisions of the Foral Law 10/1990, of November 23, on Health, which among its informative and general principles includes that of the integral conception of health and which provides that the resources, means organizational and actions of the health administrations of the Foral Community will be oriented towards the satisfaction of the right to health protection through health promotion, disease prevention and health care.
On the other hand, it should be taken into account that Royal Decree 365/2009, of March 20, established the minimum conditions and requirements for safety and quality in the use of automatic and semi-automatic external defibrillators outside the health field, a basic standard that must be respected in the development regulation.
The Navarra Health Plan 2014-2020 incorporates the development of non-medical devices as a strategy to complete the action in time-dependent emergencies, and for this it is necessary to make a differentiation of first-line devices and an adjustment of training needs to new technological realities. On the other hand, it is a requirement for the operability of the devices to have up-to-date, rigorous and operational information, differentiating priority records from those that can contribute in a less qualified way to the expected emergency action.
To this end, the new standard intends to update the provisions of the aforementioned regional decree seeking to establish the bases for the operational integration of external defibrillators into the health system, defining the most useful for the care of time-dependent emergencies.
Likewise, it intends to define the obligatory places for its installation, the people whose training is considered key for its proper functioning, the training required for its use and the necessary records to have up-to-date operational information. The use of defibrillators by health personnel is governed by its own regulations, so the requirements established in this regulation for the intervention of the first responders are not applicable.
In order to delimit the spaces in which the installation of defibrillators is considered mandatory, the consideration of the greater probability of an event requiring their use has been considered.
Comparative regulations of other Autonomous Communities have also been reviewed when defining ratios that recommend mandatory installation.
Regarding training, current regulations do not contemplate the possibilities offered by online training tools, which are explicitly incorporated into the training aspects to be included. Likewise, it is contemplated, as it could not be less, the need for the Administration to guarantee continuous access to basic training, since when defining mandatory installation spaces, a co-responsibility is required in the training of key people for their use. called “first responders”.
On the other hand, the principle of operation of mandatory installation devices requires their mandatory communication to the Administration, which must keep a permanently updated register of mandatory installation devices, as well as the material and personal conditions for their use, an issue that with the regulations in force to date have not been sufficiently resolved.
The proposed rule has been reported in accordance with the principle of equal treatment and exercise of the right to health.
In accordance with the foregoing, at the proposal of the Minister of Health, in accordance with the Council of Navarra, and in accordance with the decision adopted by the Government of Navarra in a session held on January XNUMX, two thousand and nineteen,
DECREE
Article 1
Object
The purpose of this foral decree is to regulate the installation of automated external defibrillators outside the health field, as well as the necessary training of the first people involved in the care of those who suffer cardiorespiratory arrest.
Article 2
Definitions
For the purposes of the provisions of this regional decree, it is understood by:
- a) Automated external defibrillator (AED): medical device capable of analyzing the heart rhythm, identifying fatal arrhythmias susceptible to defibrillation and administering an electric shock that restores a viable heart rhythm, with high levels of safety. This definition should be understood as including semiautomatic external defibrillators.
- b) Capacity or capacity: maximum authorized number of people that a venue can admit according to a municipal license or document issued or an equivalent statement for these purposes.
- c) First responder: the person who, due to the functions performed, is more likely to provide first care to people in cardiorespiratory arrest. For the sole purpose of applying this foral decree, the persons belonging to the following services or groups shall be understood to be included:
- Local police, municipal agents and bailiffs.
- Foral Police of Navarre.
- Fire Service of Navarra‐Nafarroako Suhiltzaileak.
- Pool lifeguards and other sports and recreational spaces.
- Persons responsible for the use of AEDs during the time they are open to the public, in the spaces and facilities listed in article 3 of this standard.
Article 3
Spaces and facilities required to have a DEA
It will be mandatory that there be installed a DEA located in a central point and equidistant from the most remote areas in the following spaces or places:
- a) Commercial establishments that have a useful commercial area of more than 2.000 square meters.
- b) Shopping centers made up of a group of commercial establishments located in one or several connected buildings, which add up to a useful commercial area of more than 2.000 square meters.
- c) Airports.
- d) Train and bus stations in towns with more than 10.000 inhabitants.
- e) Educational centers with teaching staff, non-teaching staff and students of more than 700 people.
- f) Work centers or spaces where more than 700 people work together.
