Le 20 octobre 2026, la Food and Drug Administration (FDA) des \u00c9tats-Unis a annonc\u00e9 la mise sous import alert de certains dispositifs m\u00e9dicaux fabriqu\u00e9s au Japon par Olympus Medical Systems Corporation et ses filiales. Cette mesure vise \u00e0 refuser l\u2019entr\u00e9e sur le territoire am\u00e9ricain de nouveaux lots de plusieurs cat\u00e9gories de dispositifs en raison de violations non r\u00e9solues de la r\u00e9glementation am\u00e9ricaine relative au syst\u00e8me qualit\u00e9 (Quality System regulation). L\u2019import alert 89-04 concerne notamment certains mod\u00e8les d\u2019ur\u00e9teror\u00e9noscopes, de bronchoscopes, de laparoscopes, de syst\u00e8mes automatis\u00e9s de retraitement d\u2019endoscopes, de capsules d\u2019imagerie t\u00e9l\u00e9m\u00e9trique gastro-intestinale ing\u00e9rables pour la visualisation de l\u2019intestin gr\u00eale, ainsi que d\u2019ent\u00e9roscopes.<\/p>\n
La FDA indique que, malgr\u00e9 des efforts prolong\u00e9s pour corriger les non-conformit\u00e9s, des manquements persistent dans le syst\u00e8me qualit\u00e9 d\u2019Olympus, ce qui justifie la d\u00e9cision de bloquer les futures importations des mod\u00e8les vis\u00e9s vers les \u00c9tats-Unis. L\u2019agence pr\u00e9cise que l\u2019alerte ne s\u2019applique pas aux produits associ\u00e9s tels que pi\u00e8ces de rechange, connecteurs ou consommables \u00e0 usage unique utilis\u00e9s avec ces dispositifs.<\/p>\n
La FDA recommande aux professionnels de sant\u00e9 am\u00e9ricains de prendre connaissance de la liste d\u00e9taill\u00e9e des mod\u00e8les et identifiants uniques de dispositifs (UDI) concern\u00e9s par l\u2019import alert, de continuer \u00e0 utiliser les dispositifs d\u00e9j\u00e0 en service uniquement en l\u2019absence de probl\u00e8me constat\u00e9, et de respecter strictement les instructions de nettoyage, de retraitement et de maintenance pr\u00e9vues par le fabricant. Elle rappelle de ne pas utiliser d\u2019appareils endommag\u00e9s ou ayant \u00e9chou\u00e9 au test d\u2019\u00e9tanch\u00e9it\u00e9, de programmer des inspections et op\u00e9rations de maintenance r\u00e9guli\u00e8res, et de suivre les lettres de notification en cas de rappel des dispositifs concern\u00e9s. Les professionnels sont \u00e9galement invit\u00e9s \u00e0 discuter avec les patients des b\u00e9n\u00e9fices et des risques des actes r\u00e9alis\u00e9s avec ces dispositifs, sans annuler ni reporter syst\u00e9matiquement les proc\u00e9dures, et \u00e0 signaler rapidement tout \u00e9v\u00e9nement ind\u00e9sirable \u00e0 la FDA.<\/p>\n
Les principaux acteurs mentionn\u00e9s sont la FDA, en tant qu\u2019autorit\u00e9 de r\u00e9gulation et de contr\u00f4le sanitaire des dispositifs m\u00e9dicaux aux \u00c9tats-Unis, et Olympus Medical Systems Corporation, fabricant japonais dont certains dispositifs font d\u00e9j\u00e0 l\u2019objet de rappels. Cette d\u00e9cision am\u00e9ricaine illustre l\u2019utilisation d\u2019outils de r\u00e9gulation \u00e0 la fronti\u00e8re (import alert) pour garantir la conformit\u00e9 des dispositifs m\u00e9dicaux aux exigences de qualit\u00e9 et de s\u00e9curit\u00e9, avec des enjeux potentiels en mati\u00e8re d\u2019organisation des soins, de gestion des risques infectieux li\u00e9s aux endoscopes et de s\u00e9curisation des cha\u00eenes d\u2019approvisionnement en \u00e9quipements m\u00e9dicaux. Cette \u00e9volution peut pr\u00e9senter un int\u00e9r\u00eat de suivi comparatif pour les administrations fran\u00e7aises en charge de la r\u00e9gulation des dispositifs m\u00e9dicaux et de la s\u00e9curit\u00e9 des patients. (contenu r\u00e9sum\u00e9 en fran\u00e7ais par l’IA)\u00a0\u200bLire la Suite<\/a><\/p>","protected":false},"excerpt":{"rendered":" Le 20 octobre 2026, la Food and Drug Administration (FDA) des \u00c9tats-Unis a annonc\u00e9 la mise sous import alert de certains dispositifs m\u00e9dicaux fabriqu\u00e9s au Japon par Olympus Medical Systems […]<\/p>\n","protected":false},"author":1,"featured_media":17780,"comment_status":"","ping_status":"","sticky":false,"template":"","format":"standard","meta":{"site-sidebar-layout":"default","site-content-layout":"","ast-site-content-layout":"default","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":"","ast-breadcrumbs-content":"","ast-featured-img":"","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":"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":"","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-4)","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-4)","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-4)","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":""}},"footnotes":""},"categories":[7],"tags":[260,227,226],"class_list":["post-21885","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-medicaments-et-produits-de-sante","tag-fda","tag-ia","tag-sources-etrangeres"],"_links":{"self":[{"href":"https:\/\/veilles-affaires-sociales.fr\/index.php?rest_route=\/wp\/v2\/posts\/21885","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/veilles-affaires-sociales.fr\/index.php?rest_route=\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/veilles-affaires-sociales.fr\/index.php?rest_route=\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/veilles-affaires-sociales.fr\/index.php?rest_route=\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/veilles-affaires-sociales.fr\/index.php?rest_route=%2Fwp%2Fv2%2Fcomments&post=21885"}],"version-history":[{"count":0,"href":"https:\/\/veilles-affaires-sociales.fr\/index.php?rest_route=\/wp\/v2\/posts\/21885\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/veilles-affaires-sociales.fr\/index.php?rest_route=\/wp\/v2\/media\/17780"}],"wp:attachment":[{"href":"https:\/\/veilles-affaires-sociales.fr\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=21885"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/veilles-affaires-sociales.fr\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=21885"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/veilles-affaires-sociales.fr\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=21885"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}