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      基于真实世界数据的输血输液加温器的生产调研与风险因素分析

      Production Research and Risk Factor Analysis of Transfusion and Infusion Warmer Based on Real-World Data

        摘要
      • 摘要:
        目的 对输血输液加温器生产企业调研，结合使用故障分析不良事件，为企业风险管理和临床安全使用提供支持。
        方法 以山东省参与“十四五”重点监测的7家生产企业、11家医疗机构哨点为对象，了解设备原理、结构与质量控制，采集2019年1月至2023年12月真实世界数据，统计不良事件。
        结果 生产中，开关电源稳定性、焊点牢固性等存在风险。使用时出现15种故障，不能加热、无法开机、输液管出现气泡等常见故障占比超80%。
        结论 输血输液加温器风险点与故障多，企业应针对风险改进工艺和质控，医疗机构应制定规范和维护计划，为监管提供针对性理论依据。

         

        Abstract:
        Objective To investigate the transfusion and infusion warmer manufacturers, combine the use failure to analyze adverse events, and provide support for enterprise risk management and clinical safe use.
        Methods The sentinels of 7 manufacturing enterprises and 11 medical institutions participated in the "14th Five-Year Plan" key monitoring of Shandong Province were used as the targets to understand the equipment principle, structure and quality control, and real-world data from January 2019 to December 2023 were collected to count adverse events.
        Results During production, there are risks in switching power supply stability and solder joint firmness. 15 kinds of faults occurred during use, and common faults such as inability to heat, unable to turn on the machine, and bubbles in the infusion tube accounted for more than 80%.
        Conclusion There are many risk points and failures for transfusion and infusion warmers. Enterprises should improve processes and quality control based on risks. Medical institutions should formulate specifications and maintenance plans to provide targeted theoretical basis for supervision.

         

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