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(PDF) Penser différemment les risques en radiothérapie après les accidents d’Epinal et de Toulouse

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après les accidents d’Epinal et de Toulouse</h1><div class="ds-work-card--work-authors ds-work-card--detail"><a class="ds-work-card--author js-wsj-grid-card-author ds2-5-body-md ds2-5-body-link" data-author-id="60526180" href="https://independent.academia.edu/SylvieThellier"><img alt="Profile image of Sylvie Thellier" class="ds-work-card--author-avatar" src="//a.academia-assets.com/images/s65_no_pic.png" />Sylvie Thellier</a></div><div class="ds-work-card--detail"><p class="ds-work-card--detail ds2-5-body-sm">2019</p><div class="ds-work-card--work-metadata"><div class="ds-work-card--work-metadata__stat"><span class="material-symbols-outlined" style="font-size: 20px" translate="no">visibility</span><p class="ds2-5-body-sm" id="work-metadata-view-count">…</p></div><div class="ds-work-card--work-metadata__stat"><span class="material-symbols-outlined" style="font-size: 20px" translate="no">description</span><p class="ds2-5-body-sm">14 pages</p></div><div 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ds2-5-body-md">Les accidents en RT interrogent la sécurité des patients Journée SFEN -6 juin 2019 3 ▌ Feuille de route en radiothérapie  Référentiel en assurance qualité (ASN) :  Article 8 : analyse des risques encourus par les patients  Article 11: analyse des dysfonctionnements, des événements</p><div class="ds-work-card--button-container"><button class="ds2-5-button js-swp-download-button" data-signup-modal="{&quot;location&quot;:&quot;continue-reading-button--work-card&quot;,&quot;attachmentId&quot;:120872144,&quot;attachmentType&quot;:&quot;pdf&quot;,&quot;workUrl&quot;:&quot;https://www.academia.edu/127086705/Penser_diff%C3%A9remment_les_risques_en_radioth%C3%A9rapie_apr%C3%A8s_les_accidents_d_Epinal_et_de_Toulouse&quot;}">See full PDF</button><button class="ds2-5-button ds2-5-button--secondary js-swp-download-button" 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Cette these est une contribution empirique et theorique sur la « securite en reflexion » dans des espaces de discussion (regulation froide) que l’on distingue ici de la « securite en action » (regulation chaude). Ce travail cherche a determiner de nouveaux liens entre la securite et la gestion des risques – relation eminemment connectee mais egalement chargee d’ambiguites – en donnant une place preponderante a une etape methodologique souvent delaissee, l’identification des risques. La securite des soins dependant principalement des pratiques quotidiennes exercees par le personnel soignant, il s’agirait pour les analystes de fai...</p><div class="ds-related-work--ctas"><button class="ds2-5-text-link ds2-5-text-link--inline js-swp-download-button" data-signup-modal="{&quot;location&quot;:&quot;wsj-grid-card-download-pdf-modal&quot;,&quot;work_title&quot;:&quot;Approche ergonomique de l’analyse des risques en radiothérapie : de l’analyse des modes de défaillances à la mise en discussion des modes de réussite&quot;,&quot;attachmentId&quot;:77932009,&quot;attachmentType&quot;:&quot;pdf&quot;,&quot;work_url&quot;:&quot;https://www.academia.edu/66919493/Approche_ergonomique_de_l_analyse_des_risques_en_radioth%C3%A9rapie_de_l_analyse_des_modes_de_d%C3%A9faillances_%C3%A0_la_mise_en_discussion_des_modes_de_r%C3%A9ussite&quot;,&quot;alternativeTracking&quot;:true}"><span class="material-symbols-outlined" style="font-size: 18px" translate="no">download</span><span class="ds2-5-text-link__content">Download free PDF</span></button><a class="ds2-5-text-link ds2-5-text-link--inline js-wsj-grid-card-view-pdf" href="https://www.academia.edu/66919493/Approche_ergonomique_de_l_analyse_des_risques_en_radioth%C3%A9rapie_de_l_analyse_des_modes_de_d%C3%A9faillances_%C3%A0_la_mise_en_discussion_des_modes_de_r%C3%A9ussite"><span class="ds2-5-text-link__content">View PDF</span><span