{"id":6382,"date":"2012-03-15T12:22:00","date_gmt":"2012-03-15T16:22:00","guid":{"rendered":"https:\/\/www.merkley.senate.gov\/senators-introduce-bipartisan-effort-to-make-medical-devices-safer\/"},"modified":"2023-07-24T11:10:47","modified_gmt":"2023-07-24T15:10:47","slug":"senators-introduce-bipartisan-effort-to-make-medical-devices-safer","status":"publish","type":"post","link":"https:\/\/www.merkley.senate.gov\/es\/senators-introduce-bipartisan-effort-to-make-medical-devices-safer\/","title":{"rendered":"Los senadores presentan un esfuerzo bipartidista para hacer que los dispositivos m\u00e9dicos sean m\u00e1s seguros"},"content":{"rendered":"<p><strong>Washington DC<\/strong> \u2013 Hoy, el senador Jeff Merkley de Oreg\u00f3n, junto con los senadores Chuck Grassley (R-IA), Michael Bennet (D-CO) y Herb Kohl (D-WI), presentaron la Ley bipartidista para Garantizar Dispositivos M\u00e9dicos Seguros para los Pacientes. El proyecto de ley le dar\u00eda a la Administraci\u00f3n de Alimentos y Medicamentos las herramientas que necesita para mejorar la supervisi\u00f3n de los dispositivos m\u00e9dicos. Los dispositivos m\u00e9dicos defectuosos se han asociado con miles de muertes en los \u00faltimos a\u00f1os.<\/p>\n<blockquote>\n<p>&quot;Cuando las personas mayores se someten a una cirug\u00eda de reemplazo de cadera o los pacientes card\u00edacos necesitan un stent card\u00edaco, no deber\u00edan tener que preocuparse de que el dispositivo que se supone que mejora su salud pueda en realidad enfermarlos m\u00e1s&quot;, <strong>dijo Merkley.<\/strong> \u201cUna fuerte vigilancia posterior a la comercializaci\u00f3n de los dispositivos m\u00e9dicos garantizar\u00e1 que aquellos que sean defectuosos o causen da\u00f1os puedan identificarse r\u00e1pidamente, que los pacientes y sus m\u00e9dicos puedan ser notificados y que los productos peligrosos puedan retirarse del mercado. Estas reformas de sentido com\u00fan no s\u00f3lo proteger\u00e1n a los pacientes, sino que tambi\u00e9n mejorar\u00e1n la eficiencia del sistema de atenci\u00f3n m\u00e9dica. Espero trabajar con mis colegas para la adopci\u00f3n en el Senado de esta importante iniciativa para mejorar la salud y la seguridad de los estadounidenses que dependen de dispositivos m\u00e9dicos para mejorar, sostener y, en muchos casos, salvar sus vidas\u201d.&nbsp;<\/p>\n<\/blockquote>\n<blockquote>\n<p>\u201cEl trabajo de vigilancia posterior a la comercializaci\u00f3n de la FDA debe estar facultado para poder utilizar la informaci\u00f3n importante y valiosa sobre medicamentos y dispositivos que est\u00e1 disponible cuando millones de personas comienzan a usarlos, en comparaci\u00f3n con lo que se puede saber antes de que se publique un medicamento o dispositivo. sale al mercado. Esta legislaci\u00f3n brindar\u00eda algunas de las herramientas necesarias a la FDA para que sea m\u00e1s efectiva en la atenci\u00f3n a los pacientes\u201d. <strong>Dijo Grassley.<\/strong>&nbsp;<\/p>\n<\/blockquote>\n<blockquote>\n<p>&quot;Los habitantes de Colorado esperan que los dispositivos m\u00e9dicos que utilizan les ayuden a mantenerse saludables&quot;. <strong>Bennet dijo.<\/strong>&nbsp; \u201cCon todas las presiones que supone luchar contra un problema de salud, lo \u00faltimo que alguien deber\u00eda temer es que estos dispositivos le hagan da\u00f1o o algo peor. Este proyecto de ley contribuir\u00eda en gran medida a ayudar a la FDA a trabajar de manera eficiente para garantizar que los habitantes de Colorado y los estadounidenses utilicen productos seguros que les ayuden a mantener una mejor calidad de vida\u201d.<\/p>\n<\/blockquote>\n<blockquote>\n<p>\u201cComo escuch\u00f3 de primera mano el Comit\u00e9 Especial del Senado sobre el Envejecimiento el a\u00f1o pasado, los dispositivos m\u00e9dicos defectuosos, especialmente los implantados en el cuerpo, pueden tener un impacto desastroso en la salud de quienes los usan\u201d. <strong>Dijo Kohl.