可复用超声刀手术剪清洗工艺确认及有效性评价  

Evaluation of validation and effectiveness evaluation of cleaning process for reusable ultrasonic scalpel surgical scissors

作　　者：张潇[1] 段晓杰[1] 赵岩[1] 李枝东 王权[1] 李佳戈[1] 陈亮[1] 徐丽明[1] ZHANG Xiao;DUAN Xiao-jie;ZHAO Yan(National Institutes for Food and Drug Control,Beijing 102629,China)

机构地区：[1]中国食品药品检定研究院,北京102629 [2]上海逸思医疗科技股份有限公司,上海201318

出　　处：《中国医学装备》2023年第5期37-43,共7页China Medical Equipment

摘　　要：目的:建立可重复使用超声刀手术剪(简称超声刀)的清洗工艺确认方案,并对清洗有效性进行评价,为使用单位进行清洁方法确认和确保安全使用提供依据。方法:选择模拟血液污染物,按照确定的清洗工艺,选择最严苛的清洁方法挑战条件,通过对超声刀的可复用部件刀杆进行污染物负载-清洗数次后,提取残留污染物,并检测残留污染物中总蛋白和血红蛋白残留量。根据美国食品药品监督管理局(FDA)相关指导原则、美国医疗器械促进协会(AAMI)及美国材料和试验协会(ASTM)相关标准,设定可复用超声刀满足清洁要求的残留物限量指标(总蛋白残留量<6.4μg/cm^(2),血红蛋白残留量<2.2μg/cm^(2))。结果:所建立的确认方案体系中,残留污染物的提取回收率均>79%;彻底提取验证研究中,单次提取回收率达到4次彻底提取回收的90%以上,满足实验要求。负载-清洗1次、4次、6次和8次清洗后,可重复使用超声刀总蛋白残留量均未检出,低于方法检测限(0.43μg/cm^(2));血红蛋白残留量均<0.34μg/cm^(2),低于确认方案体系的残留污染物中血红蛋白检测下限(1.10μg/cm^(2))。结论:本研究建立的可复用超声刀手术剪清洁方法确认方案及清洁有效性评价方法;经验证,可重复使用超声刀8次,污染物负载-清洗后仍能满足所规定的清洁要求。Objective:To establish a method for validating the cleaning process of reusable ultrasonic scalpel surgical scissors(hereinafter referred to as ultrasonic scalpel)and to evaluate the cleaning effectiveness,so as to provide a basis for the users to validate the cleaning method and ensure safe use of that.Methods:Selected the simulated blood pollutants,and followed with the determined cleaning process,and chose the most stringent cleaning method to challenge the conditions.After the pollutants of the cutter bar of the reusable component of the ultrasonic scalpel were loaded and cleaned several times,the residual pollutants were extracted,and then,the residual amounts of the total protein and hemoglobin in the residual pollutants were detected.The limits of the residue(the residual amount of total protein<6.4μg/cm^(2),and the hemoglobin residue<2.2μg/cm^(2))that could meet the requirement of cleaning reusable ultrasonic scalpel were set according to the relevant guiding principles of U.S.Food and Drug Administration(FDA),the relevant standards of American Association for the Promotion of Medical Devices(AAMI)and the American Society for Testing and Materials(ASTM).Results:In the established experimental system,the extraction recovery rate of the residual pollutants was larger than 79%.In the research of thoroughly extract validation,the extraction recovery rate of single time can reach to above 90%of 4 thoroughly extract validations,which could meet the requirement of experiment.The residual total protein of reusable ultrasonic scalpel did not be found after it was loaded and cleaned 1,4,6 and 8 cleanings,which was lower than lower limit of detection(LLD)(0.43μg/cm^(2)).At this time,the all residual amounts of hemoglobin were less than 0.34μg/cm^(2)that was lower than the LLD(1.10μg/cm^(2))of the hemoglobin in residual pollutants of experimental system.Conclusion:This research has established the method of validating cleaning method and evaluating the effectiveness of cleaning for reusable ultrasonic scalpel.Th

关 键 词：超声刀 可重复使用 污染物 清洗工艺确认 残留物限量指标 

分 类 号：R197.39[医药卫生—卫生事业管理]