80台在用心电监护仪质量检测结果分析与讨论

目的：通过心电监护仪的抽样质量检测,了解医疗设备应用质量状况,为研究制定医疗设备质量控制方案提供第一手资料。方法：利用医疗设备安全、性能测试仪器,依据卫生部医院管理研究所＂医疗设备通用安全质量检测作业指导＂,逐项测试心电监护仪的电气安全、性能指标。结果：外观检查,电气安全、性能检测均有不合格项,其中日期、时间显示不合格率高达50%,呼吸频率、异常心电图、血压、经皮血氧在选取的几个测试点不合格率最低1.25%,最高达41%。结论：在用设备质量状况令人堪忧,定期的质量检测相当重要,验收环节的质量检测必不可少。

Analysis and Discussion on Quality Inspection Results of Eighty ECG Monitors in Use

Objective To find out the clinical quality of medical equipment by carrying out sampling inspection on ECG monitor quality so as to get first-hand data for formulating quality control plan of medical equipment. Methods The electrical safety and performance indicators of ECG monitors were inspected respectively by specific inspection equipment as per the General Instruction to Safety and Quality Inspection of Medical Equipment issued by the Hospital Management Institute under Ministry of Health. Results Defective items had been found during the visual examination and the electrical safety and performance test. The failure rate on time and date display was up to 50% and that of respiratory rate, abnormal electrocardiogram, blood pressure and Percutaneous oxygen at selected test points was 1.25% minimum and 41% maximum. Conclusion The clinical quality of medical equipment in use now is worrying. Regular quality inspection is of great significance and before acceptance quality inspection is absolutely necessary.