Objective: The most common form of autologous blood transfusion is where blood is donated in anticipation of elective surgery. The aim of this study is to critically evaluate the product safety of autologous blood units. Material and Methods: The results are based on an analysis of the documented data and records of 22,630 cases with 21,553 patients and 49,650 autologous blood donations, blood processing and testing protocols, and reported transfusion reactions following autologous transfusions. Results: Autologous blood components are prepared individually, and an established system of quality assurance with controls of processes and products is particularly important to meet quality standards. The red cell content of autologous units cannot be standardized as in allogeneic components. Due to the differences between the laboratory screening programs for patients and donors, the risk of transmission of virus infections is different from that of allogeneic blood components. The quality of stored autologous red cells is comparable to that of allogeneic products. Conclusion: Results of systematic sterility monitoring lead to the conclusion that under the conditions practiced the risk of transfusion-associated sepsis is not higher than that associated with allogeneic products. Soluble biological response modifiers which accumulate during storage are assumed to be the cause of transfusion reactions that occur in 1 of 4,500 autologous transfusions. Incorrect allocation and handling errors continue to be a serious problem in autologous transfusions.

Autologous blood components are prepared individually, and an established system of quality assurance with controls of processes and products is particularly important to meet quality standards. The red cell content of autologous units cannot be standardized as in allogeneic components. Due to the differences between the laboratory screening programmes for patients and donors, the risk of transmission of virus infections is different from that of allogeneic blood components. The quality of stored autologous red cells is comparable to that of allogeneic products. Results of systematic sterility monitoring lead to the conclusion that under the conditions practised the risk of transfusion-associated sepsis is not higher to that of allogeneic products. Soluble biological response modifiers which accumulate during storage, are assumed to be the cause of reactions that occur in one of 4,500 autologous transfusions. Incorrect allocation and handling errors continue to be a serious problem in autologous transfusions.