Teratogenecity of Ethylene Oxide Sterilized Medical Devices on Cells Used for Biotherapy / 中华医院感染学杂志

ABSTRACT

OBJECTIVE To observe the teratogenecity of ethylene oxide sterilized materials to cells which are used for biotherapy.METHODS Three kinds of cells were cultivated in ethylene oxide sterilized culture flasks which were conserved for different time and high temperature/high pressure sterilized vitric culture flasks.NK/CIK cells induced from cord blood,human mesenchymal stem cell and CD34+ cells were cultivated in ethylene oxide sterilized culture flasks which were conserved for one day(group A),for three months(group B),for more than six months(group C) and cultivated in high temperature/high pressure sterilized vitric culture flasks(group D).After ten days,not only the growth and morphology of cells but also the breakages fragmentations and gaps in chromosomes and replication of chromosome in nucleus were observed.According to these data,the malformation rate was calculated.RESULTS Compared with groups C and D,the inductivity of groups A and B obviously degraded(P0.05).CONCLUSIONS Compared with the control group,the materials which were sterilized by ethylene oxide and conserved for less than one day and three months can bring damage to cells.However,the damage is not discovered in the materials which were conserved for more than six months.Ethylene oxide can induce cell aberrant and mutation.Therefore,it is suggests that materials be conserved for more than six months to ensure safe and effective enforcement of biotherapy.