{"id":55456,"date":"2022-07-26T15:19:10","date_gmt":"2022-07-26T19:19:10","guid":{"rendered":"https:\/\/regstaging.wpengine.com\/fda-alerts-consumers-of-unsafe-uv-levels-in-certain-disinfectant-wands\/"},"modified":"2022-08-25T11:35:34","modified_gmt":"2022-08-25T15:35:34","slug":"fda-alerts-consumers-of-unsafe-uv-levels-in-certain-disinfectant-wands","status":"publish","type":"post","link":"https:\/\/legacy.registrarcorp.com\/pt\/fda-alerts-consumers-of-unsafe-uv-levels-in-certain-disinfectant-wands\/","title":{"rendered":"A FDA Adverte aos Consumidores sobre os N\u00edveis Inseguros de Raios UV em Certos Bast\u00f5es Desinfetantes"},"content":{"rendered":"<p>A Administra\u00e7\u00e3o de Alimentos E Medicamentos dos EUA (FDA) recentemente advertiu os consumidores que certas marcas de bast\u00f5es ultravioletas (UV) podem representar um risco potencial de ferimentos quando usados. Estes bast\u00f5es s\u00e3o usados para desinfetar superf\u00edcies e matar germes em ambientes fora da maioria das instala\u00e7\u00f5es de sa\u00fade, como as resid\u00eancias. A FDA afirma que os produtos afetados podem emitir n\u00edveis inseguros de radia\u00e7\u00e3o ultravioleta C (UV-C) que podem causar danos ao usu\u00e1rio ou a qualquer pessoa pr\u00f3xima.<\/p>\n<p>Qualquer pessoa exposta por alguns segundos a n\u00edveis inseguros de UV-C pode sofrer les\u00f5es na pele e\/ou nos olhos ap\u00f3s o uso do produto.<\/p>\n<p><strong>N\u00edveis de Radia\u00e7\u00e3o Perigosos<\/strong><\/p>\n<p>O Centro de Dispositivos e Sa\u00fade Radiol\u00f3gica da FDA (CDRH) testou certos bast\u00f5es UV port\u00e1teis e os encontrou com defeito sob 21 CFR 1003.2(b)(2), que declara: &#8220;Sem considerar as especifica\u00e7\u00f5es de projeto do produto, emite radia\u00e7\u00e3o eletr\u00f4nica desnecess\u00e1ria para o desempenho de sua finalidade principal que cria um risco de ferimento, incluindo ferimentos gen\u00e9ticos a qualquer pessoa&#8221;.<\/p>\n<p>A FDA incluiu os seguintes produtos em seu aviso aos consumidores:<\/p>\n<ul>\n<li>Safe T Lite da Max-lux Corporation<br \/>\n\u2022 Varinha desinfetante UVC recarreg\u00e1vel OttLite, modelo UV10002M, da OttLite Technologies<br \/>\n\u2022 UVILIZER FLIP, modelo SG-153 da In My Bathroom LLC.<br \/>\n\u2022 Esterilizador port\u00e1til com bast\u00e3o de luz UV, tamb\u00e9m do In My Bathroom<br \/>\n\u2022 Ultraviolet Sterilamp PURPLEGLOW da Vanelc<br \/>\n\u2022 Varinha port\u00e1til de higieniza\u00e7\u00e3o UV de imagem mais n\u00edtida, modelo 101362 da MerchSource LLC<br \/>\n\u2022 SurfaceSoap UV da PhoneSoap LLC<br \/>\n\u2022 Desinfetante Magic UV Light Sanitizer Magic UV Light Sanitizer<\/li>\n<\/ul>\n<p>Em alguns casos, os produtos tamb\u00e9m continham caracter\u00edsticas que causavam riscos adicionais. Estas caracter\u00edsticas incluem a falta de informa\u00e7\u00f5es de seguran\u00e7a ou prote\u00e7\u00e3o para os usu\u00e1rios e a alega\u00e7\u00e3o de que os produtos desinfetam em segundos, indicando a probabilidade de o produto emitir um n\u00edvel inseguro de radia\u00e7\u00e3o UV-C.<\/p>\n<p>A Comiss\u00e3o Internacional de Prote\u00e7\u00e3o \u00e0 Radia\u00e7\u00e3o N\u00e3o-Ionizante (ICNIRP) recomenda limites para a emiss\u00e3o de radia\u00e7\u00e3o UV-C. Alguns dos bast\u00f5es testados pela FDA emitem at\u00e9 3.000 vezes mais radia\u00e7\u00e3o UV-C do que o n\u00edvel recomendado pela ICNIRP. Pessoas expostas a radia\u00e7\u00e3o excessiva pelo uso ou pela proximidade do produto em uso poderiam experimentar eritema, uma rea\u00e7\u00e3o cut\u00e2nea semelhante \u00e0 queimadura, ou foto ceratite, uma les\u00e3o ocular que causa dor severa e uma sensa\u00e7\u00e3o de areia nos olhos.