Evaluation of physical constraints related to the use of medical devices during the cytotoxic compounding

C. Roch1, N. Martelli1, J. Vernois2, D. Pradeau3, E. Caudron1,4 1 Service Pharmacie, Hôpital européen Georges Pompidou, AP-HP, France
2 Unité Qualité et Essais Hospitaliers, AGEPS, AP-HP, France
3 Laboratoire de Physico-chimie, AGEPS, AP-HP, France
4 Laboratoire de chimie analytique Lyp(Sys)2, Université Paris Sud, France

Introduction

In order to reduce musculoskeletal disorders (MSD) of operators, flow resistance across syringe and other different medical devices necessary for the compounding of cytotoxic, has been evaluated.

Materials and methods

The medical devices tested were Iflow® ambulatory infusion pump, Freeflex plus Luer-Lock® bags and three types of luer-lock® connectors (CAIR old and new references, CODAN) associated to a 5% glucose bags. Measurements of the flow resistance in tension and compression of a 5% glucose solution (V= 50 mL) were performed with a dynamometer for 100 to 1000 mm/min speed (or sampling/filling time of 4.8 to 48 seconds). Each measurement was repeated 5 times.

Results

Convenient sampling force should be from 20 to 30 N, including the whole system, according to operators. However, compounding of the ambulatory infusion pump was very restrictive and required higher forces (95 N to 140 N). When considering connectors and bags, compressive forces were lower than traction forces as expected. Tension forces ranged from 19 ± 7 N to 59 ± 11 N on Luer-Lock® bags. The connectors ranged from 12 ± 3 N to 59 ± 7 N and 19 ± 11N to 63 ± 3 N for CODAN and CAIR old references respectively. The last new reference showed a significant lower force with 16 ± 9 N to 27 ± 3 N.

Discussion - Conclusion

Physical constraints strongly depend of the medical device and operators. Our study allowed a judicious choice between connectors. The new CAIR reference substantially improved the conditions of compounding of the cytotoxic drug. Due to the arduousness of ambulatory infusion pump filling, a filling aid pump was implemented to reduce risk of MSD operators.

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