Blood donor selection in European Union directives: room for improvement.

Transfusion-transmissible infections have made both blood bankers and health authorities overly cautious. The general public expects and hence reinforces this policy. To obtain a high level of blood product safety, blood and plasma donors have to meet increasingly stringent eligibility criteria; however, it is not known whether this policy translates into improved outcomes for patients. There is a risk that the management of donors does not match the ambition of greater safety for patients. European directives related to the collection process and donor selection will probably be reconsidered in the next few years.The development of European directives on donor selection and their basis in the literature were reviewed with an emphasis on the background and considerations for eligibility criteria to be included in the directives.The precautionary principle appears to be the predominant reason behind the set of eligibility criteria. However, the formal eligibility criteria, put into force in 2004, do not balance with the developments of the past decade in laboratory tests and measures that have substantially reduced actual infection risks. In no cases were the effects of eligibility criteria on the donor pool and donor well-being quantified. Regional differences in the epidemiology of transfusion-transmissible infections were not taken into consideration either.First, the Authors promote the collection of epidemiological data on the incidence and prevalence of conditions in the general population and in blood and plasma donors which could pose a risk for transfused patients, in order to use these data as a basis for decision-making in donor-selection policies. Second, the Authors suggest including allowance for differential deferral criteria throughout Europe, based on factual risk levels. There should be an accepted balance between donor and patient welfare, and also between risk to transfusion safety and risk of compromising the blood supply.