Le Center for Devices and Radiological Health (CDRH) de la Food and Drug Administration (FDA) am\u00e9ricaine publie une alerte pr\u00e9coce concernant un risque potentiel \u00e9lev\u00e9 li\u00e9 \u00e0 un dispositif m\u00e9dical de ventilation n\u00e9onatale. L\u2019alerte porte sur certains circuits de ventilation jetables VentStar Resus Neo fabriqu\u00e9s par Draeger (mod\u00e8le MP00310, identifiant unique du dispositif \u2013 UDI : 04048675422358). Ces dispositifs sont utilis\u00e9s pour la ventilation d\u2019urgence et en situation critique chez le nourrisson jusqu\u2019\u00e0 10 kg (22 livres).<\/p>\n
Draeger a inform\u00e9 ses clients le 1er septembre par courrier qu\u2019un nombre de cas de fissures visibles au niveau des tuyaux de ces circuits avait \u00e9t\u00e9 signal\u00e9 par les utilisateurs avant utilisation. L\u2019entreprise recommande aux \u00e9tablissements et utilisateurs concern\u00e9s de retirer des lieux d\u2019utilisation ou de vente les r\u00e9f\u00e9rences affect\u00e9es, de contr\u00f4ler visuellement chaque tuyau avant utilisation conform\u00e9ment aux instructions d\u2019utilisation, et de jeter tout produit pr\u00e9sentant des fissures ou un tuyau d\u00e9tach\u00e9. Les produits d\u00e9fectueux ne doivent pas \u00eatre renvoy\u00e9s au fabricant. La FDA invite les utilisateurs \u00e0 consulter r\u00e9guli\u00e8rement la page d\u00e9di\u00e9e pour d\u2019\u00e9ventuelles mises \u00e0 jour, le dossier \u00e9tant en cours d\u2019examen.<\/p>\n
Le risque identifi\u00e9 est qu\u2019un tuyau fissur\u00e9 puisse se d\u00e9tacher ou fuir pendant l\u2019utilisation, entra\u00eenant une ventilation insuffisante ou retard\u00e9e, avec risque de d\u00e9saturation, d\u2019hypoxie, voire de d\u00e9c\u00e8s du patient. \u00c0 la date du 27 ao\u00fbt, Draeger n\u2019a signal\u00e9 aucun cas de blessure grave ni d\u00e9c\u00e8s li\u00e9s \u00e0 ce probl\u00e8me. L\u2019alerte concerne uniquement les \u00c9tats\u2011Unis, o\u00f9 les utilisateurs sont invit\u00e9s \u00e0 signaler tout incident ou probl\u00e8me de qualit\u00e9 via le syst\u00e8me de d\u00e9claration des \u00e9v\u00e9nements ind\u00e9sirables MedWatch de la FDA. Des coordonn\u00e9es sp\u00e9cifiques (t\u00e9l\u00e9phone et courriel) de Draeger aux \u00c9tats\u2011Unis sont \u00e9galement fournies pour les questions des clients.<\/p>\n
La FDA rappelle le r\u00f4le de l\u2019identifiant unique du dispositif (UDI) pour tracer les dispositifs m\u00e9dicaux sur le march\u00e9 am\u00e9ricain, am\u00e9liorer le rep\u00e9rage des produits concern\u00e9s et faciliter l\u2019analyse et le traitement des signalements d\u2019incidents. L\u2019agence renvoie vers la base de donn\u00e9es AccessGUDID pour l\u2019identification des dispositifs. Cette situation illustre les enjeux de s\u00e9curit\u00e9 des dispositifs m\u00e9dicaux critiques en n\u00e9onatologie, l\u2019importance des proc\u00e9dures de contr\u00f4le visuel avant utilisation et le r\u00f4le des syst\u00e8mes d\u2019identification et de vigilance pour la d\u00e9tection pr\u00e9coce et la gestion des risques. (contenu r\u00e9sum\u00e9 en fran\u00e7ais par l’IA)\u00a0\u200bLire la Suite<\/a><\/p>","protected":false},"excerpt":{"rendered":" Le Center for Devices and Radiological Health (CDRH) de la Food and Drug Administration (FDA) am\u00e9ricaine publie une alerte pr\u00e9coce concernant un risque potentiel \u00e9lev\u00e9 li\u00e9 \u00e0 un dispositif m\u00e9dical […]<\/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-17792","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\/17792","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=17792"}],"version-history":[{"count":0,"href":"https:\/\/veilles-affaires-sociales.fr\/index.php?rest_route=\/wp\/v2\/posts\/17792\/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=17792"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/veilles-affaires-sociales.fr\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=17792"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/veilles-affaires-sociales.fr\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=17792"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}