Analysis of Medical Device Alerts Issued by the Portuguese Medicines Agency: Scoping the Purpose of New Regulatory Recommendations
Autor(a) principal: | |
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Data de Publicação: | 2021 |
Outros Autores: | , |
Tipo de documento: | Artigo |
Idioma: | eng |
Título da fonte: | Repositório Científico de Acesso Aberto de Portugal (Repositórios Cientìficos) |
Texto Completo: | https://www.actamedicaportuguesa.com/revista/index.php/amp/article/view/13419 |
Resumo: | Introduction: Medical devices are healthcare technologies with a significantly growing market worldwide. This study aims to analyze medical device alerts issued by the Portuguese Medicines Agency, INFARMED, I.P. during 2017, as well as to identify the respective regulatory actions and to suggest additional recommendations.Material and Methods: All alerts on medical device alerts publicly available in the website of INFARMED, I.P. were identified and analyzed, including actions taken. Additionally, reports on medical devices from the Portuguese national competent authorities were compared with reports from other European Union member states such as Germany.Results: A total of 32 safety alerts were identified: 18 (56%) related with devices without identified records of commercialization in Portugal, six (19%) related with devices voluntarily withdrawn from the market, such as counterfeit products, and eight (25%) categorized as ‘other’. In both Portugal and Germany, 0.28 and 4.53 reports of national competent authorities per million inhabitants were identified, respectively. Diverse regulatory actions were taken, such as six compulsory indications to not acquire or use devices.Discussion: Considering that the European Union is an open market where citizens should have equal access to medical devices, the Portuguese system of medical device safety alerts seems to be functioning normally. The identified safety alerts seemed relevant, with Portugal registering a proportionally slightly lower number of alerts when compared with higher sales volume markets, which may be explained by an underreporting of this type of problems. Further studies are needed to confirm these preliminary results, although the development of databases comprising data on patients using medical devices is recommended in order to generate automatic email and text message alerts.Conclusion: A limited number of safety alerts on medical devices was identified in Portugal, with few reported cases of counterfeit or falsified devices. The Portuguese Medicines Agency contributes to the citizens’ access to quality medical devices, by issuing safety alerts, recommendations and mandatory market withdrawals for unsuitable or unsafe medical devices. |
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Analysis of Medical Device Alerts Issued by the Portuguese Medicines Agency: Scoping the Purpose of New Regulatory RecommendationsAnálise dos Alertas Sobre os Dispositivos Médicos Emitidos pela Agência Portuguesa do Medicamento: Delineando o Propósito de Novas Recomendações RegulatóriasEquipment and SuppliesPatient Safety/legislation & jurisprudenceEquipamentos e SuprimentosSegurança do Doente/legislação & jurisprudênciaIntroduction: Medical devices are healthcare technologies with a significantly growing market worldwide. This study aims to analyze medical device alerts issued by the Portuguese Medicines Agency, INFARMED, I.P. during 2017, as well as to identify the respective regulatory actions and to suggest additional recommendations.Material and Methods: All alerts on medical device alerts publicly available in the website of INFARMED, I.P. were identified and analyzed, including actions taken. Additionally, reports on medical devices from the Portuguese national competent authorities were compared with reports from other European Union member states such as Germany.Results: A total of 32 safety alerts were identified: 18 (56%) related with devices without identified records of commercialization in Portugal, six (19%) related with devices voluntarily withdrawn from the market, such as counterfeit products, and eight (25%) categorized as ‘other’. In both Portugal and Germany, 0.28 and 4.53 reports of national competent authorities per million inhabitants were identified, respectively. Diverse regulatory actions were taken, such as six compulsory indications to not acquire or use devices.Discussion: Considering that the European Union is an open market where citizens should have equal access to medical devices, the Portuguese system of medical device safety alerts seems to be functioning normally. The identified safety alerts seemed relevant, with Portugal registering a proportionally slightly lower number of alerts when compared with higher sales volume markets, which may be explained by an underreporting of this type of problems. Further studies are needed to confirm these preliminary results, although the development of databases comprising data on patients using medical devices is recommended in order to generate automatic email and text message alerts.Conclusion: A limited number of safety alerts on medical devices was identified in Portugal, with few reported cases of counterfeit or falsified devices. The Portuguese Medicines Agency contributes to the citizens’ access to quality medical devices, by issuing safety alerts, recommendations and mandatory