Analysis of adverse events of in vitro diagnostic and clinical laboratory medical devices:241 case reports
10.19745/j.1003-8868.2024135
- VernacularTitle:241例体外诊断类和临床检验类医疗器械不良事件分析
- Author:
Jian TANG
1
;
Wen-Jie YUAN
Author Information
1. 厦门市产品技术审评与审核查验中心,福建厦门 361005
- Keywords:
medical device;
in vitro diagnostic medical device;
clinical laboratory medical device;
adverse events;
monitoring of medical device
- From:
Chinese Medical Equipment Journal
2024;45(7):72-76
- CountryChina
- Language:Chinese
-
Abstract:
Totally 241 suspicious adverse event reports of in vitro diagnostic and clinical laboratory medical devices reported by medical institutions in Xiamen to the National Medical Device Adverse Event Monitoring Information System from October 2020 to October 2023 were collected.The medical devices involved in were analyzed in terms of the variety,classification and cause for adverse events,and the characteristics of the adverse events were summarized.Some suggestions were put forward including strengthening risk control of post-marketing adverse events of relevant products,enhancing quality management of the use of relevant products,actively exploring the risk signals and supervising the implementation of corrective actions.References were provided for the marketing license holders,medical institutions and supervisory authorities to improve the monitoring capacity,reduce the incidence of adverse events and ensure the safety of devices.[Chinese Medical Equipment Journal,2024,45(7):72-76]
