Evaluation of the performance and ergonomics of the 4-way MediMix four-way pump

L. Hachon , M. Moine, A. Martinet, M. Battistella, C. Mannechin,
N. Robert, D. Sankhare, J. Nicoulaud, I. Madelaine, N. Jourdan-Desrayaud
Pharmacy - Anticancer agents’ preparation unit, Saint-Louis Hospital, Greater Paris University Hospitals, Paris

Introduction

To improve the quality and safety of the manufacture of serial preparations of anticancer drugs, the use of a multipath volumetric filling machine is proposed to reconcile precision and relief of the working conditions of the hospital pharmacy technician (HPT).

Aim

To evaluate the performance and ergonomics of the MediMix Four pump composed of 2 pumps of 10 mL and 2 pumps of 50 mL.

Material and methods

Filling of syringes with extreme volumes of interest (0.5, 1, 2, 5 and 10 mL for the 10 mL pumps and 5, 10, 15, 25, 35 and 50 mL for the 50 mL pumps) were produced 6 times for each pump for 3 consecutive days from 0.9% sodium chloride bags. Controls were performed by gravimetry. Ergonomics of the device was assessed by a survey to 7 operators (HPT, HPT manager and pharmacists) using the AFNOR NZ67-133-1 criteria: compatibility, homogeneity, guidance, flexibility, explicit control, errors, and conciseness. Answers were given with the 5-point Likert scale (from 1 to 5), after several sessions of use.

Results

The mean bias was 0.68% (0.4-2.2%) for the 10 mL pumps and 0.27% (0.1-1.1%) for those of 50 mL, with coefficients of variation less than 1% for the mean of the measurements except for 0.5 mL (bias 2.2% (2.0 -2.3%)) with coefficients of variation <2%). The injected / programmed volume ratio is linear for 10 mL pumps (y = 1.0023x - 0.0111, r² = 1.00) and 50 ml (y = 1.0019x - 0.0575, r² = 1, 00). Ergonomics was insufficient (mean score of 2.6 / 5, standard deviation of 1.0) and should be optimized for routine series (mean score of 2.6 / 5, standard deviation of 0.8).

Conclusion

For the entire range of volumes, filling test were accurate, repeatable and faithful according to the manufacturer’s specifications. However, ergonomics has yet to be developed to adapt to the practices of the team.

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