Les autorit\u00e9s sanitaires am\u00e9ricaines (FDA) signalent un rappel de type le plus grave concernant certains kits d\u2019anesth\u00e9sie p\u00e9ridurale produits par Medical Action Industries. Ce rappel est qualifi\u00e9 de \u00ab correction \u00bb et ne pr\u00e9voit ni retrait des dispositifs des lieux d\u2019utilisation ou de vente, ni interruption de l\u2019usage des autres composants, mais il concerne sp\u00e9cifiquement des ampoules de chlorure de sodium potentiellement non st\u00e9riles incluses dans ces kits.<\/p>\n
Les dispositifs concern\u00e9s sont des kits d\u2019anesth\u00e9sie p\u00e9ridurale (\u00ab Single Shot Epidural \u00bb et \u00ab Epidural\/Pain TQC \u00bb) identifi\u00e9s par diff\u00e9rents num\u00e9ros de mod\u00e8le\/lot et UDI. La FDA indique que Medical Action Industries a adress\u00e9, le 23 juillet, une lettre \u00e0 tous les clients concern\u00e9s pour pr\u00e9ciser les actions correctives \u00e0 mettre en \u0153uvre avant la poursuite de l\u2019utilisation des kits.<\/p>\n
Les recommandations op\u00e9rationnelles sont les suivantes : ne pas utiliser les ampoules de chlorure de sodium (sodium chloride 0,9 % USP 10 mL flush) incluses dans les kits concern\u00e9s ; v\u00e9rifier les stocks pour identifier les kits d\u2019anesth\u00e9sie p\u00e9ridurale contenant ces ampoules ; identifier, s\u00e9parer et placer en quarantaine les kits impact\u00e9s le temps d\u2019apposer de nouvelles \u00e9tiquettes d\u2019avertissement ; retirer et \u00e9liminer syst\u00e9matiquement les ampoules de chlorure de sodium avant utilisation, les autres composants des kits pouvant continuer \u00e0 \u00eatre utilis\u00e9s. Un mod\u00e8le d\u2019\u00e9tiquette est fourni aux \u00e9tablissements pour impression et apposition sur tous les kits et cartons concern\u00e9s, \u00e0 un endroit visible sans masquer d\u2019autres informations critiques de tra\u00e7abilit\u00e9 ou de s\u00e9curit\u00e9. Si n\u00e9cessaire, des \u00e9tiquettes pr\u00e9imprim\u00e9es peuvent \u00eatre obtenues via les repr\u00e9sentants commerciaux.<\/p>\n
La raison de la correction est la pr\u00e9sence, dans certains kits de Medical Action Industries, d\u2019ampoules de chlorure de sodium fabriqu\u00e9es par la soci\u00e9t\u00e9 Huons Co., Ltd. et d\u00e9j\u00e0 rappel\u00e9es par l\u2019entreprise Spectra Medical Devices, LLC. Le risque identifi\u00e9 par la FDA est une compromission de la st\u00e9rilit\u00e9 de la solution de chlorure de sodium, pouvant exposer les patients \u00e0 des micro-organismes viables, des endotoxines et\/ou des particules \u00e9trang\u00e8res g\u00e9n\u00e9r\u00e9es au cours de la fabrication. La poursuite de l\u2019utilisation des kits sans retrait des ampoules d\u00e9fectueuses est consid\u00e9r\u00e9e comme susceptible de provoquer des blessures graves ou le d\u00e9c\u00e8s. (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 (FDA) signalent un rappel de type le plus grave concernant certains kits d\u2019anesth\u00e9sie p\u00e9ridurale produits par Medical Action Industries. Ce rappel est qualifi\u00e9 de \u00ab correction […]<\/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-17790","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\/17790","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=17790"}],"version-history":[{"count":0,"href":"https:\/\/veilles-affaires-sociales.fr\/index.php?rest_route=\/wp\/v2\/posts\/17790\/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=17790"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/veilles-affaires-sociales.fr\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=17790"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/veilles-affaires-sociales.fr\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=17790"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}