Gerenciamento do risco sanitário hospitalar na área de tecnovigilância: análise retrospectiva e prospectiva das notificações de queixas técnicas, incidentes e eventos adversos relacionados ao uso de equipamentos, materiais médico-hospitalares e kits diagnósticos no Hospital das Clínicas da Faculdade de Medicina de Botucatu-UNESP
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Data
2010-09-15
Autores
Luppi, Cláudia Helena Bronzatto [UNESP]
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Editor
Universidade Estadual Paulista (Unesp)
Resumo
O uso de materiais médico-hospitalares (MMH), equipamentos (EQ) e kits diagnósticos nos serviços de saúde devem ser acompanhados de ações que garantam a segurança e a qualidade dos produtos, visando reduzir a probabilidade de ocorrência de incidentes, agravos e sequelas nos pacientes e nos profissionais da saúde e a produção de danos ao meio ambiente. Este estudo foi realizado com o objetivo de conhecer e analisar a incidência de falhas, queixas técnicas, incidentes e eventos adversos relacionados ao uso de MMH, EQ e kits diagnósticos no HC-Unesp Botucatu, no período retrospectivo de março de 2002 a dezembro de 2006 e no período prospectivo de janeiro de 2007 a dezembro de 2007. o banco de notificações de ocorrências da área de Tecnovigilância do Projeto Hospitais Sentinela do HC-Unesp Botucatu (PHS-Botucatu) e a busca ativa nas seções hospitalares foram utilizados. A investigação das causas dos incidentes foi baseada no formulário de Notificação em Tecnovigilância Avulsa, da Agência Nacional de Vigilância Sanitária (Anvisa) e no Protocolo de Investigação de Ocorrências do PHS-Botucatu, tendo sido analisadas as seguintes variáveis: nº total de notificações na área de Tecnovigilância ocorridas em ambos os períodos; distribuição das notificações segundo consistência dos dados, forma de obtenção da informação (espontânea/ativa), tipo de produto de saúde envolvido, empresa fabricante, características do produto, causas-raízes dos problemas (falha técnica, falha de projeto, falha humana, falha de processos, falha de infra-estrutura); frequência e tipos de incidentes, eventos adversos e agravos à saúde dos pacientes e dos profissionais; frequência e tipos de danos ao meio ambiente; análise dos riscos potenciais e reais dos incidentes; análise da gravidade dos eventos adversos ou agravos e medidas preventivas e/ou corretivas tomadas...
The use of medical and hospital materials (MHM), equipment (EQ) and diagnostic kits in health care services must be accompanied by actions which can ensure product safety and quality, aiming at reducing the probability of occurrence of incidents, aggravations and sequelae in patients and health care professionals as well as environmental damage. This study was conducted with the purpose to learn about and analyze the incidence of failures, technical complaints, incidents and adverse events related to the use of MHM, EQ and diagnostic kits at the University Hospital of the Botucatu School of Medicine (HC-Unesp Botucatu) in the retrospective period of March 2002 to December 2006 and in the prospective period of January 2007 to December 2007. The occurrence report database in the Technosurveillance sector of the Sentinel Hospitals Project at HC-Unesp Botucatu (PHS-Botucatu) and active search in the hospital sectors were used. The investigation of the causes of incidents was based on the Sundry Technosurveillance Report Form of the National Health Surveillance Agency (Anvisa) and on the Protocol for Occurrence Investigation of PHS-Botucatu, from which the following variables were investigated: total number of reports in the Technosurveillance sector occurring in both periods; distribution of reports, according to data consistency, form of collection (spontaneous/active), type of health care product involved, manufacturing company, product characteristics, root causes for the problems (technical failure, design failure, human failure, process failure, infrastructure failure); frequency and types of incidents, adverse events and aggravations to patients’ and professionals’ health; frequency and types of environmental damage; analysis of potential and real risk for incidents; analysis of the severity of adverse events or aggravations and preventive and/or corrective measures taken by ... (Complete abstract click electronic access below)
The use of medical and hospital materials (MHM), equipment (EQ) and diagnostic kits in health care services must be accompanied by actions which can ensure product safety and quality, aiming at reducing the probability of occurrence of incidents, aggravations and sequelae in patients and health care professionals as well as environmental damage. This study was conducted with the purpose to learn about and analyze the incidence of failures, technical complaints, incidents and adverse events related to the use of MHM, EQ and diagnostic kits at the University Hospital of the Botucatu School of Medicine (HC-Unesp Botucatu) in the retrospective period of March 2002 to December 2006 and in the prospective period of January 2007 to December 2007. The occurrence report database in the Technosurveillance sector of the Sentinel Hospitals Project at HC-Unesp Botucatu (PHS-Botucatu) and active search in the hospital sectors were used. The investigation of the causes of incidents was based on the Sundry Technosurveillance Report Form of the National Health Surveillance Agency (Anvisa) and on the Protocol for Occurrence Investigation of PHS-Botucatu, from which the following variables were investigated: total number of reports in the Technosurveillance sector occurring in both periods; distribution of reports, according to data consistency, form of collection (spontaneous/active), type of health care product involved, manufacturing company, product characteristics, root causes for the problems (technical failure, design failure, human failure, process failure, infrastructure failure); frequency and types of incidents, adverse events and aggravations to patients’ and professionals’ health; frequency and types of environmental damage; analysis of potential and real risk for incidents; analysis of the severity of adverse events or aggravations and preventive and/or corrective measures taken by ... (Complete abstract click electronic access below)
Descrição
Palavras-chave
Enfermagem medico-cirurgica, Hospitais - Mobiliário e equipamento - Medidas de segurança, Material médico-hospitalar
Como citar
LUPPI, Claudia Helena Bronzatto. Gerenciamento do risco sanitário hospitalar na área de tecnovigilância: análise retrospectiva e prospectiva das notificações de queixas técnicas, incidentes e eventos adversos relacionados ao uso de equipamentos, materiais médico-hospitalares e kits diagnósticos no Hospital das Clínicas da Faculdade de Medicina de Botucatu-UNESP. 2010. 214 f. Tese (doutorado) - Universidade Estadual Paulista, Faculdade de Medicina de Botucatu, 2010.