Statistics and Analysis of 136 Cases of Adverse Events of International Medical Devices.
10.3969/j.issn.1671-7104.2020.02.015
- Author:
Fei ZHAO
1
;
Mingxian GAO
2
;
Pu LIU
3
;
Yang WANG
1
;
Hangyao ZHANG
1
;
Yuye ZHANG
1
;
Qin ZHAN
1
;
Shouli WANG
1
Author Information
1. Pathology Laboratory, Institute of Health and Environmental Technology, Suzhou University, Suzhou, 215123.
2. Department of Cardiology, People's Hospital of Sihong County, Sihong, 223900.
3. NAMSA China Laboratory, Shanghai, 201499.
- Publication Type:Journal Article
- Keywords:
analysis;
medical device;
serious adverse event;
statistics
- MeSH:
Equipment Safety;
Equipment and Supplies/adverse effects*;
Product Surveillance, Postmarketing;
Software
- From:
Chinese Journal of Medical Instrumentation
2020;44(2):166-171
- CountryChina
- Language:Chinese
-
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.
