医用超声耦合剂使用规范亟待制定

Standards for using medical ultrasound couplants are now necessary and urgent

医用超声耦合剂是在超声诊疗过程中涂覆、充填于探头或治疗头与人体组织之间用以透射(传输)声波的中介媒质,为医学临床不可或缺,但因其不洁所致医院感染严重威胁患者身体健康和生命安全。在相关产品标准中规定允许存在的菌落数和不可检出致病菌虽属必要,但所针对的仅仅是生产环节和制造商。卫生主管部门制定的医疗器械消毒技术规范严谨、详细,却不适用于耦合剂,使得源于耦合剂的医院感染事件难以避免。制定包括防止污染和正确选用在内的使用规范,并配合以教育培训和监督检查,才能切实保证医用超声耦合剂的临床安全。

Medical ultrasound couplants are the acoustic mediams for ultrasound transmission between ultrasound probe/applicator and human tissue.Unfortunately,contaminated couplants might induce nosocomial infection,which would threat patients body health and life safety.It is necessary and indispensable to regulate the number of revertant colonies and not-permitted pathogenic bacteria in the product standards.However,the product standards only regulate the production procedures and output of the producer.The technical specification made by the health authorities was for the disinfection of the medical apparatus and instruments,rather the ultrasound couplants,which should be sorted as'materials'.The establishment of the use standards for ultrasound couplants is now necessary and urgent for prevention of the infection accidents.At the same time,appropriate educational training,supervision and inspection should also be implemented for effectively guarantee of clinical safety of ultrasound couplants.