The new donor vigilance system in Denmark reveals regional differences in adverse reactions supposedly caused by variation in the registration
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The new donor vigilance system in Denmark reveals regional differences in adverse reactions supposedly caused by variation in the registration. / Mikkelsen, Christina; Paarup, Helene Martina; Bruun, Mie Topholm; Pedersen, Louise Ørnskov; Hasslund, Sys; Larsen, Rune; Aagaard, Bitten; Sørensen, Betina Samuelsen.
In: Vox Sanguinis, Vol. 117, No. 3, 2022, p. 321-327.Research output: Contribution to journal › Journal article › Research › peer-review
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TY - JOUR
T1 - The new donor vigilance system in Denmark reveals regional differences in adverse reactions supposedly caused by variation in the registration
AU - Mikkelsen, Christina
AU - Paarup, Helene Martina
AU - Bruun, Mie Topholm
AU - Pedersen, Louise Ørnskov
AU - Hasslund, Sys
AU - Larsen, Rune
AU - Aagaard, Bitten
AU - Sørensen, Betina Samuelsen
N1 - Publisher Copyright: © 2021 International Society of Blood Transfusion.
PY - 2022
Y1 - 2022
N2 - Background and Objectives: In recent years, there has been an increased focus among blood bank professionals on the health and safety of blood donors. In 2019, the Danish Haemovigilance Committee designed a national donor vigilance system to improve the registration of adverse reactions (AR) in blood donors. The new donor vigilance system was implemented on 1 January 2020 and we here present the results from the first year of registration. Materials and Methods: AR categories, severity level and imputability score were defined based on the definitions from the International Society of Blood Transfusion, AABB and the European Commission directive 2005/61/EC, respectively. Results: Across all severity levels, AR in Danish blood donors were found to be rare (1498 per 100,000 donations). Only 0.2% of the registered reactions were classified as serious (2.7 per 100,000 donations). Large regional differences were seen in the registration of citrate reactions and haematomas. Conclusion: Significant differences across regions in what to categorize as an AR were persistent even when including a severity score in the reporting. The Danish Haemovigilance Committee will commence a national work to align the definitions but suggests that this matter is raised to an international level as part of the current work to agree upon definitions for assessment of donor AR.
AB - Background and Objectives: In recent years, there has been an increased focus among blood bank professionals on the health and safety of blood donors. In 2019, the Danish Haemovigilance Committee designed a national donor vigilance system to improve the registration of adverse reactions (AR) in blood donors. The new donor vigilance system was implemented on 1 January 2020 and we here present the results from the first year of registration. Materials and Methods: AR categories, severity level and imputability score were defined based on the definitions from the International Society of Blood Transfusion, AABB and the European Commission directive 2005/61/EC, respectively. Results: Across all severity levels, AR in Danish blood donors were found to be rare (1498 per 100,000 donations). Only 0.2% of the registered reactions were classified as serious (2.7 per 100,000 donations). Large regional differences were seen in the registration of citrate reactions and haematomas. Conclusion: Significant differences across regions in what to categorize as an AR were persistent even when including a severity score in the reporting. The Danish Haemovigilance Committee will commence a national work to align the definitions but suggests that this matter is raised to an international level as part of the current work to agree upon definitions for assessment of donor AR.
KW - blood collection
KW - donor health
KW - donors
KW - haemovigilance
U2 - 10.1111/vox.13202
DO - 10.1111/vox.13202
M3 - Journal article
C2 - 34523137
AN - SCOPUS:85114901375
VL - 117
SP - 321
EP - 327
JO - Vox Sanguinis
JF - Vox Sanguinis
SN - 0042-9007
IS - 3
ER -
ID: 280172615