Experimental study on cytotoxicity by different sterilization methods

YE Xiaohui, ZHANG Lei, ZHANG Yabing

Anhui Journal of Preventive Medicine ›› 2024, Vol. 30 ›› Issue (1) : 61-65.

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Anhui Journal of Preventive Medicine ›› 2024, Vol. 30 ›› Issue (1) : 61-65. DOI: 10.19837/j.cnki.ahyf.2024.01.014
Original Articles

Experimental study on cytotoxicity by different sterilization methods

  • YE Xiaohui, ZHANG Lei, ZHANG Yabing
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Abstract

Objective To explore the impact of different sterilization methods on the cytotoxicity evaluation results of four medical devices or materials. Methods The extraction method and methyl thiazolyl tetrazolium (MTT) method were used to determine the cytotoxicity of four commonly used medical devices and materials [disposable medical masks,disposable multifunctional surgical dissectors (forceps),injection freeze-drying chlorinated butyl rubber stoppers,and disposable infusion sets] after different sterilization methods (ultraviolet irradiation sterilization,high-temperature and humid heat sterilization,and ethylene oxide sterilization). Results The disposable medical masks,disposable multifunctional surgical dissectors (forceps),and injection chlorinated butyl rubber stoppers all had a cytotoxicity grade of 1 under three sterilization conditions,and the cell survival rates were all above 70%.The cytotoxicity grade of disposable infusion sets under ultraviolet irradiation sterilization and high-temperature and humid heat sterilization methods was grade 1,and the cell survival rate was greater than 70%.Under the condition of ethylene oxide sterilization,the cytotoxicity grade was 2,and the cell survival rate was less than 70%. Conclusion The sterilization method of medical devices or materials can affect the determination of their cytotoxicity results.Depending on the physical and chemical properties of the product and the different materials,an appropriate sterilization method should be selected.Cytotoxicity tests must be carried out in accordance with the characteristics of the product or its clinical sterilization method.Especially for equipment products with multiple components,materials,and involving various additives.

Key words

Ultraviolet irradiation sterilization / High-temperature and humid heat sterilization / Ethylene oxide sterilization / Cytotoxicity

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YE Xiaohui, ZHANG Lei, ZHANG Yabing. Experimental study on cytotoxicity by different sterilization methods[J]. Anhui Journal of Preventive Medicine. 2024, 30(1): 61-65 https://doi.org/10.19837/j.cnki.ahyf.2024.01.014

References

[1] 田林奇,韩颖,周小婷,等.留置针的细胞毒性和遗传毒性研究[J].中国医疗器械信息,2020,26(3):22-24.
[2] 陈樱子,赵明.消毒供应中心手术器械灭菌效果的影响因素分析[J].临床医学工程,2022,29(3):319-320.
[3] 曾燕.医疗失效模式与效应在微创手术器械消毒灭菌过程中的应用分析[J].当代医学,2021,27(6):57-59.
[4] 国家药品监督管理局.医疗器械生物学评价 第12部分:样品制备与参照样品:GB/T 16886.12—2017[S].北京:中国标准出版社,2017.
[5] 国家药品监督管理局.医疗器械生物学评价 第5部分:体外细胞毒性试验:GB/T 16886.5—2017[S].北京:中国标准出版社,2017.
[6] Biological evaluation of medical devices - Part 1:Evaluation and testing within a risk management process:ISO 10993-1:2018[S].International Organization for Standardization,2018.
[7] 田林奇,韩颖,魏聪,等.两种不同细胞毒性检测方法的比较[J].中国医疗器械信息,2019,25(1):23-24+39.
[8] 李彩艳,王志超,刘灵飞,等.环氧乙烷灭菌和辐照灭菌在医疗器械灭菌中的应用[J].中国医疗器械信息,2020,26(17):175-176.
[9] 李晓娜,赵红,何倩,等.安徽省某三甲中医院2014—2018年消毒灭菌效果监测分析[J].安徽预防医学杂志,2021,27(1):29-32.
[10] 安江珊,王利妍,刘琨毅,等.晒青茶灭菌方法研究[J].轻工学报,2022,37(1):40-45.
[11] 刘海洪,崔喆,付鹏.不同灭菌方式对预灌封注射器用橡胶活塞性能影响的研究[J].橡胶工业,2022,69(3):218-221.
[12] 黄文雄.环氧乙烷用在生物医疗材料灭菌之确效[D].台湾:国立宜兰大学,2021.
[13] 王越,包世勇,沈国理,等.PVC材料导管类医疗器械DEHP析出的安全评价试验模型研究[J].中国医疗器械杂志,2018,42(3):222-224.
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