Advanced Search

Decree No. 2006 - 1637 19 December 2006 Relating To Service Providers And Distributors Of Equipment, Including Medical Devices, Aimed At Promoting The Return Home And Autonomy Of Sick People Or With A...

Original Language Title: Décret n° 2006-1637 du 19 décembre 2006 relatif aux prestataires de services et distributeurs de matériels, y compris les dispositifs médicaux, destinés à favoriser le retour à domicile et l'autonomie des personnes malades ou présentant une ...

Subscribe to a Global-Regulation Premium Membership Today!

Key Benefits:

Subscribe Now for only USD$40 per month.
Learn more about this text...

Information on this text

Summary

Application of Art. 9 of Law 2005-841.

Keywords

HEALTH , PUBLIC HEALTH , MEDICAL DISPOSITIF , SERVICE PRESTATEMENT , MATERIAL DISTRIBUTOR , MALADE PERSON , INCAPACITY , HANDICAP , AUTONOMIE , DOMICILE , ORGANIZATION


JORF n°295 of 21 December 2006 page 19238
text No. 48



Decree No. 2006-1637 of 19 December 2006 on service providers and distributors of equipment, including medical devices, to promote the return to home and autonomy of persons with disabilities or disabilities

NOR: SANP0623014D ELI: https://www.legifrance.gouv.fr/eli/decret/2006/12/19/SANP0623014D/jo/texte
Alias: https://www.legifrance.gouv.fr/eli/decret/2006/12/19/2006-1637/jo/texte


The Prime Minister,
On the report of the Minister of Health and Solidarity,
Considering the public health code, including article L. 5232-3;
Considering the penal code, in particular articles 226-13 and 226-14;
Considering the code of social action and families, including its article L. 146-8;
Considering the construction and housing code, including its article L. 111-7-3,
Decrete:

Article 1 Learn more about this article...


In chapter II of Book II, Part 5, Title III, of the Public Health Code (regulatory provisions), a single section is created as follows:


« Single Section



"Service providers and distributors of equipment



"Subsection 1



"Performance conditions


"Art. D. 5232-1. - The materials and services referred to in Article L. 5232-3 may only be delivered by service providers and distributors of equipment with competent personnel according to the type of equipment or service concerned.
"The competent staff shall include:
“(a) On the one hand, staff working with the sick person or with a disability or disability in order to provide him with the equipment and services, who have previously undergone a training whose terms and conditions are defined by order of the Minister for Health;
“(b) On the other hand, staff responsible for ensuring the application of professional rules and good practice of the issuance of materials and services, who have previously followed a training whose terms are defined by order of the Minister for Health. For the issuance of equipment and services in the first three categories defined in section D. 5232-2, these personnel are health professionals governed by Part IV of the Public Health Code.
"Art. D. 5232-2. - The materials and services referred to in section L. 5232-3, the list of which and the terms and conditions of delivery are fixed by order of the Minister for Health, are classified into four categories:
"Category 1: Materials and services for which professionals who guarantee the application of professional rules and good practice are pharmacists with a degree, title or certificate authorizing them to practise in France.
"Category 2: the materials and services for which professionals who guarantee the application of professional rules and good practice are the nurses with a degree, title or certificate authorizing them to practise in France.
"Category 3: the materials and services for which professionals who guarantee the application of professional rules and good practice are the physiotherapists with a degree, title or certificate authorizing them to practise in France.
"Category 4: Materials and services for which professionals who guarantee the application of professional rules and good practice, without necessarily being health professionals, have preceded a training set out in the Order of the Minister for Health under section D. 5232-1.
"The same professional can guarantee several activities.
"An employee physician of the service provider or the distributor of equipment may substitute for all occupations referred to in categories 1 to 4 after following the training provided for in article D. 5232-1, without prejudice to the compliance with the provisions on good practices of home-based dispensation of medical oxygen and compliance with the provisions of the Code of Medical Ethics.
"Art. D. 5232-3. - The number of professionals responsible for ensuring the application of professional rules and good practice of the issuance of materials and services must be sufficient and appropriate to the number of personnel assigned to the issuance of such materials and services to persons with disabilities or disabilities. This number can be defined by order of the Minister for Health.
"When a material or service is in several categories at a time, the professional may, at the option, be the one provided in one of these categories.
"The health professional responsible for the application of professional rules and good practice of the delivery of materials and services cannot be the prescriptor.


