{"id":6004,"date":"2019-06-21T00:00:00","date_gmt":"2019-06-20T23:00:00","guid":{"rendered":"https:\/\/blog.avinent.com\/2019\/06\/21\/que-tener-en-cuenta-al-escoger-guias-quirurgicas\/"},"modified":"2024-11-20T10:55:44","modified_gmt":"2024-11-20T09:55:44","slug":"que-tener-en-cuenta-al-escoger-guias-quirurgicas","status":"publish","type":"post","link":"https:\/\/avinent.com\/ca\/blog\/que-tener-en-cuenta-al-escoger-guias-quirurgicas\/","title":{"rendered":"\u00bfQu\u00e9 tener en cuenta al escoger gu\u00edas quir\u00fargicas?"},"content":{"rendered":"<p style=\"text-align: left\">La impresi\u00f3n 3D permite imprimir modelos complejos totalmente personalizados, reduciendo los costes y acelerando la producci\u00f3n.<\/p>\n<p style=\"text-align: left\">Las <strong>gu\u00edas quir\u00fargicas<\/strong> se engloban dentro de los productos realizados mediante fabricaci\u00f3n aditiva y la creciente demanda que ha experimentado ha provocado que aumente su control, ya que se trata de un producto m\u00e9dico que debe cumplir los mismos requisitos que cumplen los productos de su familia.<\/p>\n<p style=\"text-align: left\">Para fabricar un producto como las gu\u00edas quir\u00fargicas no solo es necesario disponer de la tecnolog\u00eda y del conocimiento necesario para dise\u00f1arlas e imprimirlas, tambi\u00e9n es imprescindible disponer de los <strong>certificados regulatorios<\/strong> que aseguran que es un producto fiable, fabricado con responsabilidad y seguridad. Para AVINENT, la m\u00e1xima prioridad es ofrecer el producto ideal que mejore la calidad de los tratamientos que ofrece, por este motivo es indispensable cumplir al pie de la letra toda la regulaci\u00f3n necesaria para los productos que fabrica y distribuye. En productos del sector m\u00e9dico, la regulaci\u00f3n asegura un sistema de vigilancia de lo que se fabrica y distribuye, ateni\u00e9ndose a riesgos potenciales que pueden derivarse de su utilizaci\u00f3n y evitar as\u00ed posibles incidentes adversos.<\/p>\n<p style=\"text-align: left\">Las gu\u00edas quir\u00fargicas de AVINENT pertenecen a la <strong>clase IIa<\/strong> de productos sanitarios, agrupados de esta manera por las reglas de decisi\u00f3n basadas en la vulnerabilidad del cuerpo humano. En funci\u00f3n de estas clases, se aplican diferentes procedimientos de evaluaci\u00f3n por parte del organismo notificado. Las gu\u00edas quir\u00fargicas constituyen un grupo especial porque est\u00e1n destinadas a ser utilizadas por un <strong>paciente en particular<\/strong> que presenta unas determinadas caracter\u00edsticas, son un art\u00edculo de <strong>uso temporal<\/strong> (&lt;60 min) y son de <strong>un solo uso<\/strong>.<\/p>\n<p><strong><span class=\"destacado\">Aspectos esenciales para escoger correctament gu\u00edas quir\u00fargicas<\/span><\/strong><\/p>\n<table>\n<tbody>\n<tr>\n<td><img decoding=\"async\" src=\"https:\/\/blog.avinent.com\/wp-content\/uploads\/sites\/9\/2019\/12\/certificado_1.png?1561125111379\" alt=\"material_jetting\" width=\"122\" height=\"122\"><\/td>\n<td>\n<p><span class=\"azul\"><strong>LICENCIA DE FABRICACI\u00d3N DEL PRODUCTO SANITARIO A MEDIDA<\/strong><\/span><\/p>\n<p>En el caso de AVINENT, incluye implantes, placas y pr\u00f3tesis para reconstrucci\u00f3n y fijaci\u00f3n \u00f3sea, y gu\u00edas quir\u00fargicas (esterilizadas o no esterilizadas). Este tipo de licencia permite a AVINENT <strong>fabricar y vender sus productos sanitarios<\/strong>, asegurando la calidad necesaria y acreditando que cumple los requisitos necesarios para ser utilizado.