无源植入性医疗器械临床使用安全的风险因素及防范策略  

Risk Factors and Prevention Strategies for Safety in Clinical Use of Non-Active Implantable Medical Devices

作　　者：张晓燕 刘雨田 王学军 朱丹丹 朱永丽 李艳娜 ZHANG Xiaoyan;LIU Yutian;WANG Xuejun;ZHU Dandan;ZHU Yongli;LI Yanna(Department of Medical Engineering,Inner Mongolia People’s Hospital,Hohhot Inner Mongolia 010017,China;Department of Orthopedics,Hohhot First Hospital,Hohhot Inner Mongolia 010030,China)

机构地区：[1]内蒙古自治区人民医院医学工程处,内蒙古呼和浩特010017 [2]呼和浩特市第一医院骨关节科,内蒙古呼和浩特010030

出　　处：《中国医疗设备》2024年第4期102-108,共7页China Medical Devices

基　　金：内蒙古自治区科技计划项目(2021GG0135);内蒙古自治区卫生健康委员会公立医院科研联合基金科技项目(2023GLLH0098)。

摘　　要：目的探讨无源植入性医疗器械(Non-Active Implantable Medical Devices,NAIMDs)临床使用安全的影响因素及相关风险防范措施。方法以“implantable medical devices”“use safety”为英文检索关键词,以“植入性医疗器械”“临床使用”“安全”为中文检索关键词,在PubMed、CNKI、万方等数据库进行文献检索、筛选及分析,整理归纳NAIMDs临床使用安全的影响因素。结果通过筛选得到51篇NAIMDs临床使用安全相关文献,确定了医护人员、患者、植入物、环境及管理是NAIMDs临床使用安全中的5个风险因素。结论NAIMDs临床使用安全的保障工作需要生产厂家、医疗机构、医护人员、患者及其家属等多方齐心协力,共同为患者健康保驾护航。Objective To explore the influencing factors and relevant risk prevention measures for the clinical use safety of non-active implantable medical devices(NAIMDs).Methods With“implantable medical devices”and“use safety”as English search keywords and“implantable medical devices”,“clinical use”and“safety”as Chinese search keywords,literature search,screening and analysis were conducted in PubMed,CNKI,Wanfang and other databases.The results were summarized and categorized accordingly to investigate the factors influencing the clinical use safety of NAIMDs.Results A total of 51 articles related to the safety of NAIMDs in clinical use were obtained,and five risk factors including medical staff,patients,implants,environment and management were identified.Conclusion Ensuring the clinical use safety of NAIMDs requires the collective efforts of manufacturers,healthcare institutions,healthcare professionals,patients,and their families.Together,they work to safeguard the health of patients.

关 键 词：无源植入性医疗器械 临床使用安全 患者安全 风险因素 风险防范措施 

分 类 号：R197.39[医药卫生—卫生事业管理]