COMPARATIVE VALIDATION OF MANUAL AND AUTO MATED METHODS FOR MIXING AND VOLUME CONTROL IN WHOLE-BLOOD COLLECTION

During blood collection, agitation and volume limitations are critical to ensure thorough mixing of the blood with the anticoagulant and obt ention of the predetermined volume. These 2 factors are essential to p revent blood activation and to obtain well standardized blood products . The objective of this study was to compare the quality of the blood collected using 2 types of collection method: tripping of a scale at a predetermined volume limit of 450 mt in the presence of manual agitat ion, and the 3 blood collection monitors currently available in France . A minimum of 100 collection procedures was performed for each of the 4 methods tested. Results were found to be equivalent using either th e manual or the automated procedures with regard to both the accuracy and reproducibility of the blood volumes obtained and the collection t imes and flow rates. The characteristics of the red blood cell concent rates, platelet concentrates and plasma units prepared from the first 30 collections of each group were assessed and compared to regulatory requirements. The quality of all these products was found to be compar able to that currently observed at quality control and no product was rejected at the release control for reasons of poor collection. An ass essment of the practicability of the different methods showed that the automated devices are subject to practical difficulties involving tra nsport and battery loading. in addition, the cost of this equipment is approximately 5 times higher than that of the scales. Ln conclusion, the results of this study show that in our hands, no significant advan tage could be expected from the use of automated blood collection moni tors as compared to simple scales with manual mixing. These results fu rther raise the question of the applicability to labile blood products of the comparative validations currently accepted in the pharmaceutic al industry in order to allow the use of correctly validated alternati ve methods.