<\/p>\n<p><strong>Resposta da FDA<\/strong><\/p>\n<p>Em 20 de julho de 2022, a FDA emitiu um aviso aos consumidores para que n\u00e3o utilizassem os produtos afetados. Antes da advert\u00eancia, a FDA emitiu Notifica\u00e7\u00e3o de Cartas de Defeito aos fabricantes que distribu\u00edam produtos que n\u00e3o eram seguros atrav\u00e9s de testes da FDA. As empresas que receberam a notifica\u00e7\u00e3o tiveram 15 dias para responder ao FDA com: (1) uma refuta\u00e7\u00e3o, (2) um pedido de isen\u00e7\u00e3o, ou (3) um Plano de A\u00e7\u00e3o Corretiva (PAC) indicando como ir\u00e3o abordar os problemas citados, bem como uma c\u00f3pia de uma Carta de Notifica\u00e7\u00e3o enviada por escrito aos compradores e distribuidores. Nas cartas, a FDA notificou as empresas que se n\u00e3o tomassem medidas para resolver os problemas ap\u00f3s 15 dias, poderiam ser obrigadas a enviar um aviso \u00e0s pessoas afetadas de acordo com o 21 CFR 1003.11(c).<\/p>\n<div class=\"callout-row text-center margin-bottom\">\n<h3>Obtenha ajuda com a conformidade com a FDA<\/h3>\n<p>Os especialistas regulat\u00f3rios da Registrar Corp ajudam as empresas a cumprir com as regulamenta\u00e7\u00f5es da FDA.<\/p>\n<p>Para obter ajuda com os requerimentos da FDA, ligue para +1-757-224-0177, envie um email para: <a href=\"mailto:info@registrarcorp.com\">info@registrarcorp.com<\/a>, ou acesse nosso chat 24 horas em: <a href=\"https:\/\/regstaging.wpengine.com\/livechat\">regstaging.wpengine.com\/livechat<\/a>.<\/p>\n<p class=\"btn-row\"><a class=\"btn btn-red-white\" href=\"https:\/\/regstaging.wpengine.com\/pt\/fda-medical-devices\/?lead_source=blog\">Obtenha Assist\u00eancia<\/a><\/p>\n<\/div>\n","protected":false},"excerpt":{"rendered":"<p>A Administra\u00e7\u00e3o de Alimentos E Medicamentos dos EUA (FDA) recentemente advertiu os consumidores que certas marcas de bast\u00f5es ultravioletas (UV) podem representar um risco potencial de ferimentos quando usados. Estes bast\u00f5es s\u00e3o usados para desinfetar superf\u00edcies e matar germes em ambientes fora da maioria das instala\u00e7\u00f5es de sa\u00fade, como as resid\u00eancias. A FDA afirma que<\/p>\n","protected":false},"author":30,"featured_media":55368,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"content-type":"","om_disable_all_campaigns":false,"inline_featured_image":false,"_genesis_hide_title":false,"_genesis_hide_breadcrumbs":false,"_genesis_hide_singular_image":false,"_genesis_hide_footer_widgets":false,"_genesis_custom_body_class":"","_genesis_custom_post_class":"","_genesis_layout":"","footnotes":""},"categories":[99],"tags":[],"class_list":{"0":"post-55456","1":"post","2":"type-post","3":"status-publish","4":"format-standard","5":"has-post-thumbnail","7":"category-medical-devices-pt","8":"entry"},"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v20.9 (Yoast SEO v25.5) - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>A FDA Adverte aos Consumidores sobre os N\u00edveis Inseguros de Raios UV em Certos Bast\u00f5es Desinfetantes - Registrar<\/title>\n<meta name=\"robots\" content=\"noindex, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<meta