Examination of notifications of technical defects in technical surveillance at a public university hospital

Detalhes bibliográficos
Autor(a) principal: Schmitt, Marcia Danieli
Data de Publicação: 2016
Outros Autores: Haddad, Maria do Carmo Fernandez Lourenço, Rossaneis, Mariana Angela, Pissinati, Paloma de Souza Cavalcante, Vannuchi, Marli Terezinha Oliveira
Tipo de documento: Artigo
Idioma: por
Título da fonte: Vigilância Sanitária em Debate
Texto Completo: https://visaemdebate.incqs.fiocruz.br/index.php/visaemdebate/article/view/750
Resumo: Objective: To analyze the notifications of technical complaints in technical surveillance at a public university hospital. Methods: cross-sectional, retrospective, descriptive study of quantitative approach, performed at a public university hospital. Data were collected through a survey of notifications of technical complaints of non-conformities related to medical and hospital supplies used in health care, subject to the system of Notification and Research in Health Surveillance (Notivisa). Data were transcribed and tabulated in the statistical analysis program Statistical Package for Social Sciences (SPSS) version 20.0. Results: among the 207 notifications, 83.70% were related to changes in the product itself; from these, 97.10% were related to alleged quality deviation. The most notified products were the equipment (33.80%), the syringe (8.20%) and the sleeve (8.20%). As for the risk classification, 72.00% were medium risk and 4.80% were maximum risk to health. Conclusion: The analyzed reports were mostly related to medical products widely used in health care, which endangers patient safety. Notifying failures would therefore help identifying problems before they cause damage, contributing to post-market surveillance.
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spelling Examination of notifications of technical defects in technical surveillance at a public university hospitalAnálise das notificações de queixas técnicas em tecnovigilância em hospital universitário públicoGestão da SegurançaSegurança do PacienteGarantia da Qualidade dos Cuidados de SaúdeAdministração de Materiais no HospitalVigilância SanitáriaSecurity ManagementPatient SafetyQuality AssuranceHealth CareMaterials ManagementHospitalSanitary SurveillanceObjective: To analyze the notifications of technical complaints in technical surveillance at a public university hospital. Methods: cross-sectional, retrospective, descriptive study of quantitative approach, performed at a public university hospital. Data were collected through a survey of notifications of technical complaints of non-conformities related to medical and hospital supplies used in health care, subject to the system of Notification and Research in Health Surveillance (Notivisa). Data were transcribed and tabulated in the statistical analysis program Statistical Package for Social Sciences (SPSS) version 20.0. Results: among the 207 notifications, 83.70% were related to changes in the product itself; from these, 97.10% were related to alleged quality deviation. The most notified products were the equipment (33.80%), the syringe (8.20%) and the sleeve (8.20%). As for the risk classification, 72.00% were medium risk and 4.80% were maximum risk to health. Conclusion: The analyzed reports were mostly related to medical products widely used in health care, which endangers patient safety. Notifying failures would therefore help identifying problems before they cause damage, contributing to post-market surveillance.Objetivo: Analisar as notificações de queixas técnicas em tecnovigilância em hospital universitário público. Métodos: Estudo transversal, retrospectivo, descritivo, de abordagem quantitativa, realizado em um hospital universitário público. A coleta de dados ocorreu por meio do levantamento das notificações de queixas técnicas de inconformidades relacionadas a materiais médico-hospitalares utilizados na área da saúde e submetidas ao Sistema de Notificação e Investigação em