market withdrawals for unsuitable or unsafe medical devices.Introdução: Os dispositivos médicos são tecnologias de saúde com um significativo crescimento a nível mundial. Foi objetivo deste trabalho analisar os alertas sobre dispositivos médicos emitidos pela Agência Portuguesa do Medicamento: INFARMED, I.P. durante 2017, identificar as respetivas ações regulatórias e sugerir recomendações.Material e Métodos: Todos os alertas e ações sobre dispositivos médicos publicamente disponíveis no website do INFARMED, I.P. foram identificados e analisados. Adicionalmente, os relatórios da autoridade competente nacional sobre dispositivos médicos foram comparados com relatórios de outros países da União Europeia como a Alemanha.Resultados: Identificou-se um total de 32 alertas de segurança de dispositivos médicos: 18 (56%) sem registos de comercialização em Portugal, seis (19%) voluntariamente retirados do mercado, como produtos contrafeitos, e oito (25%) categorizados como ‘outros’. Em Portugal e na Alemanha foram identificados 0,28 e 4,53 relatórios de autoridades competentes por milhão de habitantes, respetivamente. Diversas ações regulamentares foram tomadas, como seis indicações obrigatórias para não adquirir ou utilizar dispositivos médicos.Discussão: Considerando que a União Europeia é um mercado aberto no qual os cidadãos detêm igual acesso à utilização de dispositivos médicos, o sistema Português de alertas de segurança sobre estes dispositivos parece ter uma atividade normal. Os alertas de segurança identificados aparentam ser relevantes, com Portugal a registar um número ligeiramente inferior de alertas quando proporcionalmente comparado com outros mercados de maior volume de vendas, o que eventualmente pode ser explicado por uma subnotificação deste tipo de problemas. São necessários estudos adicionais para confirmar estes resultados preliminares, sendo o desenvolvimento de bases de dados sobre o uso de dispositivos médicos pelos doentes recomendado de forma a gerar emails e alertas telefónicos automáticos.Conclusão: Foi identificado um número limitado de alertas de segurança em dispositivos médicos em Portugal, com escassas notificações de contrafação ou falsificação. A Agência Portuguesa de Medicamentos contribui para o acesso dos cidadãos a dispositivos médicos de qualidade, através da emissão de alertas de segurança, recomendações e retirada obrigatória de dispositivos médicos inadequados ou inseguros do mercado.Ordem dos Médicos2021-03-01info:eu-repo/semantics/publishedVersioninfo:eu-repo/semantics/articleapplication/pdfapplication/pdfapplication/vnd.openxmlformats-officedocument.wordprocessingml.documentapplication/pdfhttps://www.actamedicaportuguesa.com/revista/index.php/amp/article/view/13419oai:ojs.www.actamedicaportuguesa.com:article/13419Acta Médica Portuguesa; Vol. 34 No. 3 (2021): March; 201-208Acta Médica Portuguesa; Vol. 34 N.º 3 (2021): Março; 201-2081646-07580870-399Xreponame:Repositório Científico de Acesso Aberto de Portugal (Repositórios Cientìficos)instname:Agência para a Sociedade do Conhecimento (UMIC) - FCT - Sociedade da Informaçãoinstacron:RCAAPenghttps://www.actamedicaportuguesa.com/revista/index.php/amp/article/view/13419https://www.actamedicaportuguesa.com/revista/index.php/amp/article/view/13419/6272https://www.actamedicaportuguesa.com/revista/index.php/amp/article/view/13419/12319https://www.actamedicaportuguesa.com/revista/index.php/amp/article/view/13419/12459https://www.actamedicaportuguesa.com/revista/index.php/amp/article/view/13419/12578Direitos de Autor (c) 2021 Acta Médica Portuguesainfo:eu-repo/semantics/openAccessPires, CarlaDuarte, DinahCavaco, Afonso2022-12-20T11:06:52Zoai:ojs.www.actamedicaportuguesa.com:article/13419Portal AgregadorONGhttps://www.rcaap.pt/oai/openaireopendoar:71602024-03-19T16:20:20.854269Repositório Científico de Acesso Aberto de Portugal (Repositórios Cientìficos) - Agência para a Sociedade do Conhecimento (UMIC) - FCT - Sociedade da Informaçãofalse |
dc.title.none.fl_str_mv |
Analysis of Medical Device Alerts Issued by the Portuguese Medicines Agency: Scoping the Purpose of New Regulatory Recommendations Análise dos Alertas Sobre os Dispositivos Médicos Emitidos pela Agência Portuguesa do Medicamento: Delineando o Propósito de Novas Recomendações Regulatórias |
title |
Analysis of Medical Device Alerts Issued by the Portuguese Medicines Agency: Scoping the Purpose of New Regulatory Recommendations |
spellingShingle |
Analysis of Medical Device Alerts Issued by the Portuguese Medicines Agency: Scoping the Purpose of New Regulatory Recommendations Pires, Carla Equipment and Supplies Patient Safety/legislation & jurisprudence Equipamentos e Suprimentos Segurança do Doente/legislação & jurisprudência |
title_short |
Analysis of Medical Device Alerts Issued by the Portuguese Medicines Agency: Scoping the Purpose of New Regulatory Recommendations |
title_full |
Analysis of Medical Device Alerts Issued by the Portuguese Medicines Agency: Scoping the Purpose of New Regulatory Recommendations |
title_fullStr |
Analysis of Medical Device Alerts Issued by the Portuguese Medicines Agency: Scoping the Purpose of New Regulatory Recommendations |
title_full_unstemmed |
Analysis of Medical Device Alerts Issued by the Portuguese Medicines Agency: Scoping the Purpose of New Regulatory Recommendations |
title_sort |
