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

Abstract

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.