Les autorit\u00e9s sanitaires des \u00c9tats\u2011Unis signalent un rappel de dispositifs m\u00e9dicaux de type Imager II Angiographic Catheters, fabriqu\u00e9s par l\u2019entreprise Boston Scientific. Ce rappel, identifi\u00e9 par la Food and Drug Administration (FDA) comme de niveau de gravit\u00e9 le plus \u00e9lev\u00e9 (risque de blessure grave ou de d\u00e9c\u00e8s en cas de poursuite d\u2019utilisation), concerne le retrait de certains cath\u00e9ters des lieux d\u2019utilisation et de vente.<\/p>\n
Les cath\u00e9ters Imager II sont utilis\u00e9s pour r\u00e9aliser des images de zones sp\u00e9cifiques de la vascularisation p\u00e9riph\u00e9rique. Boston Scientific a inform\u00e9, par courrier en date du 24 ao\u00fbt, l\u2019ensemble des clients concern\u00e9s (principalement des \u00e9tablissements de sant\u00e9) et leur a demand\u00e9 de retirer tous les Imager II Angiographic Catheters de leurs stocks. La FDA indique \u00eatre inform\u00e9e de cette d\u00e9marche et de la liste des dispositifs concern\u00e9s. Les clients doivent cesser imm\u00e9diatement toute utilisation et toute distribution, isoler les produits affect\u00e9s, v\u00e9rifier leur inventaire \u00e0 l\u2019aide des codes UPN figurant sur les conditionnements internes et externes (codes pouvant diff\u00e9rer), compl\u00e9ter et renvoyer un formulaire de suivi (Reply Verification Tracking Form \u2013 RVTF), puis retourner les produits \u00e0 Boston Scientific. Il est pr\u00e9cis\u00e9 que les lots sont commercialis\u00e9s par conditionnements de cinq unit\u00e9s mais que les quantit\u00e9s d\u00e9clar\u00e9es doivent correspondre au nombre d\u2019unit\u00e9s individuelles retourn\u00e9es. Les \u00e9tablissements sont invit\u00e9s \u00e0 relayer l\u2019information \u00e0 l\u2019ensemble du personnel concern\u00e9 et aux autres structures auxquelles ces produits auraient \u00e9t\u00e9 transf\u00e9r\u00e9s. Il est recommand\u00e9 de continuer \u00e0 appliquer la prise en charge habituelle pour la surveillance des patients d\u00e9j\u00e0 trait\u00e9s avec ces cath\u00e9ters.<\/p>\n
Le rappel est motiv\u00e9 par un probl\u00e8me de fabrication affectant l\u2019extr\u00e9mit\u00e9 (tip) du cath\u00e9ter. Boston Scientific a identifi\u00e9 des niveaux r\u00e9duits d\u2019agents stabilisants dans les embouts, susceptibles d\u2019augmenter le risque de d\u00e9gradation et de d\u00e9tachement de la pointe. Bien qu\u2019aucune hausse des signalements de d\u00e9tachement de l\u2019extr\u00e9mit\u00e9 n\u2019ait \u00e9t\u00e9 constat\u00e9e pour les lots concern\u00e9s, l\u2019entreprise indique que les dispositifs ont \u00e9t\u00e9 fabriqu\u00e9s en dehors des sp\u00e9cifications de conception approuv\u00e9es et d\u00e9cide de les retirer du march\u00e9. Boston Scientific a en outre choisi d\u2019arr\u00eater la commercialisation de ce produit. Le principal effet ind\u00e9sirable d\u00e9crit en cas de d\u00e9tachement intravasculaire de l\u2019extr\u00e9mit\u00e9 est un allongement de la proc\u00e9dure li\u00e9 au besoin de remplacer le dispositif, m\u00eame si la source n\u2019apporte pas davantage de donn\u00e9es chiffr\u00e9es sur la fr\u00e9quence ou la gravit\u00e9 clinique des \u00e9v\u00e9nements.<\/p>\n
Cette situation met en jeu la s\u00e9curit\u00e9 des dispositifs m\u00e9dicaux invasifs, la surveillance des incidents et la gestion des rappels de produits par les autorit\u00e9s de r\u00e9gulation (ici la FDA) et les fabricants, avec des implications organisationnelles pour les \u00e9tablissements de sant\u00e9 (gestion des stocks, tra\u00e7abilit\u00e9, information interne et suivi des patients). Elle peut pr\u00e9senter un int\u00e9r\u00eat pour le suivi comparatif des pratiques de mat\u00e9riovigilance et de gestion des risques li\u00e9s aux dispositifs m\u00e9dicaux dans d\u2019autres pays, dont la France. (contenu r\u00e9sum\u00e9 en fran\u00e7ais par l’IA)\u00a0\u200bLire la Suite<\/a><\/p>","protected":false},"excerpt":{"rendered":" Les autorit\u00e9s sanitaires des \u00c9tats\u2011Unis signalent un rappel de dispositifs m\u00e9dicaux de type Imager II Angiographic Catheters, fabriqu\u00e9s par l\u2019entreprise Boston Scientific. Ce rappel, identifi\u00e9 par la Food and Drug […]<\/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-19034","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\/19034","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=19034"}],"version-history":[{"count":0,"href":"https:\/\/veilles-affaires-sociales.fr\/index.php?rest_route=\/wp\/v2\/posts\/19034\/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=19034"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/veilles-affaires-sociales.fr\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=19034"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/veilles-affaires-sociales.fr\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=19034"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}