湖北省医院外来医疗器械与植入物管理情况调查

 目的 了解医院消毒供应中心规范(WS 310—2016)三项标准实施以后湖北省医疗机构外来医疗器械及植入物的管理情况。方法 根据WS 310.1—2016要求,设计问卷调查表,采用多阶段分层随机抽样的方法选取湖北省二级及以上医疗机构作为调查对象,对外来医疗器械与植入物的处理现状及说明书提供情况进行调查。结果 参与调查的医院中,75.76%的医院实现了外来医疗器械与植入物的集中供应,76.36%的医院按照厂家要求的方法对外来器械进行清洗、消毒,75.15%的医院灭菌方法与参数符合说明书要求,56.97%的医院会将使用后的外来器械送回CSSD进行再次清洗、消毒,仅28.48%的医院表示可以收到所有外来器械的产品说明书。三级医院与三级以下医院在外来医疗器械与植入物的集中供应、使用后再次清洗消毒、说明书提供情况方面比较,差异均有统计学意义(均P＜0.05)。结论 湖北省医疗机构外来医疗器械与植入物的清洗、消毒、灭菌未完全符合相关标准规定,且外来器械供应商提供产品说明书的比例偏低,三级医院的执行率较三级以下医院更好。各级医疗机构应按照相关规定,加强对外来医疗器械的管理,以保障医疗质量与患者安全。

Management of loaner medical instruments and implants in hospitals in Hubei Province

Objective To understand the management of loaner medical instruments and implants in medical institutions in Hubei Province after the implementation of three standards of Regulation for central sterile supply department in hospital (WS 310-2016). Methods According to the requirements of WS 310.1-2016, questionnaire was designed, multi-stage stratified random sampling method was adopted to select secondary and above medical institutions in Hubei Province as the survey objects, the handling status of loaner medical instruments and implants as well as the provision of product instructions was surveyed. Results Among hospitals participating in the survey, 75.76% achieved the centralized supply of loaner medical instruments and implants, 76.36% cleaned and disinfected the loaner medical instruments according to the methods required by the manufacturers, 75.15% met the requirements of sterilization methods and parameters of instructions, and 56.97% returned the used loaner medical instruments to central sterile supply department (CSSD) for re-cleaning and disinfection, only 28.48% of hospitals indicated that they could receive the product instruction of all loaner medical instruments. There were significant differences in the centralized supply, re-cleaning and disinfection after use, as well as the provision of instructions of loaner medical instruments and implants between tertiary hospitals and hospitals below tertiary level (all P<0.05). Conclusion The cleaning, disinfection, and sterilization of loaner medical instruments and implants in hospitals in Hubei Province do not fully meet the relevant standards, and the proportion of product instructions provided by manufacturers is low, the implementation rate of tertiary hospitals is better than that of hospitals below tertiary le-vel. Medical institutions at all levels should strengthen the management of loaner medical instruments in accordance with relevant regulations to ensure medical quality and patient safety.