护理学报2026,Vol.33Issue(2):58-62,5.DOI:10.16460/j.issn2097-6569.2026.02.058
广东省183家医院消毒供应中心外来医疗器械及植入物首次灭菌验证现状调查
Initial sterilization verification for loaner surgical instruments and implants in central sterile supply departments:a survey of 183 hospitals in Guangdong Province
肖敏 1赵玲珑 1钟丽华 1任素桃 1张小燕2
作者信息
- 1. 南方医科大学南方医院消毒供应中心,广东 广州 510515
- 2. 南方医科大学口腔医院消毒供应中心,广东 广州 510260
- 折叠
摘要
Abstract
Objective To investigate the current status of initial sterilization validation for loaner medical devices and implants in Central Sterile Supply Departments(CSSDs)of 183 hospitals in Guangdong Province,and to provide evidence for developing standard-ized initial sterilization validation protocols for loaned medical devices.Methods Convenience sampling was employed to select 183 CSSDs in Guangdong Province to concuct an online questionnaire assessing the current status of initial sterilization validation practices for loaner medical devices and implants.Results Among the 183 surveyed CSSDs,101(55.2%)were from tertiary hospitals,and 82(44.8%)from secondary hospitals.CSSDs in tertiary hospitals demonstrated statistically significant superiority(P<0.01)compared to those in secondary hospitals in implant supervision and approval,Supply-Processing-Distribution(SPD)system utilization,the scope of initial sterilization validation,and dedicated sterilization program configuration.Strict control of sterilization package weight(≤7 kg)was implemented in 146 CSSDs(79.8%).Only 48 CSSDs(26.2%)could ensure that the internal configuration of routinely received packages was completely consistent with that used during initial sterilization validation.Conclusion Tertiary hospitals outperform secondary hospitals in both loaned device management and the implementation of initial sterilization validation.However,the methods of initial sterilization validation require further standardization,with particular attention needed to ensure consistency between routine receiving procedures and the initial sterilization verification process.关键词
消毒供应中心/外来医疗器械/植入物/灭菌/首次验证/质量管理/追溯系统Key words
Central Sterile Supply Department/loaned medical devices/implants/sterilization/initial validation/quality manage-ment/traceability system分类
医药卫生引用本文复制引用
肖敏,赵玲珑,钟丽华,任素桃,张小燕..广东省183家医院消毒供应中心外来医疗器械及植入物首次灭菌验证现状调查[J].护理学报,2026,33(2):58-62,5.