<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<table>\n<tbody>\n<tr>\n<td><img decoding=\"async\" src=\"https:\/\/blog.avinent.com\/wp-content\/uploads\/sites\/9\/2019\/12\/material.png?1561125265999\" alt=\"material_jetting\" width=\"125\" height=\"125\"><\/td>\n<td>\n<p><span class=\"azul\"><strong>MATERIAL<\/strong><\/span><\/p>\n<p>Para producir las gu\u00edas quir\u00fargicas, AVINENT utiliza <strong>poliamida<\/strong>, un material <strong>biocompatible<\/strong> seg\u00fan el USP biological test, que a la vez posee un magn\u00edfico cuadro de propiedades mec\u00e1nicas, una tenacidad muy elevada, es esterilizable y dispone de unas excelentes caracter\u00edsticas de deslizamiento y resistencia al desgaste. AVINENT, obtiene un certificado de an\u00e1lisis de cada lote de material antes de ser utilizado para verificar que cumple con las especificaciones t\u00e9cnicas.<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<table>\n<tbody>\n<tr>\n<td><img decoding=\"async\" src=\"https:\/\/blog.avinent.com\/wp-content\/uploads\/sites\/9\/2019\/12\/calidad.png?1561125398366\" alt=\"material_jetting\" width=\"132\" height=\"132\"><\/td>\n<td>\n<p><span class=\"azul\"><strong>CONTROL EN EL M\u00c9TODO DE FABRICACI\u00d3N<\/strong><\/span><\/p>\n<p>Es necesario que todo el proceso, desde el dise\u00f1o con software hasta la fabricaci\u00f3n, este certificado. Durante el proceso de fabricaci\u00f3n, se lleva a cabo un <strong>exhaustivo control de calidad<\/strong> mediante calibraciones y revisiones peri\u00f3dicas de toda la tecnolog\u00eda y su funcionamiento, y a la vez, se aplican controles biol\u00f3gicos constantes y limpiezas de termodesinfecci\u00f3n validadas para asegurar que tanto el m\u00e9todo de fabricaci\u00f3n, como la tecnolog\u00eda y el entorno donde se fabrican las piezas, cumplen unos estrictos est\u00e1ndares de calidad y limpieza.<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<p><img loading=\"lazy\" decoding=\"async\" class=\"responsive\" src=\"https:\/\/blog.avinent.com\/wp-content\/uploads\/sites\/9\/2019\/12\/guies1.jpg?1561125585398\" alt=\"guies1\" width=\"730\" height=\"1033\"><\/p>\n<p>AVINENT, por tanto, cumple de manera adecuada los requisitos t\u00e9cnico-sanitarios para la fabricaci\u00f3n a medida de gu\u00edas quir\u00fargicas (de corte y de guiaje o posicionamiento) mediante la impresi\u00f3n 3D, usando como material la poliamida.<\/p>\n<p>Al consumir productos sanitarios, es preciso ser consciente de la importancia de que estos est\u00e9n regulados y re\u00fanan los requisitos esenciales de seguridad, calidad y ofrecimiento de prestaciones e informaci\u00f3n al consumidor que tienen que cumplir los productos.\t\t<\/p>\n","protected":false},"excerpt":{"rendered":"<p>La impresi\u00f3n 3D permite imprimir modelos complejos totalmente personalizados, reduciendo los costes y acelerando la producci\u00f3n. Las gu\u00edas quir\u00fargicas se engloban dentro de los productos realizados mediante fabricaci\u00f3n aditiva y la creciente demanda que ha experimentado ha provocado que aumente su control, ya que se trata de un producto m\u00e9dico que debe cumplir los mismos [&hellip;]<\/p>\n","protected":false},"author":2,"featured_media":4929,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"inline_featured_image":false,"footnotes":""},"categories":[39],"tags":[47,49,51],"profesional_medics":[],"segment":[172],"class_list":["post-6004","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-consejos","tag-materiales","tag-impresion-3d","tag-cirugia-guiada","segments-craneomaxilofacial"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v26.8 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>\u25b7\u00bfQu\u00e9 tener en cuenta al escoger gu\u00edas quir\u00fargicas? 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