全国311家医院外来医疗器械及植入物规范处理现状调查

Investigation on the status quo of standardized handling procedures for foreign medical devices and implants in 311 hospitals across the country

目的了解全国消毒供应中心(CSSD)外来医疗器械及植入物处理现状,为贯彻落实行业标准提供科学依据。方法通过制订调查问卷,对全国311家医院的CSSD外来医疗器械及植入物规范处理流程现状进行调查。结果32.80%的医院未对外来医疗器械及植入物进行首次接收验证;26.79%的医院未对首次接收验证的外来医疗器械及植入物建立档案;23.16%的医院未对外来医疗器械及植入物采用联合清洗方法;71.38%的医院未对外来医疗器械及植入物清洗质量采用定量检测法进行检查;58.84%的医院有超大或超重包问题;25.72%的医院外来医疗器械盛装容器不规范;64.63%的医院外来医疗器械及植入物灭菌程序未经验证;65.28%的医院外来医疗器械及植入物灭菌参数有效性测试方法不全面;46.95%的医院使用后不能回到CSSD清洗消毒,38.26%的医院在厂商取件时没有交接记录。结论遵照行业标准及指南规范要求,建立外来医疗器械及植入物规范处理流程,强化其质量控制,确保其质量安全。

Objective To understand the current status of the treatment of foreign medical devices and implants in central sterile supply departments across the country,and to provide a scientific basis for the implementation of industry standards.Methods A questionnaire was formulated and used to investigate the current status of the standardized handling procedures for foreign medical devices and implants in 311 hospitals across the country.Results 32.80%of hospitals did not conduct the first acceptance verification of foreign medical devices and implants;26.79%of hospitals did not establish files for foreign medical devices and implants that had the first acceptance verification;23.16%of hospitals did not adopt combined cleaning method for foreign medical devices and implants;71.39%of hospitals did not adopt quantitative detection methods to check the cleaning quality of foreign medical devices and implants;58.84%of hospitals had problems with oversized or overweight packages;25.72%of hospitals had irregular packaging containers for foreign medical devices;64.63%of hospitals had unverified sterilization procedures for foreign medical devices and implants;65.28%of hospitals had incomplete methods for testing the validity of sterilization parameters for foreign medical devices and implants;46.95%of hospitals could not return to CSSD for cleaning and sterilization after use,and 38.26%of hospitals had not handover records when manufacturers picked up the devices.Conclusion In accordance with the industry standards and guidelines,standardized handling procedures for foreign medical devices and implants should be established,and the quality control should be strengthened to ensure the quality and safety of foreign medical devices and implants.