Le Centre for Devices and Radiological Health (CDRH) de la Food and Drug Administration (FDA) des \u00c9tats\u2011Unis a publi\u00e9 une alerte pr\u00e9coce concernant un probl\u00e8me potentiellement \u00e0 haut risque affectant certains dispositifs m\u00e9dicaux. L\u2019alerte vise des \u00ab Presource Kits \u00bb de la soci\u00e9t\u00e9 Cardinal Health, des kits de commodit\u00e9 utilis\u00e9s pour des proc\u00e9dures m\u00e9dicales ou chirurgicales, qui peuvent contenir des sets de perfusion BD Alaris concern\u00e9s par un rappel ant\u00e9rieur de BD et CareFusion 303, Inc.<\/p>\n
Les sets de perfusion incrimin\u00e9s peuvent entra\u00eener des dysfonctionnements des pompes \u00e0 perfusion, se traduisant par un comportement impr\u00e9visible de la pompe (sous\u2011perfusion, sur\u2011perfusion ou absence de perfusion), avec un risque potentiel d\u2019\u00e9v\u00e9nements ind\u00e9sirables graves. La gravit\u00e9 et la nature des cons\u00e9quences d\u00e9pendent de plusieurs facteurs, en particulier chez les populations les plus vuln\u00e9rables et \u00e0 haut risque, comme les nouveau\u2011n\u00e9s, les enfants et les patients en \u00e9tat critique. Au 19 ao\u00fbt 2026, le fabricant BD n\u2019a rapport\u00e9 aucun cas de blessure grave ni de d\u00e9c\u00e8s li\u00e9s \u00e0 ce probl\u00e8me.<\/p>\n
Cardinal Health a envoy\u00e9 le 24 septembre une lettre \u00e0 l\u2019ensemble des clients concern\u00e9s, leur demandant de localiser et mettre en quarantaine les kits affect\u00e9s, d\u2019en informer les cliniciens, et d\u2019apposer sur la face avant de chaque kit Presource une \u00e9tiquette d\u2019avertissement bien visible indiquant que les sets de perfusion BD Alaris rappel\u00e9s doivent \u00eatre retir\u00e9s et \u00e9limin\u00e9s. Des \u00e9tiquettes suppl\u00e9mentaires peuvent \u00eatre obtenues sur demande aupr\u00e8s de Cardinal Health. Les distributeurs sont invit\u00e9s \u00e0 informer leurs propres clients s\u2019ils ont redistribu\u00e9 des kits concern\u00e9s. La FDA recommande au public et aux \u00e9tablissements de sant\u00e9 de suivre les mises \u00e0 jour publi\u00e9es sur sa page d\u00e9di\u00e9e, l\u2019agence poursuivant son examen de ce probl\u00e8me de dispositif \u00e0 risque potentiel \u00e9lev\u00e9.<\/p>\n
Les kits de commodit\u00e9 Presource regroupent divers instruments, pansements, autres mat\u00e9riels et \u00e9ventuellement des composants pharmaceutiques pour faciliter la r\u00e9alisation d\u2019un acte m\u00e9dical ou chirurgical unique. L\u2019alerte s\u2019applique au territoire des \u00c9tats\u2011Unis. Les clients am\u00e9ricains confront\u00e9s \u00e0 des r\u00e9actions ind\u00e9sirables, \u00e0 des probl\u00e8mes de qualit\u00e9 ou ayant des questions sont invit\u00e9s \u00e0 contacter le service Quality Systems de Cardinal Health. Cette situation illustre des enjeux de s\u00e9curit\u00e9 des dispositifs m\u00e9dicaux, de gestion des rappels de composants int\u00e9gr\u00e9s dans des kits pr\u00e9assembl\u00e9s et de protection des patients les plus vuln\u00e9rables, dans un contexte de coordination entre l\u2019autorit\u00e9 de r\u00e9gulation f\u00e9d\u00e9rale (FDA) et les fabricants\/distributeurs (Cardinal Health, BD, CareFusion). (contenu r\u00e9sum\u00e9 en fran\u00e7ais par l’IA)\u00a0\u200bLire la Suite<\/a><\/p>","protected":false},"excerpt":{"rendered":" Le Centre for Devices and Radiological Health (CDRH) de la Food and Drug Administration (FDA) des \u00c9tats\u2011Unis a publi\u00e9 une alerte pr\u00e9coce concernant un probl\u00e8me potentiellement \u00e0 haut risque affectant […]<\/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-21596","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\/21596","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=21596"}],"version-history":[{"count":0,"href":"https:\/\/veilles-affaires-sociales.fr\/index.php?rest_route=\/wp\/v2\/posts\/21596\/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=21596"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/veilles-affaires-sociales.fr\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=21596"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/veilles-affaires-sociales.fr\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=21596"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}