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Guide sur la sécurité et l'assurance de qualité de la transplantation d'organes, de tissus et de cellules - 3e édition & addendum 2009 (2009)

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Blood transfusion and organ transplantation
Format : Paper Papier PDF PDF
978-92-871-6567-1
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Format :
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Language :
French
Size :
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Number of pages :
188
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La transplantation d'organes constitue le plus souvent le seul traitement disponible en cas de défaillance terminale d'organes. La transplantation de tissus et de cellules offre des avantages thérapeutiques importants et une amélioration de la qualité de vie, mais soulève un certain nombre de questions de principe.Le Conseil de l'Europe représente l'institution principale en matière de définition des normes dans ce domaine. Il étudie la transplantation d'organes des points de vue éthique et humain, respectant à cet égard le principe de la non-commercialisation et du don volontaire de substances d'origine humaine qui est à la base de toutes les questions éthiques. Il travaille sur des thèmes tels que l'assurance de la sécurité et de la qualité des organes, tissus et cellules, sur les moyens de faire face à la pénurie d'organes et de donneurs vivants, ou encore sur la façon de prévenir et de réduire le trafic d'organes.Cette 3e édition du guide s'applique à la transplantation d'organes, de tissus et de cellules d'origine humaine pratiquée avec une finalité thérapeutique. Son but est de donner des orientations à toutes les personnes concernées afin de garantir la meilleure qualité possible des organes, tissus et cellules, de réduire les risques, et par là même d'optimiser le taux de réussite des transplantations. Ce guide comprend des normes de sécurité et d'assurance de qualité pour la collecte, la conservation, le traitement et la distribution des organes, tissus et cellules d'origine humaine (allogènes et autologues) utilisés à des fins de transplantation.Un addendum a été ajouté à la 3e édition de ce guide, afin de traiter spécifiquement des critères de prévention de la transmission de néoplasies via le don d'organes. Cet addendum a été finalisé dans le cadre du Comité européen (accord partiel) sur la transplantation d'organes (CD-P-TO), un nouveau comité agissant sous l'égide de la Direction Européenne de la Qualité du Médicament & Soins de Santé (DEQM) depuis 2007.

Chapitre 1 - Introduction
1.1.    Introduction et champ d'application
1.2.   Intérêt de la transplantation
1.3.   Risques de la transplantation
1.4.   Aspects éthiques
1.5.   Gestion de qualité
1.6.   Questions concernant l'organisation

Chapitre 2 - Gestion de qualité : principes destinés à assurer la qualité des organes, tissus et cellules
2.1.    Introduction
2.2.   Principes généraux
2.3.   Exemples de systèmes de gestion de qualité
2.4.   Terminologie
2.5.   Management de la qualité

Chapitre 3 - Sélection des donneurs
3.1.   Exigences générales
3.2.   Donneurs décédés
3.3.   Donneurs vivants
3.4.   Prélèvement de résidus opératoires
3.5.   Nouveau contrôle des donneurs vivants de matériel allogénique conservé

Chapitre 4 - Prélèvement et préservation des organes
4.1.    Donneurs décédés
4.2.    Donneurs vivants
4.3.    Conservation, conditionnement, transport et traçabilité des organes

Chapitre 5 - Prélèvement de tissus et de cellules
5.1.   Prélèvement sur des donneurs décédés
5.2.   Prélèvement sur des donneurs vivants
5.3.   Identifiant unique du donneur
5.4. Etiquetage et conditionnement
5.5. Documentation relative au prélèvement
5.6. Stockage et transport jusqu'à l'unité de transformation
5.7. Cellules souches hématopoïétiques : problèmes particuliers

Chapitre 6 - Etablissements de conservation de tissus
6.1     Conditions générales d'organisation d'un établissement de conservation de tissus
6.2.   Locaux et matériel
6.3.   Transformation, conservation et stockage des tissus et des cellules
6.4. Délivrance de tissus ou de cellules
6.5. Distribution
6.6. Traçabilité
6.7. Transport
6.8. Retour à l'inventaire
6.9. Délivrance exceptionnelle
6.10. Réactions et événements indésirables et non-conformités
6.11. Stockage et distribution des tissus et cellules a l'hôpital

Chapitre 7 - Pratique de la transplantation
7.1.    Questions concernant l'organisation
7.2.    Période prétransplantatoire
7.3.    Periode péritransplantatoire
7.4.    Periode post-transplantatoire
7.5.    Utilisation d'organes, de tissus et de cellules à d'autres fins que la transplantation

Annexe 1 - Comite d'experts sur la sécurité et l'assurance de qualité des organes, tissus et cellules (SP-SQA)
Annexe 2 - Liste des normes/orientations pertinentes
Annexe 3 - Facteurs à prendre en considération pour évaluer le risque de propagation de maladies transmissibles par un donneur
Annexe 4 - Définitions
Annexe 5 - Protocole additionnel à la Convention sur les droits de l'homme et la biomédecine relatif à la transplantation d'organes et de tissus d'origine humaine
Addendum 2009 - Critères de prévention de la transmission des néoplasies via le don d'organes

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