class="material-symbols-outlined" style="font-size: 18px" translate="no">chevron_right</span></a></div></div><div class="ds-related-work--container js-wsj-grid-card" data-collection-position="1" data-entity-id="127086719" data-sort-order="default"><a class="ds-related-work--title js-wsj-grid-card-title ds2-5-body-md ds2-5-body-link" href="https://www.academia.edu/127086719/Analyse_des_risques_en_radioth%C3%A9rapie">Analyse des risques en radiothérapie</a><div class="ds-related-work--metadata"><a class="js-wsj-grid-card-author ds2-5-body-sm ds2-5-body-link" data-author-id="60526180" href="https://independent.academia.edu/SylvieThellier">Sylvie Thellier</a></div><p class="ds-related-work--metadata ds2-5-body-xs">Radioprotection, 2019</p><p class="ds-related-work--abstract ds2-5-body-sm">À la suite de la survenue des accidents d&#39;Épinal (détecté en 2006) et de Toulouse (détecté en 2007), la radioprotection des patients a été remise en avant dans le travail de tous les acteurs concernés et s&#39;est imposée de fait comme incontournable. En conséquence, la réglementation concernant la gestion des risques en radiothérapie a évolué en France. En l&#39;absence de méthode propre pour analyser les risques médicaux, des méthodes d&#39;analyse des risques issues des sciences de l&#39;ingénieur ont été transposées en 2009 en radiothérapie. Il s&#39;agit notamment de la méthode d&#39;analyse des modes de défaillance et de leurs effets (AMDEC) adoptée par l&#39;Autorité de sûreté nucléaire dans son guide méthodologique. Mais l&#39;application de l&#39;AMDEC en radiothérapie a révélé des difficultés d&#39;utilisation qui entrent en résonance avec certaines difficultés décrites dans la littérature internationale. Cet article, issu d&#39;une recherche en ergonomie conduite dans le domaine de la gestion des risques et de la sécurité des patients en radiothérapie, fait le point sur les forces et faiblesses de la méthode AMDEC. Mots clés : radiothérapie / gestion des risques / analyse des risques a priori / AMDEC / sécurité des patients Abstract -Risk analysis in radiotherapy. Part 1: Strengths and weaknesses of the FMEA method. As a consequence of the Épinal and Toulouse accidents detected in 2006 and 2007 respectively, radiological protection became a major and critical concern for all actors. Thus, the regulation regarding the management of risk in radiation therapy was updated. In the absence of a specific method of analysis of medical risks, methods developed by engineers were transposed in radiotherapy. The FMEA method (failure mode and effects analysis) has been adopted by the French nuclear safety authority (ASN) for the risk evaluation in external radiotherapy. But the application of FMEA to radiation therapy has shown intrinsic difficulties similar to those encountered in other domains. This article, resulting from a research in ergonomics in the domain of risk management and patient security, makes the point on the strengths and weaknesses of FMEA.</p><div class="ds-related-work--ctas"><button class="ds2-5-text-link ds2-5-text-link--inline js-swp-download-button" data-signup-modal="{&quot;location&quot;:&quot;wsj-grid-card-download-pdf-modal&quot;,&quot;work_title&quot;:&quot;Analyse des risques en radiothérapie&quot;,&quot;attachmentId&quot;:120872166,&quot;attachmentType&quot;:&quot;pdf&quot;,&quot;work_url&quot;:&quot;https://www.academia.edu/127086719/Analyse_des_risques_en_radioth%C3%A9rapie&quot;,&quot;alternativeTracking&quot;:true}"><span class="material-symbols-outlined" style="font-size: 18px" translate="no">download</span><span class="ds2-5-text-link__content">Download free PDF</span></button><a class="ds2-5-text-link ds2-5-text-link--inline js-wsj-grid-card-view-pdf" href="https://www.academia.edu/127086719/Analyse_des_risques_en_radioth%C3%A9rapie"><span class="ds2-5-text-link__content">View PDF</span><span class="material-symbols-outlined" style="font-size: 18px" translate="no">chevron_right</span></a></div></div><div