{"id":44858,"date":"2024-06-11T10:12:56","date_gmt":"2024-06-11T08:12:56","guid":{"rendered":"https:\/\/www.sssh.ch\/forum\/swissmedic-apporte-un-soutien-essentiel-aux-etablissements-de-sante-en-mettant-a-leur-disposition-des-guides-et-listes-de-controle-dans-les-domaines-du-retraitement-de-la-maintenance-et-de-la-vigilan\/"},"modified":"2024-06-11T17:28:30","modified_gmt":"2024-06-11T15:28:30","slug":"swissmedic-apporte-un-soutien-essentiel-aux-etablissements-de-sante-en-mettant-a-leur-disposition-des-guides-et-listes-de-controle-dans-les-domaines-du-retraitement-de-la-maintenance-et-de-la-vigilan","status":"publish","type":"forum","link":"https:\/\/sssh.ch\/it\/forum\/swissmedic-apporte-un-soutien-essentiel-aux-etablissements-de-sante-en-mettant-a-leur-disposition-des-guides-et-listes-de-controle-dans-les-domaines-du-retraitement-de-la-maintenance-et-de-la-vigilan\/","title":{"rendered":"Swissmedic apporte un soutien essentiel aux \u00e9tablissements de sant\u00e9 en mettant \u00e0 leur disposition des guides et listes de contr\u00f4le dans les domaines du retraitement, de la maintenance et de la vigilance"},"content":{"rendered":"\t\t<div data-elementor-type=\"wp-post\" data-elementor-id=\"44858\" class=\"elementor elementor-44858 elementor-44825\" data-elementor-post-type=\"forum\">\n\t\t\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-c189627 elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"c189627\" data-element_type=\"section\" data-e-type=\"section\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-452de20\" data-id=\"452de20\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-350536a elementor-widget elementor-widget-text-editor\" data-id=\"350536a\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p>En tant qu\u2019autorit\u00e9 nationale de surveillance des produits th\u00e9rapeutiques, Swissmedic est \u00e9galement responsable de la surveillance des dispositifs m\u00e9dicaux et de leur conformit\u00e9 dans les h\u00f4pitaux suisses. Conform\u00e9ment \u00e0 l\u2019<a href=\"https:\/\/www.fedlex.admin.ch\/eli\/cc\/2020\/552\/fr\" target=\"_blank\" rel=\"noopener\">Ordonnance sur les dispositifs m\u00e9dicaux (ODim)<\/a> et \u00e0 l\u2019<a href=\"https:\/\/www.fedlex.admin.ch\/eli\/cc\/2022\/291\/fr\" target=\"_blank\" rel=\"noopener\">Ordonnance sur les dispositifs m\u00e9dicaux de diagnostic in vitro (ODiv)<\/a>, les \u00e9tablissements de sant\u00e9 sont soumis \u00e0 des obligations dans les domaines de la vigilance, de la maintenance, de la cybers\u00e9curit\u00e9 ainsi que du retraitement des dispositifs m\u00e9dicaux destin\u00e9s \u00e0 \u00eatre utilis\u00e9s dans les h\u00f4pitaux. Ces derniers sont \u00e9galement soumis \u00e0 l\u2019obligation l\u00e9gale de collaboration et d\u2019information et sont tenus de collaborer avec Swissmedic dans le cadre d\u2019une inspection hospitali\u00e8re.<\/p>\n<p>Afin de faciliter la compr\u00e9hension des exigences l\u00e9gales par les h\u00f4pitaux et de leur permettre de mettre en \u0153uvre de mani\u00e8re autonome des am\u00e9liorations dans les domaines susmentionn\u00e9s, Swissmedic publie r\u00e9guli\u00e8rement sur son site Internet des guides et aide-m\u00e9moire. Ces documents sont g\u00e9n\u00e9ralement \u00e9labor\u00e9s en collaboration avec des experts du domaine consid\u00e9r\u00e9 et donnent des informations d\u00e9taill\u00e9es et pratiques sur les th\u00e8mes du retraitement, de la maintenance et de la vigilance. Vous les trouverez <a href=\"https:\/\/www.swissmedic.ch\/swissmedic\/fr\/home\/dispositifs-medicaux\/retraitement-et-maintenance.html\" target=\"_blank\" rel=\"noopener\">ici<\/a>.