Les autorit\u00e9s sanitaires am\u00e9ricaines (Food and Drug Administration \u2013 FDA) signalent un rappel de dispositifs m\u00e9dicaux de type StatStrip Glucose Hospital Meter System, utilis\u00e9s pour la mesure de la glyc\u00e9mie \u00e0 l\u2019h\u00f4pital. Ce rappel, class\u00e9 par la FDA comme le plus grave niveau de rappel (risque de blessure grave ou de d\u00e9c\u00e8s en cas de poursuite d\u2019utilisation), concerne sp\u00e9cifiquement le mod\u00e8le le plus r\u00e9cent \u00ab Gen 2.0 \u00bb du StatStrip Glucose Hospital Meter, et ne s\u2019applique pas aux mod\u00e8les ant\u00e9rieurs, notamment le mod\u00e8le \u00ab Gen 1.86 \u00bb.<\/p>\n
Le fabricant Nova Biomedical a adress\u00e9 le 31 juillet, puis de mani\u00e8re actualis\u00e9e le 5 octobre, une lettre \u00e0 l\u2019ensemble des clients concern\u00e9s pour leur recommander de retirer tous les appareils StatStrip Glucose Hospital Meters Gen 2.0 des lieux d\u2019utilisation ou de vente, dans l\u2019attente d\u2019une mise \u00e0 jour logicielle corrective. Les dispositifs concern\u00e9s incluent au moins les r\u00e9f\u00e9rences suivantes : StatStrip Glucose Hospital Meter System (mod\u00e8le n\u00b0 63685, UDI\/DI 00385480636858) et Glucose Hospital Meter System Multipack (mod\u00e8le n\u00b0 66739, UDI\/DI 00385480636858.<\/p>\n
Dans l\u2019intervalle, Nova Biomedical pr\u00e9conise aux utilisateurs plusieurs mesures de gestion du risque lorsque l\u2019usage se poursuit faute de solution alternative. Pour les \u00e9tablissements dont le dossier patient informatis\u00e9 (Electronic Medical Record \u2013 EMR) est interfac\u00e9 avec des donn\u00e9es d\u2019admission, de sortie et de transfert (Admission, Discharge, Transfer \u2013 ADT), il est recommand\u00e9 de v\u00e9rifier que le param\u00e8tre de validation des identifiants patients (\u00ab Validate Patient ID\u2019s \u00bb) est activ\u00e9 dans le logiciel NovaNet. Le fabricant recommande \u00e9galement de configurer les compteurs StatStrip de mani\u00e8re \u00e0 d\u00e9connecter automatiquement l\u2019op\u00e9rateur apr\u00e8s chaque test, via le menu \u00ab Logoff Setup \u00bb de NovaNet, en s\u00e9lectionnant un mode de d\u00e9connexion apr\u00e8s chaque test.<\/p>\n
Par ailleurs, il est demand\u00e9 aux op\u00e9rateurs de v\u00e9rifier syst\u00e9matiquement, apr\u00e8s chaque lecture de code-barres, que l\u2019identifiant patient affich\u00e9 sur le dispositif correspond bien au patient test\u00e9, et de confirmer la concordance du nom, de la date de naissance et des autres \u00e9l\u00e9ments d\u2019identification avant de valider. Une v\u00e9rification suppl\u00e9mentaire de l\u2019identifiant patient est \u00e9galement requise au moment de l\u2019affichage du r\u00e9sultat de glyc\u00e9mie, sans se fier au seul contr\u00f4le effectu\u00e9 au moment du scan initial. En cas d\u2019attribution d\u2019un r\u00e9sultat de glyc\u00e9mie au mauvais patient, l\u2019administrateur doit \u00eatre imm\u00e9diatement inform\u00e9. Le texte indique que ces recommandations sont destin\u00e9es aux utilisateurs qui ne disposent pas de dispositif alternatif, dans l\u2019attente de la mise \u00e0 jour logicielle.<\/p>\n
Ce rappel rel\u00e8ve directement de la r\u00e9gulation am\u00e9ricaine des dispositifs m\u00e9dicaux (FDA) et implique un fabricant priv\u00e9 (Nova Biomedical). Il pr\u00e9sente un int\u00e9r\u00eat pour le suivi des politiques de s\u00e9curit\u00e9 des dispositifs de diagnostic in vitro utilis\u00e9s en milieu hospitalier, notamment en ce qui concerne la tra\u00e7abilit\u00e9 des identifiants patients, la pr\u00e9vention des erreurs d\u2019attribution de r\u00e9sultats biologiques et la gestion des risques en cas de d\u00e9faillance logicielle. (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 (Food and Drug Administration \u2013 FDA) signalent un rappel de dispositifs m\u00e9dicaux de type StatStrip Glucose Hospital Meter System, utilis\u00e9s pour la mesure de la glyc\u00e9mie […]<\/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-21597","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\/21597","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=21597"}],"version-history":[{"count":0,"href":"https:\/\/veilles-affaires-sociales.fr\/index.php?rest_route=\/wp\/v2\/posts\/21597\/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=21597"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/veilles-affaires-sociales.fr\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=21597"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/veilles-affaires-sociales.fr\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=21597"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}