class="ds-related-work--container js-wsj-grid-card" data-collection-position="2" data-entity-id="127086688" data-sort-order="default"><a class="ds-related-work--title js-wsj-grid-card-title ds2-5-body-md ds2-5-body-link" href="https://www.academia.edu/127086688/L_analyse_des_risques_d_un_syst%C3%A8me_sociotechnique_complexe_le_cas_de_la_radioth%C3%A9rapie">L’analyse des risques d’un système sociotechnique complexe : le cas de la radiothérapie</a><div class="ds-related-work--metadata"><a class="js-wsj-grid-card-author ds2-5-body-sm ds2-5-body-link" data-author-id="60526180" href="https://independent.academia.edu/SylvieThellier">Sylvie Thellier</a></div><p class="ds-related-work--metadata ds2-5-body-xs">Cancer/Radiothérapie, 2019</p><p class="ds-related-work--abstract ds2-5-body-sm">en Français La complexité croissante des situations de travail en radiothérapie (évolutions des technologies, dynamique de changement, accroissement des contraintes, évolution de l&#39;action collective, des métiers, des interfaces entre les Hommes, des Interfaces Homme-Machine, etc.) et les limites des méthodes classiques de type AMDEC (Analyse des Modes de Défaillances, de leurs Effets et de leur Criticité) pour analyser les risques encourus par les patients en radiothérapie génèrent des difficultés pour identifier comment les situations de travail d&#39;une équipe soignante peuvent conduire à des situations risquées pour les patients. Ce constat nous a amené à développer une nouvelle méthode d&#39;analyse des risques : les Espaces de Partage et d&#39;Exploration de la Complexité du Travail (EPECT). L&#39;objectif de cet article est de présenter cette démarche visant à mieux sécuriser un processus de soin (fiabilisation des pratiques, mise à jour du travail prescrit, définition de mesures de prévention et de correction, poursuite des réflexions) à partir d&#39;une compréhension de la complexité des situations de travail en radiothérapie et d&#39;une modification de notre manière de penser les risques. The increasing complexity of radiotherapy work situations (technological developments, dynamics of change, increased constraints, evolution of collective actions, of professions, of interfaces between people, of humanmachine interfaces, etc.) and the limits of traditional FMEA method (Failure Mode and Effects Analysis) for analysing the risks incurred by radiotherapy patients generate difficulties in identifying how the work situations of a healthcare team can generate risky situations for patients. This observation has led us to develop a new method of risk analysis: the Work Complexity Sharing and Exploration Spaces (EPECT in French). The objective of this article is to better secure a care process (making practices more reliable, updating prescribed work, defining preventive and corrective measures, continuing reflections) based on an understanding of the complexity of radiotherapy work situations and a change in our way of thinking about risks.</p><div class="ds-related-work--ctas"><button class="ds2-5-text-link ds2-5-text-link--inline js-swp-download-button" data-signup-modal="{&quot;location&quot;:&quot;wsj-grid-card-download-pdf-modal&quot;,&quot;work_title&quot;:&quot;L’analyse des risques d’un système sociotechnique complexe : le cas de la radiothérapie&quot;,&quot;attachmentId&quot;:120872119,&quot;attachmentType&quot;:&quot;pdf&quot;,&quot;work_url&quot;:&quot;https://www.academia.edu/127086688/L_analyse_des_risques_d_un_syst%C3%A8me_sociotechnique_complexe_le_cas_de_la_radioth%C3%A9rapie&quot;,&quot;alternativeTracking&quot;:true}"><span class="material-symbols-outlined" style="font-size: 18px" translate="no">download</span><span class="ds2-5-text-link__content">Download free PDF</span></button><a class="ds2-5-text-link ds2-5-text-link--inline js-wsj-grid-card-view-pdf" href="https://www.academia.edu/127086688/L_analyse_des_risques_d_un_syst%C3%A8me_sociotechnique_complexe_le_cas_de_la_radioth%C3%A9rapie"><span class="ds2-5-text-link__content">View