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. Administración de riesgo en tecnovigilancia: construcción y validación de un instrumento de evaluación de producto Médico hospitalarioCon la continua incorporación de tecnologías en la salud, la administración de riesgo hospitalario debe ser implantada para sistematizar la monitorización de eventos adversos, ejecutando acciones para el control y eliminación de sus daños. Como parte de esas acciones, la Tecnovigilancia actúa en los procedimientos de adquisición, utilización y control de calidad de productos y equipamientos en el área de la salud. El objetivo de este estudio fue construir y validar un instrumento de evaluación de productos Médico hospitalarios. Se trata de un estudio cuantitativo, exploratorio, longitudinal y de desarrollo metodológico, fundamentado en el modelo de gestión de calidad Seis Sigma, que tiene como base principal las etapas componentes del Ciclo DMAIC. Para la obtención de datos y la validación de contenido, se utilizó la técnica Delphi con profesionales de la Red Brasileña de Hospitales Centinela. Se concluyó que el instrumento desarrollado posibilitó evaluar el producto, diferenciando los resultados entre las marcas probadas y retratando el propósito inicial del estudio de calificar las evaluaciones realizadas.

Evaluating the intervening factors in patient safety: focusing on hospital nursing staff

“…For this, the hospital institution has the responsibility to propose programs for team education regarding clear and precise concepts relating to what adverse events are, what types there are, and the importance of their recording and notification (21) , qualifying them for new care demands or changes in the care process (22) .…”

Best practice of nurse managers in risk management

“…This being so, the continuing adoption of new technology in the area of health, in particular in the ambit of Nursing, has led the organizations to implement risk management, thus systematizing the supervision of adverse events with the aim of having greater safety in the actions carried out (9) . In Brazil, this is substantiated through the Sentinel Network (10) .…”

“…The risk management program aims to prevent risk or harm to clients and thus to provide safe, quality care (9) . However, it may be noted that patient safety is not totally understood by the nursing professionals, improvement being necessary in their interpretation and understanding regarding this phenomenon (8) .…”

Validación y clasificación de la escala de creencias de los padres de niños prematuros

“…A avaliação da validade de qualquer instrumento deve estabelecer-se em um processo contínuo e permanente, a fim de evidenciar qualquer necessidade de adaptação ou reformulação aos variados contextos (Kuwabara, Évora, & Oliveira, 2010). Reflexos culturais, sociais e de desenvolvimento dos países e das regiões amostrais também podem influenciar.…”