<\/strong> \u201cLa tecnolog\u00eda innovadora ha proporcionado dispositivos m\u00e9dicos valiosos que salvan vidas, prolongan la vida y reducen el sufrimiento, pero el impulso para llevar nuevas tecnolog\u00edas al mercado no debe realizarse poniendo en riesgo la seguridad del paciente. Esta legislaci\u00f3n ayudar\u00e1 a lograr ese equilibrio necesario y delicado entre seguridad e innovaci\u00f3n\u201d.<\/p>\n<\/blockquote>\n<p>Los problemas de seguridad y los retiros del mercado de ciertos dispositivos m\u00e9dicos, incluidas caderas de metal sobre metal, mallas quir\u00fargicas y bombas de infusi\u00f3n programables implantables, han puesto en duda si la FDA y su Centro de Dispositivos y Salud Radiol\u00f3gica (CDRH) tienen las herramientas necesarias para proteger a los pacientes. y mantener los dispositivos da\u00f1inos fuera del mercado. Un promedio de 700 dispositivos m\u00e9dicos diferentes han sido retirados del mercado cada a\u00f1o desde 2005. Los dispositivos da\u00f1inos o defectuosos se asociaron con la muerte de casi 5.000 estadounidenses s\u00f3lo en 2009.<\/p>\n<p>La legislaci\u00f3n se basa en dos importantes iniciativas bipartidistas para mejorar la supervisi\u00f3n de los dispositivos m\u00e9dicos:<\/p>\n<ul>\n<li>Requiere que la FDA emita una regla final de Identificador \u00danico de Dispositivo (UDI) para finales de 2012, exigiendo que los dispositivos implantables lleven un identificador num\u00e9rico \u00fanico para que los productos puedan ser rastreados a lo largo de la cadena de distribuci\u00f3n y una vez que se est\u00e9n utilizando con pacientes. El programa UDI se cre\u00f3 hace casi cinco a\u00f1os pero la FDA no lo ha implementado.<\/li>\n<li>Agrega dispositivos m\u00e9dicos a la iniciativa de vigilancia poscomercializaci\u00f3n Sentinel, lanzada en 2008. Sentinel es un sistema electr\u00f3nico nacional integrado que actualmente monitorea la seguridad de los medicamentos recetados despu\u00e9s de la aprobaci\u00f3n de la FDA, una vez que los medicamentos se comercializan a los pacientes.&nbsp;<\/li>\n<\/ul>\n<p>El proyecto de ley ha sido respaldado por Consumers Union, National Women&#039;s Health Network, National Research Center for Women and Families, Health Care Supply Chain Association, Premier Healthcare Alliance, Association of American Medical Colleges, Alliance for Advancing Nonprofit Health Care y National Association for Continence. , Fundaci\u00f3n MedicAlert, Ciudadano P\u00fablico y Uni\u00f3n de Cient\u00edficos Preocupados.<\/p>","protected":false},"excerpt":{"rendered":"<p>Washington, DC &ndash; Today, Oregon&rsquo;s Senator Jeff Merkley, with Senators Chuck Grassley (R-IA), Michael Bennet (D-CO) and Herb Kohl (D-WI), introduced the bipartisan Ensuring Safe Medical Devices for Patients Act. The bill would give the Food and Drug Administration the tools it needs to improve oversight of medical devices. &nbsp;Defective medical devices have been associated [&hellip;]<\/p>\n","protected":false},"author":2,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"inline_featured_image":false,"footnotes":""},"categories":[24],"tags":[43,37],"class_list":["post-6382","post","type-post","status-publish","format-standard","hentry","category-press-releases","tag-bipartisan-actions","tag-health-care"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.2 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Senators Introduce Bipartisan Effort to Make Medical Devices Safer - Merkley<\/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.merkley.senate.gov\/es\/senators-introduce-bipartisan-effort-to-make-medical-devices-safer\/\" \/>\n<meta property=\"og:locale\" content=\"es_MX\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Senators Introduce Bipartisan Effort to Make Medical Devices Safer - Merkley\" \/>\n<meta property=\"og:description\" content=\"Washington, DC &ndash; Today, Oregon&rsquo;s Senator Jeff Merkley, with Senators Chuck Grassley (R-IA), Michael Bennet (D-CO) and Herb Kohl (D-WI), introduced the bipartisan Ensuring Safe Medical Devices for Patients Act. 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