PDF</span><span class="material-symbols-outlined" style="font-size: 18px" translate="no">chevron_right</span></a></div></div><div class="ds-related-work--container js-wsj-grid-card" data-collection-position="3" data-entity-id="127086685" data-sort-order="default"><a class="ds-related-work--title js-wsj-grid-card-title ds2-5-body-md ds2-5-body-link" href="https://www.academia.edu/127086685/Analyse_d_un_accident_de_radioth%C3%A9rapie_sous_l_angle_des_facteurs_humains_et_organisationnels">Analyse d’un accident de radiothérapie sous l’angle des facteurs humains et organisationnels</a><div class="ds-related-work--metadata"><a class="js-wsj-grid-card-author ds2-5-body-sm ds2-5-body-link" data-author-id="60526180" href="https://independent.academia.edu/SylvieThellier">Sylvie Thellier</a></div><p class="ds-related-work--metadata ds2-5-body-xs">Radioprotection, 2009</p><p class="ds-related-work--abstract ds2-5-body-sm">Depuis septembre 2005, l&#39;Institut de radioprotection et de sûreté nucléaire (IRSN) étudie les activités de traitement par radiothérapie sous l&#39;angle des facteurs humains et organisationnels, afin d&#39;améliorer la sécurité des traitements. Bénéficiant d&#39;une expérience d&#39;analyse des événements dans l&#39;industrie nucléaire, l&#39;IRSN a utilisé cette approche pour diffuser en mars 2008, pour la première fois en France, l&#39;analyse approfondie d&#39;un accident de radiothérapie sous l&#39;angle des facteurs humains et organisationnels. La méthode d&#39;analyse est basée sur des entretiens et sur les traces écrites conservées par le centre hospitalier. Cette analyse visait à identifier les causes de l&#39;écart constaté entre la dose prescrite par le radiothérapeute et la dose effectivement reçue par le patient. Ainsi, l&#39;IRSN a tout d&#39;abord constaté que les moyens de communication verbale (réunions techniques communes) et écrite (protocoles de traitement) n&#39;ont pas permis, pour ce traitement, la transmission des informations nécessaires à la bonne réalisation des champs d&#39;irradiation par les manipulateurs. Ensuite, cette analyse a fait apparaître qu&#39;au cours de la préparation et de la réalisation de ce traitement, différents facteurs ont conduit à ce que des contrôles prévus ne soient pas réalisés. Enfin, l&#39;analyse a révélé que des zones d&#39;ombre persistent sur le déroulement de cet accident, faute de traçabilité d&#39;un certain nombre d&#39;actions clés. L&#39;article identifie des pistes d&#39;amélioration dans trois domaines : la coopération entre les praticiens, le contrôle des actions et la traçabilité des actions. ABSTRACT A human factor analysis of a radiotherapy accident. Since September 2005, IRSN studies activities of radiotherapy treatment from the angle of the human and organizational factors to improve the reliability of treatment in radiotherapy. Experienced in nuclear industry incidents analysis, IRSN analysed and diffused in March 2008, for the first time in France, the detailed study of a radiotherapy accident from the angle of the human and organizational factors. The method used for analysis is based on interviews and documents kept by the hospital. This analysis aimed at identifying the causes of the difference recorded between the dose prescribed by the radiotherapist and the dose effectively received by the patient. Neither verbal nor written communication (intra-service meetings and protocols of treatment) allowed information to be transmitted correctly in order to permit radiographers to adjust the irradiation zones correctly. This analysis highlighted the fact that during the preparation and the carrying out of the treatment, various factors led planned controls to not be performed. Finally, this analysis highlighted the fact that unsolved areas persist in the report over this</p><div class="ds-related-work--ctas"><button class="ds2-5-text-link ds2-5-text-link--inline