{"id":24178,"date":"2022-09-26T05:03:45","date_gmt":"2022-09-26T05:03:45","guid":{"rendered":"https:\/\/www.emballagedigest.fr\/?p=24178"},"modified":"2022-09-26T07:41:54","modified_gmt":"2022-09-26T07:41:54","slug":"urgo-choisit-sea-vision-pour-le-marquage-et-le-controle-de-ses-dispositifs-medicaux-publi-communique","status":"publish","type":"post","link":"https:\/\/www.emballagedigest.fr\/en\/urgo-choisit-sea-vision-pour-le-marquage-et-le-controle-de-ses-dispositifs-medicaux-publi-communique\/","title":{"rendered":"Urgo choisit SEA Vision pour le marquage et le contr\u00f4le de ses dispositifs m\u00e9dicaux (publi-communiqu\u00e9)"},"content":{"rendered":"<p>Le nouveau r\u00e8glement europ\u00e9en 2017\/745, entr\u00e9 en application le 26 mai 2020, vient renforcer les obligations de tra\u00e7abilit\u00e9 et de transparence de la cha\u00eene des dispositifs m\u00e9dicaux (DM). Un syst\u00e8me d\u2019identification unique devra dor\u00e9navant figurer sur le DM selon deux formats&nbsp;: un format d\u2019identification et saisie automatique des donn\u00e9es (code lin\u00e9aire, code 2D, RFID) et un format lisible par l\u2019homme. Les donn\u00e9es suivantes seront imprim\u00e9es \u00e0 minima sur le produit&nbsp;: identifiant du produit (IUD-ID), num\u00e9ro de lot, date de p\u00e9remption.<\/p>\n<p>Les logiciels de tous les op\u00e9rateurs devront pouvoir lire et enregistrer \u00e9lectroniquement les informations s\u2019y rapportant pour assurer la tra\u00e7abilit\u00e9 des DM sur l\u2019ensemble de la cha\u00eene de distribution et, pour certains produits, jusqu\u2019au patient. Inutile de souligner l\u2019importance de l\u2019enjeu pour les fabricants qui portent la responsabilit\u00e9 de la mise en place du dispositif selon un planning d\u00e9j\u00e0 fig\u00e9. <\/p>\n<p><strong>Un dispositif de contr\u00f4le unique<\/strong> <br \/>\nPour ce projet d\u2019envergure les laboratoires URGO n\u2019ont pas h\u00e9sit\u00e9 longtemps sur le choix du partenaire pour les accompagner dans la mise en place du syst\u00e8me de contr\u00f4le. En effet, seule l\u2019expertise de SEA Vision en acquisition d\u2019images et la flexibilit\u00e9 de la solution propos\u00e9e garantissait \u00e0 URGO une bonne prise en compte des sp\u00e9cificit\u00e9s des produits pansements et \u00e9tuis de ses gammes UrgoStart, UrgoTul, Silver range, Sanyrene et Traditional wound care. <br \/>\nL\u2019enjeu principal \u00e9tait d\u2019\u00e9viter les faux rejets de produits non retraitables pour r\u00e9duire autant que possible les pertes financi\u00e8res associ\u00e9es. Ceci supposait d\u2019une part un marquage optimal pour une parfaite r\u00e9p\u00e9tabilit\u00e9 mais \u00e9galement un syst\u00e8me de contr\u00f4le adapt\u00e9 (luminosit\u00e9 et r\u00e9solution du syst\u00e8me de vision).<\/p>\n<p>La solution, install\u00e9e par SEA Vision, repose en premier lieu sur un \u00e9clairage \u00e9tudi\u00e9 permettant un contr\u00f4le fiable sur des produits r\u00e9fl\u00e9chissants malgr\u00e9 les interf\u00e9rences inh\u00e9rentes \u00e0 l\u2019\u00e9clairage ext\u00e9rieur. Pour simplifier le pilotage, le dispositif d\u2019impression retenu et install\u00e9 par URGO est directement et int\u00e9gralement command\u00e9 par le syst\u00e8me de contr\u00f4le. La cr\u00e9ation des masques et l\u2019envoi des donn\u00e9es \u00e0 imprimer s\u2019effectuent depuis ce dernier. La ligne n\u2019est ainsi \u00e9quip\u00e9e que d\u2019une seule interface conviviale. <br \/>\nLa v\u00e9rification du grade du code en ligne s\u2019effectue par un algorithme d\u2019\u00e9mulation de la norme ISO15415 qui permet de contr\u00f4ler la qualit\u00e9 d\u2019impression sur 100% des codes imprim\u00e9s (cadence de 3 \u00e0 4 produits \/sec), garantissant ainsi le seuil minimal requis par la r\u00e9glementation.