An observational study to evaluate the efficiency and safety of ioversol pre-filled syringes compared with ioversol bottles in contrast-enhanced examinations.

Vogl, Thomas J; Wessling, Johannes; Buerke, Boris

BACKGROUND The use of pre-filled syringes for contrast media (CM) administration allows efficient and optimized workflow during radiologic diagnostic procedures, and reduces the risk of contamination, providing benefits for both patients and healthcare workers. PURPOSE To compare the efficiency and safety of ioversol (Optiray(TM)) bottles and pre-filled syringes in clinical practice. MATERIAL AND METHODS This was an observational, non-interventional, prospective, multicenter study conducted at 72 centers in Germany. Patients undergoing contrast-enhanced computed tomography (CT) examinations with ioversol were enrolled. The use of ioversol bottles and pre-filled syringes in the diagnostic procedure was recorded in terms of efficiency (residual volume, re-use of CM) and safety (adverse events [AEs]). RESULTS A total of 10,836 patients were enrolled and included in this study. Ioversol bottles and syringes were used in 72% and 28% of cases, respectively. Analysis of the volume of CM in bottles before and after examinations, together with the volume used during the examination, suggested that in 22.5% of cases a new bottle was connected during the procedure. Further analysis revealed that in 80.2% of cases, the remaining volume of CM in the bottles could potentially be used for subsequent investigations, compared with <1% of cases for pre-filled syringes. For the total study population, AEs and serious AEs were reported in 30 (0.28%) and four (0.037%) patients, respectively, with no significant difference observed between ioversol bottles and syringes. CONCLUSION Administration of ioversol for contrast-enhanced CT examinations is associated with a low incidence of AEs and is generally safe and well tolerated. Ioversol pre-filled syringes were associated with lower residual volumes and less potential re-use compared with bottles.