La Food and Drug Administration (FDA) des \u00c9tats-Unis a class\u00e9 comme de gravit\u00e9 maximale un rappel visant certains dispositifs de Becton Dickinson (BD), en raison de risques de blessures graves ou de d\u00e9c\u00e8s en cas d\u2019utilisation sans correction. Sont concern\u00e9s divers kits de commodit\u00e9 et plateaux de proc\u00e9dures BD contenant des ampoules de chlorure de sodium fabriqu\u00e9es par Huons Co., Ltd., d\u00e9j\u00e0 rappel\u00e9es par l\u2019entreprise Elevaris Medical Devices. La mesure ne porte que sur ces ampoules : les autres composants des kits peuvent continuer \u00e0 \u00eatre utilis\u00e9s.<\/p>\n
La FDA indique que BD a adress\u00e9, le 10 ao\u00fbt, une lettre \u00e0 tous les clients concern\u00e9s d\u00e9taillant les actions \u00e0 mettre en \u0153uvre. Les \u00e9tablissements doivent : identifier et mettre en quarantaine les kits contenant des ampoules de chlorure de sodium concern\u00e9es ; ne pas utiliser ces ampoules ; \u00e9tiqueter les kits\/plateaux pour signaler clairement la pr\u00e9sence des ampoules rappel\u00e9es, sans masquer les informations r\u00e9glementaires ou de tra\u00e7abilit\u00e9 ; s\u2019assurer de la disponibilit\u00e9 d\u2019une source alternative locale de chlorure de sodium avant l\u2019entr\u00e9e en salle de proc\u00e9dure. Lors de l\u2019ouverture du kit, l\u2019ampoule doit \u00eatre retir\u00e9e et d\u00e9truite sur le lieu d\u2019utilisation, dans un environnement contr\u00f4l\u00e9 et st\u00e9rile, afin de pr\u00e9server la st\u00e9rilit\u00e9 des autres composants.<\/p>\n
BD pr\u00e9cise que, si une ampoule affect\u00e9e a d\u00e9j\u00e0 \u00e9t\u00e9 utilis\u00e9e sans incident, aucun traitement ou suivi clinique suppl\u00e9mentaire n\u2019est requis. En cas d\u2019incident li\u00e9 \u00e0 une ampoule concern\u00e9e, l\u2019\u00e9v\u00e9nement doit \u00eatre d\u00e9clar\u00e9 selon les proc\u00e9dures de l\u2019\u00e9tablissement et les mesures n\u00e9cessaires doivent \u00eatre prises. Pour les patients d\u00e9j\u00e0 pris en charge avec des lots concern\u00e9s, aucun suivi sp\u00e9cifique n\u2019est demand\u00e9 pour les patients asymptomatiques ; ceux pr\u00e9sentant des effets ind\u00e9sirables susceptibles d\u2019\u00eatre li\u00e9s \u00e0 l\u2019usage de ces ampoules doivent b\u00e9n\u00e9ficier d\u2019une \u00e9valuation m\u00e9dicale appropri\u00e9e.<\/p>\n
Le motif de la correction tient au risque de rupture de st\u00e9rilit\u00e9 des ampoules de chlorure de sodium. Les effets sanitaires potentiels incluent infections locales ou syst\u00e9miques, r\u00e9actions inflammatoires, sepsis, thrombose, dysfonction d\u2019organe ou autres complications graves, en particulier chez les patients vuln\u00e9rables. Au 29 juillet, BD n\u2019a signal\u00e9 aucun d\u00e9c\u00e8s ni blessure grave li\u00e9s \u00e0 ce probl\u00e8me. Les dispositifs en cause sont des kits de commodit\u00e9 contenant notamment des cath\u00e9ters, des pansements et d\u2019autres mat\u00e9riaux et composants pharmaceutiques destin\u00e9s aux proc\u00e9dures m\u00e9dicales. (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) des \u00c9tats-Unis a class\u00e9 comme de gravit\u00e9 maximale un rappel visant certains dispositifs de Becton Dickinson (BD), en raison de risques de blessures graves […]<\/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-18753","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\/18753","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=18753"}],"version-history":[{"count":0,"href":"https:\/\/veilles-affaires-sociales.fr\/index.php?rest_route=\/wp\/v2\/posts\/18753\/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=18753"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/veilles-affaires-sociales.fr\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=18753"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/veilles-affaires-sociales.fr\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=18753"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}