L\u2019autorit\u00e9 am\u00e9ricaine de r\u00e9gulation des dispositifs m\u00e9dicaux (FDA, via le Center for Devices and Radiological Health \u2013 CDRH) signale un probl\u00e8me potentiel de s\u00e9curit\u00e9 jug\u00e9 \u00e0 risque \u00e9lev\u00e9 concernant certains dispositifs de perfusion. L\u2019alerte porte sur des sets de perfusion BD Alaris Pump Infusion Sets int\u00e9gr\u00e9s dans des kits de soins dits \u00ab Presource Kits \u00bb fournis par Cardinal Health. La FDA indique que Cardinal Health a envoy\u00e9, le 23 septembre, une lettre \u00e0 l\u2019ensemble des clients concern\u00e9s, leur recommandant d\u2019actualiser les modalit\u00e9s d\u2019utilisation de ces kits pour tenir compte d\u2019un rappel d\u00e9j\u00e0 initi\u00e9 par BD et CareFusion 303, Inc. (BD Alaris Pump Infusion Set Recall).<\/p>\n
Les Presource Kits concern\u00e9s contiennent des sets de perfusion BD Alaris faisant l\u2019objet de ce rappel. Cardinal Health demande aux \u00e9tablissements de sant\u00e9 d\u2019identifier dans leurs stocks les produits concern\u00e9s, de consulter la lettre client de BD et ses annexes, et d\u2019ajuster si n\u00e9cessaire les pratiques cliniques (choix du set de perfusion, du type de pompe, modalit\u00e9s d\u2019utilisation).<\/p>\n
La lettre de BD recommande de revoir les informations de performance des sets de perfusion (Pump Infusion Set Performance Disclosures) et, si les performances du syst\u00e8me BD Alaris Pump avec les sets identifi\u00e9s ne sont pas jug\u00e9es cliniquement appropri\u00e9es, de recourir \u00e0 une autre pompe (par exemple le module seringue BD Alaris Syringe Module ou une autre pompe \u00e0 seringue si BD Alaris n\u2019est pas disponible). En l\u2019absence de pompe \u00e0 seringue, l\u2019utilisation des sets rappel\u00e9s reste possible mais uniquement avec prudence, un renforcement de la surveillance clinique et le respect strict des avertissements d\u00e9j\u00e0 communiqu\u00e9s pour le syst\u00e8me Alaris.<\/p>\n
BD pr\u00e9conise \u00e9galement des mesures de r\u00e9duction des risques, issues du manuel utilisateur du syst\u00e8me BD Alaris Infusion System (versions v12.3 \u00e0 v12.6), qui portent notamment sur : l\u2019exactitude des d\u00e9bits et bolus (position du contenant de solution par rapport au module de pompe, limit\u00e9 \u00e0 21 pouces au-dessus du module), le temps de d\u00e9clenchement des alarmes (bonne position de la tubulure sur les capteurs de pression, absence de pinces ferm\u00e9es, coudes ou \u00e9crasements, contr\u00f4le du goutte-\u00e0-goutte et de l\u2019\u00e9vent si applicable, non\u2011utilisation de la fonction de pression s\u00e9lectionnable au\u2011del\u00e0 de 50 mmHg pour des d\u00e9bits < 10 mL\/h), et la gestion du bolus post\u2011occlusion (arr\u00eat du flux vers le patient, \u00e9ventuelle d\u00e9connexion via robinet pour d\u00e9lester la pression en pesant le risque de d\u00e9connexion par rapport au risque de bolus involontaire).<\/p>\n
La FDA indique qu\u2019elle est en cours d\u2019analyse de ce probl\u00e8me de dispositif potentiellement \u00e0 haut risque et qu\u2019elle mettra \u00e0 jour l\u2019information publique au fur et \u00e0 mesure de la disponibilit\u00e9 de nouveaux \u00e9l\u00e9ments. Aucune donn\u00e9e chiffr\u00e9e ni information sur des incidents cliniques n\u2019est fournie dans le texte. L\u2019enjeu principal est la s\u00e9curit\u00e9 des perfusions r\u00e9alis\u00e9es avec les syst\u00e8mes BD Alaris, l\u2019ad\u00e9quation des param\u00e8tres de perfusion et la pr\u00e9vention des erreurs de d\u00e9bit ou de bolus, avec un impact direct potentiel sur la s\u00e9curit\u00e9 des patients dans les \u00e9tablissements utilisant ces dispositifs. Cette alerte peut pr\u00e9senter un int\u00e9r\u00eat de veille pour les administrations fran\u00e7aises en mati\u00e8re de dispositifs m\u00e9dicaux et de s\u00e9curit\u00e9 des soins, en particulier pour le suivi des rappels et des recommandations d\u2019usage \u00e9mises par les autorit\u00e9s am\u00e9ricaines et les fabricants. (contenu r\u00e9sum\u00e9 en fran\u00e7ais par l'IA)\u00a0\u200bLire la Suite<\/a><\/p>","protected":false},"excerpt":{"rendered":" L\u2019autorit\u00e9 am\u00e9ricaine de r\u00e9gulation des dispositifs m\u00e9dicaux (FDA, via le Center for Devices and Radiological Health \u2013 CDRH) signale un probl\u00e8me potentiel de s\u00e9curit\u00e9 jug\u00e9 \u00e0 risque \u00e9lev\u00e9 concernant certains […]<\/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-21636","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\/21636","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=21636"}],"version-history":[{"count":0,"href":"https:\/\/veilles-affaires-sociales.fr\/index.php?rest_route=\/wp\/v2\/posts\/21636\/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=21636"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/veilles-affaires-sociales.fr\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=21636"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/veilles-affaires-sociales.fr\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=21636"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}