Modelo de gerenciamento de risco em radiologia intervencionista para fins regulatórios
Autor(a) principal: | |
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Data de Publicação: | 2013 |
Tipo de documento: | Tese |
Idioma: | por |
Título da fonte: | Repositório Institucional da UFS |
Texto Completo: | https://ri.ufs.br/handle/riufs/5342 |
Resumo: | The number of invasive procedures using interventional radiology has increased significantly in recent years. This fact is due to several factors, such as the aging population, the increased of obese population, which has immediate effects on the number of cancer and vascular diseases, the increased of incidence rate of alcoholism and hepatitis, which provide increased of cirrhosis, among others. Some medical specialties use this modality very often, in particular, the angiology, the cardiology, the hepatology and the neurology. The Interventional Radiology, however, can involve high doses and long exposure times, being considered currently the radiology practice of largest medical and occupational exposures, with the possibility of, not only stochastic, but also deterministic events, such as necrosis, erythema, epilation and cancer. In this context, the international studies indicate the need to revise the reference levels, to develop methodologies for dosimetry of patients and staff, including continuously optimization of dose parameters, such as filtration, collimation and rectification, to develop quality control tools and training in radiation protection for those involved in Interventional Radiology. In Brazil, the literature indicated ten publications addressing this topic, and three deal with the technical aspects of equipment performance, four of occupational exposures, medical exposures of two and a review general aspects of interventional radiology. The publications have reported studies that were performed by evaluating a maximum of two equipment, with results indicating high medical and occupational exposures, low image quality and the need to implement quality assurance programs. It is noteworthy that no studies have examined thoroughly the procedure, in others words, exposures and equipment performances, and they were restricted to one service. On the other hand, besides the few papers published, there is no specific legislation on the country, because the Federal Regulation SVS/MS 453/98 only addresses the general issues of fluoroscopy. Thus, the lack of studies about the reality of Interventional Radiology procedures, as well as more complete information of the procedures, require the new studies, especially now that the National Agency of Sanitary Surveillance - ANVISA is updating the Federal Regulation SVS/MS 453/98. Then, aiming to help filling a gap of knowledge in Medical Physics in Brazil and at Brazilian legislation, the objective of this study was to evaluate interventional radiology services in two states, Bahia and Santa Catarina, to characterize the technologies and practices used and the risk to patients and workers, proposing technical requirements and testing protocols, adequate to the actual situation, without losing the perspective of international standards and recommendations, as well as to develop the of Effective Potential Risk Assessment Model (EPRAM), a tool for auditing and risk management, that is an adaptation of a methodology for auditing radiology services, and to validate it in 20 rooms of interventional radiology procedures of 16 services in two Brazilian states. The results showed that no services meet the minimum requirements of the law and, even if some basic and essential requirements for safety were not considered, only 5 (25%) of the rooms were at potential effective risk acceptable |
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Navarro, Valéria Coelho Costahttp://lattes.cnpq.br/6492048904483467Maia, Ana Figueiredohttp://lattes.cnpq.br/86814944532748522017-09-26T18:27:32Z2017-09-26T18:27:32Z2013-08-24https://ri.ufs.br/handle/riufs/5342The number of invasive procedures using interventional radiology has increased significantly in recent years. This fact is due to several factors, such as the aging population, the increased of obese population, which has immediate effects on the number of cancer and vascular diseases, the increased of incidence rate of alcoholism and hepatitis, which provide increased of cirrhosis, among others. Some medical specialties use this modality very often, in particular, the angiology, the cardiology, the