La Food and Drug Administration (FDA) des \u00c9tats-Unis a actualis\u00e9 une alerte pr\u00e9coce concernant un rappel de dispositifs de surveillance Portrait Mobile Monitoring Solution fabriqu\u00e9s par GE HealthCare. L\u2019autorit\u00e9 indique d\u00e9sormais que ces dispositifs peuvent entra\u00eener des probl\u00e8mes de sant\u00e9 temporaires ou r\u00e9versibles et, plus rarement, des probl\u00e8mes graves. Il s\u2019agit d\u2019un rappel portant uniquement sur la mise \u00e0 jour des instructions d\u2019utilisation, sans retrait des dispositifs du march\u00e9 ni des \u00e9tablissements de soins. Le motif du rappel a \u00e9t\u00e9 reformul\u00e9 pour plus de clart\u00e9, sans modification de la liste des produits concern\u00e9s ni des recommandations d\u2019utilisation.<\/p>\n
Sont concern\u00e9s les dispositifs Portrait Mobile fonctionnant avec certaines versions du logiciel Portrait Core Services, notamment : PORTRAIT CORE SERVICES SOFTWARE V1.1, V1.0.5, PORTRAIT COMPUTE AND CORE SERVICES V1.2 et un kit de rechargement logiciel FRU, identifi\u00e9s par leurs num\u00e9ros de r\u00e9f\u00e9rence et identifiants uniques de dispositif. La FDA signale que GE HealthCare a adress\u00e9, le 20 juillet, une lettre \u00e0 tous les clients concern\u00e9s pour les informer de nouvelles consignes d\u2019utilisation.<\/p>\n
Les recommandations de GE HealthCare, relay\u00e9es par la FDA, pr\u00e9cisent que les dispositifs Portrait Mobile \u00e9quip\u00e9s des versions V1.0.5, V1.1 ou V1.2 du logiciel peuvent continuer \u00e0 \u00eatre utilis\u00e9s, sous r\u00e9serve de mettre en place une solution de surveillance alternative ad\u00e9quate pour les patients avant toute mise \u00e0 jour logicielle. Les \u00e9tablissements doivent se r\u00e9f\u00e9rer \u00e0 un addendum au manuel d\u2019utilisation fourni par GE HealthCare, conserver cet addendum avec le manuel et s\u2019assurer que l\u2019ensemble des utilisateurs potentiels est inform\u00e9 du probl\u00e8me et des actions \u00e0 mettre en \u0153uvre.<\/p>\n
Le correctif fait suite \u00e0 la d\u00e9tection, lors d\u2019une mise \u00e0 jour logicielle dans un \u00e9tablissement, de dysfonctionnements entra\u00eenant la sortie non intentionnelle de certains patients du syst\u00e8me de surveillance Portrait et la r\u00e9initialisation de tous les param\u00e8tres d\u2019alarme aux valeurs par d\u00e9faut usine. Dans ce cas, le dispositif ne tient plus compte des param\u00e8tres d\u2019alarme personnalis\u00e9s par patient ou par secteur de soins, ce qui peut conduire \u00e0 une perte de surveillance ou \u00e0 l\u2019absence d\u2019alarme attendue au niveau du Hub et de l\u2019interface centrale. Au 29 juillet, GE HealthCare n\u2019avait signal\u00e9 aucun d\u00e9c\u00e8s ni blessure grave li\u00e9s \u00e0 cet incident.<\/p>\n
Le dispositif Portrait Mobile Monitoring Solution est destin\u00e9 \u00e0 l\u2019acquisition, au stockage, au calcul, \u00e0 l\u2019affichage et \u00e0 l\u2019exportation des donn\u00e9es de surveillance de patients adultes et p\u00e9diatriques, ainsi qu\u2019\u00e0 la g\u00e9n\u00e9ration d\u2019alarmes en temps r\u00e9el. La mesure prise par la FDA et GE HealthCare illustre l\u2019importance de la gestion des risques li\u00e9s aux mises \u00e0 jour logicielles des dispositifs m\u00e9dicaux connect\u00e9s, en particulier en mati\u00e8re de continuit\u00e9 de la surveillance et de s\u00e9curit\u00e9 des patients dans les \u00e9tablissements de sant\u00e9. Des coordonn\u00e9es sont fournies aux clients am\u00e9ricains pour signaler tout incident ou probl\u00e8me de qualit\u00e9 et pour obtenir des informations compl\u00e9mentaires. (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 actualis\u00e9 une alerte pr\u00e9coce concernant un rappel de dispositifs de surveillance Portrait Mobile Monitoring Solution fabriqu\u00e9s par GE HealthCare. L\u2019autorit\u00e9 indique […]<\/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-17793","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\/17793","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=17793"}],"version-history":[{"count":0,"href":"https:\/\/veilles-affaires-sociales.fr\/index.php?rest_route=\/wp\/v2\/posts\/17793\/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=17793"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/veilles-affaires-sociales.fr\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=17793"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/veilles-affaires-sociales.fr\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=17793"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}