超声手术刀刀头在多次清洗、消毒和灭菌后的性能变化研究

Study on Performance Change of Ultrasonic Surgical Tip After Multiple Washing,Disinfection and Sterilization

目的研究超声手术刀刀头在多次清洗、消毒和灭菌后的性能变化,探究高值医用耗材重复使用的可行性。方法设计清洗、消毒和灭菌方案,测试超声手术刀刀头在多次清洗、消毒和灭菌后的尖端主振幅、尖端横向振幅、静态(空载)电功率、夹紧力、抓持力。结果分析不同方案的数据结果表明,试验后尖端主振幅、尖端横向振幅、静态(空载)电功率、夹紧力、抓持力5项性能指标均满足技术要求的指标,均未发生显著变化,也未出现超出技术要求规定的情况。结论超声手术刀刀头在多次清洗、消毒和灭菌后在一定程度上仍能保持性能的准确性,可为此类高值医用耗材重复使用后关键性能指标评价提供一定的参考。

Objective To study the performance change of ultrasonic surgical tip after multiple washing,disinfection and sterilization,and explore the feasibility of reuse of high value medical consumables.Methods Washing,disinfection and sterilization schemes were designed to test the principal amplitude of the tip,transverse amplitude of the tip,static(no-load)electric power,clamping force and gripping force of the ultrasonic scalpel blade head after multiple washing,disinfection and sterilization.Results After analyzing the data results of different methods,the five performance indexes of tip main amplitude,tip lateral amplitude,static(no-load)electric power,clamping force and gripping force all met the technical requirements,and there was no significant change,and there was no situation beyond the technical requirements.Conclusion Ultrasonic surgical tip can still maintain the accuracy of performance to a certain extent after multiple washing,disinfection and sterilization,which can provide a certain reference for the evaluation of key performance indexes of such high-value medical consumables after feasibility of reuse.