呼吸机质量检测和风险评估的研究与实践

Research and Practice in Ventilator Quality Inspection and Risk Assessment

目的:通过对呼吸机的使用环境条件和临床应用情况进行调研,制定适合临床工程技术人员操作的《呼吸机临床应用质量检测和风险评估作业指导书》。方法:按照卫生部医院管理研究所《临床工程指引》的细则要求,参照国际、国内医用电气设备标准以及医疗设备计量检定规程,制订《呼吸机临床应用质量检测和风险评估作业指导书》,并按照该作业指导对在用呼吸机的外观状态、电气安全、机械通气参数、安全报警功能及机械通气模式等项目进行质量检测和风险评估。结果:抽样检测的79台呼吸机合格率为77.2%,不合格的因素主要表现在:接地电阻超出范围、气源压力超标、后备电池失效、氧电池失效、无开机自检功能、无气道压力下限报警、无压控通气模式、无流量触发功能;在机械通气参数中,潮气量、吸气压力水平、呼气末正压超标;少数临床使用人员没有接受过正规的操作培训等。结论:该指导书能够指导和帮助临床工程技术人员对呼吸机安全问题进行管理并承担常规安全监测工作。

Objective To develop the Working Instructions of Quality inspection and Risk Assessment in Clinical Applications of Ventilators（the Working Instructions） for clinical engineers through research in environmental conditions in the use of the ventilator and its clinical applications.Methods The Working Instructions was made in accordance with the detailed requirements of the National Institute of Hospital Administration specified in Clinical Engineering Guidelines and with reference to both international and domestic Medical Electrical Equipment Criteria as well as Metrological Verification Regulations of Medical Equipment;Following the Working Instructions on ventilator appearance,electrical safety,mechanical ventilation parameters,functions of safety alarm and mechanical ventilation modes,conduct project quality inspection and risk assessment.Results Sampling inspection of 79 ventilators showed a passing rate of 77.2%.Nullifying factors are mainly reflected in e.g.earth resistance or air or O2 supply pressure exceeding standard,back-up battery failure,O2 Sensor failure,no Power On Self-Test feature,no lower airway pressure alarm,no PCV mode,no flow triggered function;failures in mechanical ventilation arguments such as tidal volume,aspiratory pressure level or PEEP;and some operators with no technical training,etc.Conclusion To guide and help clinical engineers in management of security issues of ventilator and general security monitoring work.