Risk Analysis and Recommendations for Clinical Use of Infant Incubators Based on Real-World Data
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 Ⅲgeneral hospitals was the largest,with a total of 345 cases,accounting for 47.3%.Among the 729 cases reported,the number of non-consequential 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.
infant incubatorreal-word datamedical device adverse eventsrisk analysisrisk control
国家科技期刊平台
NSTL
万方数据
