过氧化氢低温等离子体灭菌器不良事件分析  

Analysis of adverse events of hydrogen peroxide low temperature plasma sterilizers

作　　者：赵燕 赵玉娟[2] 王新沛[3] 孙欣[4] 杨建卫 ZHAO Yan;ZHAO Yu-juan;WANG Xin-pei(Medical Device Monitoring and Evaluation Division,Center for Drug Reevaluation,NMPA,Beijing,100022,China;不详)

机构地区：[1]国家药品监督管理局药品评价中心器械监测与评价部,北京100022 [2]山东省药品不良反应监测中心器械监测评价科,山东济南250014 [3]山东大学生物医学工程系,山东济南250100 [4]山东省立医院医学工程部,山东济南250021

出　　处：《中国医学装备》2022年第1期161-164,共4页China Medical Equipment

摘　　要：目的:分析过氧化氢低温等离子体灭菌器不良事件发生情况及原因,为临床灭菌器的安全使用提出改进对策。方法:检索美国食品药品监督管理局(FDA)制造商和用户设备体验(MAUDE)数据库中2010-2020年过氧化氢低温等离子体灭菌器不良事件报告,对检索的2866例不良事件报告进行统计分析,并对山东省内过氧化氢低温等离子体灭菌器设备量较多的10家医院从设备启用年限、内部配置、常见故障、更换配件频率以及设备维护保养等多个环节进行现场调研分析。结果:在过氧化氢低温等离子体灭菌器不良事件中,主要表现为烟雾、油雾、气味、过氧化氢泄露、残留、皮肤反应、灭菌失败和被灭菌物品损坏等,其中灭菌器故障所致不良事件为2655例(占92.6%);灭菌器发出烟雾、气味和油雾为2170例(占75.7%),与组件故障、操作使用不规范和维护保养不当有较大关系。结论:过氧化氢低温等离子体灭菌器监管部门、生产企业和使用单位应利用不良事件监测结果进行改进,保障过氧化氢低温等离子体灭菌器使用安全。Objective:To analyze the adverse events and causes of hydrogen peroxide low temperature plasma sterilizers and put forward countermeasures for its safe use.Methods:The adverse event reports of hydrogen peroxide low-temperature plasma sterilizer in the 2010-2020 the database of U.S.Food and Drug Administration(FDA)Manufacturer and User Facility Device Experience(MAUDE)were searched by the Product Code"MLR",and statistical analysis was conducted on the retrieved 2,866 adverse event reports.Field investigation was carried out in 10 hospitals with large number of hydrogen peroxide plasma sterilizers in Shandong Province in terms of age,internal configuration,common malfunction and problems,frequency of replacement of fittings and maintenance of the equipment.Results:The main adverse events of hydrogen peroxide low temperature plasma sterilizers were smoke,oil mist,odor,hydrogen peroxide leakage,residue,skin reaction,sterilization failure and damage of sterilized items,which were related to component failure,irregular operation and improper maintenance.At present,the method of verifying sterilization effect of sterilization effect of slender lumen instruments may not be accurate,and some indicators affecting sterilization effect were lack of standard requirements.Conclusion:Regulatory authorities,manufacturers and users of hydrogen peroxide low-temperature plasma sterilizers should make use of the adverse event monitoring results to make improvement and ensure the safe use of the product.

关 键 词：过氧化氢低温等离子体灭菌器 医疗器械 不良事件 风险 监测 

分 类 号：R197.39[医药卫生—卫生事业管理]