js-swp-download-button" data-signup-modal="{&quot;location&quot;:&quot;wsj-grid-card-download-pdf-modal&quot;,&quot;work_title&quot;:&quot;Analyse d’un accident de radiothérapie sous l’angle des facteurs humains et organisationnels&quot;,&quot;attachmentId&quot;:120872112,&quot;attachmentType&quot;:&quot;pdf&quot;,&quot;work_url&quot;:&quot;https://www.academia.edu/127086685/Analyse_d_un_accident_de_radioth%C3%A9rapie_sous_l_angle_des_facteurs_humains_et_organisationnels&quot;,&quot;alternativeTracking&quot;:true}"><span class="material-symbols-outlined" style="font-size: 18px" translate="no">download</span><span class="ds2-5-text-link__content">Download free PDF</span></button><a class="ds2-5-text-link ds2-5-text-link--inline js-wsj-grid-card-view-pdf" href="https://www.academia.edu/127086685/Analyse_d_un_accident_de_radioth%C3%A9rapie_sous_l_angle_des_facteurs_humains_et_organisationnels"><span class="ds2-5-text-link__content">View PDF</span><span class="material-symbols-outlined" style="font-size: 18px" translate="no">chevron_right</span></a></div></div><div class="ds-related-work--container js-wsj-grid-card" data-collection-position="4" data-entity-id="31591313" data-sort-order="default"><a class="ds-related-work--title js-wsj-grid-card-title ds2-5-body-md ds2-5-body-link" href="https://www.academia.edu/31591313/L_analyse_de_la_complexit%C3%A9_de_l_activit%C3%A9_pour_identifier_les_risques_encourus_par_les_patients_en_radioth%C3%A9rapie">L’analyse de la complexité de l’activité pour identifier les risques encourus par les patients en radiothérapie</a><div class="ds-related-work--metadata"><a class="js-wsj-grid-card-author ds2-5-body-sm ds2-5-body-link" data-author-id="60526180" href="https://independent.academia.edu/SylvieThellier">Sylvie Thellier</a></div><p class="ds-related-work--metadata ds2-5-body-xs">Congrès Lambda Mu 20 de Maîtrise des Risques et de Sûreté de Fonctionnement, 2016</p><div class="ds-related-work--ctas"><button class="ds2-5-text-link ds2-5-text-link--inline js-swp-download-button" data-signup-modal="{&quot;location&quot;:&quot;wsj-grid-card-download-pdf-modal&quot;,&quot;work_title&quot;:&quot;L’analyse de la complexité de l’activité pour identifier les risques encourus par les patients en radiothérapie&quot;,&quot;attachmentId&quot;:51922610,&quot;attachmentType&quot;:&quot;pdf&quot;,&quot;work_url&quot;:&quot;https://www.academia.edu/31591313/L_analyse_de_la_complexit%C3%A9_de_l_activit%C3%A9_pour_identifier_les_risques_encourus_par_les_patients_en_radioth%C3%A9rapie&quot;,&quot;alternativeTracking&quot;:true}"><span class="material-symbols-outlined" style="font-size: 18px" translate="no">download</span><span class="ds2-5-text-link__content">Download free PDF</span></button><a class="ds2-5-text-link ds2-5-text-link--inline js-wsj-grid-card-view-pdf" href="https://www.academia.edu/31591313/L_analyse_de_la_complexit%C3%A9_de_l_activit%C3%A9_pour_identifier_les_risques_encourus_par_les_patients_en_radioth%C3%A9rapie"><span class="ds2-5-text-link__content">View PDF</span><span class="material-symbols-outlined" style="font-size: 18px" translate="no">chevron_right</span></a></div></div><div class="ds-related-work--container js-wsj-grid-card" data-collection-position="5" data-entity-id="16958882" data-sort-order="default"><a class="ds-related-work--title js-wsj-grid-card-title ds2-5-body-md ds2-5-body-link" href="https://www.academia.edu/16958882/Les_accidents_lors_d_explorations_radiologiques">Les accidents lors d’explorations radiologiques</a><div class="ds-related-work--metadata"><a class="js-wsj-grid-card-author ds2-5-body-sm ds2-5-body-link" data-author-id="36464003" href="https://independent.academia.edu/PhilippejeanBousquet">Philippe-jean Bousquet</a></div><p class="ds-related-work--metadata ds2-5-body-xs">2009</p><p class="ds-related-work--abstract ds2-5-body-sm">Hypersensitivity reactions to radio-contrast media are frequent (3.8% to 12% for iodinated products, less for gadolinium agents), and are most likely due to their intrinsic toxicity. Rarely the cause is