摘要
目的:对医疗机构阴道超声探头消毒与感染风险情况进行问卷调查,为临床阴道超声探头消毒的监管提供依据。方法:采用问卷星调查方式,于2021年12月在全国范围内对医疗机构使用天然胶乳橡胶避孕套作为日常经阴道超声检查防止探头交叉感染措施的相关情况,开展临床超声科医护人员在线开放不记名问卷调查,分析天然胶乳橡胶避孕套在阴道超声检查使用中存在的风险因素,提出风险控制建议。结果:共回收有效问卷1673份,涉及24个省份的医疗机构,其中以河北省内医疗机构为主的问卷810份(占48.42%)。避孕套应用于阴道超声检查存在超适应证使用和破裂后引发相关感染风险,无菌性耦合剂中消毒剂成分存在破坏阴道内菌群环境,增加阴道超声次生风险的可能性。结论:超声诊疗过程中耦合剂和隔离产品等均为阴道超声探头相关感染的影响因素。产品注册人、使用单位及政府监管部门应依据各自职责,加强对阴道超声探头使用全过程进行安全风险控制,保障阴道超声探头使用安全。
Objective:To carry out a questionnaire survey on the disinfection and risk of infection of transvaginal ultrasound probe,and to put forward suggestions on the rational use of transvaginal ultrasound examination.Methods:Through questionnaire star survey,an online anonymous questionnaire survey was conducted for medical staff in the department of clinical ultrasonography nationwide in December 2021 regarding the relevant information on the use of natural latex rubber condoms as a measure for routine transvaginal ultrasound examination by medical institutions to prevent probe cross-infection.The risk factors existing in the use of natural latex rubber condom in transvaginal ultrasound examination were analyzed,and the suggestions of risk control were proposed.Results:A total of 1,673 valid questionnaires were collected,involving medical institutions in 24 provinces,among which 810questionnaires were mainly collected from medical institutions in Hebei Province(accounting for 48.42%).The use of condoms in transvaginal ultrasound examination had the risk of infection caused by off-label use and rupture,and the disinfectant ingredients in aseptic coupling agent might have the potential to destroy the microflora environment in the vagina and increase the secondary risk of transvaginal ultrasound.Conclusion:Coupling agents and isolation products are the influencing factors of transvaginal ultrasound probe-related infection in the process of ultrasound diagnosis and treatment.The registrant and user of the product as well as government regulatory department shall,in accordance with their respective responsibilities,strengthen the whole-process risk control of the use of transvaginal ultrasound probes to ensure the safety of public use of the equipment.
作者
刘欣欣
闫玲
赵一飞
谢颖
王芳
赵燕
LIU Xin-xin;YAN Ling;ZHAO Yi-fei(不详;Hebei Pharmacovigilance Center,Shijiazhuang 050090,China)
出处
《中国医学装备》
2022年第9期162-167,共6页
China Medical Equipment
关键词
阴道超声探头消毒
天然胶乳橡胶避孕套
问卷调研
医疗器械不良事件
Disinfection of transvaginal ultrasound probe
Natural latex rubber condom
Questionnaire survey
Medical device adverse events
