2021年国家监督抽检无菌型医用超声耦合剂无菌指标情况分析  

Analysis on Sterility Index of Sterile Medical Ultrasonic Couplant Under National Supervision and Sampling Inspection in 2021

作　　者：华渤文 李玲 梅享林 HUA Bo-wen;LI Ling;MEI Xiang-lin(Hubei Institute of Medical Device Quality Supervision and Inspection,Hubei Wuhan 430075)

机构地区：[1]湖北省医疗器械质量监督检验研究院,湖北武汉430075

出　　处：《中国医疗器械信息》2023年第3期17-19,共3页China Medical Device Information

摘　　要：目的:掌握国内医疗器械生产企业无菌型医用超声耦合剂无菌指标的合格情况,为有关部门的监管和风险监测提供依据。方法:依据相关标准和企业产品技术要求对国内8家医疗器械生产企业的10批次无菌型医用超声耦合剂无菌指标进行抽检。结果:8家生产企业的10批次无菌型医用超声耦合剂无菌指标均为合格。结论:本次抽查的无菌型医用超声耦合剂生产企业重视产品的灭菌控制,质量管理水平、产品质量不断提升。但由于本次抽检的生产企业样本量过少,加上本次抽检的耦合剂均为无菌型,不能全面体现国内医用超声耦合剂生产企业的真实状况。目前国内医用超声耦合剂生产厂家的生产水平参差不齐,仍需进一步对医用超声耦合剂的生产、监管、使用环节加强控制。Objective: To master the qualification of sterility indicators of sterile medical ultrasonic couplant in domestic medical device manufacturers, and provide basisof supervision and risk monitoring for relevant departments. Methods: According to the relevant standards, 10 batches of sterile medical ultrasonic couplantsfrom 8 domestic medical device manufacturers were randomly inspected. Results:10 batches of sterile medical ultrasonic couplants from 8 manufacturers werequalified. Conclusion: At present, domestic sterile medical ultrasound couplant manufacturers attach importance to the sterilization control of products;Besides,the quality management level and product quality are constantly improving. However, because the sample size of the manufacturers in this sampling inspectionis small, and the coupling agents in this sampling inspection are sterile, the real situation of domestic medical ultrasound couplant manufacturers can't be fullyreflected. The production level of domestic manufacturers of medical ultrasound couplant is uneven, so it is necessary to further strengthen the control of theproduction, supervision and use of medical ultrasound couplant.

关 键 词：医用超声耦合剂 无菌检查 抽检 质量控制 

分 类 号：TB324[一般工业技术—材料科学与工程]