immunological. Epidemiological surveys have shown that ionic products are more often involved and, that important risk factors are a previous identicial reaction after an injection and asthma. Nowadays, all moderate</p><div class="ds-related-work--ctas"><button class="ds2-5-text-link ds2-5-text-link--inline js-swp-download-button" data-signup-modal="{&quot;location&quot;:&quot;wsj-grid-card-download-pdf-modal&quot;,&quot;work_title&quot;:&quot;Les accidents lors d’explorations radiologiques&quot;,&quot;attachmentId&quot;:42368862,&quot;attachmentType&quot;:&quot;pdf&quot;,&quot;work_url&quot;:&quot;https://www.academia.edu/16958882/Les_accidents_lors_d_explorations_radiologiques&quot;,&quot;alternativeTracking&quot;:true}"><span class="material-symbols-outlined" style="font-size: 18px" translate="no">download</span><span class="ds2-5-text-link__content">Download free PDF</span></button><a class="ds2-5-text-link ds2-5-text-link--inline js-wsj-grid-card-view-pdf" href="https://www.academia.edu/16958882/Les_accidents_lors_d_explorations_radiologiques"><span class="ds2-5-text-link__content">View PDF</span><span class="material-symbols-outlined" style="font-size: 18px" translate="no">chevron_right</span></a></div></div><div class="ds-related-work--container js-wsj-grid-card" data-collection-position="6" data-entity-id="88163891" data-sort-order="default"><a class="ds-related-work--title js-wsj-grid-card-title ds2-5-body-md ds2-5-body-link" href="https://www.academia.edu/88163891/Lanalyse_des_risques_en_radioth%C3%A9rapie_quelle_alternative_%C3%A0_lAMDEC">L&#39;analyse des risques en radiothérapie : quelle alternative à l&#39;AMDEC?</a><div class="ds-related-work--metadata"><a class="js-wsj-grid-card-author ds2-5-body-sm ds2-5-body-link" data-author-id="33646691" href="https://independent.academia.edu/LucieCuvelier">Lucie Cuvelier</a></div><p class="ds-related-work--metadata ds2-5-body-xs">2018</p><p class="ds-related-work--abstract ds2-5-body-sm">The present research falls within the fields of risk management and patient safety. It focuses exclusively on the implementation of the prospective approach through the Failure Mode Effects Analysis (FMEA). The FMEA method has been controversial. Its effectiveness in minimizing accident risk in a human and complex sociotechnical system is called into question by its methodological limits in radiation therapy. This work proposes an alternative method which provides a link between the daily work of a medical team and the patient risks. The risk is thought differently in &quot;Spaces for Sharing and Exploring the Complexity of Work&quot;. The aim of this space of discussion is to analyze the weakening process of success modes which are mobilized to deal with the complexity of work.</p><div class="ds-related-work--ctas"><button class="ds2-5-text-link ds2-5-text-link--inline js-swp-download-button" data-signup-modal="{&quot;location&quot;:&quot;wsj-grid-card-download-pdf-modal&quot;,&quot;work_title&quot;:&quot;L&#39;analyse des risques en radiothérapie : quelle alternative à l&#39;AMDEC?&quot;,&quot;attachmentId&quot;:92191770,&quot;attachmentType&quot;:&quot;pdf&quot;,&quot;work_url&quot;:&quot;https://www.academia.edu/88163891/Lanalyse_des_risques_en_radioth%C3%A9rapie_quelle_alternative_%C3%A0_lAMDEC&quot;,&quot;alternativeTracking&quot;:true}"><span class="material-symbols-outlined" style="font-size: 18px" translate="no">download</span><span class="ds2-5-text-link__content">Download free PDF</span></button><a class="ds2-5-text-link ds2-5-text-link--inline js-wsj-grid-card-view-pdf" href="https://www.academia.edu/88163891/Lanalyse_des_risques_en_radioth%C3%A9rapie_quelle_alternative_%C3%A0_lAMDEC"><span class="ds2-5-text-link__content">View PDF</span><span class="material-symbols-outlined" style="font-size: 18px" translate="no">chevron_right</span></a></div></div><div class="ds-related-work--container js-wsj-grid-card" data-collection-position="7" data-entity-id="107593446" data-sort-order="default"><a