- g) Sports centers, swimming pools and any sports or recreational facility with an authorized or expected capacity of more than 500 people.
- h) Establishments, facilities or spaces in which shows, cultural or recreational activities are held with an authorized capacity of more than 700 people.
- i) Any other space or facility with a capacity of more than 700 people.
- j) In towns that have local police, municipal agents or bailiffs, a DEA will be available, which must be carried at least in an operational patrol vehicle. In towns with more than 10.000 inhabitants, DEA will be available in at least 50% of the operational patrol vehicles.
- k) The Navarre Foral Police will have a defibrillator in at least one of the operational patrols dependent on the Pamplona Central Police Station, and the Alsasua, Elizondo, Estella, Tafalla, Sangüesa and Tudela police stations.
- l) Residences and day centers for the elderly with disabilities with more than 100 beds.
Article 4
AED installation and maintenance
- The obligation to install and maintain AEDs in adequate operating conditions in the spaces or places indicated in article 3 of this regional decree will fall on the physical or legal persons who own them.
- AEDs must comply with current regulations governing medical devices. The persons responsible for the entities that install them will be obliged to maintain and preserve them in accordance with the manufacturer's instructions.
- The AEDs will be located in a visible and accessible place and will be duly indicated by universal signage recommended by the International Resuscitation Coordination Committee (ILCOR), including the telephone number 112-SOS Navarra. In the same location, the rules of use will be posted in the official languages of the town and in other languages at the discretion of the owner of the facility.
Article 5
Declaration of responsibility for the DEA installation
- The natural or legal persons obliged to install a DEA in accordance with the provisions of this foral decree must make a responsible declaration addressed to the Department of Health within a maximum period of 30 days from its installation, indicating identifying data of the natural or legal person who performs the same, the place where the device will be installed, as well as the identification and contact information of the person or persons who can use the AED if necessary and their time availability. Said responsible declaration must be made according to the model established in Annex I of this regional decree.
- Once the suitability of the declaration has been verified, the DEA will be registered in the registry provided for in article 10.1 b).
- Natural or legal persons not obliged to install DEA may make the same communication, being obliged to comply with the
- The modification of the data contained in the responsible statement and the withdrawal of any of the DEAs must also be subject to a responsible statement within 15 days from the date said modification or withdrawal occurs.
Article 6
Use of AEDs
- The AEDs of mandatory installation will be used by non-health personnel trained in accordance with the provisions of this regional decree with the support of the health emergency services in the terms established in this article.
- Each action with an AED will entail immediate communication with the emergency telephone number 112-SOS Navarra for the urgent activation of the chain of survival.
- After each use, the person who has used the AED will notify the emergency medical service that comes to the scene of the incident, and this will reflect it in its care protocol in order to assess the effectiveness of the use of the AED in the care of patients. time-dependent emergencies.
- Exceptional situations that exempt the use of the AED by trained personnel are considered to be those in which the installation of the AED is not considered among the mandatory ones defined in this regional decree or when it is not possible to have a person trained for immediate intervention. In the event that a trained person arrives at the site, they will have preference for the use of the AED until the arrival of the health team.
Article 7
Training of the first people involved
- The natural or legal persons responsible for the places or spaces indicated in article 3 will determine the number of first responders who must be trained in the use of AEDs, so as to guarantee that there is at least one person trained during the entire schedule. of their operation.
- The first responders must have training or accredited qualifications that enable them to use AEDs in accordance with the provisions of basic state regulations or, failing that, take a theoretical-practical initial training course that contains at least the program and the evaluation procedure established in Annex II of this regional decree.
- The initial training course will have a minimum duration of six hours divided into three hours of basic theoretical training given preferably online and three hours of practical training given in person. The Department of Health will make available to the training entities a theoretical training module with the proposed content. The maximum number of attendees in the face-to-face part will be eight per instructor. The face-to-face part of the course will be dedicated to practical training in airway clearance techniques, basic cardiopulmonary resuscitation and use of the AED. This part must be coordinated and directed in person by medical or nursing professionals trained in advanced life support. In addition, other people with a degree in medicine, nursing, professional training in health emergencies, or with training as instructors in basic life support may be teachers, although the face-to-face conducting of the courses will be limited to the people defined in the previous paragraph.
- To teach the courses, it will be necessary to have at least the following material: one adult mannequin for every four people to be trained, one child mannequin for every eight people to be trained, a simulation defibrillator with patches for every eight people to be trained, and items for cleaning and disinfection of the material between uses.
