Abstract:

Objective To investigate the current status of functional testing of reusable medical devices of hospital central sterile supply departments（CSSDs） in China’s 29 provinces（autonomous regions and municipalities），and to analyze the main problems in the practice of functional testing of reusable medical devices，in order to better guide its clinical practice. Methods Using the convenience sampling method，the investigation was conducted by the status quo questionnaire of device function testing. 291 hospitals in 29 provinces（autonomous regions and municipalities） were investigated through the support of Professional Committee of CSSDs from September 13 to 21，2022. The questionnaire included 4 aspects：testing methods of reuse medical device function，required materials or equipment of device function testing，classification of device function，and execution，process and staff training of device function testing. The related influencing factors of systematic device function test was analyzed. Results A total of 291 questionnaires were collected and 281 were valid，the recovery rate of which was 96.56%.The functional testing methods in some CSSDs were not comprehensive.27（9.61%） CSSDs provided all the materials or equipment for functional testing and 204（72.60%） CSSDs partially provided those. 176（73.33%） CSSDs tended to classify device functions as “intact，surface damage，in need of repair，and in need of replacement”. 41（14.59%） CSSDs graded device function. Only 144 CSSDs（51.25%） regularly conducted system function testing. The influencing factors were regionalization of CSSDs（P=0.044），establishment of a standard operation process（P=0.035），provision （P=0.021） or provision（P=0.003） of the materials or equipment required for functional testing of the device，and training（P=0.007）. Conclusion The application of functional detection of reuse medical devices in CSSD is still in the initial stage.The device function detection method of the CSSD staff needs to be further improved.The overall situation of equipment and materials required for device function testing are acceptable，but further specification is required.The device function classification and evaluation mechanism have been preliminarily established and needs to be further promoted. CSSD managers can further implement device functional testing for staff from establishing standard operation process，actively providing materials or equipment required for functional testing，and strengthening training.

Key words: Central Supply，Hospital, Reuse of Medical Devices, Functional Detection, Nursing Administration Research

摘要：

目的 调查29个省（区、市）医院消毒供应中心（central sterile supply department，CSSD）复用医疗器械功能检测的开展现状，分析存在的主要问题，以便更好地指导功能检测临床实践。 方法 采用便利抽样法，利用自行编制的复用医疗器械功能检测现状调查问卷，于2022年9月13日—21日通过消毒供应专业委员会对29个省（区、市）291所医院CSSD进行调查。问卷内容包括复用医疗器械功能检测方法、器械功能检测所需材料或设备、器械功能分级以及工作人员器械功能检测执行、流程、培训情况等4个方面，并分析影响CSSD定期进行系统器械功能检测的相关因素。结果 共回收291份问卷，有效问卷281份，有效问卷回收率为96.56%。281所医院中，部分CSSD器械功能检测方法不全面。分别有27所（9.61%）、204所（72.60%）医院CSSD全部提供及部分提供了器械功能检测所需的材料或设备。176所（73.33%）医院CSSD倾向将器械功能分为“完好”“表面损伤”“需要维修”“需要替换”，41所（14.59%）医院CSSD对器械功能进行了分级。144所（51.25%）医院CSSD定期进行系统的功能检测。区域化CSSD（P=0.044）、建立标准作业流程（P=0.035）、部分提供（P=0.021）或全部提供（P=0.003）器械功能检测所需要的材料或设备、开展培训（P=0.007）是CSSD定期进行系统功能检测的独立保护因素。 结论 CSSD工作人员的器械功能检测方法有待进一步完善。器械功能检测所需设备和材料配备整体情况尚可，但需进一步规范。器械功能分级评价机制已初步建立，需进一步推动。CSSD管理者可从建立标准作业流程、积极提供功能检测所需的材料或设备、加强培训等方面进一步落实工作人员器械功能检测。

关键词: 中心供应室，医院, 复用医疗器械, 功能检测, 护理管理研究