101例医疗器械形成异物遗留患者体内的不良事件  

Analysis of the Medical Device Adverse Events in 101 Cases of Foreign Body in the Formation of Medical Devices

作　　者：卞蓉蓉[1] 李尧[1] 赵敏[1] 马丹华[1] 宋杏芳 杨婷婷 Bian Rongrong;Li Yao;Zhao Min;Ma Danhua;Song Xingfang;Yang Tingting(Corresponding Autho;Center for ADR Monitoring of Jiangsu,Nanjing Jiangsu 210002,China)

机构地区：[1]江苏省药品不良反应监测中心,江苏南京210002

出　　处：《医疗装备》2018年第17期49-51,共3页Medical Equipment

摘　　要：目的对医疗器械在各种治疗中形成异物,并遗留在患者体内的不良事件进行研究,对相关数据特征和影响因素进行分析,为降低该类不良事件的发生率提出控制措施和建议。方法对2013-2017年江苏省药品不良反应监测中心收集到的101例医疗器械形成异物遗留在患者体内的不良事件进行统计分析和典型病例阐述。结果Ⅲ类医疗器械形成术中遗留异物的报告最多,遗留异物最多部位的前3名为血管、腹腔和盆腔。50.50%的异物遗留发生后将异物取出;91.09%的不良事件为产品因素导致;59.41%的异物在外科手术中产生。结论生产企业应注重产品质量,从材料选择、产品设计、生产工序、包装标识等角度不断提升产品安全性,降低产品形成异物遗留体内的风险。ObjectiveTo probe into the characteristics and influencing factors of medical device adverse events cases induced by foreign bodies left in the body, so as to provide effective resolutions for safety use. Methods101 cases of foreign body in the formation of medical devices in Jiangsu from 2013 to 2017 were collected and analyzed, and the typical cases were described. ResultsAccording to the statistics, adverse events of class Ⅲ medical device were the most, and the top three legacypositions were vessels, abdominal cavity and pelvic cavity. 50.50% of the foreign materials were removed; 91.09% of the reasons are attributed to the product factors; 59.41% of the foreign bodies occurredin surgery. Conclusion Manufacturers should keep improving product safety and reduce the risk of product form foreign bodies left in the bodyin many aspects, such as the material selection, product design, production process, packaging and so on.

关 键 词：异物遗留 医疗器械 不良事件 监测 风险因素 

分 类 号：R472.3[医药卫生—护理学]