<\/p>\n<p>Les derni\u00e8res publications ainsi que les documents de r\u00e9f\u00e9rence correspondants sont accessibles en cliquant sur les liens suivants\u00a0:<\/p>\n<ul>\n<li><a href=\"https:\/\/www.swissmedic.ch\/dam\/swissmedic\/fr\/dokumente\/medizinprodukte\/mep_urr\/checkliste_revalidation.pdf.download.pdf\/Checklist_revalidation_F_form.pdf\" target=\"_blank\" rel=\"noopener\">Check-list de contr\u00f4le d\u2019un rapport de revalidation d\u2019un proc\u00e9d\u00e9 de lavage et d\u00e9sinfection en LD pour instruments chirurgicaux ou en cabine de lavage pour les \u00e9tablissements de soins(PDF, 346 kB, 08.01.2024)<\/a><\/li>\n<li><a href=\"https:\/\/www.swissmedic.ch\/dam\/swissmedic\/fr\/dokumente\/medizinprodukte\/mep_urr\/guide_validation_allgemeines1.pdf.download.pdf\/Guide_validation_F1.pdf\" target=\"_blank\" rel=\"noopener\">Guide suisse de validation et de contr\u00f4le de routine des proc\u00e9d\u00e9s de lavage et de d\u00e9sinfection des dispositifs m\u00e9dicaux &#8211; Partie 1: G\u00e9n\u00e9ralit\u00e9s(PDF, 3 MB, 23.01.2019)<\/a><\/li>\n<li><a href=\"https:\/\/www.swissmedic.ch\/dam\/swissmedic\/fr\/dokumente\/medizinprodukte\/mep_urr\/guide_validation_teil2.pdf.download.pdf\/Guide_validation_F2.pdf\" target=\"_blank\" rel=\"noopener\">Guide suisse de validation et de contr\u00f4le de routine des proc\u00e9d\u00e9s de lavage et de d\u00e9sinfection des dispositifs m\u00e9dicaux &#8211; Partie 2: Proc\u00e9d\u00e9 de nettoyage m\u00e9canique et de d\u00e9sinfection thermique \u2013 LD pour instruments chirurgicaux, mat\u00e9riel d\u2019anesth\u00e9sie, bacs, plats, r\u00e9cipients, ustensiles, verrerie, etc.(PDF, 2 MB, 23.01.2019)<\/a><\/li>\n<li><a href=\"https:\/\/www.swissmedic.ch\/dam\/swissmedic\/fr\/dokumente\/medizinprodukte\/mep_urr\/checklist-sterilisateurs_e2.pdf.download.pdf\/Checklist_sterilisateurs_F_E2.pdf\" target=\"_blank\" rel=\"noopener\">Check-liste de contr\u00f4le d\u2019un rapport de qualification de performance (QP) d\u2019un st\u00e9rilisateur \u00e0 la vapeur d\u2019eau\u00a0(PDF, 237 kB, 25.10.2023)<\/a><\/li>\n<li><a href=\"https:\/\/www.swissmedic.ch\/dam\/swissmedic\/fr\/dokumente\/medizinprodukte\/infos\/schweizerische_leitlinie_validierung_und_routineueberwachung_von_sterilisationsprozessen_in_spitaelern.pdf.download.pdf\/Guide%20validation_2023_F.pdf\" target=\"_blank\" rel=\"noopener\">Guide suisse pour la validation et le contr\u00f4le de routine des proc\u00e9d\u00e9s de st\u00e9rilisation \u00e0 la vapeur d\u2019eau dans les h\u00f4pitaux(PDF, 454 kB, 09.05.2023)<\/a><\/li>\n<li><a href=\"https:\/\/www.swissmedic.ch\/dam\/swissmedic\/fr\/dokumente\/medizinprodukte\/mep_urr\/schweiz-leitlinie-transport.pdf.download.pdf\/Guide%20suisse%20pour%20le%20transport%20des%20dispositifs%20m%C3%A9dicaux%20r%C3%A9utilisables%20souill%C3%A9s%20et%20retrait%C3%A9s%20pour%20les%20centrales%20de%20st%C3%A9rilisation.pdf\" target=\"_blank\" rel=\"noopener\">Guide suisse pour le transport des dispositifs m\u00e9dicaux r\u00e9utilisables souill\u00e9s et retrait\u00e9s pour les centrales de st\u00e9rilisation\u00a0(PDF, 426 kB, 25.09.2023)<\/a><\/li>\n<\/ul>\n\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<\/div>\n\t\t","protected":false},"featured_media":0,"template":"","meta":{"_acf_changed":false,"site-sidebar-layout":"no-sidebar","site-content-layout":"page-builder","ast-site-content-layout":"full-width-container","site-content-style":"default","site-sidebar-style":"default","ast-global-header-display":"","ast-banner-title-visibility":"","ast-main-header-display":"","ast-hfb-above-header-display":"","ast-hfb-below-header-display":"","ast-hfb-mobile-header-display":"","site-post-title":"disabled","ast-breadcrumbs-content":"","ast-featured-img":"disabled","footer-sml-layout":"","ast-disable-related-posts":"","theme-transparent-header-meta":"","adv-header-id-meta":"","stick-header-meta":"","header-above-stick-meta":"","header-main-stick-meta":"","header-below-stick-meta":"","astra-migrate-meta-layouts":"default","ast-page-background-enabled":"default","ast-page-background-meta":{"desktop":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center 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