Functional evaluation of medical devices

• Autor(a) principal: Trindade, Evelinda
• Data de Publicação: 2019
• Outros Autores: Hayashi, Elza Leiko Otubo, Melchior, Stela Candioto, Vicente, Maria Glória
• Tipo de documento: Artigo
• Idioma: por; eng
• Título da fonte: Vigilância Sanitária em Debate
• Texto Completo: https://visaemdebate.incqs.fiocruz.br/index.php/visaemdebate/article/view/1366
• topic: Technology Assessment Biomedical; Medical Devices Assessment Tools; Prequalification; Medical Devices; Avaliação de Tecnologia Biomédica; Fichas de Avaliação Funcional de Materiais; Pré-Qualificação; Dispositivos Médicos

Introduction: Acquisition of hospital medical devices and supplies without the analysis of quality and performance may result in the occurrence of technical complaints or adverse events, patients’ or users’ health risks, and characterizes misuse of public resources. Objective: This review studies functional evaluation of hospital medical devices, which may contribute for risk prevention. Method: A systematic literature review on instruments and tools for medical devices functional evaluation was performed in bibliographic databases [MEDLINE, LILACS, SciELO, Cochrane, ECRI] and the Ministry of Health website. Results: Ten publications contained the selected inclusion criteria [and were English and Portuguese publications from 2005 to 2019], comprising eight clinical studies on the functional evaluation of specific hospital medical devices and two reviews of conceptual aspects and methods for devices incorporation. Conclusions: While it is recognized that a growing number of health facilities conduct purchases pre-assessment, the paucity of published studies indicates insufficient process standardization and often requires efforts duplication. This article points out that the functional evaluation of medical-hospital articles can be a significant preventive strategy to verify their quality and performance, without disregarding that the topic deserves further study.