hepatology and the neurology. The Interventional Radiology, however, can involve high doses and long exposure times, being considered currently the radiology practice of largest medical and occupational exposures, with the possibility of, not only stochastic, but also deterministic events, such as necrosis, erythema, epilation and cancer. In this context, the international studies indicate the need to revise the reference levels, to develop methodologies for dosimetry of patients and staff, including continuously optimization of dose parameters, such as filtration, collimation and rectification, to develop quality control tools and training in radiation protection for those involved in Interventional Radiology. In Brazil, the literature indicated ten publications addressing this topic, and three deal with the technical aspects of equipment performance, four of occupational exposures, medical exposures of two and a review general aspects of interventional radiology. The publications have reported studies that were performed by evaluating a maximum of two equipment, with results indicating high medical and occupational exposures, low image quality and the need to implement quality assurance programs. It is noteworthy that no studies have examined thoroughly the procedure, in others words, exposures and equipment performances, and they were restricted to one service. On the other hand, besides the few papers published, there is no specific legislation on the country, because the Federal Regulation SVS/MS 453/98 only addresses the general issues of fluoroscopy. Thus, the lack of studies about the reality of Interventional Radiology procedures, as well as more complete information of the procedures, require the new studies, especially now that the National Agency of Sanitary Surveillance - ANVISA is updating the Federal Regulation SVS/MS 453/98. Then, aiming to help filling a gap of knowledge in Medical Physics in Brazil and at Brazilian legislation, the objective of this study was to evaluate interventional radiology services in two states, Bahia and Santa Catarina, to characterize the technologies and practices used and the risk to patients and workers, proposing technical requirements and testing protocols, adequate to the actual situation, without losing the perspective of international standards and recommendations, as well as to develop the of Effective Potential Risk Assessment Model (EPRAM), a tool for auditing and risk management, that is an adaptation of a methodology for auditing radiology services, and to validate it in 20 rooms of interventional radiology procedures of 16 services in two Brazilian states. The results showed that no services meet the minimum requirements of the law and, even if some basic and essential requirements for safety were not considered, only 5 (25%) of the rooms were at potential effective risk acceptableO número de procedimentos invasivos utilizando a Radiologia Intervencionista vem aumentando significativamente nos últimos anos. Este fato é decorrente de vários fatores, como por exemplo, o envelhecimento da população e o aumento da população obesa, que tem reflexos imediatos no número de câncer e doenças vasculares, o aumento no índice de alcoolismo e de hepatite, que proporcionam aumento de cirroses, entre outros. Algumas especialidades médicas já se apropriaram desta prática, em especial, a angiologia, a cardiologia, a hepatologia e a neurologia. A Radiologia Intervencionista, entretanto, pode envolver doses elevadas de radiação e longos tempos de exposição, sendo considerada, atualmente, a prática radiológica de maiores exposições médicas e ocupacionais, com a possibilidade de eventos determinísticos, além dos estocásticos, podendo provocar assim necroses, eritemas, epilação e câncer. Neste contexto, os estudos e recomendações internacionais apontam para a necessidade de revisão dos níveis de referência, desenvolvimento de metodologias para dosimetria de pacientes e equipe, otimização dos fatores que influenciam na dose, a exemplo de filtração, colimação e retificação, desenvolvimento e aplicação de ferramentas de controle de qualidade e treinamento em proteção radiológica para os envolvidos em Radiologia Intervencionista. No Brasil, o levantamento bibliográfico indicou dez publicações abordando este tema, sendo que, três tratam dos aspectos técnicos relativos ao desempenho dos equipamentos, quatro de exposições ocupacionais, duas das exposições médicas e uma revisa aspectos gerais da radiologia