{"id":28977,"date":"2020-05-12T17:38:17","date_gmt":"2020-05-12T17:38:17","guid":{"rendered":"http:\/\/www.cremeb.org.br\/?p=28977"},"modified":"2020-05-19T13:50:26","modified_gmt":"2020-05-19T13:50:26","slug":"respirador-particulado-apresenta-falha-na-filtragem","status":"publish","type":"post","link":"https:\/\/www.cremeb.org.br\/index.php\/noticias\/respirador-particulado-apresenta-falha-na-filtragem\/","title":{"rendered":"Respirador particulado apresenta falha na filtragem"},"content":{"rendered":"

A Anvisa alerta que\u00a0os\u00a0respiradores particulados\u00a0provenientes da China\u00a0podem n\u00e3o proporcionar prote\u00e7\u00e3o adequada aos profissionais de sa\u00fade.\u00a0A\u00a0FDA (Food\u00a0and\u00a0Drug\u00a0Administration), autoridade regulat\u00f3ria americana, revogou a autoriza\u00e7\u00e3o de uso emergencial a diversos respiradores particulados do tipo N95, PFF2 ou equivalentes que haviam sido autorizados no contexto atual da pandemia do novo\u00a0coronav\u00edrus.<\/p>\n

Esses produtos, em monitoramento\u00a0de desempenho\u00a0realizado pelo\u00a0National\u00a0Institute\u00a0for\u00a0Occupational\u00a0Safety\u00a0and\u00a0Health (NIOSH), o Instituto Nacional de Seguran\u00e7a e Sa\u00fade Ocupacional\u00a0dos Estados Unidos, n\u00e3o demonstraram efici\u00eancia m\u00ednima de filtragem de part\u00edculas de 95%.<\/p>\n

\u00c9 importante esclarecer que esses respiradores s\u00e3o m\u00e1scaras faciais de prote\u00e7\u00e3o individual. Apesar da semelhan\u00e7a do nome, os respiradores de que trata este texto n\u00e3o s\u00e3o aquelas m\u00e1quinas de alto custo que auxiliam os pacientes com insufici\u00eancia respirat\u00f3ria grave causada pela Covid-19.<\/p>\n

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Nesta ter\u00e7a-feira\u00a0(12\/5),\u00a0a\u00a0Resolu\u00e7\u00e3o RE n\u00ba 1.552, de 15 de\u00a0maio de 2020<\/a>, publicada no Di\u00e1rio Oficial da Uni\u00e3o (D.O.U.), determinou a interdi\u00e7\u00e3o cautelar do uso desses produtos como respiradores em servi\u00e7os de sa\u00fade. A Ag\u00eancia tem um acordo de confidencialidade, firmado em 2010 com a FDA,\u00a0para o compartilhamento de informa\u00e7\u00f5es acerca da seguran\u00e7a, efic\u00e1cia e qualidade dos produtos\u00a0que regulamenta.\u00a0A medida, por\u00e9m, poder\u00e1 ser revertida mediante a apresenta\u00e7\u00e3o de laudo emitido por laborat\u00f3rio acreditado pelo Instituto Nacional de Metrologia, Qualidade e Tecnologia, o Inmetro, atestando a efici\u00eancia de filtragem em concord\u00e2ncia com o padr\u00e3o requerido\u00a0para respiradores particulados\u00a0N95, PFF2 ou equivalentes.<\/p>\n<\/div>\n

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Reclassifica\u00e7\u00e3o<\/h4>\n<\/div>\n
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Diante da dificuldade de obten\u00e7\u00e3o de equipamentos de prote\u00e7\u00e3o individual\u00a0(EPIs)\u00a0em um cen\u00e1rio de emerg\u00eancia em sa\u00fade p\u00fablica, a Anvisa entende que \u00e9 cab\u00edvel o uso desses produtos \u2013 desde que rotulados com o novo uso e atendidos os crit\u00e9rios m\u00ednimos de qualidade exigidos \u2013 em atividades que n\u00e3o exijam respiradores\u00a0N95, PFF2 e equivalentes, por exemplo, como m\u00e1scaras de uso n\u00e3o profissional.<\/p>\n<\/div>\n

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As importadoras que decidirem rotular novamente os produtos para novos usos devem encaminhar a notifica\u00e7\u00e3o de a\u00e7\u00e3o de campo \u00e0 Anvisa, conforme estabelecido na\u00a0Resolu\u00e7\u00e3o da Diretoria Colegiada (RDC) 23\/2012<\/a>.\u00a0Caso a empresa importadora tenha Autoriza\u00e7\u00e3o de Funcionamento\u00a0(AFE), o formul\u00e1rio de notifica\u00e7\u00e3o da a\u00e7\u00e3o de campo dever\u00e1 ser enviado via peticionamento eletr\u00f4nico, pelo Sistema Solicita. Caso a empresa n\u00e3o seja cadastrada na Ag\u00eancia, o formul\u00e1rio de notifica\u00e7\u00e3o dever\u00e1 ser enviado por mensagem eletr\u00f4nica para o endere\u00e7o\u00a0recall.tecno@anvisa.gov.br<\/a>. Outras orienta\u00e7\u00f5es est\u00e3o dispon\u00edveis em\u00a0A\u00e7\u00f5es de campo<\/a>, no portal.<\/p>\n<\/div>\n

