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Statistics and Analysis of 136 Cases of Adverse Events of International Medical Devices / 中国医疗器械杂志
Chinese Journal of Medical Instrumentation ; (6): 166-171, 2020.
Article in Chinese | WPRIM | ID: wpr-942721
ABSTRACT
To explore the law and characteristics of adverse events of medical devices and to provide research methods and basis for reducing the recurrence of similar adverse events, we collect medical devices safety information from five representative countries in the world, and make statistics and analysis on the types of events, the types of management and the causes of events. The results show that among 136 serious adverse events, the top three causes of recall are product design factors, software factors, and component defects. In order to reduce the application risk of medical devices, it is suggested that product designers, operating users and medical institutions should correctly implement the monitoring and evaluation system of medical devices.
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Full text: Available Index: WPRIM (Western Pacific) Main subject: Product Surveillance, Postmarketing / Software / Equipment and Supplies / Equipment Safety Language: Chinese Journal: Chinese Journal of Medical Instrumentation Year: 2020 Type: Article

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Full text: Available Index: WPRIM (Western Pacific) Main subject: Product Surveillance, Postmarketing / Software / Equipment and Supplies / Equipment Safety Language: Chinese Journal: Chinese Journal of Medical Instrumentation Year: 2020 Type: Article