Analysis and countermeasures of suspected medical devices adverse events of hospital
10.3969/J.ISSN.1672-8270.2016.12.007
- VernacularTitle:医院可疑医疗设备不良事件的分析与对策
- Author:
Yifang JIANG
;
Xiaokun GAO
- Keywords:
Medical device;
Adverse events;
Hypersensitivity;
Countermeasures;
Monitoring and reporting of adverse events
- From:
China Medical Equipment
2016;13(12):20-24
- CountryChina
- Language:Chinese
-
Abstract:
Objective:To sort out cases of suspected medical device adverse events in Subei hospital, analysis for the reasons of adverse events, and propose measures to ensure the safe clinical use of medical devices.Methods: From the National Adverse Drug Reaction Monitoring Centre database, 300 cases of suspicious medical device adverse events were selected from cities and provinces. The number of categories of adverse events involving medical devices and the main reasons resulting adverse events were analyzed by SPSS.Results: The main reasons resulting the medical device adverse events were quality-related issues of the product, biological incompatibility existing between the patient and the physical device, and improper operation or use.Conclusion: The enterprises of medical devices should product on the basis of GMP strictly to ensure the quality of product. The medical institutions should ask hypersensitivity of patients actively and operate on the basis of SOP strictly to improve the work of monitoring and reporting.