Analysis of Medical Device Alerts Issued by the Portuguese Medicines Agency: Scoping the Purpose of New Regulatory Recommendations |
author |
Pires, Carla |
author_facet |
Pires, Carla Duarte, Dinah Cavaco, Afonso |
author_role |
author |
author2 |
Duarte, Dinah Cavaco, Afonso |
author2_role |
author author |
dc.contributor.author.fl_str_mv |
Pires, Carla Duarte, Dinah Cavaco, Afonso |
dc.subject.por.fl_str_mv |
Equipment and Supplies Patient Safety/legislation & jurisprudence Equipamentos e Suprimentos Segurança do Doente/legislação & jurisprudência |
topic |
Equipment and Supplies Patient Safety/legislation & jurisprudence Equipamentos e Suprimentos Segurança do Doente/legislação & jurisprudência |
description |
Introduction: Medical devices are healthcare technologies with a significantly growing market worldwide. This study aims to analyze medical device alerts issued by the Portuguese Medicines Agency, INFARMED, I.P. during 2017, as well as to identify the respective regulatory actions and to suggest additional recommendations.Material and Methods: All alerts on medical device alerts publicly available in the website of INFARMED, I.P. were identified and analyzed, including actions taken. Additionally, reports on medical devices from the Portuguese national competent authorities were compared with reports from other European Union member states such as Germany.Results: A total of 32 safety alerts were identified: 18 (56%) related with devices without identified records of commercialization in Portugal, six (19%) related with devices voluntarily withdrawn from the market, such as counterfeit products, and eight (25%) categorized as ‘other’. In both Portugal and Germany, 0.28 and 4.53 reports of national competent authorities per million inhabitants were identified, respectively. Diverse regulatory actions were taken, such as six compulsory indications to not acquire or use devices.Discussion: Considering that the European Union is an open market where citizens should have equal access to medical devices, the Portuguese system of medical device safety alerts seems to be functioning normally. The identified safety alerts seemed relevant, with Portugal registering a proportionally slightly lower number of alerts when compared with higher sales volume markets, which may be explained by an underreporting of this type of problems. Further studies are needed to confirm these preliminary results, although the development of databases comprising data on patients using medical devices is recommended in order to generate automatic email and text message alerts.Conclusion: A limited number of safety alerts on medical devices was identified in Portugal, with few reported cases of counterfeit or falsified devices. The Portuguese Medicines Agency contributes to the citizens’ access to quality medical devices, by issuing safety alerts, recommendations and mandatory market withdrawals for unsuitable or unsafe medical devices. |
publishDate |
2021 |
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2021-03-01 |
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info:eu-repo/semantics/publishedVersion |
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info:eu-repo/semantics/article |
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https://www.actamedicaportuguesa.com/revista/index.php/amp/article/view/13419 oai:ojs.www.actamedicaportuguesa.com:article/13419 |
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https://www.actamedicaportuguesa.com/revista/index.php/amp/article/view/13419 |
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oai:ojs.www.actamedicaportuguesa.com:article/13419 |
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eng |
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eng |
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https://www.actamedicaportuguesa.com/revista/index.php/amp/article/view/13419 https://www.actamedicaportuguesa.com/revista/index.php/amp/article/view/13419/6272 https://www.actamedicaportuguesa.com/revista/index.php/amp/article/view/13419/12319 https://www.actamedicaportuguesa.com/revista/index.php/amp/article/view/13419/12459 https://www.actamedicaportuguesa.com/revista/index.php/amp/article/view/13419/12578 |
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Direitos de Autor (c) 2021 Acta Médica Portuguesa info:eu-repo/semantics/openAccess |
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Ordem dos Médicos |
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Ordem dos Médicos |
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Acta Médica Portuguesa; Vol. 34 No. 3 (2021): March; 201-208 Acta Médica Portuguesa; Vol. 34 N.º 3 (2021): Março; 201-208 1646-0758 0870-399X reponame:Repositório Científico de Acesso Aberto de Portugal (Repositórios Cientìficos) instname:Agência para a Sociedade do Conhecimento (UMIC) - FCT - Sociedade da Informação instacron:RCAAP |
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Agência para a Sociedade do Conhecimento (UMIC) - FCT - Sociedade da Informação |
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Repositório Científico de Acesso Aberto de Portugal (Repositórios Cientìficos) |
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Repositório Científico de Acesso Aberto de Portugal (Repositórios Cientìficos) - Agência para a Sociedade do Conhecimento (UMIC) - FCT - Sociedade da Informação |
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