{"id":44854,"date":"2024-06-11T10:12:10","date_gmt":"2024-06-11T08:12:10","guid":{"rendered":"https:\/\/www.sssh.ch\/forum\/libre-expression-des-membres\/"},"modified":"2024-06-11T17:33:04","modified_gmt":"2024-06-11T15:33:04","slug":"libre-expression-des-membres","status":"publish","type":"forum","link":"https:\/\/sssh.ch\/it\/forum\/libre-expression-des-membres\/","title":{"rendered":"Libre expression des membres"},"content":{"rendered":"\t\t
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Vous nous faites r\u00e9guli\u00e8rement part de remarques ou questions par messagerie, ou au cours des journ\u00e9es de formation. Ce compte-rendu ne pr\u00e9tend pas \u00eatre exhaustif, et est le reflet de quelques \u00e9changes de ces derni\u00e8res semaines :<\/p>\n

Le responsable du bloc op\u00e9ratoire et de la st\u00e9rilisation n\u2019a pas de formation reconnue en Suisse en mati\u00e8re de retraitement des dispositifs m\u00e9dicaux, mais les 4 collaboratrices au sein du SRDM sont form\u00e9es niveau 1, et une d\u2019entre elle envisage de suivre la proc\u00e9dure de qualification selon l\u2019article 32 en 2025. Sommes-nous en conformit\u00e9 par rapport aux BPR ?<\/em><\/p>\n

Non, car le chapitre 4.3.1 des BPR exige que le responsable du processus de retraitement des dispositifs m\u00e9dicaux justifie d\u2019une exp\u00e9rience et d\u2019une formation ad\u00e9quate (Ste 2, TDM, ou \u00e9quivalences valid\u00e9es). La priorit\u00e9 de l\u2019\u00e9tablissement est de garantir que le personnel responsable soit form\u00e9. Le responsable doit faire les d\u00e9marches ad\u00e9quates pour faire valoir la reconnaissance de ses qualifications en Suisse.<\/p>\n

Lors de la requalification annuelle de mes laveur-d\u00e9sinfecteurs pour instruments, le partenaire de validation n\u2019a pas utilis\u00e9 la souillure test que j\u2019utilise en routine pour les contr\u00f4les mensuels du nettoyage. Puis-je accepter le rapport de validation ?<\/em><\/p>\n

L\u2019objectif de la qualification des performances est de rendre compte de la conformit\u00e9 de l\u2019ensemble des param\u00e8tres critiques dans les conditions d\u2019exploitation en routine. Ces contr\u00f4les font partie int\u00e9grante du syst\u00e8me qualit\u00e9 du SRDM. Il ne doit pas y avoir d\u2019\u00e9carts entre les conditions de requalification et le fonctionnement en routine. Une meilleure planification de la validation aurait \u00e9vit\u00e9 ce probl\u00e8me. L\u2019\u00e9tablissement est le donneur d\u2019ordre. Seule une analyse de risques d\u00fbment argument\u00e9e permettrait d\u2019accepter le rapport, en d\u00e9montrant l\u2019\u00e9quivalence des tests utilis\u00e9s, ce qui est difficile du fait de leur composition.<\/p>\n

Les horaires d\u2019ouverture du SRDM sont de 6h30 \u00e0 20h00 du lundi au vendredi. En dehors de ces horaires, le personnel de bloc op\u00e9ratoire (TSO) retraite le mat\u00e9riel en urgence et lib\u00e8re les charges st\u00e9rilis\u00e9es. Est-ce conforme ?<\/em><\/p>\n

Le personnel qui retraite les dispositifs m\u00e9dicaux doit \u00eatre form\u00e9. Il doit avoir valid\u00e9 le certificat STE 1 ou \u00eatre au b\u00e9n\u00e9fice d\u2019un titre jug\u00e9 \u00e9quivalent. En Suisse Romande par exemple, les \u00e9tudiants TSO \u00e0 ES Sant\u00e9 Lausanne suivent des cours de formation en mati\u00e8re de retraitement des dispositifs m\u00e9dicaux et passent l\u2019examen ATS niveau 1 \u00e0 Espace Comp\u00e9tences \u00e0 Cully en m\u00eame temps que les autres agents de st\u00e9rilisation en formation. Ils doivent r\u00e9ussir l\u2019examen sous peine de ne pas valider leur premi\u00e8re ann\u00e9e d\u2019\u00e9tude.<\/p>\n