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Covid-19: medidas de preven\u00e7\u00e3o<\/h4>\n<\/div>\n
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Para saber mais sobre as medidas de preven\u00e7\u00e3o e controle a serem adotadas pelos servi\u00e7os de sa\u00fade, consulte a\u00a0Nota T\u00e9cnica 4\/2020<\/a>. O documento aborda, inclusive, a indica\u00e7\u00e3o dos diferentes tipos de m\u00e1scaras de acordo com o procedimento que ser\u00e1 realizado. Observa-se tamb\u00e9m que a Anvisa tem disponibilizado, aqui\u00a0no portal,\u00a0orienta\u00e7\u00f5es atualizadas sobre as medidas que est\u00e3o sendo adotadas pela Ag\u00eancia a fim de prevenir riscos e proteger a sa\u00fade de todos.<\/p>\n

 <\/p>\n<\/div>\n

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\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n
Fabricante<\/strong><\/td>\nModelo<\/strong><\/td>\nPa\u00eds de Fabrica\u00e7\u00e3o<\/strong><\/td>\n<\/tr>\n
Anhui Baishidun Protective Equipment Co., Ltd.<\/span><\/td>\nBaishidun FFP2<\/td>\nChina<\/td>\n<\/tr>\n
Anhui RYZUR Medical Equipment Manufacturing Co., Ltd.<\/span><\/td>\nKN95B<\/td>\nChina<\/td>\n<\/tr>\n
Changning Lingjiakang Protective Products Factory<\/span><\/td>\nKN95 Stereo Protective Mask<\/td>\nChina<\/td>\n<\/tr>\n
Daddybaby Co., Ltd.<\/td>\nKN95 4-PLY<\/td>\nChina<\/td>\n<\/tr>\n
Dongguan Oukangda Medical Technology Co., Ltd.<\/span><\/td>\nSelf-Priming Filter Respirator Kangerda KN95 Particulate Respirator<\/span><\/td>\nChina<\/td>\n<\/tr>\n
Dongguan Xianda Medical Equipment Co., Ltd.<\/span><\/td>\nKN95 Protective Mask<\/td>\nChina<\/td>\n<\/tr>\n
Garry Galaxy Biotechnology Co., Ltd.<\/span><\/td>\nRespirator Mask With TruTone Technology<\/span><\/td>\nChina<\/td>\n<\/tr>\n
Guangdong Fei Fan Mstar Technology LTD<\/span><\/td>\nPurvigor KN95<\/td>\nChina<\/td>\n<\/tr>\n
Guangdong Nafei Industrial Holding Co., Ltd.<\/span><\/td>\nE cient Nursing Protective Mask NAFY Protective Mask<\/span><\/td>\nChina<\/td>\n<\/tr>\n
Guangdong Qian Jing Testing Co., LTD.<\/span><\/td>\nDNW Protective Mask<\/td>\nChina<\/td>\n<\/tr>\n
Guangdong Shantou Machinery<\/td>\nKN95 Mask<\/td>\nChina<\/td>\n<\/tr>\n
Guangdong Zhizhen Biological Medicine Co., Ltd.<\/span><\/td>\nKN95 Three- Dimensional Protective Respirator<\/td>\nChina<\/td>\n<\/tr>\n
Guangzhou Huashan Biotechnology Co., Ltd.<\/span><\/td>\nGF-Mask KN95 Mask<\/td>\nChina<\/td>\n<\/tr>\n
Guangzhou Sunjoy Auto Supplies Co., Ltd.<\/span><\/td>\nK1 Self Suction Filter Respirator<\/span><\/td>\nChina<\/td>\n<\/tr>\n
Guanyang Yuhan Textile Co., Ltd.<\/span><\/td>\nKN95 Protective Face Mask<\/td>\nChina<\/td>\n<\/tr>\n
Hangzhou Senrunqing Technology Co., Ltd.<\/span><\/td>\nKN95 Mask-C<\/td>\nChina<\/td>\n<\/tr>\n
Huizhou Huinuo Technology Co., Ltd.<\/span><\/td>\nHV-N White KN95<\/td>\nChina<\/td>\n<\/tr>\n
Huizhou Zhongna Medical Technology Co., Ltd<\/span><\/td>\nAnysound KN95 Self- Priming Filter & Anti- Particle Respirator<\/span><\/td>\nChina<\/td>\n<\/tr>\n
Jining Jianda Medical Device Technology Co., Ltd.<\/span><\/td>\nPM2.5 KN95<\/td>\nChina<\/td>\n<\/tr>\n
Kindly Care Products Co., Ltd.<\/span><\/td>\nY-9500<\/td>\nChina<\/td>\n<\/tr>\n
Kindly Care Products Co., Ltd.<\/span><\/td>\nY-9500<\/td>\nChina<\/td>\n<\/tr>\n
King Year and Packaging Co., Ltd.<\/span><\/td>\nSelf-Breathing Filtration Particle- Preventive Respirator<\/span><\/td>\nChina<\/td>\n<\/tr>\n
King Year and Packaging Co., Ltd.<\/span><\/td>\nSelf-Breathing Filtration Particle- Preventive Respirator<\/span><\/td>\nChina<\/td>\n<\/tr>\n
Nantong Gold-Sufang Weaving Co. Ltd.<\/span><\/td>\nKN95 Face Mask<\/td>\nChina<\/td>\n<\/tr>\n
Ningbo Green Health Science & Technology Co., Ltd.<\/span><\/td>\nKN95 Protective Mask Disposable Protective Mask (Non-Medical)<\/span><\/td>\nChina<\/td>\n<\/tr>\n
Ningbo YiXin Intelligentized Science and Technology Co. Ltd.<\/span><\/td>\nKN95 (Non-medical)<\/td>\nChina<\/td>\n<\/tr>\n
Purvigor<\/td>\nKN95 Antibacterial Mask<\/td>\nChina<\/td>\n<\/tr>\n
San Jiao<\/td>\nJS95-01<\/td>\nChina<\/td>\n<\/tr>\n
Shenzhen Hangsen Star Technology Co., Ltd.<\/span><\/td>\nAlchemy KN95 Face Mask A1<\/span><\/td>\nChina<\/td>\n<\/tr>\n
Shenzhen Sanai Medical Devices Group Co., Ltd.<\/span><\/td>\nDisposable Protective Mask<\/td>\nChina<\/td>\n<\/tr>\n
Sinpup Health (Shenzhen) Co., Ltd.<\/span><\/td>\nFace Mask KN95<\/td>\nChina<\/td>\n<\/tr>\n
Tongcheng Chengfeng Protective Equipment Co., Ltd.<\/span><\/td>\nWanhuizhong Anti- Dust Respirator<\/td>\nChina<\/td>\n<\/tr>\n
Zhejiang Kanghao Medical Instruments Co., Ltd.<\/span><\/td>\nKN95 Respirator<\/td>\nChina<\/td>\n<\/tr>\n
Zhongshan Cassiey Biotechnology Co., Ltd.<\/span><\/td>\nN95 Masks + Particulate Protection Respirator<\/td>\nChina<\/td>\n<\/tr>\n
Zhongshan Zhongxin Medical Technology Co., Ltd.<\/span><\/td>\nProtective Mask<\/td>\nChina<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<\/div>\n<\/div>\n<\/article>\n<\/div>\n
<\/div>\n

