消毒型医用超声耦合剂注册现状调查与分析

Investigation on the Premarket Approval of Medical Ultrasound Disinfecting Coupling Agent

目前国内经注册的消毒型医用超声耦合剂,从产品名称、适用范围、生产及消毒效果评价等方面存在命名不规范、适用范围不科学,没有作为消毒产品进行监督管理。其非无菌型产品适用在创口、非完好皮肤、腔道黏膜及对婴儿等超声诊疗过程中存在较大的感染风险。

Currently,domestic registered disinfection medical ultrasonic couplers are not standardized and scientifically applied in terms of product name,application scope,production and disinfection effect evaluation,etc.,and they are not supervised and managed as disinfection products.Its non-sterile products are suitable for wounds,unintact skin,luminal mucosa and infants in the process of ultrasonic diagnosis and treatment,which have a greater risk of infection.