En tant qu\u2019apprenti TDM je suis amen\u00e9 \u00e0 lib\u00e9rer des charges en fin de premi\u00e8re ann\u00e9e car j\u2019ai suivi une formation interne par l\u2019\u00e9quipe du SRDM.<\/em><\/p>\n

L\u2019apprentissage CFC TDM en 3 ans a \u00e9t\u00e9 formalis\u00e9 en fonction d\u2019un rythme d\u2019acquisition des connaissances au cours des 6 semestres de la formation. La comp\u00e9tence D, relative \u00e0 la st\u00e9rilisation des dispositifs m\u00e9dicaux, n\u2019est abord\u00e9e qu\u2019en deuxi\u00e8me ann\u00e9e. Il n\u2019est donc pas possible d\u2019affecter un apprenti premi\u00e8re ann\u00e9e dans un secteur pour lequel les connaissances th\u00e9oriques n\u2019ont pas \u00e9t\u00e9 enseign\u00e9es dans les \u00e9coles de formation. M\u00eame si la lib\u00e9ration de la charge du st\u00e9rilisateur est contre-sign\u00e9e par du personnel form\u00e9, le rythme de l\u2019apprentissage n\u2019est pas respect\u00e9.<\/p>\n

Le rapport annuel de validation de la thermo-soudeuse est-il suffisant pour d\u00e9montrer que les emballages sous sachets papier-plastique sont valid\u00e9s ?<\/em><\/p>\n

Non, il s\u2019agit uniquement de la qualification de l\u2019\u00e9quipement. La validation des emballages doit notamment tenir compte, en sus, des familles de dispositifs m\u00e9dicaux emball\u00e9s. La SGSV\/SSSH\/SSSO travail \u00e0 la r\u00e9daction d\u2019un prochain guide Suisse qui sera sp\u00e9cifique \u00e0 la validation et aux contr\u00f4les de tous les types de syst\u00e8mes d\u2019emballage, et sera annex\u00e9 aux BPR. Concernant la thermo-soudeuse, veillez toujours \u00e0 demander le rapport de maintenance de l\u2019\u00e9quipement, et pas uniquement le rapport de validation.<\/p>\n

Un nouveau dispositif m\u00e9dical import\u00e9 des USA, dont la mise sur le march\u00e9 a \u00e9t\u00e9 autoris\u00e9 en Suisse, recommande de st\u00e9riliser \u00e0 132\u00b0C pendant 4 minutes. Comment r\u00e9agir puisqu\u2019en Suisse nous devons st\u00e9riliser \u00e0 134\u00b0C 18 minutes ?<\/em><\/p>\n

Effectivement, vous devez contacter le fabricant ou le distributeur pour exiger une instruction correspondant aux exigences de l\u2019Ordonnance sur les Epid\u00e9mies. C\u2019est g\u00e9n\u00e9ralement bien accept\u00e9, et vous pouvez joindre la r\u00e9ponse au dossier du dispositif m\u00e9dical. En cas d\u2019instructions incompl\u00e8tes ou ne correspondant pas aux exigences de retraitement nationales, vous devez faire une d\u00e9claration de mat\u00e9riovigilance au sein de votre \u00e9tablissement, car il peut y avoir un risque qu\u2019apr\u00e8s retraitement le dispositif m\u00e9dical ne soit ni s\u00fbr, ni fonctionnel.<\/p>\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 center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"tablet":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"mobile":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""}},"ast-content-background-meta":{"desktop":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"tablet":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"mobile":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""}}},"forum_cat":[1319],"parution":[],"page_sommaire":[],"class_list":["post-44854","forum","type-forum","status-publish","hentry","forum_cat-forum-2-2024-it"],"acf":[],"yoast_head":"\nLibre expression des membres - 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