过氧化氢低温等离子体灭菌器不良事件分析.pdfVIP

中国医学装备2022年1月第19卷第1期 China Medical Equipment 2022 January Vol.19 No.1 学术论著 过氧化氢低温等离子体灭菌器不良事件分析* 赵 燕① 赵玉娟②* 王新沛③ 孙 欣④ 杨建卫② [文章编号] 1672-8270(2022)01-0161-04 [中图分类号] R197.39 [文献标识码] A [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2 866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2 655例(占92.6%)；灭菌器发出烟雾、气味和油雾为2 170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。 [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 DOI: 10.3969/J.ISSN.1672-8270.2022.01.037 Analysis of adverse events of hydrogen peroxide low temperature plasma sterilizers/ZHAO Yan, ZHAO Yu-juan, WANG Xin-pei, et al//China Medical Equipment,2022,19(1):161-164. [Abstract] 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 item