Les autorit\u00e9s sanitaires am\u00e9ricaines signalent un rappel de dispositifs m\u00e9dicaux d\u2019Assistance circulatoire Impella, class\u00e9 par la Food and Drug Administration (FDA) comme de type le plus grave, en raison d\u2019un risque de blessures graves ou de d\u00e9c\u00e8s en cas de poursuite de l\u2019utilisation. Le rappel concerne les Automated Impella Controllers (AIC) fabriqu\u00e9s par l\u2019entreprise Abiomed, utilis\u00e9s dans les h\u00f4pitaux pour la prise en charge de patients, et impose le retrait de certains appareils des lieux d\u2019utilisation ou de vente.<\/p>\n
Sont notamment concern\u00e9s les produits suivants : Impella Controller, Packaged, US (code produit 0042-0000-US, UDI-DI 00813502010022), Impella Optical Controller, Packaged, US (0042-0010-US, UDI-DI 00813502010985) et Optical, AIC, Impella Controller, Pkgd, US (0042-0040-US, UDI-DI 00813502011401). Tous les AIC sont inclus dans le p\u00e9rim\u00e8tre de cette action \u00e0 l\u2019\u00e9chelle mondiale, avec une mise en \u0153uvre progressive du retrait et du remplacement des composants.<\/p>\n
Le rappel est motiv\u00e9 par des probl\u00e8mes de reconnaissance de la cassette de purge, li\u00e9s \u00e0 des d\u00e9faillances d\u2019un composant appel\u00e9 \u00ab purge flag \u00bb dans l\u2019assemblage du capteur de pression de purge. Ce composant interagit avec le disque de purge et permet \u00e0 l\u2019appareil de reconna\u00eetre que le disque est correctement ins\u00e9r\u00e9. Ces d\u00e9faillances entra\u00eenent des alarmes associ\u00e9es et peuvent compromettre le fonctionnement s\u00fbr du dispositif.<\/p>\n
La FDA indique qu\u2019Abiomed a adress\u00e9 le 12 ao\u00fbt une lettre \u00e0 tous les clients concern\u00e9s recommandant de retirer de l\u2019usage et de la vente l\u2019ensemble des Automated Impella Controllers affect\u00e9s. Dans l\u2019attente de l\u2019intervention de maintenance et du remplacement par Abiomed, les h\u00f4pitaux sont toutefois autoris\u00e9s \u00e0 continuer d\u2019utiliser leur stock interne afin d\u2019assurer la continuit\u00e9 des soins, sous r\u00e9serve du respect de consignes op\u00e9rationnelles pr\u00e9cises.<\/p>\n
En cas de d\u00e9faillance du composant purge flag et d\u2019alarme associ\u00e9e, il est demand\u00e9, conform\u00e9ment aux instructions d\u2019utilisation (IFU), de r\u00e9ins\u00e9rer d\u2019abord le disque de purge pour tenter d\u2019\u00e9teindre l\u2019alarme. Si cette action ne permet pas de r\u00e9soudre le probl\u00e8me, il convient de basculer sur un contr\u00f4leur Impella de secours. Abiomed rappelle \u00e9galement que des proc\u00e9dures de nettoyage inappropri\u00e9es peuvent endommager les composants plastiques, dont le purge flag, et enjoint \u00e0 nettoyer l\u2019appareil avec un d\u00e9tergent doux tel que sp\u00e9cifi\u00e9 dans les IFU. Les op\u00e9rations de maintenance pr\u00e9ventive de routine doivent \u00eatre effectu\u00e9es annuellement selon ces m\u00eames instructions.<\/p>\n
Abiomed met en place une intervention de terrain : son \u00e9quipe de service contactera les \u00e9tablissements pour planifier le remplacement des composants purge flag et purge retainer dans l\u2019assemblage du capteur de pression de purge et organiser le retour des appareils identifi\u00e9s. Les \u00e9tablissements sont invit\u00e9s \u00e0 relayer l\u2019information \u00e0 tous les services concern\u00e9s (gestion, transport, stockage, utilisation des produits), \u00e0 informer tout autre \u00e9tablissement ayant re\u00e7u ces dispositifs, et \u00e0 afficher l\u2019avis dans un lieu visible. Les \u00e9l\u00e9ments disponibles mettent en \u00e9vidence un dispositif de gestion de risque coordonn\u00e9 par le fabricant sous contr\u00f4le de la FDA, avec des implications directes pour la s\u00e9curit\u00e9 des patients et l\u2019organisation hospitali\u00e8re, dans un cadre de rappel mondial. (contenu r\u00e9sum\u00e9 en fran\u00e7ais par l’IA)\u00a0\u200bLire la Suite<\/a><\/p>","protected":false},"excerpt":{"rendered":" Les autorit\u00e9s sanitaires am\u00e9ricaines signalent un rappel de dispositifs m\u00e9dicaux d\u2019Assistance circulatoire Impella, class\u00e9 par la Food and Drug Administration (FDA) comme de type le plus grave, en raison d\u2019un […]<\/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-18752","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\/18752","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=18752"}],"version-history":[{"count":0,"href":"https:\/\/veilles-affaires-sociales.fr\/index.php?rest_route=\/wp\/v2\/posts\/18752\/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=18752"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/veilles-affaires-sociales.fr\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=18752"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/veilles-affaires-sociales.fr\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=18752"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}