Validation of an automated dose-dispensing system for 18F-FDG administrations and associated reduction in operator...

The current procedure at our centre for partitioning multidose vials of fluorine-18-fluorodeoxyglucose (F-FDG) is based on a manual method. To reduce extremity dose while reducing contamination risk, maintaining product sterility and improving the accuracy of injected activity, we recently purchased a new semiautomated partitioning system (μDDS-A). This work reports on the operating characteristics of the system and its validation for clinical use in terms of dispensing accuracy and extremity dose reduction.

A range of operators carried out 300 automated partitioning procedures by following a typical working-day setup. The accuracy of the activity resulting from system partitioning compared with true syringe activity was determined. We also determined the precision of system-determined activity when compared with user-requested activity. The cumulative finger dose for automated and manual partitioning techniques was measured at the fingertip using a digital dosimeter, recording the dose at different stages of the procedure.

The results of comparisons made between the final syringe activity measured by the system and the measurement of the true syringe activity independently of the system were within ±5% for 96.63% of syringes. Precision of the syringe activity provided by the system with respect to the user-requested activity was within ±10% for 96.96% of measurements. Average finger doses compared with a manual partitioning method showed a reduction of up to 80% when relying only on the system measurement of activity.

The μDDS-A reproducibly partitions a vial of F-FDG and offers a significant reduction in extremity dose to the operator of up to 80% in comparison with a manual partition technique.