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Previous issue date: 2011 / Fundação Oswaldo Cruz. Instituto Nacional de Controle de Qualidade em Saúde / Os fios para sutura cirúrgica e os cateteres venosos centrais são produtos para a saúde amplamente utilizados nas intervenções médicas e cirúrgicas nos diversos serviços de saúde, tanto no sistema público, quanto privado. Considerando que o uso de produtos para a saúde pode acarretar algum tipo de risco ao usuário, é importante o monitoramento do uso desses produtos na etapa de pós-comercialização, quando são utilizados em larga escala, com a finalidade de se conhecer seu comportamento, verificar se existem falhas de funcionamento, identificar eventos adversos em decorrência dessas falhas, criar estratégias de prevenção, de minimização ou de contenção dos riscos. No Brasil, a vigilância pós-comercialização dos produtos para a saúde - ou Tecnovigilância - é atribuição do Sistema Nacional de Vigilância Sanitária (SNVS). O objetivo principal deste estudo foi avaliar o comportamento do fio para sutura cirúrgica e do cateter venoso central, comercializados no Brasil, analisando as notificações registradas no Sistema Nacional de Notificações de Eventos Adversos e Queixas Técnicas (NOTIVISA) de 2006 a 2009. Segundo os critérios estabelecidos na norma vigente de Tecnovigilância foram registradas 94 e 119 ocorrências de eventos adversos e 162 e 228 de queixas técnicas para o fio de sutura cirúrgica e para o cateter venoso central respectivamente. A notificação mais grave referente ao cateter foi a excessiva rigidez do fio guia levando ao óbito do paciente, quanto ao fio para sutura os agravos à saúde que ocorreram durante o procedimento cirúrgico foram considerados os eventos adversos mais graves, pois, exigiram do paciente o prolongamento da hospitalização já existente. / The wires for surgical sutures and central venous catheters health products are widely used in medical and surgical interventions in different health services, both in the public system and private sectors. Whereas the use of health products may result in some kind of risk to the user, it is important to monitor the use of these products in the stage of post-marketing, when used in large scale in order to know their behavior, see if there are faults, identify adverse events due to these failures, develop strategies for prevention, mitigation or prevention of risks. In Brazil, the post-marketing surveillance of health products - or Technical surveillance - is the responsibility of the National Sanitary Surveillance (SNVS). The main objective of this study was to evaluate the behavior of the wire for surgical suture and the central venous catheter, marketed in Brazil, analyzing the notifications registered in the National Reports of adverse events and technical complaints (NOTIVISA) from 2006 to 2009. According to the criteria established in the current Technical surveillance were recorded 94 and 119 occurrences of adverse events and 162 and 228 technical complaints for the wire for the surgical suture and the central venous catheter respectively. The notification for the most serious catheter was the excessive rigidity of the guide wire leading to the death of the patient, the wire of suture thread to the health problems that occurred during the surgical procedure were considered more severe adverse events, because the patient required prolonged existing hospitalization. These data strongly indicate the high risk associated with use of central venous catheter and wire for surgical sutures and support the necessity of the cooperation of all entities of SNVS, including the Public Health Laboratories, to verify the compliance of these products, as well as properly and immediate notification by health professionals of adverse events and technical complaints. It is also important to incorporate minimum standards of technologies management to the routine health services, including the acquisition of products, as well as the training of human resources for its use. And added to the other proposed measures, the adoption of compulsory certification setting forth the minimum quality requirements, which would allow the improvement in standards of safety and efficacy of wire of surgical suture and the central venous catheter.
| Identifer | oai:union.ndltd.org:IBICT/oai:www.arca.fiocruz.br:icict/10836 |
| Date | January 2011 |
| Creators | Morais, Luciene de Oliveira |
| Contributors | Gemal, André Luiz, Mello, Marcia Sarpa de Campos, Villas Bôas, Maria Helena Simões, Delgado, Isabella Fernandes, Friedrich, Karen, Delgado, Isabella Fernandes, Friedrich, Karen |
| Source Sets | IBICT Brazilian ETDs |
| Language | Portuguese |
| Detected Language | English |
| Type | info:eu-repo/semantics/publishedVersion, info:eu-repo/semantics/masterThesis |
| Source | reponame:Repositório Institucional da FIOCRUZ, instname:Fundação Oswaldo Cruz, instacron:FIOCRUZ |
| Rights | info:eu-repo/semantics/openAccess |
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