Vigilância Sanitária (Notivisa). Os dados foram transcritos e tabulados no programa de análise estatística Statistical Package for Social Sciences (SPSS) versão 20.0. Resultados: Dentre as 207 notificações, 83,70% relacionavam-se a alterações do próprio produto, destas, 97,10% apresentavam suspeita de desvio de qualidade e os produtos mais notificados foram o equipo (33,80%), a seringa (8,20%) e a luva (8,20%). Quanto à classificação de risco, 72,00% apresentaram médio risco e 4,80% risco máximo a saúde. Conclusão: As notificações analisadas foram, em sua maioria, de produtos médico-hospitalares amplamente utilizados nos serviços de saúde, colocando em risco a segurança do paciente. Assim, notificar as falhas possibilita identificar problemas antes de causar danos, contribuindo com a vigilância pós-mercado.Instituto Nacional de Controle de Qualidade em Saúde2016-08-30info:eu-repo/semantics/articleinfo:eu-repo/semantics/publishedVersion"Peer-reviewed article""Artículo revisado por pares""Artigo avaliado pelos pares"application/pdfhttps://visaemdebate.incqs.fiocruz.br/index.php/visaemdebate/article/view/75010.22239/2317-269X.00750Health Surveillance under Debate: Society, Science & Technology ; Vol. 4 No. 3 (2016): August; 35-41Vigilancia en Salud en Debate: Sociedad, Ciencia y Tecnología; Vol. 4 Núm. 3 (2016): Agosto; 35-41Vigil Sanit Debate, Rio de Janeiro; v. 4 n. 3 (2016): Agosto; 35-412317-269Xreponame:Vigilância Sanitária em Debateinstname:Fundação Oswaldo Cruz (FIOCRUZ)instacron:FIOCRUZporhttps://visaemdebate.incqs.fiocruz.br/index.php/visaemdebate/article/view/750/329Copyright (c) 2016 Vigilância Sanitária em Debate: Sociedade, Ciência & Tecnologia (Health Surveillance under Debate: Society, Science & Technology) – Visa em Debatehttps://creativecommons.org/licenses/by-nc-nd/4.0info:eu-repo/semantics/openAccessSchmitt, Marcia DanieliHaddad, Maria do Carmo Fernandez LourençoRossaneis, Mariana AngelaPissinati, Paloma de Souza CavalcanteVannuchi, Marli Terezinha Oliveira2023-06-27T15:17:11Zoai:ojs.visaemdebate.incqs.fiocruz.br:article/750Revistahttps://visaemdebate.incqs.fiocruz.br/index.php/visaemdebatePUBhttps://visaemdebate.incqs.fiocruz.br/index.php/visaemdebate/oaiincqs.visaemdebate@fiocruz.br || gisele.neves@fiocruz.br2317-269X2317-269Xopendoar:2023-06-27T15:17:11Vigilância Sanitária em Debate - Fundação Oswaldo Cruz (FIOCRUZ)false
dc.title.none.fl_str_mv Examination of notifications of technical defects in technical surveillance at a public university hospital
Análise das notificações de queixas técnicas em tecnovigilância em hospital universitário público
title Examination of notifications of technical defects in technical surveillance at a public university hospital
spellingShingle Examination of notifications of technical defects in technical surveillance at a public university hospital
Schmitt, Marcia Danieli
Gestão da Segurança
Segurança do Paciente
Garantia da Qualidade dos Cuidados de Saúde
Administração de Materiais no Hospital
Vigilância Sanitária
Security Management
Patient Safety
Quality Assurance
Health Care
Materials Management
Hospital
Sanitary Surveillance
title_short Examination of notifications of technical defects in technical surveillance at a public university hospital
title_full Examination of notifications of technical defects in technical surveillance at a public university hospital
title_fullStr Examination of notifications of technical defects in technical surveillance at a public university hospital
title_full_unstemmed Examination of notifications of technical defects in technical surveillance at a public university hospital
title_sort Examination of notifications of technical defects in technical surveillance at a public university hospital
author Schmitt, Marcia Danieli
author_facet Schmitt, Marcia Danieli
Haddad, Maria do Carmo Fernandez Lourenço
Rossaneis, Mariana Angela
Pissinati, Paloma de Souza Cavalcante
Vannuchi, Marli Terezinha Oliveira
author_role author
author2 Haddad, Maria do Carmo Fernandez Lourenço
