{"id":3797,"date":"2010-05-06T16:21:57","date_gmt":"2010-05-06T15:21:57","guid":{"rendered":"http:\/\/catai.net\/blog\/\/?p=3797"},"modified":"2010-05-19T13:54:58","modified_gmt":"2010-05-19T12:54:58","slug":"e-salud-a-control-de-calidad","status":"publish","type":"post","link":"https:\/\/catai.net\/blog\/2010\/05\/e-salud-a-control-de-calidad\/","title":{"rendered":"e-Salud a control de calidad."},"content":{"rendered":"

Tal como El Pais<\/a> explicaba en su edicion del 13 Abril 2010, la receta\u00a0electr\u00f3nica\u00a0ha sido un desastre en Madrid.<\/p>\n

Con lo\u00a0f\u00e1cil\u00a0que hubiera sido aplicar la directiva comunitaria de Aparatos\u00a0M\u00e9dicos\u00a0 <\/span>DIR 2007\/47\/EC y una vez salio, aplicar la\u00a0transposici\u00f3n\u00a0legislativa Espa\u00f1ola RD-1591\/2009 en vigor desde el <\/span>21 de Marzo del 2010 y de las que hemos dado cuenta muchas veces<\/a> en nuestro blog.
\n\"http:\/\/cepco.hispamat.com\/Uploads\/imgs\/logos\/MarcadoCE_Logo.jpg\"<\/p>\n

SI HUBIERA LLEVADO LA MARCA CE<\/strong> DE APARATO MEDICO (incluido el software) NO HUBIERA OCURRIDO ESTO. Porque….\u00a0aunque el fabricante lo hubiera hecho por encargo, gratuitamente o por imposici\u00f3n del sistema, (1) el aparato deber\u00eda haber pasado antes de su puesta en servicio por un sistema de etiquetado, deber\u00eda ir acompa\u00f1ado de instrucciones de utilizaci\u00f3n y espec\u00edficamente detallar para que ha sido dise\u00f1ado y validado. (2)\u00a0el fabricante tendr\u00eda que haber entrenado a los usuarios para que sepan utilizarlo correctamente, sin riesgo para el enfermo y sin riesgo para \u00e9l medico o sanitario, incluida la responsabilidad legal.<\/span><\/em><\/span><\/span><\/em><\/p>\n

\n

EN RESUMEN:\u00a0Los aparatos que muestren el etiquetado CE tendr\u00e1n que proporcionar garant\u00eda de informaci\u00f3n (no podr\u00e1 haber productos secretos); de seguridad (deber\u00e1n haber sido testeado); de funcionalidad (con validaci\u00f3n previa a su puesta en funcionamiento real); de calidad (deben tener un sistema de dise\u00f1o de calidad ISO-13485). En caso contrario, solo podr\u00e1n ser considerados como un demostrador<\/strong><\/span><\/em>.<\/span><\/em><\/strong><\/em><\/p>\n

No se olviden de nuestra entrada de que ya no hay espacio para amateurs…<\/a>…<\/p>\n

\n

La odisea que explica El Pais,\u00a0podr\u00eda\u00a0haberse evitado:<\/p>\n

\n

“Ya a principios de marzo empezaron a compartir sus experiencias en\u00a0blogs<\/em> y foros de Internet -el m\u00e1s frecuentado se llama\u00a0Afectados por la aplicaci\u00f3n AP-Madrid-<\/em> y a finales de ese mes empezaron a ponerse de acuerdo para quejarse por escrito a la Consejer\u00eda de Sanidad. AP-Madrid “est\u00e1 interfiriendo en la atenci\u00f3n diaria a los pacientes”, denunciaron los m\u00e9dicos del centro de salud San Andr\u00e9s (Villaverde). Adem\u00e1s, “puede ocasionar graves problemas de praxis m\u00e9dica<\/strong>“. A causa, por ejemplo, de “la obligatoriedad de transcribir posolog\u00edas que no son reales<\/strong>” o de “la impresi\u00f3n de recetas que no corresponden a la prescripci\u00f3n realizada<\/strong>“.<\/p>\n<\/div>\n<\/div>\n

Sanidad adjudic\u00f3 su dise\u00f1o a la empresa Stacks por 6,3 millones de euros. Se hicieron pruebas piloto, versiones y m\u00e1s versiones, pero no funcionaba bien.<\/p>\n

Adem\u00e1s, la multinacional francesa Cegedim, especializada en almacenar, elaborar y vender datos a la industria farmac\u00e9utica, compr\u00f3 la empresa desarrolladora de AP-Madrid, Stacks, poco despu\u00e9s de que \u00e9sta ganara el concurso<\/p>\n

