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Title:: Study on A New Method of Repeated Exposure Systemic Toxicity Test of Medical Devices —— Dual Routes of Parenteral Administration Method on Rat

Author(s):: FAN Chunguang; HOU Li; ZHAN Rongkai; XU Jing; ZHU Fuyu; Shandong Quality Inspection Center for Medical Devices，Key Lab of Biological Evaluation of Medical Devices of Shandong Province, Jinan 250101，China

Keywords:: Medical devices; Repeated exposure systemic toxicity test on rat; Dual routes of parenteral administration method; Extracts injection method; Nonpolar extracts

摘要:: 为评价医疗器械极性及非极性可沥滤物同时接触人体时产生重复接触全身毒性的可能性，该研究设计了大鼠胃肠外双途径接触试验法并验证其可行性。本研究设计了空白对照组，腹腔注射玉米油组和胃肠外双途径接触组（尾静脉注射生理盐水，同时腹腔注射玉米油）。试验期间每天进行临床观察，每周称重。14 d后，取血进行临床病理检测、大体病理以及组织病理学检查并将数据进行统计学分析。与对照组相比，双途径接触组各项指标均未见毒性相关性改变。结果表明该试验法能够使大鼠同时充分接触极性及非极性浸提介质又不引起不良病理反应。

Abstract:: In order to evaluate the potential of repeated exposure systemic toxicity of medical devices when both polar and nonpolar leachables of medical devices contact human body simultaneously, dual routes of parenteral administration method on rat was designed and the feasibility was validated. Blank control group, intraperitoneal injection with corn oil group and dual routes ( intravenous injection with normal saline and intraperitoneal injection with corn oil ) of parenteral administration group were designed in the study. Clinical observation was conducted everyday during the study. Animals were weighed weekly intervals. After 14 days, clinical pathology analysis of the blood specimens, gross pathology and a histopathology examination were conducted and data were analyzed statistically. As a result, compared to the control animals, there were no toxicity-related changes in the dual routes test group on the parameters above. The results show that the method can make the rat fully contact with both polar and nopolar extraction medium simultaneously but not induce adverse effect to the rat.