Rossaneis, Mariana Angela
Pissinati, Paloma de Souza Cavalcante
Vannuchi, Marli Terezinha Oliveira
author2_role author
author
author
author
dc.contributor.author.fl_str_mv Schmitt, Marcia Danieli
Haddad, Maria do Carmo Fernandez Lourenço
Rossaneis, Mariana Angela
Pissinati, Paloma de Souza Cavalcante
Vannuchi, Marli Terezinha Oliveira
dc.subject.por.fl_str_mv Gestão da Segurança
Segurança do Paciente
Garantia da Qualidade dos Cuidados de Saúde
Administração de Materiais no Hospital
Vigilância Sanitária
Security Management
Patient Safety
Quality Assurance
Health Care
Materials Management
Hospital
Sanitary Surveillance
topic Gestão da Segurança
Segurança do Paciente
Garantia da Qualidade dos Cuidados de Saúde
Administração de Materiais no Hospital
Vigilância Sanitária
Security Management
Patient Safety
Quality Assurance
Health Care
Materials Management
Hospital
Sanitary Surveillance
description Objective: To analyze the notifications of technical complaints in technical surveillance at a public university hospital. Methods: cross-sectional, retrospective, descriptive study of quantitative approach, performed at a public university hospital. Data were collected through a survey of notifications of technical complaints of non-conformities related to medical and hospital supplies used in health care, subject to the system of Notification and Research in Health Surveillance (Notivisa). Data were transcribed and tabulated in the statistical analysis program Statistical Package for Social Sciences (SPSS) version 20.0. Results: among the 207 notifications, 83.70% were related to changes in the product itself; from these, 97.10% were related to alleged quality deviation. The most notified products were the equipment (33.80%), the syringe (8.20%) and the sleeve (8.20%). As for the risk classification, 72.00% were medium risk and 4.80% were maximum risk to health. Conclusion: The analyzed reports were mostly related to medical products widely used in health care, which endangers patient safety. Notifying failures would therefore help identifying problems before they cause damage, contributing to post-market surveillance.
publishDate 2016
dc.date.none.fl_str_mv 2016-08-30
dc.type.driver.fl_str_mv info:eu-repo/semantics/article
info:eu-repo/semantics/publishedVersion
"Peer-reviewed article"
"Artículo revisado por pares"
"Artigo avaliado pelos pares"
format article
status_str publishedVersion
dc.identifier.uri.fl_str_mv https://visaemdebate.incqs.fiocruz.br/index.php/visaemdebate/article/view/750
10.22239/2317-269X.00750
url https://visaemdebate.incqs.fiocruz.br/index.php/visaemdebate/article/view/750
identifier_str_mv 10.22239/2317-269X.00750
dc.language.iso.fl_str_mv por
language por
dc.relation.none.fl_str_mv https://visaemdebate.incqs.fiocruz.br/index.php/visaemdebate/article/view/750/329
dc.rights.driver.fl_str_mv https://creativecommons.org/licenses/by-nc-nd/4.0
info:eu-repo/semantics/openAccess
rights_invalid_str_mv https://creativecommons.org/licenses/by-nc-nd/4.0
eu_rights_str_mv openAccess
dc.format.none.fl_str_mv application/pdf
dc.publisher.none.fl_str_mv Instituto Nacional de Controle de Qualidade em Saúde
publisher.none.fl_str_mv Instituto Nacional de Controle de Qualidade em Saúde
dc.source.none.fl_str_mv Health Surveillance under Debate: Society, Science & Technology ; Vol. 4 No. 3 (2016): August; 35-41
Vigilancia en Salud en Debate: Sociedad, Ciencia y Tecnología; Vol. 4 Núm. 3 (2016): Agosto; 35-41
Vigil Sanit Debate, Rio de Janeiro; v. 4 n. 3 (2016): Agosto; 35-41
2317-269X
reponame:Vigilância Sanitária em Debate
instname:Fundação Oswaldo Cruz (FIOCRUZ)
instacron:FIOCRUZ
instname_str Fundação Oswaldo Cruz (FIOCRUZ)
instacron_str FIOCRUZ
institution FIOCRUZ
reponame_str Vigilância Sanitária em Debate
collection Vigilância Sanitária em Debate
repository.name.fl_str_mv Vigilância Sanitária em Debate - Fundação Oswaldo Cruz (FIOCRUZ)
repository.mail.fl_str_mv incqs.visaemdebate@fiocruz.br || gisele.neves@fiocruz.br
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