Risk Analysis and Recommendations for Clinical Use of Infant Incubators
Based on Real-World Data
QU Yan1, NIU Huifang2
1. Department of Medical Engineering, Qingdao Women and Children’s Hospital, Qingdao Shandong 266003, China;
2. Shandong Center for Adverse Drug Reaction Monitoring, Jinan Shandong 250014, China
Abstract：Objective To count and analyze the causes and risks of adverse events of infant incubators, and provide technical support
for the safe and compliant use of infant incubators after listing, safety supervision and the risk management of product life cycle by
manufacturers. Methods The real-world data of infant incubators after listing from January 2019 to December 2022 were collected
from the Shandong provincial database of the National Adverse Event Monitoring Information System for Medical Devices, and the
types of adverse events, possible injuries, causes and risk factors of infant incubators were discussed through attribution analysis
by using Excel for statistics. Results A total of 729 cases of adverse events in infant incubators were collected, and the statistics
found that medical institutions were the main sources of adverse events in infant incubators, among which the number of grade Ⅲ
general hospitals was the largest, with a total of 345 cases, accounting for 47.3%. Among the 729 cases reported, the number of nonconsequential
events was the largest, with a total of 546 cases, accounting for 74.9%. Functional failure or damage to the equipment,
design defects, component quality issues, or improper use and maintenance were common causes of adverse events in infant
incubators. The potential risks of infant incubator in clinical use mainly included mechanical structure safety risk, alarm failure
risk, noise risk and electrical safety risk. Conclusion To reduce the occurrence of adverse events in the clinical use of infant
incubators, medical institutions, manufacturers and regulatory authorities should work together to ensure the compliance and
safe use of infant incubators.
曲彦1，牛惠芳2. 基于真实世界数据的婴儿培养箱临床使用
风险分析与建议[J]. 中国医疗设备, 2024, 39(3): 98-102.
QU Yan1, NIU Huifang2. Risk Analysis and Recommendations for Clinical Use of Infant Incubators
Based on Real-World Data. China Medical Devices, 2024, 39(3): 98-102.
