German Red Cross Blood Donation Service West, Centre for Transfusion Medicine Münster, Sperlichstrasse 15, Münster, Germany.
Vox Sang. 2011 May;100(4):359-66. doi: 10.1111/j.1423-0410.2010.01432.x. Epub 2010 Oct 28.
National guidelines for monitoring bacterial contamination of blood components were introduced in Germany in 1997. Between 1998 and 2002, numerous measures were implemented to prevent bacterial contamination. This study investigates their impact on contamination rates.
Culture-based testing for bacterial detection on a random sample of blood components is part of routine quality control in German blood establishments. Using standardized questionnaires, data from the production periods 1998, 2001 and 2005/2006 were collected and analysed.
The bacterial contamination rate of RBCs was reduced from 0·157% in 1998 to 0·029% in 2005/2006 (P<0·001). While the contamination rate of apheresis PCs remained nearly unchanged over the years, it dramatically decreased for pooled PCs by 70% to a contamination rate of 0·158% (P=0·001) within the last observation period, similar to that of apheresis PCs. The contamination rate of plasma decreased from 0·100% in 1998 to 0·019% in 2005/2006 (P=0·002).
Precautionary measures significantly reduced bacterial contamination rates of blood components. Long-term monitoring with standardized methods is appropriate to evaluate the cumulative effect of contamination-preventing measures.
1997 年，德国出台了用于监测血液成分细菌污染的国家指南。1998 年至 2002 年期间，采取了大量措施来预防细菌污染。本研究旨在调查这些措施对污染率的影响。
对血液成分的随机样本进行基于培养的细菌检测是德国血站常规质量控制的一部分。使用标准化问卷，收集并分析了 1998 年、2001 年和 2005/2006 年生产期间的数据。
RBC 的细菌污染率从 1998 年的 0.157%降低至 2005/2006 年的 0.029%（P<0.001）。虽然单采 PC 的污染率多年来基本保持不变，但在最后观察期内，混合 PC 的污染率显著降低了 70%，达到 0.158%（P=0.001），与单采 PC 的污染率相似。血浆的污染率从 1998 年的 0.100%降至 2005/2006 年的 0.019%（P=0.002）。
预防措施显著降低了血液成分的细菌污染率。使用标准化方法进行长期监测，适合评估污染预防措施的累积效果。