intervencionista. Mesmo as publicações tendo relatado estudos que foram realizados através da avaliação de alguns equipamentos, os resultados indicam altas exposições ocupacionais e médica, baixa qualidade da imagem e necessidade de implantação de programas de garantia de qualidade. Vale ressaltar que nenhum dos estudos avaliou de forma completa o procedimento, incluindo as questões da legislação vigente, as exposições e o desempenho do equipamento. Além dos poucos trabalhos publicados, tem-se a inexistência de legislação específica sobre o tema, pois a Portaria Federal SVS/MS 453/98, aborda apenas as questões gerais de fluoroscopia. Assim, a inexistência de estudos mais amplos sobre a realidade dos procedimentos de Radiologia Intervencionista, bem como de informações mais completas dos procedimentos, demandam a realização de novos estudos, principalmente neste momento em que a ANVISA, está atualizando a Portaria SVS/MS 453/98, sendo possível que os resultados dos estudos sejam utilizados com subsídios para aspectos técnicos da nova versão da norma brasileira. Então, com a perspectiva de contribuir para suprir uma lacuna do conhecimento na Física Médica brasileira, bem como da legislação, o objetivo deste trabalho foi avaliar serviços de radiologia intervencionista em dois estados, Bahia e Santa Catarina, para caracterizar as tecnologias e práticas utilizadas, bem como a situação de risco para os pacientes e trabalhadores, propondo requisitos técnicos e protocolos de testes, adequados à realidade encontrada, sem perder a perspectiva dos padrões e recomendações internacionais, bem como desenvolver o MARPE, uma ferramenta para auditoria e gerenciamento de risco, a partir da adaptação de uma metodologia desenvolvida para auditorias de serviços de radiodiagnóstico, validando-a em 20 salas de procedimentos de radiologia intervencionista de 16 serviços nos dois estados brasileiro. Os resultados obtidos mostraram que nenhum serviço cumpria os requisitos mínimos da legislação vigente e mesmo se alguns requisitos básico e indispensável de segurança, não fossem considerados, apenas 5 (25%) das salas avaliadas estavam em situação de risco potencial efetivo aceitávelapplication/pdfporRadiologia médica - Administração de riscoRaios XFísica médicaMedical physicsRadiology, MedicalRisk managementX-raysCNPQ::CIENCIAS EXATAS E DA TERRA::FISICAModelo de gerenciamento de risco em radiologia intervencionista para fins regulatóriosinfo:eu-repo/semantics/publishedVersioninfo:eu-repo/semantics/doctoralThesisPós-Graduação em Físicainfo:eu-repo/semantics/openAccessreponame:Repositório Institucional da UFSinstname:Universidade Federal de Sergipe (UFS)instacron:UFSORIGINALVALERIA_COELHO_COSTA_NAVARRO.pdfapplication/pdf2165671https://ri.ufs.br/jspui/bitstream/riufs/5342/1/VALERIA_COELHO_COSTA_NAVARRO.pdf579f50dfc0778285575b9efed0188d33MD51TEXTVALERIA_COELHO_COSTA_NAVARRO.pdf.txtVALERIA_COELHO_COSTA_NAVARRO.pdf.txtExtracted texttext/plain213615https://ri.ufs.br/jspui/bitstream/riufs/5342/2/VALERIA_COELHO_COSTA_NAVARRO.pdf.txt1a5db64873fc83affab0b2ea3bd83c75MD52THUMBNAILVALERIA_COELHO_COSTA_NAVARRO.pdf.jpgVALERIA_COELHO_COSTA_NAVARRO.pdf.jpgGenerated Thumbnailimage/jpeg1398https://ri.ufs.br/jspui/bitstream/riufs/5342/3/VALERIA_COELHO_COSTA_NAVARRO.pdf.jpg1792c932b887f30c1c308c102846874cMD53riufs/53422019-07-30 19:17:36.665oai:ufs.br:riufs/5342Repositório InstitucionalPUBhttps://ri.ufs.br/oai/requestrepositorio@academico.ufs.bropendoar:2019-07-30T22:17:36Repositório Institucional da UFS - Universidade Federal de Sergipe (UFS)false |
dc.title.por.fl_str_mv |
Modelo de gerenciamento de risco em radiologia intervencionista para fins regulatórios |
title |
Modelo de gerenciamento de risco em radiologia intervencionista para fins regulatórios |
spellingShingle |
Modelo de gerenciamento de risco em radiologia intervencionista para fins regulatórios Navarro, Valéria Coelho Costa Radiologia médica - Administração de risco Raios X Física médica Medical physics Radiology, Medical Risk management X-rays CNPQ::CIENCIAS EXATAS E DA TERRA::FISICA |
title_short |
Modelo de gerenciamento de risco em radiologia intervencionista para fins regulatórios |
title_full |
Modelo de gerenciamento de risco em radiologia intervencionista para fins regulatórios |
title_fullStr |
Modelo de gerenciamento de risco em radiologia intervencionista para fins regulatórios |
title_full_unstemmed |
Modelo de gerenciamento de risco em radiologia intervencionista para fins regulatórios |
title_sort |
