Time and Cost Savings with Bio-Set® Device in Reconstituting FVIII Concentrate.

Introduction: Bio-Set® (Biodome, Issoire France) is a new needleless device developed for the reconstitution of a factor VIII concentrate, Kogenate® FS (Bayer HealthCare, Elkhart IN).

Objectives: Quantitate time required to prepare FVIII concentrate for infusion and estimate the cost of medical waste produced using 3 reconstitution methods.

Methods: 161 subjects (35 patients; 67 caregivers; and 59 nurses) were recruited from the US and Canada following an IRB-approved protocol. Reconstitution methods were Bio-Set®, the conventional 2 vial transfer needle reconstitution method, and 2 vial Baxject method (Baxter Healthcare, Westlake Village CA). Video and interviewer demonstrations were conducted, then participants practiced each reconstitution method once before performing a timed round. Diluent volume for the conventional reconstitution method and Baxject were controlled at 5 mL. After each timed round, participants separated reconstitution refuse into either medical waste or regular trash. The weights of component pieces were added and a cost for disposal of the medical waste was determined.

Results: Participants completed preparation of the infusion with Bio-Set® in the shortest amount of time compared to the conventional method and Baxject (both p<0.0001). Results were similar across the 3 participant groups. The average weight of medical waste was lowest for Bio-Set® and highest for Baxject. The resulting disposal cost was significantly lower for Bio-Set® (p<0.0001).

Conclusions: The results of the time study showed a reduction of 33% in infusion preparation time with the Bio-Set® when compared to the conventional method and 29% when compared to the Baxject. The cost of disposal of medical waste should be reduced with the use of the Bio-Set®.