全国311所医院外来医疗器械及植入物管理现状问卷调查

Current status of management of foreign devices and implants in 311 hospitals in China

  • 摘要: 目的 调查全国医院消毒供应中心外来医疗器械及植入物管理现状。方法 参照消毒供应中心行业标准及《外来医疗器械清洗消毒及灭菌技术操作指南》等相关要求,制定调查问卷,于2020年7月-12月通过微信网络平台对全国医院外来医疗器械与植入物管理现状进行调查。结果 共收回有效问卷311份。全国311所医院中,27.01%的医院未签订服务协议,27.65%的医院未建立多科室联合规范管理及准入制度;15.11%的医院未建立外来医疗器械及植入物质量追溯管理制度;36.01%的医院未建立外来器械处理专人专岗;20.58%的医院未开展外来医疗器械专项培训;46.95%的医院非首次使用的外来医疗器械及植入物未在手术前一日15∶00前送达;44.69%的医院无法完全获取规范的外来器械及植入物说明书;64.63%的医院外来医疗器械及植入物灭菌程序未经过验证;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。结论 在外来器械及植入物管理中,对消毒供应中心行业标准及《操作指南》落实上还存在不足,需进一步加强规范管理,建立健全各种制度及质量追溯体系,提高外来器械及植入物说明书获取比例,规范处理流程及灭菌有效性验证,不断提高外来医疗器械及植入物管理质量,保障使用安全。

     

    Abstract: OBJECTIVE To investigate the current status of management of foreign medical devices and implants in central sterilization and supply centers in China.METHODS With reference to the industry standards for hospital sterilization supply centers and the "Operation guide for cleaning, disinfection and sterilization technology of foreign medical devices" and other related requirements, a questionnaire was developed to investigate the current status of management of foreign medical devices and implants in 311 hospitals in China.RESULTS A total of 311 valid questionnaires were retrieved. Of the 311 hospitals across the country, 27.01% of the hospitals did not sign a service agreement, 27.65% of the hospitals did not establish a multi-department joint foreign device and implant access system; 15.11% of the hospitals have not established a quality traceability management system for foreign devices and implants; 36.01% of the hospitals have not established special posts for handling foreign devices; 20.58% of the hospitals have not carried out special training for foreign devices; 46.95% of the hospitals did not use foreign devices and implants for the first time that were delivered at 15:00 before the day of surgery; the manufacturers instructions for foreign devices and implants could not be available in 44.69% of the hospitals; 64.63% of the hospitals had unverified sterilization procedures for foreign devices and implants; 65.28% of the hospital had incomplete methods for testing the validity of sterilization parameters for foreign devices and implants.CONCLUSION The industrial standards of disinfection supply center and the "Operation guide for cleaning, disinfection and sterilization technology of foreign medical devices" have not been fully implemented in the management of foreign devices and implants. It is necessary to further strengthen the standardized management, establish and complete various rules and regulations and quality traceability system, raise the acquisition proportion of instructions of external devices and implants and standardize the treatment process and sterilization effectiveness verification so as to continuously improve the management quality of foreign devices and implants and guarantee the safety of use.

     

/

返回文章
返回