Modelo de gerenciamento de risco em radiologia intervencionista para fins regulatórios |
author |
Navarro, Valéria Coelho Costa |
author_facet |
Navarro, Valéria Coelho Costa |
author_role |
author |
dc.contributor.author.fl_str_mv |
Navarro, Valéria Coelho Costa |
dc.contributor.advisor1Lattes.fl_str_mv |
http://lattes.cnpq.br/6492048904483467 |
dc.contributor.advisor1.fl_str_mv |
Maia, Ana Figueiredo |
dc.contributor.authorLattes.fl_str_mv |
http://lattes.cnpq.br/8681494453274852 |
contributor_str_mv |
Maia, Ana Figueiredo |
dc.subject.por.fl_str_mv |
Radiologia médica - Administração de risco Raios X Física médica |
topic |
Radiologia médica - Administração de risco Raios X Física médica Medical physics Radiology, Medical Risk management X-rays CNPQ::CIENCIAS EXATAS E DA TERRA::FISICA |
dc.subject.eng.fl_str_mv |
Medical physics Radiology, Medical Risk management X-rays |
dc.subject.cnpq.fl_str_mv |
CNPQ::CIENCIAS EXATAS E DA TERRA::FISICA |
description |
The number of invasive procedures using interventional radiology has increased significantly in recent years. This fact is due to several factors, such as the aging population, the increased of obese population, which has immediate effects on the number of cancer and vascular diseases, the increased of incidence rate of alcoholism and hepatitis, which provide increased of cirrhosis, among others. Some medical specialties use this modality very often, in particular, the angiology, the cardiology, the hepatology and the neurology. The Interventional Radiology, however, can involve high doses and long exposure times, being considered currently the radiology practice of largest medical and occupational exposures, with the possibility of, not only stochastic, but also deterministic events, such as necrosis, erythema, epilation and cancer. In this context, the international studies indicate the need to revise the reference levels, to develop methodologies for dosimetry of patients and staff, including continuously optimization of dose parameters, such as filtration, collimation and rectification, to develop quality control tools and training in radiation protection for those involved in Interventional Radiology. In Brazil, the literature indicated ten publications addressing this topic, and three deal with the technical aspects of equipment performance, four of occupational exposures, medical exposures of two and a review general aspects of interventional radiology. The publications have reported studies that were performed by evaluating a maximum of two equipment, with results indicating high medical and occupational exposures, low image quality and the need to implement quality assurance programs. It is noteworthy that no studies have examined thoroughly the procedure, in others words, exposures and equipment performances, and they were restricted to one service. On the other hand, besides the few papers published, there is no specific legislation on the country, because the Federal Regulation SVS/MS 453/98 only addresses the general issues of fluoroscopy. Thus, the lack of studies about the reality of Interventional Radiology procedures, as well as more complete information of the procedures, require the new studies, especially now that the National Agency of Sanitary Surveillance - ANVISA is updating the Federal Regulation SVS/MS 453/98. Then, aiming to help filling a gap of knowledge in Medical Physics in Brazil and at Brazilian legislation, the objective of this study was to evaluate interventional radiology services in two states, Bahia and Santa Catarina, to characterize the technologies and practices used and the risk to patients and workers, proposing technical requirements and testing protocols, adequate to the actual situation, without losing the perspective of international standards and recommendations, as well as to develop the of Effective Potential Risk Assessment Model (EPRAM), a tool for auditing and risk management, that is an adaptation of a methodology for auditing radiology services, and to validate it in 20 rooms of interventional radiology procedures of 16 services in two Brazilian states. The results showed that no services meet the minimum requirements of the law and, even if some basic and essential requirements for safety were not considered, only 5 (25%) of the rooms were at potential effective risk acceptable |
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2013 |
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2013-08-24 |
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