 <\/p>\n

Fonte: Anvisa<\/p>\n","protected":false},"excerpt":{"rendered":"

A Anvisa alerta que\u00a0os\u00a0respiradores particulados\u00a0provenientes da China\u00a0podem n\u00e3o proporcionar prote\u00e7\u00e3o adequada aos profissionais de sa\u00fade.\u00a0A\u00a0FDA (Food\u00a0and\u00a0Drug\u00a0Administration), autoridade regulat\u00f3ria americana, revogou […]<\/p>\n","protected":false},"author":2,"featured_media":28978,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_expiration-date-status":"saved","_expiration-date":0,"_expiration-date-type":"","_expiration-date-categories":[],"_expiration-date-options":[]},"categories":[1],"tags":[],"acf":[],"_links":{"self":[{"href":"https:\/\/www.cremeb.org.br\/index.php\/wp-json\/wp\/v2\/posts\/28977"}],"collection":[{"href":"https:\/\/www.cremeb.org.br\/index.php\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.cremeb.org.br\/index.php\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.cremeb.org.br\/index.php\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/www.cremeb.org.br\/index.php\/wp-json\/wp\/v2\/comments?post=28977"}],"version-history":[{"count":1,"href":"https:\/\/www.cremeb.org.br\/index.php\/wp-json\/wp\/v2\/posts\/28977\/revisions"}],"predecessor-version":[{"id":28979,"href":"https:\/\/www.cremeb.org.br\/index.php\/wp-json\/wp\/v2\/posts\/28977\/revisions\/28979"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.cremeb.org.br\/index.php\/wp-json\/wp\/v2\/media\/28978"}],"wp:attachment":[{"href":"https:\/\/www.cremeb.org.br\/index.php\/wp-json\/wp\/v2\/media?parent=28977"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.cremeb.org.br\/index.php\/wp-json\/wp\/v2\/categories?post=28977"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.cremeb.org.br\/index.php\/wp-json\/wp\/v2\/tags?post=28977"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}