- The people who have completed the initial training course referred to in sections 2, 3 and 4 of this article will attend a two-hour practical on-site continuous training session every two years, as specified in Annex III of this regional decree. The maximum number of attendees will be twelve per instructor and the rest of the requirements established in said sections must be met.
- Any person not included in section 1 of this article may also take the training courses that are included in Annexes II and III, by registering in the courses organized by the Government of Navarra when availability allows, or in the courses given by public or private training entities that meet the requirements established in this regional decree.
Article 8
Requirements of the training entities or persons
- The courses for first responders will be organized by educational entities dependent on the Government of Navarra or other public or private entities or individuals who meet the requirements established in this regional decree.
- The persons or entities that intend to teach the initial and continuing education courses described in article 7 of this regional decree must submit to the Department of Health, prior to the start of the activity, a responsible declaration according to the model established in the Annex. IV accompanying the documentation indicated therein.
- Once the suitability of the declaration has been verified, it will be registered in the register provided for in article 10.1a).
- The additions and withdrawals of teaching staff and any other modification that affects the requirements of the courses, as well as the cessation of the activity, must be the subject of a new responsible declaration within a period of 15 days from when they occur.
Article 9
Certificates
- The completion and passing of the evaluation tests of the courses referred to in article 7 will entail the delivery of a certificate accrediting the completion of the course by the training entity or person, which will include the issuing entity and the date of completion. , according to the model included in Annex V.
- The training entities or individuals must keep a record of the courses taken and the certificates issued.
- For the purposes of accrediting the training referred to in this regional decree, the certificates issued by entities or persons that teach similar courses in accordance with the regulations in force in other Autonomous Communities or in other Member States of the European Union will have the same validity.
Article 10
Administrative records
The following records will be maintained, attached to the Department of Health:
- a) Register of natural or legal persons who have made a responsible declaration to give training courses for the use of AEDs in Navarra.
- b) Register of AEDs installed, communicated by means of a responsible declaration.
Article 11
Inspection and control
The Department of Health will inspect the activities of the training entities and persons who have made a responsible declaration of their activity, as well as the facilities of the natural or legal persons who have communicated that they have defibrillators, in order to verify their adequacy to what established in this foral decree.
ADDITIONAL PROVISION
Unique additional provision
Training of health personnel and first responders
People with health qualifications in medicine, nursing, professional training in health emergencies or other health professionals whose curriculum includes cardiopulmonary resuscitation and use of the AED, must carry out continuous training according to their specific training plans.
Personnel without official health qualifications who provide services in ambulance transport must certify the training established for the first persons involved in article 7 of this regional decree.
TRANSITORY DISPOSITIONS
First transitory provision
Previously trained people
Persons required to take the training course established in article 7 and in the sole additional provision of this regional decree who have a valid certificate accrediting having completed initial or continuing training as required by Regional Decree 176/2011, of August 31, which regulates the use of automatic and semi-automatic external defibrillators outside the health field in the Foral Community of Navarra, they will not need to take the initial training course. These certificates will be valid under the same conditions and with the same effects as those regulated in this standard.
Second transitory provision
Previously authorized training centers
The training entities that have authorizations in force to teach courses in accordance with the provisions of the aforementioned Provincial Decree 176/2011, of August 31, may maintain them during the period of validity established therein. After that period, if they wish to continue their teaching activity, they must proceed in accordance with the provisions of this regional decree.
Third transitory provision
Transitional adaptation period
A transitory period of six months is established for compliance with the obligations contained in articles 3, 7 and 8 of this decree.
statutory.
REPEAL PROVISION
Unique derogatory provision
Regulatory repeal
Provincial Decree 176/2011, of August 31, which regulates the use of external automatic and semiautomatic defibrillators outside the health field in the Comunidad Foral de Navarra, and any provisions of equal or lower rank that oppose this are hereby repealed. foral decree.
FINAL PROVISIONS
first final provision
development faculties
The Minister of Health is authorized to issue the necessary provisions for the development of this regional decree.
Second final provision
Entry into force
This regional decree will enter into force the day after its publication in the Official Gazette of Navarra.
Pamplona, January 30, 2019.
The President of the Government of Navarra, Uxue Barkos Berruezo.
The Minister of Health, Fernando Domínguez Cunchillos.
Download here the regulations on DEA DESA defibrillators in Navarra
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