L\u2019autorit\u00e9 am\u00e9ricaine de r\u00e9gulation des m\u00e9dicaments et dispositifs m\u00e9dicaux (FDA) signale un rappel correctif, class\u00e9 comme le plus s\u00e9rieux (risque de blessure grave ou de d\u00e9c\u00e8s en cas d\u2019usage sans correction), concernant certains kits m\u00e9dicaux de la soci\u00e9t\u00e9 AVID Medical contenant des ampoules de chlorure de sodium 0,9 % de 10 ml. Ce rappel ne vise pas au retrait des dispositifs de leur lieu d\u2019utilisation ou de vente, mais \u00e0 la correction des kits concern\u00e9s.<\/p>\n
Les dispositifs vis\u00e9s sont des \u00ab convenience kits \u00bb de diff\u00e9rents types, notamment des plateaux de bloc nerveux continu (CONTINUOUS NERVE BLOCK TRAY, mod\u00e8le BMCN001-05), des plateaux d\u2019anesth\u00e9sie p\u00e9ridurale \u00e0 injection unique (18G SINGLE SHOT EPI TRAY, mod\u00e8le DPGE002-02), des plateaux de biopsie de base (BASIC BIOPSY TRAY, mod\u00e8le PM415) et des kits de biopsie d\u2019imagerie (UNIV IMAGING BIOPSY TRUCUSTOM, mod\u00e8le VARV042-03), identifi\u00e9s par une s\u00e9rie de num\u00e9ros de lots et UDI sp\u00e9cifiques. La FDA indique \u00eatre inform\u00e9e qu\u2019AVID Medical a adress\u00e9 une lettre aux clients concern\u00e9s recommandant la correction des kits par retrait des composants affect\u00e9s par un rappel \u00e9mis par Huons Co., Ltd.<\/p>\n
La mesure principale consiste \u00e0 ne pas utiliser les ampoules de chlorure de sodium contenues dans les kits concern\u00e9s. Les \u00e9tablissements doivent v\u00e9rifier leurs stocks, isoler et mettre en quarantaine les kits identifi\u00e9s, puis apposer sur ceux-ci des \u00e9tiquettes d\u2019avertissement sp\u00e9cifiques avant toute utilisation. Le mod\u00e8le d\u2019\u00e9tiquette est fourni pour impression et apposition sur l\u2019ensemble des kits et cartons en stock, dans un emplacement visible, sans masquer d\u2019autres informations critiques de l\u2019\u00e9tiquetage. Si n\u00e9cessaire, des \u00e9tiquettes pr\u00e9imprim\u00e9es peuvent \u00eatre demand\u00e9es au repr\u00e9sentant commercial. Tous les autres composants des kits peuvent continuer \u00e0 \u00eatre utilis\u00e9s une fois les ampoules de chlorure de sodium retir\u00e9es et jet\u00e9es.<\/p>\n
Selon AVID Medical, certains kits p\u00e9riduraux peuvent contenir des ampoules de chlorure de sodium fabriqu\u00e9es par Huons Co., Ltd. et rappel\u00e9es par Spectra Medical Devices, LLC en raison de doutes sur la qualit\u00e9 du produit et la garantie de st\u00e9rilit\u00e9 de la solution de chlorure de sodium injectable 0,9 % en ampoule de 10 ml. L\u2019utilisation de ces ampoules est susceptible d\u2019exposer les patients \u00e0 des agents microbiologiques viables, ce qui motive la classification du rappel par la FDA et les consignes strictes de retrait des ampoules au sein des kits. Cette situation illustre un enjeu de s\u00e9curit\u00e9 des soins et de cha\u00eene d\u2019approvisionnement en dispositifs m\u00e9dicaux st\u00e9riles pouvant int\u00e9resser le suivi des politiques de s\u00e9curit\u00e9 sanitaire et de mat\u00e9riovigilance. (contenu r\u00e9sum\u00e9 en fran\u00e7ais par l’IA)\u00a0\u200bLire la Suite<\/a><\/p>","protected":false},"excerpt":{"rendered":" L\u2019autorit\u00e9 am\u00e9ricaine de r\u00e9gulation des m\u00e9dicaments et dispositifs m\u00e9dicaux (FDA) signale un rappel correctif, class\u00e9 comme le plus s\u00e9rieux (risque de blessure grave ou de d\u00e9c\u00e8s en cas d\u2019usage sans […]<\/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-18141","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\/18141","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=18141"}],"version-history":[{"count":0,"href":"https:\/\/veilles-affaires-sociales.fr\/index.php?rest_route=\/wp\/v2\/posts\/18141\/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=18141"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/veilles-affaires-sociales.fr\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=18141"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/veilles-affaires-sociales.fr\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=18141"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}