Objective: To analyze various injuries and causing factors caused by adverse events or suspected adverse events and other factors in medical devices, put forward countermeasures and solutions. Methods: Data mining on Chinese knowledge resource integrated databases and bibliography, related websites, literature metrology, extraction of terms of medical device items and terms of damage caused by devices based on the literature review, statistical damage term frequency, intercepting high frequency injure term, a graphic clustering tool kit (gCLUTO) is used to double clustering visualization analysis for medical device items-damage terms. Discuss the prevention and control measures and technical support plan for medical device injury risks. Results: the data obtained 373 medical device items, 409 damage terms, 166 high frequency injure terms for interception (threshold frequency ≥5. The double clustering visualization analysis showed that medical devices lead to injury mainly in 5 categories: ①Radiotherapy, X ray, medical laser, nuclear medicine, ventilator and other equipment and esophageal stents and so on caused burn, mechanical injury, esophagus injury, skin injury, lung injury, etc. ②The scratching, infection, bleeding, cross infection, etc. caused by sharp instruments and intubation apparatus. ③The electrosurgical units, physiotherapy, ophthalmic laser, endoscope, implant equipment, medical dressings and other devices caused electrical shock, burns, skin irritation, eye injuries and other injuries. ④The central venous catheter, venous indwelling needle, infusion and injection apparatus, suture, orthopedic implants as a result of vascular injury, obstruction, phlebitis, thrombosis, scleroma, nonunion, rejection, residual debris, etc. ⑤The hemodialysis machines and accessories, MRI, IUD, thermotherapy bed, surgical patch, analgesic pump, polyacrylamide hydrogel and other equipment caused nausea, vomiting, dizziness, pulmonary edema, arrhythmia, implantation failure, bag erosion and so on. The properties of injury involved 22 clinical specialties and clinical technical procedures. Conclusions: The research of clinical injury caused by medical devices is a hot topic of concern. The damage can be roughly classified into two categories: medical device related injury and user related injury. The former causes the main factors of injury to radiation, electric shock, mechanical force, acoustics, optics, thermal, chemistry, biology, material science, control, software, metering and so on. The latter involves the human factors on operation of medical instruments. They are also related to environmental factors of equipment and users onsite. Suggested that prevention and control countermeasures should be formulated from three aspects: strengthening evidence-based analysis of medical devices induced injures, establishing risk management system based on medical device adverse event reporting and standardizing procedures of medical device operation technologies for meeting the clinical pathway.%目的:分析医疗器械在不良事件或可疑不良事件以及其他因素情形下导致的各种伤害及其原因,提出对策与解决方案.方法:对中文知识服务平台以及书目、相关网站进行数据挖掘和文献计量;通过文献评阅提取医疗器械品目词与所致伤害术语词,构建两者双向矩阵,统计伤害术语频次,截取高频伤害术语词,采用图形聚类工具包(gCLUTO)进行医疗器械品目-伤害术语词双聚类可视化分析,讨论应对医疗器械导致伤害的防控对策与技术保障方案.结果:数据挖掘获得373个医疗器械品目、409个伤害术语词;设≥5次伤害词频为阈值截取高频伤害词为166个.经双聚类可视化分析,医疗器械导致伤害主要集中于以下5种类型:①放射治疗、X射线、医用激光、核医学、呼吸机等设备及食道支架等导致的灼伤、机械损伤、食道损伤、皮肤损伤、肺损伤等伤害;②各种锐器械、插管等导致的刺伤、划伤、感染、出血、交叉感染等;③高频电刀、理疗、眼科激光、腔镜、植入器材、医用敷料等设备导致的电击、灼伤、皮肤刺激反应、眼损伤等伤害;④中心静脉导管等导管、静脉留置针、输注器械、缝合线、骨科植入物等导致的血管损伤、阻塞、静脉炎、血栓、硬结、不愈合、排异反应、碎片残留等;⑤血透机及附件、MRI、宫内节育器、温热理疗床、外科补片、镇痛泵、聚丙烯酰胺水凝胶等器材导致的恶心、呕吐、头晕、肺水肿、心律失常、植入失败、囊袋侵蚀等伤害;伤害性质涉及22个临床专业及临床程序.结论:医疗器械可能导致的临床伤害研究,是一逐渐被关注的热点领域.导致伤害大致可归纳为医疗器械相关伤害和使用(者)相关伤害两类,前者造成伤害主要因素的工程学性质为辐射、电击、机械力、声学、光学、热能、化学、生物、材料学、控制、软件、计量等,后者更多涉及医疗器械操作的人因因素,两者均与器械、使用者所处的环境因素相关.建议从加强医疗器械可能导致伤害原因的循证分析、建立基于医疗器械不良事件报告的风险管理体系及切合临床路径的医疗器械操作技术规范三个方面制定风险管理防控对策.
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