"Subsection 2



“Professional rules


"Art. D. 5232-4. - The service provider and the distributor of equipment act in all circumstances in the interest of the sick person or persons with disabilities. They respect his dignity and privacy and those of his family.
"They respect the choices of this person and his surroundings.
"Art. D. 5232-5. - The service provider and the distributor of materials support the sick person or persons with disabilities or disabilities with the same conscience without discrimination and without seeking to exploit his or her confidence in a personal or financial advantage.
"It is prohibited for them any practice that would jeopardize the independence of the medical team in charge of the sick or disabled person in relation to his or her freedom of prescription.
"Art. D. 5232-6. - The service provider and the distributor of equipment respect the right of the person with a disability or disability to address the health professional of his or her choice.
"It is forbidden for them to slander a health professional, to meditate on him or to echo words that could harm him in the exercise of his profession.
"They only deliver the categories of equipment they have knowledge, experience and regular practice.
"Art. D. 5232-7. - When the person with a disability or disability is taken care of by the multidisciplinary team, the service provider and the equipment distributor shall cooperate with the members of the team in the interest of the team and its surroundings.
"Art. D. 5232-8. - The service provider and the distributor of equipment are held in professional secrecy.
"The secret covers not only what was entrusted to him, but also what he saw, read, heard, noticed or understood.
"The service provider and the distributor of materials teach all their employees about their professional secrecy obligations and ensure that they comply with them.
"Art. D. 5232-9. - The service provider and the distributor of equipment update their professional knowledge and keep informed of the evolution of good practices, legislation and regulations.


"Subsection 3



« Rules of good practice


"Art. D. 5232-10. - The service provider and the distributor of equipment provide a comprehensive service that is inseparable to all the elements defined by order of the Minister for Health.
"According to the categories of equipment, their importance to the autonomy of the sick person or with a disability or disability or to the need to ensure continuity of treatment, in the event of repairs requiring the immobilization of equipment for more than one day, the service provider and the distributor of equipment provide him with replacement equipment with the same performance and characteristics as the original equipment and, for personalised equipment, a replacement material as close as possible.
"Art. D. 5232-11. - Where they exist, the service provider and the distributor of equipment comply with the prescription and preconization of equipment issued by the multidisciplinary team under the conditions provided for in Article L. 146-8 of the Code of Social Assistance and the Family.
"They deliver the equipment and services that are best suited to the sick person's treatment or self-reliance needs within a time-frame that is compatible with the treatment or self-reliance of the sick person or with a disability or disability.
"Art. D. 5232-12. - The service provider and the equipment distributor shall apply the operating and safety advice provided by the equipment manufacturer.
"They deliver to the sick person or persons with a disability or disability or to his or her surroundings all information and explanations relating to the service and equipment provided under conditions defined by the Minister for Health.
"Art. D. 5232-13. - The service provider and the distributor of equipment have the capacity to operate a space reserved for this purpose, including at least a space that meets the accessibility requirements for persons with disabilities in accordance with the provisions of Article L. 111-7-3 of the Construction and Housing Code and the regulations governing facilities receiving the public of the 5th class. This space reserved for the personalised reception of the person, including the tests, if applicable, meets phone and visual insulation conditions to ensure the patient's confidentiality of the performance.
"For the issuance of equipment for compensation for the lack of movement, this premises includes at least a sufficient space for the removal or movement of equipment.
"Art. D. 5232-14. - In order to deliver the equipment that is most suited to the needs of the sick person or with a disability or disability, the service provider and the equipment distributor ask the prescriptor or multidisciplinary team responsible for establishing a personal compensation plan for any additional information they deem necessary, especially when they consider being insufficiently informed about the evolution of the person's pathology.
"The Service Provider and the Distributor of Materials shall inform, as appropriate and according to the material issued, the prescriptor or the multidisciplinary team referred to above on the material delivered to the person for his or her follow-up.
"Art. D. 5232-15. - In the event that the service provider and the distributor of equipment would not be able to deliver the equipment and services adapted to the sick person or persons with disabilities or disabilities, they shall immediately notify the person or their surroundings, if any, and the inform that they are free to resort to another provider or distributor that may meet their expectations. »

Article 2 Learn more about this article...


Service providers and distributors of equipment referred to in section L. 5232-3 may continue to have staff who do not comply with the provisions of this Order until December 31, 2009, without prejudice to the compliance with the provisions on good home-based dispensing of medical oxygen.
Effective January 1, 2010, these personnel will either have to have validated their experience under conditions fixed by order of the Minister of Health or hold the validation certificate of the training provided for in section D. 5232-1.

Article 3 Learn more about this article...


The Minister of Health and Solidarity is responsible for the execution of this Order, which will be published in the Official Journal of the French Republic.


Done in Paris, 19 December 2006.


Dominique de Villepin


By the Prime Minister:


Minister of Health and Solidarity,

Xavier Bertrand


Download the document in RTF (weight < 1MB) Extrait du Journal officiel électronique authentifié (format: pdf, weight : 0.35 Mo) Download the document in RDF (format: rdf, weight < 1 MB)