Risk Management in Technovigilance: construction and Validation of a Medical-Hospital Product Evaluation Instrument

Revista Latino-Americana de Enfermagem

Cleuza Catsue Takeda Kuwabara¹  Yolanda Dora Martinez Évora²  Márcio Mattos Borges De Oliveira¹ 

[1] ,Universidade de São Paulo Escola de Enfermagem de Ribeirão PretoSP ,Brazil

关键词: Safety Management;    Evaluation Studies;    Validation Studies;    Quality Assurance;    Health Care;    Gerenciamento de Segurança;    Estudos de Avaliação;    Estudos de Validação;    Garantia da Qualidade dos Cuidados de Saúde;    Administración de la Seguridad;    Estudios de Evaluación;    Estudios de Validación;    Garantía de la Calidad de Atención de Salud;   

DOI  :  10.1590/S0104-11692010000500015

来源: SciELO

【 摘 要 】

With the continuous incorporation of health technologies, hospital risk management should be implemented to systemize the monitoring of adverse effects, performing actions to control and eliminate their damage. As part of these actions, Technovigilance is active in the procedures of acquisition, use and quality control of health products and equipment. This study aimed to construct and validate an instrument to evaluate medical-hospital products. This is a quantitative, exploratory, longitudinal and methodological development study, based on the Six Sigma quality management model, which has as its principle basis the component stages of the DMAIC Cycle. For data collection and content validation, the Delphi technique was used with professionals from the Brazilian Sentinel Hospital Network. It was concluded that the instrument developed permitted the evaluation of the product, differentiating between the results of the tested brands, in line with the initial study goal of qualifying the evaluations performed.

【 授权许可】

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