En septiembre pasado, Sanidad tuvo que contratar a otra empresa (Everis) por 2,4 millones de euros para acelerar la implantaci\u00f3n de AP-Madrid. Stacks-Cegedim no ha sido penalizada por los retrasos, aunque la consejer\u00eda explica que “ha fraccionado los pagos en funci\u00f3n del grado de cumplimiento de los hitos y se le ha exigido un mayor n\u00famero de recursos y desarrollos de nuevas funcionalidades”.<\/p>\n

Bibliografia:<\/p>\n

Departamento de Anatomia Patologica a Tenor de la Legislacion vigente.”<\/span><\/span><\/a>. en <\/span><\/span><\/span>Rev.Esp.Pat. (2009) Vol. 42, n.\u00ba 1:17-23<\/span><\/span><\/a><\/p>\n

http:\/\/en.wikipedia.org\/wiki\/Medical_device<\/span><\/span><\/a> <\/span><\/a><\/p>\n

MINISTERIO DE SANIDAD Y POL\u00cdTICA SOCIAL Productos sanitarios. Real Decreto 1591\/2009, de 16 de octubre, por el que se regulan los productos sanitarios. BOE 268 de 6 Noviembre 2009. pp: 92708 a 92778. Disponible en <\/span><\/span>http:\/\/www.boe.es\/boe\/dias\/2009\/11\/06\/<\/span><\/span><\/a><\/p>\n

IEC 60601-1: 2006. Seguridad en los equipos electrom\u00e9dicos incluyendo los PESS o subsistemas electr\u00f3nicos programables. Disponible en <\/span>http:\/\/www.tecno-med.es\/boletin\/60601-1aprobacion-cenelec.pdf<\/span><\/a> <\/span><\/span><\/p>\n

ISO 14971:2007 specifies a process for a manufacturer to identify the hazards associated with medical devices. <\/span>Disponible en <\/span><\/span>http:\/\/www.iso.org\/iso\/iso_catalogue\/catalogue_tc\/catalogye_detail.htm?csnumber=38193<\/a><\/p>\n

<\/a> <\/span><\/span><\/span>“Anatom\u00eda Patol\u00f3gica Digital. Control de calidad y pato-inform\u00e1tica.”<\/span><\/span><\/span><\/a> <\/span><\/span><\/span>en<\/span><\/span><\/span> <\/span><\/span><\/span>Rev. Esp. Patol (2009) Vol 42, n\u00ba 2: 85-95<\/span><\/span><\/a> Disponible en <\/span><\/span><\/span>http:\/\/www.patologia.es\/volumen42\/vol42-num2\/42-2n02.htm<\/span><\/span><\/a><\/p>\n

“Quality labels for e-health”<\/a> (PDF<\/a>).\u00a0IET Communications, 2008, 2,(2),pp. 202-207<\/a><\/p>\n

\n","protected":false},"excerpt":{"rendered":"

Tal como El Pais explicaba en su edicion del 13 Abril 2010, la receta\u00a0electr\u00f3nica\u00a0ha sido un desastre en Madrid. Con lo\u00a0f\u00e1cil\u00a0que hubiera sido aplicar la directiva comunitaria de Aparatos\u00a0M\u00e9dicos\u00a0 DIR 2007\/47\/EC y una vez salio, aplicar la\u00a0transposici\u00f3n\u00a0legislativa Espa\u00f1ola RD-1591\/2009 en vigor desde el 21 de Marzo del 2010 y de las que hemos dado cuenta […]<\/p>\n","protected":false},"author":3,"featured_media":0,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"give_campaign_id":0,"_jetpack_newsletter_access":"","_jetpack_dont_email_post_to_subs":false,"_jetpack_newsletter_tier_id":0,"_jetpack_memberships_contains_paywalled_content":false,"_jetpack_hide_featured_image":false,"_jetpack_featured_image_duplicate_dismissed":0,"_jetpack_feature_clip_id":0,"_jetpack_memberships_contains_paid_content":false,"footnotes":"","jetpack_publicize_message":"","jetpack_publicize_feature_enabled":true,"jetpack_social_post_already_shared":false,"jetpack_social_options":{"image_generator_settings":{"template":"highway","default_image_id":0,"font":"","enabled":false},"version":2},"jetpack_post_was_ever_published":false},"categories":[24,28,29,32],"tags":[],"class_list":["post-3797","post","type-post","status-publish","format-standard","hentry","category-productividad","category-sanidad","category-seguridad","category-sociedad_red"],"yoast_head":"\ne-Salud a control de calidad. | Telemedicina<\/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:\/\/catai.net\/blog\/2010\/05\/e-salud-a-control-de-calidad\/\" \/>\n<meta property=\"og:locale\" content=\"es_ES\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"e-Salud a control de calidad. | Telemedicina\" \/>\n<meta property=\"og:description\" content=\"Tal como El Pais explicaba en su edicion del 13 Abril 2010, la receta\u00a0electr\u00f3nica\u00a0ha sido un desastre en Madrid. 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