If I add an enhanced visual inspection to my blood processing procedures prior to leukoreduction, do I need to repeat it before distribution?
FDA’s regulations require visual inspection procedures during storage and prior to distribution, and these regulations must be followed. However, because an initial enhanced visual inspection may help to identify any units with particulate matter, and because leukoreduction greatly reduces the number of units containing particulates, a second inspection after leukoreduction probably would not add significant benefit to the safety of the blood. FDA’s current thinking is that the enhanced inspection of whole blood and red cells is best performed by the collection centers prior to leukoreduction and need not be repeated after leukocyte reduction or by transfusion services.
