基于美国MAUDE数据库的二氧化碳冷冻治疗仪不良事件监测数据分析  

Analysis of Adverse Events Monitoring Data of Carbon Dioxide Cryotherapy Instrumen Based on FDA MAUDE Database

作　　者：余超 周鹃 罗培 万凯化 李穗 徐玉茗 YU Chao;ZHOU Juan;LUO Pei;WAN Kai-hua;LI Sui;XU Yu-ming(Jiangxi Drug Adverse Reaction Monitoring Center,Jiangxi Nanchang 330046)

机构地区：[1]江西省药品不良反应监测中心,江西南昌330006

出　　处：《中国医疗器械信息》2020年第5期6-7,共2页China Medical Device Information

摘　　要：目的:汇总二氧化碳冷冻治疗仪不良事件发生情况及相关问题,为进一步提高其使用安全提供建议.方法:收集2009~2019年美国食品药品监督管理局MAUDE数据库中1231例二氧化碳冷冻治疗仪有关伤害病例报告,采用文献资料法确定其不良事件发生的原因,并针对产品风险提出相关控制措施及建议.结果:二氧化碳冷冻治疗仪不良事件主要以术中或术后出血、眼球痛、头痛、黄斑部增殖性病变等表现为主.结论:监管部门、生产企业等相关单位应加强风险意识,健全监测相关的工作制度,提升产品治疗,保障公众用制冷设备安全.Objective:To summarize the adverse events of carbon dioxide cryotherapy apparatus and related issues,and provide suggestions for further improving the safety of its use.Methods:A collection of 1231 cases of injury related to carbon dioxide cryotherapy in the US Food and Drug Administration's MAUDE database from 2009 to 2019 was used to determine the cause of adverse events using the literature method,and related control measures and recommendations were proposed for product risks.Results:The adverse events of the CO2 cryotherapy device were mainly manifested by intraoperative or postoperative bleeding,eyeball pain,headache,and macular proliferative lesions.Conclusion:Supervisory departments,manufacturing companies and other relevant units should strengthen their awareness of risks,improve the relevant monitoring work system,improve product treatment,and ensure the safety of public refrigeration equipment.

关 键 词：二氧化碳冷冻治疗仪 医疗器械不良事件监测 风险因素 文献分析 

分 类 号：R197.39[医药卫生—卫生事业管理]