Determination Of Radiation Sterilization Dose Of Central Venous Catheter And Systematic Study Of Radiation Adaptability

PurposeTo determine the radiation sterilization dose of the central venous catheter and systematically evaluate the radiation adaptability after the radiation sterilization of the central venous catheter so as to provide a basis for the safe application of the central venous catheter after radiation sterilization.MethodTo use ISO11137 Standard to determine the radiation sterilization dose of the central venous catheter and conduct the following tests of the sample after the radiation sterilization: tests of the blood coagulation function (TT,PT,APTT,Fg) , the platelet function (TXB2,Platelet Count) and the hemolysis rate; chromosome aberration test (Ames Test), micronucleus test, accelerated aging test, seal peeling test, agar attack and vacuum leakage test. To evaluate the radiation adaptability of the central venous catheter in terms of biocompatibility as well as the physical and chemical properties of packaging and products.ResultAs for the sample after radiation sterilization, no influence is shown in the blood coagulation function and the platelet function both before and after the whole blood of healthy people flows through the central venous catheter box, with the hemolysis rate being 1.38% (less than 5%), which is up to the medical appliance hemolysis test requirements. Ames Test shows that there is no evident difference in the number of revertant colonies existing in the central venous catheter leaching liquor and in the negative control group under both active and non-active conditions. The micronucleus test indicates that in the three different-dose groups of the leaching liquor of central venous catheter system, there is no increase is found in the occurrence frequency of the micronucleus and in the ratio of polychromatic erythrocytes to normoblast. Statistic analysis shows that between the individual treatment groups and the negative control group, no significant difference is found in the occurrence of micronuclei, no and genetic toxicity is found (no chromosomal aberration is caused), no allergy nor intracutaneous irritation is caused and no change is found in the material quality and performance of the packing material of product, and the blood compatibility proves to be desirable.ConclusionAfter the radiation sterilization with determined dose, the central venous catheter is of good radiation adaptability, and thus radiation sterilization, as a means of sterilization for medical appliances, is worth popularizing.