The new donor vigilance system in Denmark reveals regional differences in adverse reactions supposedly caused by variation in the registration

Abstract

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.

Safety and protection of plasma donors: A scoping review and evidence gap map

“…About half of the articles ( n = 18) had only assessed AE frequency, whereas the other half ( n = 17) investigated plasmapheresis‐related factors that may be associated with the occurrence of AEs (in order of frequency): donor characteristics (age, sex, body weight and body mass index; or pre‐donation values of blood pressure, pulse and blood volume; or IgG, total protein, haemoglobin [Hb] and haematocrit [Hct] levels); donor status (first time vs. repeat); donation volume per session; plasma collection device or programme; cumulative number of donations; donation frequency; or other factors (extracorporeal blood volume [41], geographical region of plasma collection [37] or donation with or without saline infusion [21]). …”

“…Assessed AEs included vasovagal reactions ( n = 17), complications with local symptoms (directly caused by needle insertion) ( n = 14), apheresis‐related events ( n = 14), allergic reactions ( n = 11), major cardiovascular events ( n = 11) or other ( n = 14; including fractures, non‐localized infections or AEs classified as ‘other’ according to the adopted vigilance scheme). The ‘Standard for Surveillance of Complications Related to Blood Donation’ [4] was the most commonly used tool [34–40].…”

“…Of the 35 articles, over 40% mentioned the measurement of AEs without specifying the type of events, adopted surveillance tool or categorization (classified as 'generic' in the EGM at https://cebap.org/storage/ cebap/schroyens-2023-egm.html) (Figure 3 7. or other factors (extracorporeal blood volume [41], geographical region of plasma collection [37] or donation with or without saline infusion [21]).…”

A rare vascular injury in a blood donor after whole blood donation

“…It is important to register the incidence and severity of any AR for haemovigilance to elaborate strategies that will minimize future AR. 1 In addition, AR can have a negative impact on donor return thereby affecting blood supplies. 2 Overall, the most commonly reported complications are immediate vasovagal reactions and rare complications include generalized allergic reactions and major blood vessel injury.…”

A Danish national, multicentre evaluation of the new donor vigilance system among different staff groups

“…In January 2020, the Danish Haemovigilance Committee implemented a new national donor vigilance system. The system was based on three parameters: (1) adverse reaction categories as defined by the ISBT; (2) severity as defined by the AABB; and (3) a modified version of imputability levels adapted to donor vigilance by the ISBT [1].…”