property=\"og:locale\" content=\"pt_PT\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"A FDA Adverte aos Consumidores sobre os N\u00edveis Inseguros de Raios UV em Certos Bast\u00f5es Desinfetantes\" \/>\n<meta property=\"og:description\" content=\"A Administra\u00e7\u00e3o de Alimentos E Medicamentos dos EUA (FDA) recentemente advertiu os consumidores que certas marcas de bast\u00f5es ultravioletas (UV) podem representar um risco potencial de ferimentos quando usados. Estes bast\u00f5es s\u00e3o usados para desinfetar superf\u00edcies e matar germes em ambientes fora da maioria das instala\u00e7\u00f5es de sa\u00fade, como as resid\u00eancias. A FDA afirma que\" \/>\n<meta property=\"og:url\" content=\"https:\/\/legacy.registrarcorp.com\/pt\/fda-alerts-consumers-of-unsafe-uv-levels-in-certain-disinfectant-wands\/\" \/>\n<meta property=\"og:site_name\" content=\"Registrar\" \/>\n<meta property=\"article:published_time\" content=\"2022-07-26T19:19:10+00:00\" \/>\n<meta property=\"article:modified_time\" content=\"2022-08-25T15:35:34+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/legacy.registrarcorp.com\/wp-content\/uploads\/2022\/07\/UV.png\" \/>\n\t<meta property=\"og:image:width\" content=\"800\" \/>\n\t<meta property=\"og:image:height\" content=\"533\" \/>\n\t<meta property=\"og:image:type\" content=\"image\/png\" \/>\n<meta name=\"author\" content=\"Mason Grandusky\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:label1\" content=\"Written by\" \/>\n\t<meta name=\"twitter:data1\" content=\"Mason Grandusky\" \/>\n\t<meta name=\"twitter:label2\" content=\"Est. reading time\" \/>\n\t<meta name=\"twitter:data2\" content=\"3 minutes\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\/\/schema.org\",\"@graph\":[{\"@type\":\"Article\",\"@id\":\"https:\/\/legacy.registrarcorp.com\/pt\/fda-alerts-consumers-of-unsafe-uv-levels-in-certain-disinfectant-wands\/#article\",\"isPartOf\":{\"@id\":\"https:\/\/legacy.registrarcorp.com\/pt\/fda-alerts-consumers-of-unsafe-uv-levels-in-certain-disinfectant-wands\/\"},\"author\":{\"name\":\"Mason Grandusky\",\"@id\":\"https:\/\/legacy.registrarcorp.com\/pt\/#\/schema\/person\/5460f453ed04f326b4ef5280009675f2\"},\"headline\":\"A FDA Adverte aos Consumidores sobre os N\u00edveis Inseguros de Raios UV em Certos Bast\u00f5es Desinfetantes\",\"datePublished\":\"2022-07-26T19:19:10+00:00\",\"dateModified\":\"2022-08-25T15:35:34+00:00\",\"mainEntityOfPage\":{\"@id\":\"https:\/\/legacy.registrarcorp.com\/pt\/fda-alerts-consumers-of-unsafe-uv-levels-in-certain-disinfectant-wands\/\"},\"wordCount\":645,\"publisher\":{\"@id\":\"https:\/\/legacy.registrarcorp.com\/pt\/#organization\"},\"image\":{\"@id\":\"https:\/\/legacy.registrarcorp.com\/pt\/fda-alerts-consumers-of-unsafe-uv-levels-in-certain-disinfectant-wands\/#primaryimage\"},\"thumbnailUrl\":\"https:\/\/legacy.registrarcorp.com\/wp-content\/uploads\/2022\/07\/UV.png\",\"articleSection\":[\"Medical Devices\"],\"inLanguage\":\"pt\"},{\"@type\":\"WebPage\",\"@id\":\"https:\/\/legacy.registrarcorp.com\/pt\/fda-alerts-consumers-of-unsafe-uv-levels-in-certain-disinfectant-wands\/\",\"url\":\"https:\/\/legacy.registrarcorp.com\/pt\/fda-alerts-consumers-of-unsafe-uv-levels-in-certain-disinfectant-wands\/\",\"name\":\"A FDA Adverte aos Consumidores sobre os N\u00edveis Inseguros de Raios UV em Certos Bast\u00f5es Desinfetantes - 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