Putting the spotlight on donation‐related risks and donor safety – are we succeeding in protecting donors?

Abstract

Background and objective The European consortium project TRANSPOSE (TRANSfusion and transplantation: PrOtection and SElection of donors) aimed to assess and evaluate the risks to donors of Substances of Human Origin (SoHO), and to identify gaps between current donor vigilance systems and perceived risks. Materials and methods National and local data from participating organizations on serious and non‐serious adverse reactions in donors were collected from 2014 to 2017. Following this, a survey was performed among participants to identify risks not included in the data sets. Finally, participants rated the risks according to severity, level of evidence and prevalence. Results Significant discrepancies between anticipated donor risks and the collected data were found. Furthermore, many participants reported that national data on adverse reactions in donors of stem cells, gametes, embryos and tissues were not routinely collected and/or available. Conclusions These findings indicate that there is a need to further develop and standardize donor vigilance in Europe and to include long‐term risks to donors, which are currently underreported, ensuring donor health and securing the future supply of SoHO.

Blood donor eligibility criteria for medical conditions: A BEST collaborative study

“…Knowledge about the frequency and natural history of medical conditions such as coronary artery disease, monoclonal gammopathy of undetermined significance, immune thrombocytopenia purpura and epilepsy may be helpful in designing criteria [15, 19–22]. A robust donor haemovigilance system, which includes post‐implementation monitoring of the impact of changes on donor reactions, would provide data to assess donor safety criteria [23]. Finally, data linkage studies of donors and recipients assess theoretical transmissibility of various medical conditions, such as cancer and neurodegenerative diseases [24, 25].…”

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

“…Data on adverse reactions (AR) are continuously registered and regularly assessed, and have resulted in changes in policies, products and practises within transfusion medicine [1]. In Europe, however, despite the known donation‐associated risks to blood donors, reporting of AR in donors remains voluntary and heterogeneous [2]. In contrast, registration of the AR in recipients has been mandatory since introduced in 2002 in the EU Directive 2002/98/EC.…”