<\/p>\n<p><img decoding=\"async\" src=\"https:\/\/www.emballagedigest.fr\/dotclear\/images\/2022\/BONUS\/sep\/sea_article2.jpg\" alt=\"Texte Alternatif\" style=\"float:right; margin: 0 0 1em 1em;\" \/><\/p>\n<p>La r\u00e9cup\u00e9ration des donn\u00e9es stock\u00e9es dans l\u2019ERP des laboratoires URGO s\u2019effectue par un middleware interfac\u00e9. Ainsi, lors du lancement d\u2019un lot, l\u2019op\u00e9rateur n\u2019a qu\u2019\u00e0 s\u00e9lectionner dans un menu d\u00e9roulant l\u2019ordre de production. L\u2019absence de saisie \u00e9limine les risques d\u2019erreurs et garantit d\u2019imprimer des donn\u00e9es exactes (data integrity). Pour un fonctionnement optimal le syst\u00e8me est enti\u00e8rement automatis\u00e9.<br \/>\nLe recul pris depuis la premi\u00e8re installation en novembre 2021 a permis d\u2019apporter les correctifs n\u00e9cessaires \u00e0 la recette. A date, ce sont d\u00e9j\u00e0 10 lignes d\u2019un premier site qui ont d\u00e9j\u00e0 \u00e9t\u00e9 \u00e9quip\u00e9es. <br \/>\nL\u2019objectif des laboratoires URGO est de poursuivre le d\u00e9ploiement au rythme d\u2019une ligne par mois.<br \/>\nL\u2019extr\u00eame flexibilit\u00e9 du dispositif install\u00e9 par SEA Vision ouvre la possibilit\u00e9 d\u2019un \u00e9largissement aux nombreux autres produits concern\u00e9s par les nouvelles dispositions r\u00e9glementaires ainsi que celle d\u2019une possible externalisation.<\/p>\n<p><strong>La culture de l\u2019innovation technologique au service de l\u2019industrie pharmaceutique<\/strong><br \/>\nCe sont 25 ann\u00e9es d\u2019expertise en conception et d\u00e9veloppement de logiciels et syst\u00e8mes de vision sp\u00e9cifiquement d\u00e9di\u00e9s \u00e0 l\u2019industrie pharmaceutique et un investissement continu en R&amp;D qui permettent \u00e0 SEA Vision de proposer les solutions technologiques (certifi\u00e9es EU\/UL\/CAS) les plus innovantes pour r\u00e9pondre aux besoins des projets les plus complexes. <\/p>\n<p><em><strong>SEA Vision&nbsp;: l\u2019ambition de l\u2019excellence !<\/strong><\/em><\/p>\n<p>\n<a href=\"https:\/\/www.seavision-group.com\/\">www.seavision-group.com<\/a><\/p>\n<p><img decoding=\"async\" src=\"https:\/\/www.emballagedigest.fr\/dotclear\/images\/2022\/BONUS\/sep\/sea_logo.jpg\" alt=\"Texte Alternatif\" style=\"float:left; margin: 0 1em 1em 0;\" \/><\/p>","protected":false},"excerpt":{"rendered":"<p>Le nouveau r\u00e8glement europ\u00e9en 2017\/745, entr\u00e9 en application le 26 mai 2020, vient renforcer les obligations de tra\u00e7abilit\u00e9 et de transparence de la cha\u00eene des dispositifs m\u00e9dicaux (DM). Un syst\u00e8me d\u2019identification unique devra dor\u00e9navant figurer sur le DM selon deux formats&nbsp;: un format d\u2019identification et saisie automatique des donn\u00e9es (code lin\u00e9aire, code 2D, RFID) et un format lisible par l\u2019homme. Les donn\u00e9es suivantes seront imprim\u00e9es \u00e0 minima sur le produit&nbsp;: identifiant du produit (IUD-ID), num\u00e9ro de lot, date de p\u00e9remption.<\/p>","protected":false},"author":1,"featured_media":34178,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"inline_featured_image":false,"iawp_total_views":1,"footnotes":""},"categories":[],"tags":[],"class_list":["post-24178","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v24.4 - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>Urgo choisit SEA Vision pour le marquage et le contr\u00f4le de ses dispositifs m\u00e9dicaux (publi-communiqu\u00e9) - Emballage Digest<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/www.emballagedigest.fr\/en\/urgo-choisit-sea-vision-pour-le-marquage-et-le-controle-de-ses-dispositifs-medicaux-publi-communique\/\" \/>\n<meta property=\"og:locale\" content=\"en_GB\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Urgo choisit SEA Vision pour le marquage et le contr\u00f4le de ses dispositifs m\u00e9dicaux (publi-communiqu\u00e9) - Emballage Digest\" \/>\n<meta property=\"og:description\" content=\"Le nouveau r\u00e8glement europ\u00e9en 2017\/745, entr\u00e9 en application le 26 mai 2020, vient renforcer les obligations de tra\u00e7abilit\u00e9 et de transparence de la cha\u00eene des dispositifs m\u00e9dicaux (DM). 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