class="ds-related-work--title js-wsj-grid-card-title ds2-5-body-md ds2-5-body-link" href="https://www.academia.edu/107593446/Drame_de_Rennes_risque_et_vigilance_dans_les_essais_cliniques">Drame de Rennes : risque et vigilance dans les essais cliniques</a><div class="ds-related-work--metadata"><a class="js-wsj-grid-card-author ds2-5-body-sm ds2-5-body-link" data-author-id="6470347" href="https://univ-paris7.academia.edu/philippeamielinsermfr">Philippe Amiel</a></div><p class="ds-related-work--metadata ds2-5-body-xs">2016</p><p class="ds-related-work--abstract ds2-5-body-sm">Le drame de Rennes — un volontaire sain qui decede dans le cours d’un essai clinique de premiere administration chez l’etre humain d’une molecule en developpement — nous rappelle que la participation aux essais biomedicaux n’est pas une situation anodine. On peut, a cette occasion, se souvenir que les drames sanitaires et les &amp;quot;horor stories&amp;quot; de l’experimentation sur l’etre humain ont ete le moteur de l’evolution reglementaire sur les essais. Et que la reglementation des essais de premiere administration chez l’homme, qui sera sans doute precisee en reponse a l’accident, n’a d’efficacite que conjuguee a une extreme vigilance des experimentateurs.</p><div class="ds-related-work--ctas"><button class="ds2-5-text-link ds2-5-text-link--inline js-swp-download-button" data-signup-modal="{&quot;location&quot;:&quot;wsj-grid-card-download-pdf-modal&quot;,&quot;work_title&quot;:&quot;Drame de Rennes : risque et vigilance dans les essais cliniques&quot;,&quot;attachmentId&quot;:106219366,&quot;attachmentType&quot;:&quot;pdf&quot;,&quot;work_url&quot;:&quot;https://www.academia.edu/107593446/Drame_de_Rennes_risque_et_vigilance_dans_les_essais_cliniques&quot;,&quot;alternativeTracking&quot;:true}"><span class="material-symbols-outlined" style="font-size: 18px" translate="no">download</span><span class="ds2-5-text-link__content">Download free PDF</span></button><a class="ds2-5-text-link ds2-5-text-link--inline js-wsj-grid-card-view-pdf" href="https://www.academia.edu/107593446/Drame_de_Rennes_risque_et_vigilance_dans_les_essais_cliniques"><span class="ds2-5-text-link__content">View PDF</span><span class="material-symbols-outlined" style="font-size: 18px" translate="no">chevron_right</span></a></div></div><div class="ds-related-work--container js-wsj-grid-card" data-collection-position="8" data-entity-id="20266788" data-sort-order="default"><a class="ds-related-work--title js-wsj-grid-card-title ds2-5-body-md ds2-5-body-link" href="https://www.academia.edu/20266788/Prise_en_charge_du_risque_h%C3%A9mostatique_au_cours_des_actes_de_radiologie_interventionnelle">Prise en charge du risque hémostatique au cours des actes de radiologie interventionnelle</a><div class="ds-related-work--metadata"><a class="js-wsj-grid-card-author ds2-5-body-sm ds2-5-body-link" data-author-id="41483470" href="https://independent.academia.edu/ChristopheTeriitehau">Christophe Teriitehau</a></div><p class="ds-related-work--metadata ds2-5-body-xs">Journal de Radiologie, 2011</p><p class="ds-related-work--abstract ds2-5-body-sm">Periprocedural management of hemostasis risk in interventional radiology</p><div class="ds-related-work--ctas"><button class="ds2-5-text-link ds2-5-text-link--inline js-swp-download-button" data-signup-modal="{&quot;location&quot;:&quot;wsj-grid-card-download-pdf-modal&quot;,&quot;work_title&quot;:&quot;Prise en charge du risque hémostatique au cours des actes de radiologie interventionnelle&quot;,&quot;attachmentId&quot;:41169884,&quot;attachmentType&quot;:&quot;pdf&quot;,&quot;work_url&quot;:&quot;https://www.academia.edu/20266788/Prise_en_charge_du_risque_h%C3%A9mostatique_au_cours_des_actes_de_radiologie_interventionnelle&quot;,&quot;alternativeTracking&quot;:true}"><span class="material-symbols-outlined" style="font-size: 18px" translate="no">download</span><span class="ds2-5-text-link__content">Download free PDF</span></button><a class="ds2-5-text-link