Evaluation of a new subcutaneous daratumumab administration device

Introduction – Objective
Daratumumab is a monoclonal anti-CD38 antibody mainly used for the treatment of myeloma and administered subcutaneously (SC) over 3 to 5 minutes. Its manual administration technique may contribute to musculoskeletal disorders (MSDs) among nurses. Due to organizational constraints, the use of an electric syringe pump is not currently feasible for this treatment in our hematology day hospital (HDH). In this context, a pump with subcutaneous administration set (Versapump, NS Medical) was evaluated as an alternative.

Materials and methods
The evaluated device is a calibrated mechanical spring pump equipped with a flow regulator, connected to a 70 cm extension with a secure 26G 9mm crimped needle. A prospective study was conducted over a one-month period within the HDH. A questionnaire was developed for nurses and patients. The evaluation criteria for each administration included: ergonomics for nurses, injection performance as measured by administration time, and patient comfort, among those who had previously received at least one manual injection. The economic impact of the device was also assessed.

Results
A total of 33 administrations performed by 5 nurses (out of the 6 dedicated to this activity) were analyzed. All nurses reported being satisfied (100%) regarding the ergonomics of the device, with no reported MSDs during use (thumb pain and postural discomfort). Patient comfort was also improved, with 99% reporting a decrease in pain during injection (less painful SC overpressure). The mean administration time was 4.84 ± 0.50 minutes (4.3 to 6.4 minutes), with a coefficient of variation of 10%, suggesting good consistency. The residual volume was 0.28 mL, corresponding to 1.87% of the total volume of 15 mL, and was considered negligible. The economic analysis showed an additional cost of €4000 when using the mechanical device with a SC microperfuser set and €10000 when using a hypodermic needle based on 2,000 administrations of daratumumab SC per year.

Discussion - Conclusion
The mechanical device may improve the administration of subcutaneous daratumumab by enhancing nurses’ ergonomics and reducing injection-related pain for patients. Although the delivered flow rate was consistent, flow rate control was less precise than an electric syringe pump. The mechanical device offers several practical advantages, including a shorter setup time, a relatively short administration time, and no need for an electrical power supply. Despite the additional cost of the device, the substantial ergonomic benefits for nurses and the associated organizational gains may help offset the initial investment.