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

Q4 Medicine

中国医疗器械杂志 Pub Date : 2025-07-30 DOI:10.12455/j.issn.1671-7104.240688

Hongfeng Bi, Yonggang Wang, Zhendong Wang, Yuan Fu, Huifang Niu

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引用次数: 0

Abstract

Objective: To investigate the transfusion and infusion warmer manufacturers, combine the use failures to analyze adverse events, and provide support for enterprise risk management and clinical safe use.

Methods: The sentinels from 7 manufacturing enterprises and 11 medical institutions that participated in Shandong Province's key monitoring program during the "14th Five-Year Plan" period were targeted. This was done by understanding the equipment's principles, structures, and quality control. Additionally, 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. Fifteen 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, so enterprises should improve processes and quality control to address risks, and medical institutions should formulate specifications and maintenance plans to provide targeted theoretical basis for supervision.

查看原文本刊更多论文

[基于实际数据的输液器生产研究及风险因素分析]。

目的：对输液加热器生产企业进行调查，结合使用失败情况分析不良事件，为企业风险管理和临床安全使用提供支持。方法：选取山东省“十四五”期间参与重点监测项目的7家生产企业和11家医疗机构作为监测对象。这是通过了解设备的原理、结构和质量控制来完成的。此外，还收集了2019年1月至2023年12月的真实数据，以统计不良事件。结果：在生产过程中，开关电源的稳定性和焊点的牢固性存在风险。在使用过程中发生了15种故障，常见故障如不能加热、不能开机、输液管有气泡等占80%以上。结论：输液加温器存在诸多风险点和故障，企业应完善流程和质量控制以应对风险，医疗机构应制定规范和维护方案，为有针对性的监管提供理论依据。

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来源期刊

中国医疗器械杂志 Medicine-Medicine (all)

CiteScore

0.40

自引率

0.00%

发文量

8086

期刊介绍： Chinese Journal of Medical Instrumentation mainly reports on the development, progress, research and development, production, clinical application, management, and maintenance of medical devices and biomedical engineering. Its aim is to promote the exchange of information on medical devices and biomedical engineering in China and turn the journal into a high-quality academic journal that leads academic directions and advocates academic debates.