{"id":7245,"date":"2020-04-01T09:27:06","date_gmt":"2020-04-01T15:27:06","guid":{"rendered":"https:\/\/saluddigital.com\/?p=7245"},"modified":"2025-10-21T15:21:25","modified_gmt":"2025-10-21T21:21:25","slug":"covid-19-la-fda-emite-una-guia-sobre-dispositivos-de-monitoreo-remoto-no-invasivos","status":"publish","type":"post","link":"https:\/\/saluddigital.com\/en\/comunidades-conectadas\/covid-19-la-fda-emite-una-guia-sobre-dispositivos-de-monitoreo-remoto-no-invasivos\/","title":{"rendered":"COVID-19: FDA publishes a guidance for Non-Invasive remote monitoring devices"},"content":{"rendered":"
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The Food and Drugs Administration (FDA), published a guidance about enforcement policies for non-invasive remote monitoring devices used to support patient monitoring during the coronavirus disease-2019 (COVID-19), public health emergency.<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t
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The FDA made this guidance to provide a policy to help expand the availability and capability of non-invasive remote monitoring devices, namely telemedicine devices. Devices that supports patient monitoring while reducing patient contact and exposure to COVID-19.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t

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This policy will only be available during the public health emergency derived by COVID-19 pandemic. Due to the health emergency, the guide has been implemented immediately without any changes or comments from the public.<\/p>

The FDA is allowing that the hardware used for remote monitoring will be commercially available, even with additional information about COVID-19. This represents a perfect telemedicine tool in times of health crisis.<\/p>

In addition, modification of hardware to cover specific needs, such as adding Bluetooth or other ways for connecting devices, is considered.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t

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\u201cAllowing these devices to be used remotely can help health care providers access information about a patient\u2019s vital signs while the patient is at home, reducing the need for hospital visits and minimizing the risk of exposure to coronavirus,\u201d said FDA Principal Deputy Commissioner Dr. Abernethy, when referring to the steps taken by the FDA.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t

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\n\t\t\t\t\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/i><\/span>\n\t\t\t\t\t\t\t\t<\/i><\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t\t\tBIBLIOGRAPHY<\/a>\n\t\t\t\t\t<\/div>\n\n\t\t\t\t\t

FDA<\/strong><\/p>

https:\/\/www.fda.gov\/media\/136290\/download<\/a><\/p>

https:\/\/www.fda.gov\/regulatory-information\/search-fda-guidance-documents\/enforcement-policy-non-invasive-remote-monitoring-devices-used-support-patient-monitoring-during<\/a><\/p>

https:\/\/www.fda.gov\/news-events\/press-announcements\/coronavirus-covid-19-update-fda-allows-expanded-use-devices-monitor-patients-vital-signs-remotely<\/a><\/p><\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<\/div>","protected":false},"excerpt":{"rendered":"

La Administraci\u00f3n de Alimentos y Medicamentos (FDA por sus siglas en ingl\u00e9s), public\u00f3 un documento sobre pol\u00edtica orientada a dispositivos de monitoreo durante la emergencia en salud p\u00fablica por COVID-19. La FDA emiti\u00f3 una gu\u00eda para proporcionar pol\u00edticas que aporten a la expansi\u00f3n de la disponibilidad y utilizaci\u00f3n de dispositivos de monitoreo remoto no invasivos, es decir, herramientas de telemedicina. Dispositivos que favorecen al monitoreo del paciente, reduciendo contacto con el paciente y as\u00ed evitar la exposici\u00f3n al COVID-19. Esta pol\u00edtica \u00fanicamente estar\u00e1 vigente durante el estado de emergencia en salud p\u00fablica derivado por la pandemia de coronavirus.\u00a0 Debido a la emergencia sanitaria, la gu\u00eda ha sido implementada de inmediato sin haber cambios o comentarios por parte de la ciudadan\u00eda. La FDA est\u00e1 permitiendo que el hardware utilizado para realizar monitoreos remotos pueda ser comercializado adem\u00e1s con informaci\u00f3n adicional sobre el COVID-19. Lo que representa una herramienta perfecta de telemedicina en tiempos de crisis en salud como la que esta atravesando el mundo y Estados Unidos. Adem\u00e1s, est\u00e1 considerada la modificaci\u00f3n en los hardware para cubrir necesidades espec\u00edficas, como a\u00f1adir Bluetooth u otras formas para la conexi\u00f3n de dispositivos. \u201cPermitir que estos dispositivos se utilicen de forma remota puede ayudar a los proveedores de atenci\u00f3n m\u00e9dica a acceder a informaci\u00f3n sobre los signos vitales de un paciente mientras el paciente est\u00e1 en casa, lo que reduce la necesidad de visitas al hospital y minimiza el riesgo de exposici\u00f3n al coronavirus\u201d dijo la Dra. Abernethy comisionada principal de la FDA al referirse a las medidas tomadas por la FDA. BIBLIOGRAF\u00cdA FDA https:\/\/www.fda.gov\/media\/136290\/download https:\/\/www.fda.gov\/regulatory-information\/search-fda-guidance-documents\/enforcement-policy-non-invasive-remote-monitoring-devices-used-support-patient-monitoring-during https:\/\/www.fda.gov\/news-events\/press-announcements\/coronavirus-covid-19-update-fda-allows-expanded-use-devices-monitor-patients-vital-signs-remotely<\/p>","protected":false},"author":1,"featured_media":7246,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[154,1502],"tags":[145],"class_list":["post-7245","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-comunidades-conectadas","category-coronavirus","tag-noticias"],"aioseo_notices":[],"_links":{"self":[{"href":"https:\/\/saluddigital.com\/en\/wp-json\/wp\/v2\/posts\/7245","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/saluddigital.com\/en\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/saluddigital.com\/en\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/saluddigital.com\/en\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/saluddigital.com\/en\/wp-json\/wp\/v2\/comments?post=7245"}],"version-history":[{"count":0,"href":"https:\/\/saluddigital.com\/en\/wp-json\/wp\/v2\/posts\/7245\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/saluddigital.com\/en\/wp-json\/wp\/v2\/media\/7246"}],"wp:attachment":[{"href":"https:\/\/saluddigital.com\/en\/wp-json\/wp\/v2\/media?parent=7245"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/saluddigital.com\/en\/wp-json\/wp\/v2\/categories?post=7245"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/saluddigital.com\/en\/wp-json\/wp\/v2\/tags?post=7245"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}