BACKGROUND AND OBJECTIVES: National guidelines for monitoring the bacterial contamination rate of blood components were introduced in Germany in 1997. The objective of this study was to present and evaluate the results of sterility testing of platelet concentrates (PCs) prepared by different methods. MATERIALS AND METHODS: The analysis of results of sterility testing of blood component production from transfusion medicine centres in Germany in 1998 and 2001 was based on information collected using standardized questionnaires. RESULTS: The bacterial contamination rates for single-donor PCs derived from whole blood and apheresis (0.210% vs. 0.156%) were comparable and showed no significant difference. However, pooled PCs produced from four buffy coats using the sterile docking procedure showed a significantly higher bacterial contamination rate compared with single-donor PCs derived from whole blood and apheresis (0.184% vs. 0.604%). CONCLUSIONS: Use of standardized methods for sterility monitoring is sufficient to assess collection and production processes in terms of hygiene and yields reliable data on bacterial contamination rates of blood components. The methods described are suitable for using to analyse the efficiency of newly introduced methods to reduce bacterial contamination rates of blood components (e.g. diversion, bacteria screening and pathogen inactivation).
BACKGROUND AND OBJECTIVES: National guidelines for monitoring the bacterial contamination rate of blood components were introduced in Germany in 1997. The objective of this study was to present and evaluate the results of sterility testing of platelet concentrates (PCs) prepared by different methods. MATERIALS AND METHODS: The analysis of results of sterility testing of blood component production from transfusion medicine centres in Germany in 1998 and 2001 was based on information collected using standardized questionnaires. RESULTS: The bacterial contamination rates for single-donor PCs derived from whole blood and apheresis (0.210% vs. 0.156%) were comparable and showed no significant difference. However, pooled PCs produced from four buffy coats using the sterile docking procedure showed a significantly higher bacterial contamination rate compared with single-donor PCs derived from whole blood and apheresis (0.184% vs. 0.604%). CONCLUSIONS: Use of standardized methods for sterility monitoring is sufficient to assess collection and production processes in terms of hygiene and yields reliable data on bacterial contamination rates of blood components. The methods described are suitable for using to analyse the efficiency of newly introduced methods to reduce bacterial contamination rates of blood components (e.g. diversion, bacteria screening and pathogen inactivation).
Authors: Gabriele Walther-Wenke; Walter Däubener; Margarethe Heiden; Jochen Hoch; Britt Hornei; Peter Volkers; Carl Heinz Wirsing von König Journal: Transfus Med Hemother Date: 2011-07-11 Impact factor: 3.747