Evaluation of Risk Minimisation Measures for Blood Components - Based on Reporting Rates of Transfusion-Transmitted Reactions (1997-2013)

被引：22
作者：
Funk, Markus B. [1 ]
Heiden, Margarethe [2 ]
Volkers, Peter [3 ]
Lohmann, Annette [1 ]
Keller-Stanislawski, Brigitte [1 ]
机构：
[1] Paul Ehrlich Inst, Div Safety Med Prod & Med Devices, D-63225 Langen, Germany
[2] Paul Ehrlich Inst, Div Transfus Med, D-63225 Langen, Germany
[3] Paul Ehrlich Inst, Sect Biostat, D-63225 Langen, Germany
来源：
TRANSFUSION MEDICINE AND HEMOTHERAPY | 2015年 / 42卷 / 04期
关键词：
Reporting rate; Risk minimisation measures; Blood components; Transfusion reaction; Haemovigilance; ACUTE LUNG INJURY; REDUCTION; PLASMA;
D O I：
10.1159/000381996
中图分类号：
R5 [内科学];
学科分类号：
1002 ; 100201 ;
摘要：
Background: To assess the impact of safety measures, we compared reporting rates of transfusion-related reactions before and after the implementation of six measures in 1999, 2004, 2006, 2008 and 2009. Methods: Reporting rates of transfusion-transmitted bacterial infection (TTBI), viral infection (TTVI) and immune-mediated transfusion-related acute lung injury (TRALI) were calculated on the basis of confirmed annual reports and distributed blood components. Results: The introduction of HCV NAT testing caused a significant reduction of HCV reporting rate from 1:0.6 to 1:83.16 million administered blood components (p < 0.0001), donor screening for antibodies to hepatitis B core antigen caused a reduction of HBV reporting rate from 1:2.90 to 1:10.70 million units (p = 0.0168). A significant reduction from 1:0.094 to 1:2.42 million fresh frozen plasma (FFP) units could also be achieved by risk minimisation TRALI measures (p < 0.0001). Implementation of pre-donation sampling did not result in a significant decrease in TTBI, whereas limitation of shelf life for platelet concentrate (PC) minimised the TTBI reporting rate from 1:0.088 to 1:0.19 million PC units (p = 0.041). For HIV NAT pool testing, no significant reduction in HIV transmission was found due to very low reporting rates (1:10 million versus 1:27 million blood components, p = 0.422). Conclusion: On the basis of haemovigilance data, a significant benefit could be demonstrated for four of six implemented safety measures. (C) 2015 S. Karger GmbH, Freiburg
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收藏
页码：240 / 246
页数：7
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