北京生物医学工程

医疗设备临床使用风险控制计算分析方法研究

An approach to risk control calculation and analysis for clinical use of medical equipment

作者：周伟斌李海云

单位：北京积水潭医院设备科（北京 100035）首都医科大学生物医学工程学院（北京 100069）

关键词：医疗设备; 风险评估; 雷达图; 风险控制; 失效模式和效果分析; 呼吸机

分类号：R318.04

出版年·卷·期（页码）：2019·38·5（498-503）

摘要：

目的医疗设备在临床诊断和治疗中发挥重要作用，医疗设备临床使用风险将影响临床诊疗的质量和水平,如何进行有效的医疗设备风险控制是临床医疗设备管理面临的一个重要技术问题。为此，本文提出一种医疗设备临床使用风险控制计算分析方法。方法应用失效模式和效果分析(failure mode and effect analysis,FMEA)方法分析临床医疗过程中医疗设备使用的主要风险环节和风险特征，探索医疗设备临床应用风险的数值计算，提出医疗设备临床使用风险控制计算分析方法，并将此方法应用于呼吸机。结果应用所提出的医疗设备临床使用风险计算分析方法，获得呼吸机临床使用的风险特征参数及临床使用风险雷达图，实现呼吸机临床使用风险的动态监控。结论本文建立的临床医疗设备风险控制计算分析方法可为临床医疗设备使用风险的数值评估和跟踪监控提供新的技术支撑。

Objective Medical equipment plays an important role in clinical diagnosis and treatment. The clinical use risk of medical equipment will affect the quality and level of clinical diagnosis and treatment. How to carry out effective risk control of medical equipment is an important technical problem facing the management of clinical medical equipment. Therefore，we propose a risk control calculation and analysis method for clinical medical equipment. Methods Applying FMEA (failure mode and effect analysis) principle, we analyzed the main risk links and risk characteristics of the use of medical equipment in the clinical medical process, explored the numerical calculation of the risk of clinical application of medical equipment, proposed a risk control calculation and analysis method for clinical medical equipment, and applied this method to breathing machine. Results Utilizing the risk calculation method of clinical use of medical equipment, the risk characteristic parameters and radar chart of clinical use of breathing machine were obtained，dynamic monitoring of breathing machine use risk could be achieved. Conclusions The method of risk control calculation and analysis of clinical medical equipment established in this paper can provide new technical support for the numerical evaluation and tracking and monitoring of clinical medical equipment use risk.

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