La Food and Drug Administration (FDA) am\u00e9ricaine, via son Centre for Devices and Radiological Health (CDRH), diffuse une alerte pr\u00e9coce concernant un probl\u00e8me potentiellement \u00e0 haut risque affectant des dispositifs m\u00e9dicaux de soutien circulatoire fabriqu\u00e9s par Abiomed. Il s\u2019agit des \u00ab Automated Impella Controllers \u00bb (AIC), utilis\u00e9s pour piloter des pompes cardiaques Impella. Sont concern\u00e9s plusieurs mod\u00e8les d\u2019unit\u00e9s de commande conditionn\u00e9es pour le march\u00e9 am\u00e9ricain, identifi\u00e9s par les codes produits 0042-0000-US, 0042-0010-US et 0042-0040-US, chacun assorti d\u2019un identifiant UDI-DI distinct.<\/p>\n
Abiomed a inform\u00e9 l\u2019ensemble de ses clients concern\u00e9s, au niveau mondial, de la mise en \u0153uvre d\u2019un retrait progressif de tous les AIC en raison de probl\u00e8mes de reconnaissance de la cassette de purge. Ces dysfonctionnements sont li\u00e9s \u00e0 des d\u00e9faillances d\u2019un composant interne (\u00ab purge flag \u00bb) au sein de l\u2019assemblage du capteur de pression de purge, qui intervient dans la reconnaissance correcte du disque de purge par le contr\u00f4leur.<\/p>\n
Dans l\u2019attente de l\u2019intervention du fabricant, la FDA indique, en coh\u00e9rence avec les recommandations d\u2019Abiomed, que les h\u00f4pitaux peuvent continuer \u00e0 utiliser leur stock d\u2019AIC pour assurer la continuit\u00e9 des soins. En cas de d\u00e9faillance du composant de purge et d\u2019alarme associ\u00e9e, il est demand\u00e9 de r\u00e9ins\u00e9rer le disque de purge conform\u00e9ment aux instructions d\u2019utilisation (IFU). Si cette action ne r\u00e9sout pas l\u2019alarme, l\u2019\u00e9tablissement doit basculer sur un contr\u00f4leur Impella de secours.<\/p>\n
Abiomed recommande en outre de respecter des proc\u00e9dures de nettoyage non agressives, avec un d\u00e9tergent doux, afin d\u2019\u00e9viter d\u2019endommager les composants plastiques, notamment le \u00ab purge flag \u00bb, et de r\u00e9aliser une maintenance pr\u00e9ventive annuelle des AIC conform\u00e9ment aux IFU. Le fabricant pr\u00e9voit une op\u00e9ration de remplacement des composants incrimin\u00e9s (purge flag et purge retainer dans l\u2019assemblage du capteur de pression de purge) et son \u00e9quipe de service sur le terrain contactera les \u00e9tablissements pour organiser l\u2019\u00e9change des pi\u00e8ces et le retour des dispositifs identifi\u00e9s. Les structures de sant\u00e9 sont invit\u00e9es \u00e0 diffuser l\u2019avis en interne (personnels de gestion, transport, stockage et utilisation des produits), \u00e0 informer les autres \u00e9tablissements \u00e9ventuellement destinataires de ces dispositifs et \u00e0 afficher l\u2019avis dans un lieu visible.<\/p>\n
La FDA continue d\u2019examiner ce probl\u00e8me de dispositif m\u00e9dical potentiellement \u00e0 haut risque et annonce qu\u2019elle actualisera la page web d\u00e9di\u00e9e au fur et \u00e0 mesure de la disponibilit\u00e9 d\u2019informations nouvelles significatives. Cette alerte illustre un cas de gestion coordonn\u00e9e entre autorit\u00e9 de r\u00e9gulation et fabricant, en situation de risque potentiel pour la s\u00e9curit\u00e9 des patients, avec maintien contr\u00f4l\u00e9 de l\u2019usage des dispositifs pour pr\u00e9server la continuit\u00e9 des soins, tout en organisant un retrait et une correction technique \u00e0 l\u2019\u00e9chelle mondiale. (contenu r\u00e9sum\u00e9 en fran\u00e7ais par l’IA)\u00a0\u200bLire la Suite<\/a><\/p>","protected":false},"excerpt":{"rendered":" La Food and Drug Administration (FDA) am\u00e9ricaine, via son Centre for Devices and Radiological Health (CDRH), diffuse une alerte pr\u00e9coce concernant un probl\u00e8me potentiellement \u00e0 haut risque affectant des dispositifs […]<\/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-17794","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\/17794","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=17794"}],"version-history":[{"count":0,"href":"https:\/\/veilles-affaires-sociales.fr\/index.php?rest_route=\/wp\/v2\/posts\/17794\/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=17794"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/veilles-affaires-sociales.fr\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=17794"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/veilles-affaires-sociales.fr\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=17794"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}