一次性使用白细胞过滤器质量控制必要性探讨

Discussion about necessity of quality control on leukocyte removal filters for single use

目的探讨对一次性使用白细胞过滤器的质量控制,是确保去白细胞血液产品质量的重要措施。方法对国内5个厂家及同一厂家不同批次的一次性使用白细胞过滤器均采用相同的质量指标进行评估。评估指标有:过滤效果(白细胞残留量、红细胞回收率)、细菌内毒素、无菌试验、一般检查(外观、密闭性、标签、其他)。结果5个厂家的一次性使用白细胞过滤器的质量存在差异,并有2个厂家的产品质量检查结果不符合要求;对同一厂家的一次性使用白细胞过滤器质量检查45批次,其质量也存在差异,且均体现在过滤效果上。结论建立对一次性使用白细胞过滤器进行质量控制,是十分有必要的,使用单位应对供方实施质量评价合格准入制及每批用前经质量检查合格后放行制。

Objective To find out that the quality control of leukocyte removal filters for single use is a significant step for ensuring the quality of leukocyte-removing blood products. Methods According to the same quality guideline,we evaluated the leukocyte removal filters for single use, which were from five domestic factories and different batches from the same factory. The evaluating indexes：filter effect （residue volume of WBC, recovery rate of RBC）, bacterial endotoxin, sterility test, general examination （appearance, tightness, label, etc. ） Results. There was quality difference among the leukocyte removal filters for single use, which were from five domestic factories. Moreover,the products from two of them were not up to the standard. While evaluating 45 batches of leukocyte removal filters for single use from one same factory, there was also quality difference, especially the filter effect. Conclusion It is fairy necessary to have quality control on the leukocyte removal filters for single use. Before issued out,the leukocyte removal filters for single use should be qualified. Also before using the product, users should evaluate it, and make sure it is up to the standard.