Research on the Efficacy of Fulfillment of Medical Device Adverse Event Monitoring Entities and Safeguard Mechanism / 中国医疗器械杂志
Chinese Journal of Medical Instrumentation
; (6): 58-61, 2018.
Article
en Zh
| WPRIM
| ID: wpr-775554
Biblioteca responsable:
WPRO
ABSTRACT
OBJECTIVES@#To solve the problem that medical device adverse event monitoring entities perform their duties inadequately, to provide reference for perfecting the post-market surveillance system.@*METHODS@#Through theoretical and empirical research, the paper explored the ways to improve the performance of monitoring the adverse events of medical devices.@*RESULTS@#The survey found that the number of adverse event monitoring reports was few and the quality of report was poor. The root causes included lack of motivation of monitoring entities, the imperfect monitoring system, and the monitoring capability failure, etc.@*CONCLUSIONS@#The methods such as strengthening the main body responsibility consciousness, establishing evaluation system and accountability system, building social work network, are beneficial to the adverse events monitoring.
Palabras clave
Texto completo:
1
Base de datos:
WPRIM
Asunto principal:
Vigilancia de Productos Comercializados
/
Encuestas y Cuestionarios
/
Equipos y Suministros
/
Seguridad de Equipos
Idioma:
Zh
Revista:
Chinese Journal of Medical Instrumentation
Año:
2018
Tipo del documento:
Article