摘要
目的:统计分析重症监护室常用医疗设备召回数据,从其召回数据变化趋势和具体风险类型制定相应的管理策略。方法:收集2017-2020年国家药品监督管理局官方网站发布的重症监护室相关医疗设备召回数据,从器械类型、器械名称、召回时间、召回级别、召回原因和召回方式6个维度对数据进行统计分析,结合行业内的先进管理经验和临床实践制定针对性的管理策略。结果:共计238例召回事件均为主动召回,其中2017年45例,2018年86例,2019年44例和2020年63例,2020年重症监护室医疗设备召回事件在当年总召回事件中占比增长明显为31.5%。召回的医疗设备主要集中于医用诊察和监护器械;注输、护理和防护器械;呼吸、麻醉和急救器械3类,较高风险性的一级召回和二级召回事件多源于电池故障、报警失效和功能异常3种功能型风险。结论:阶段性地统计和分析重症监护室相关常用医疗设备召回事件,有助于医护人员识别和监测重症监护室重点类型医疗设备的功能型风险并进行风险管理,保障患者生命安全。
Objective:To statistically analyze the recall data of commonly used medical equipment in intensive care unit,and to explore the corresponding management strategies from the recall changing trends and specific hazard types.Methods:The data on medical equipment recalls for intensive care units published on the official website of National Medical Products Administration during the period from 2017 to 2020 was collected.The statistical analysis of the data was conducted from 6 aspects of the type and name of the medical equipment,recall time,recall class,recall reason and recall method,the pertinent management strategies were formulated based on the advanced management experience in the industry and clinical practice.Results:A total of 238 cases were all voluntary recalls,including 45 cases in 2017,86 cases in 2018,44 cases in 2019 and 63 cases in 2020.In 2020,the proportion of medical equipment recalls in intensive care units in total recalls in that year increased significantly,to 31.5%.The recalled medical equipment mainly focused on three types,including equipment for medical diagnosis and monitoring;equipment for infusion,nursing and protection;and equipment for respiratory,anesthesia and first aid.Highly harmful level-one and level-two recalls were mostly attributed to three functional hazards:battery failure,alarm failure and abnormal functions.Conclusion:Periodical statistics and analysis of recalls of commonly used medical equipment in intensive care units can help medical staff identify and monitor the functional hazards of key types of medical equipment in intensive care units and carry out risk management to ensure the safety of patients.
作者
汤晶晶
顾怡蓉
郭大为
刘文宏
王海燕
TANG Jing-jing;GU Yirong;GUO Da-wei(ICU,Department of Neurology,Beijing Shijitan Hospital,Capital Medical University,Beijing 100038,China;不详)
出处
《中国医学装备》
2022年第3期177-180,共4页
China Medical Equipment
关键词
重症监护室
功能型风险
医疗设备召回
召回原因
潜在缺陷
Intensive care unit(ICU)
Functional hazard
Medical equipment recall
Recall reason
Latent defects