ds2-5-text-link--inline js-wsj-grid-card-view-pdf" href="https://www.academia.edu/20266788/Prise_en_charge_du_risque_h%C3%A9mostatique_au_cours_des_actes_de_radiologie_interventionnelle"><span class="ds2-5-text-link__content">View PDF</span><span class="material-symbols-outlined" style="font-size: 18px" translate="no">chevron_right</span></a></div></div><div class="ds-related-work--container js-wsj-grid-card" data-collection-position="9" data-entity-id="78943625" data-sort-order="default"><a class="ds-related-work--title js-wsj-grid-card-title ds2-5-body-md ds2-5-body-link" href="https://www.academia.edu/78943625/1324_Risques_et_responsabilite_en_radiologie_diagnostique_et_interventionnelle_aspects_ethiques_et_medico_legaux">1324 Risques et responsabilite en radiologie diagnostique et interventionnelle : aspects ethiques et medico-legaux</a><div class="ds-related-work--metadata"><a class="js-wsj-grid-card-author ds2-5-body-sm ds2-5-body-link" data-author-id="42308712" href="https://independent.academia.edu/StephanosFinitsis">Stephanos Finitsis</a></div><p class="ds-related-work--metadata ds2-5-body-xs">Journal de Radiologie, 2004</p><p class="ds-related-work--abstract ds2-5-body-sm">Risks and responsibilities in diagnostic and interventional radiology. Ethical and medicolegal considerations.</p><div class="ds-related-work--ctas"><button class="ds2-5-text-link ds2-5-text-link--inline js-swp-download-button" data-signup-modal="{&quot;location&quot;:&quot;wsj-grid-card-download-pdf-modal&quot;,&quot;work_title&quot;:&quot;1324 Risques et responsabilite en radiologie diagnostique et interventionnelle : aspects ethiques et medico-legaux&quot;,&quot;attachmentId&quot;:85826209,&quot;attachmentType&quot;:&quot;pdf&quot;,&quot;work_url&quot;:&quot;https://www.academia.edu/78943625/1324_Risques_et_responsabilite_en_radiologie_diagnostique_et_interventionnelle_aspects_ethiques_et_medico_legaux&quot;,&quot;alternativeTracking&quot;:true}"><span class="material-symbols-outlined" style="font-size: 18px" translate="no">download</span><span class="ds2-5-text-link__content">Download free PDF</span></button><a class="ds2-5-text-link ds2-5-text-link--inline js-wsj-grid-card-view-pdf" href="https://www.academia.edu/78943625/1324_Risques_et_responsabilite_en_radiologie_diagnostique_et_interventionnelle_aspects_ethiques_et_medico_legaux"><span class="ds2-5-text-link__content">View PDF</span><span class="material-symbols-outlined" style="font-size: 18px" translate="no">chevron_right</span></a></div></div></div></div><div class="ds-sticky-ctas--wrapper js-loswp-sticky-ctas hidden"><div class="ds-sticky-ctas--grid-container"><div class="ds-sticky-ctas--container"><button class="ds2-5-button js-swp-download-button" data-signup-modal="{&quot;location&quot;:&quot;continue-reading-button--sticky-ctas&quot;,&quot;attachmentId&quot;:120872144,&quot;attachmentType&quot;:&quot;pdf&quot;,&quot;workUrl&quot;:null}">See full PDF</button><button class="ds2-5-button ds2-5-button--secondary js-swp-download-button" data-signup-modal="{&quot;location&quot;:&quot;download-pdf-button--sticky-ctas&quot;,&quot;attachmentId&quot;:120872144,&quot;attachmentType&quot;:&quot;pdf&quot;,&quot;workUrl&quot;:null}"><span class="material-symbols-outlined" style="font-size: 20px" translate="no">download</span>Download PDF</button></div></div></div><div class="ds-below-fold--grid-container"><div class="ds-work--container js-loswp-embedded-document"><div class="attachment_preview" data-attachment="Attachment_120872144" style="display: none"><div class="js-scribd-document-container"><div class="scribd--document-loading js-scribd-document-loader" style="display: block;"><img alt="Loading..." src="//a.academia-assets.com/images/loaders/paper-load.gif" /><p>Loading Preview</p></div></div><div style="text-align: center;"><div class="scribd--no-preview-alert js-preview-unavailable"><p>Sorry, preview is currently unavailable. 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