Le Center for Devices and Radiological Health (CDRH) de la Food and Drug Administration (FDA) des \u00c9tats\u2011Unis publie une alerte pr\u00e9coce concernant un probl\u00e8me potentiellement \u00e0 haut risque affectant certains ventilateurs m\u00e9dicaux VOCSN fabriqu\u00e9s par Ventec Life Systems Inc., op\u00e9rant sous le nom React Health. L\u2019autorit\u00e9 am\u00e9ricaine annonce qu\u2019elle tiendra le public inform\u00e9 et actualisera sa page d\u00e9di\u00e9e au fur et \u00e0 mesure de l\u2019obtention de nouvelles informations significatives.<\/p>\n
L\u2019alerte concerne l\u2019ensemble des dispositifs VOCSN ventilator dont les num\u00e9ros de s\u00e9rie sont \u00e9gaux ou sup\u00e9rieurs \u00e0 112786, couvrant plusieurs mod\u00e8les et variantes, y compris des versions destin\u00e9es au march\u00e9 japonais (VOCSN+Pro, VC+Pro, VOCSN, VCSN+Pro, V+Pro, V+ Pro Emergency, VC, VC (Japan), V*Home), identifi\u00e9s par des r\u00e9f\u00e9rences internes (model numbers, packaged part numbers) et des identifiants UDI-DI sp\u00e9cifiques. La FDA indique que React Health a adress\u00e9, le 17 septembre, une lettre \u00e0 tous les clients concern\u00e9s, recommandant des instructions d\u2019utilisation mises \u00e0 jour et de nouveaux protocoles d\u2019inspection.<\/p>\n
Le probl\u00e8me op\u00e9rationnel signal\u00e9 se traduit notamment par des red\u00e9marrages r\u00e9currents de l\u2019appareil ou des alarmes \u00ab System Fault 10 \u00bb. En cas de survenue de ce dysfonctionnement, les utilisateurs sont invit\u00e9s \u00e0 recourir \u00e0 un dispositif de ventilation de secours si n\u00e9cessaire et \u00e0 contacter React Health pour une intervention de maintenance. Il est explicitement demand\u00e9 aux patients de ne pas interrompre la ventilation, sauf si une solution alternative adapt\u00e9e est disponible et que cette d\u00e9cision est prise sur instruction du clinicien traitant.<\/p>\n
React Health recommande en outre que le mat\u00e9riel de ventilation alternatif soit non seulement disponible, mais \u00e9galement fonctionnel, v\u00e9rifi\u00e9 r\u00e9guli\u00e8rement et pr\u00eat \u00e0 \u00eatre utilis\u00e9 imm\u00e9diatement. Les ventilateurs doivent \u00eatre plac\u00e9s sur une surface plane et stable ou fix\u00e9s via un support (roll stand) ou un sac de transport VOCSN afin de limiter les chutes et impacts susceptibles d\u2019alt\u00e9rer leur fonctionnement. En cas de chute ou de choc, un protocole de v\u00e9rification (Checkout Procedure) d\u00e9crit dans le manuel clinique et technique VOCSN Series Ventilator Portfolio (r\u00e9f\u00e9rence LBL\u201100001) doit \u00eatre r\u00e9alis\u00e9 avant toute r\u00e9utilisation sur patient, afin de confirmer la performance du dispositif.<\/p>\n
Les utilisateurs sont invit\u00e9s \u00e0 respecter les recommandations des manuels, notamment celles relatives \u00e0 la surveillance, \u00e0 la pr\u00e9paration aux situations d\u2019urgence, \u00e0 la formation des aidants et \u00e0 la disponibilit\u00e9 de dispositifs de ventilation de secours lors de toute utilisation du ventilateur. Pour les patients d\u00e9pendants d\u2019une ventilation m\u00e9canique, la pr\u00e9sence permanente d\u2019un \u00e9quipement de ventilation alternatif, tel qu\u2019un ventilateur de secours, est explicitement pr\u00e9conis\u00e9e. L\u2019alerte souligne ainsi des enjeux de s\u00e9curit\u00e9 des dispositifs m\u00e9dicaux vitaux, d\u2019organisation des soins \u00e0 domicile et de continuit\u00e9 de la prise en charge des patients ventil\u00e9s. (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) des \u00c9tats\u2011Unis publie une alerte pr\u00e9coce concernant un probl\u00e8me potentiellement \u00e0 haut risque affectant 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-18577","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\/18577","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=18577"}],"version-history":[{"count":0,"href":"https:\/\/veilles-affaires-sociales.fr\/index.php?rest_route=\/wp\/v2\/posts\/18577\/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=18577"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/veilles-affaires-sociales.fr\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=18577"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/veilles-affaires-sociales.fr\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=18577"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}