Research on the Whole-process Cloud Monitoring Mode of Diagnostic Medical Devices Adverse Events.
10.3969/j.issn.1671-7104.2019.03.013
- Author:
Yangdui MAO
1
;
Jing DING
1
;
Wenxia REN
1
;
Qing ZHU
1
;
Yongbing ZHANG
1
;
Min XIE
1
Author Information
1. Zhejiang Pharmaceutical College, Ningbo, 315100.
- Publication Type:Journal Article
- Keywords:
in vitro diagnostic medical devices adverse events;
monitoring procedures;
whole-process cloud monitoring mode
- MeSH:
China;
Equipment and Supplies;
Reagent Kits, Diagnostic;
Risk Management
- From:
Chinese Journal of Medical Instrumentation
2019;43(3):205-208
- CountryChina
- Language:Chinese
-
Abstract:
OBJECTIVE:To improve the monitoring mode of diagnostic medical devices adverse events.
METHODS:By discussing the objective laws of the characteristics, performances and causes of diagnostic medical devices adverse events, the key points of monitoring work were clarified.
RESULTS:The whole-process cloud monitoring mode for adverse events of diagnostic medical devices was constructed based on risk management, and the working procedures for the four core links i.e. collection and report, investigation, analysis and evaluation, and controlling were formulated.
CONCLUSIONS:The whole-process cloud monitoring mode contributes to improve the monitoring level and efficiency of diagnostic medical devices adverse events in China, so as to strengthen risk control capability and ensure the public can use medical devices safely.
