Comparative study of the different Closed System Transfer Devices available in France for the preparation of injectable immunotherapies.

Albaut V.1, Brobst M.1, Colliat F.2, Castel D.1
1 Pharmacie, Centre Hospitalier Alès Cévennes, Alès, France
2 Pharmacie, Hôpitaux du bassin Thau, Sète, France

Context
The Centralized Cytotoxic Reconstitution Unit (CCRU) currently uses Closed System Transfer Devices (CSTDs) in downgrade mode for the preparation of immunotherapies. Losses of products have been observed to a greater or lesser extent depending on the molecules. Monoclonal antibodies being expensive molecules, product loss has a real economic impact.

Objectives
Comparison of the CSTDs available in France to allow a given institution to choose the most suitable device for their needs.

Materials and methods
Training in the use of each device was provided to a working group (interns and pharmacy technicians). The samples were then tested with a dummy product, lidocaine. A scoring grid has been established to evaluate practicality, safety, comfort, handling time and cost. The leakage was assessed by a visual test with fluorescein. In parallel, the average volume of product lost was estimated by the difference in mass between the initial product and the product collected by the CSTD. The results were analyzed by a statistical test of analysis of variances (ANOVA). In order to complete the scoring grid, the samples were finally tested in real practice, within the CCRU, taking into account additional parameters (viscosity of the drug, size of the vials, wearing of gloves and constraints related to the controlled atmosphere area).

Results
Six CSTDs were evaluated: Tevadaptor®, Equashield®, Chemoclave®, Phaseal®, Phaseal Optima® and QimoHarpoon®. The ANOVA test didn’t show significant difference on the product loss between the different CSTDs. Regarding the tightness, none of the devices showed fluorescein leakage. The Tevadaptor® and Equashield® systems were the most satisfactory according to the scoring grid, followed by Chemoclave®. Then, Phaseal® and Phaseal Optima® as well as QimoHarpoon® were less easy to use (QimoHarpoon® being the most complex system) and less comfortable. Finally, a great variability of prices should be noted.

Discussion
The degree of requirement of the manipulations carried out corresponds to the expectations of chemotherapy units. The loss of product and the tightness are not the main criteria for choosing a CSTD. Moreover, a high price is not linked to a better use in practice. As a result, this study presents the strenghts and weaknesses of each CSTD and could be a good decision support tool to help a given institution to choose a CSTD, according to its criteria.

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