Preparation of 5-Fluorouracil elastomeric devices : does Facilimix® make life easier ?

Emilie Seguin, Sonia Martelli, Antoine Bruneau, Aline Mouradian, Marie-Laure Brandely-Piat, Rui Batista Unité de préparations Stériles Ophtalmologiques et Oncologiques, Service de Pharmacie, Hôpital Cochin, Groupe Hospitalier Centre Université de Paris, AP-HP, 27 rue du Faubourg St Jacques, 75014 Paris, France

Introduction
Our unit production prepares about 150 5-Fluorouracil (5Fu) elastomeric devices (Folfusor®, Baxter) per month. During the compounding process, operators report difficulty in filling, due to the pressure required to fill the elastomeric reservoir. In order to reduce the risk of MusculoSkeletal Disorders (MSD) and to facilitate the preparation of elastomeric devices, we tested a semi-automatic preparation device, the Facilimix® (Becton Dickinson). This is a portable system to assist with withdrawing and injection requiring the use of 50mL captive syringes. The objective of this trial was to assess the satisfaction of the operators in terms of ease of use, safety and time saving.

Method
An evaluation form was drawn up and completed by the operators. It mainly assessed the accuracy of withdrawing and filling, as well as the ergonomics of the Facilimix®. For this last criterion, an adapted version of the OSHA (Occupational Safety and Health Administration) self-questionnaire quantifying the risk of MSD was used. Preparation times were measured by extracting the corresponding video sequences.

Results
The trial lasted 6 days during which 28 elastomeric devices were prepared by 4 operators. The ergonomics of the Facilimix® is a major asset: all the operators found it to be compact and easy to handle (weight <1kg). The MSD evaluation focused on 4 items: repetitiveness, manual effort, awkward postures and skin overpressure, each item being scored from 1 to 7 (7 being the worst score). The average total score was 22/28 for manual preparation and 10/28 for semi-automated preparation: the risk of MSD is therefore reduced by using Facilimix®. The speed of withdrawal and injection was also appreciated (75% of operators), despite the fact that the push button was too sensitive during withdrawal (100% of operators). The average preparation time was 10 minutes, identical to that of manual preparation. This lack of difference is linked to the handling of the captive syringes, which counterbalances the faster withdrawal/injection speed. In addition, 50% of the operators noted leakage of 5Fu at the luer-lock tip of the captive syringe during disconnection between the captive syringe and the spike of the vial (20 elastomeric devices/28).

Discussion/conclusion
The use of the Facilimix® made it easier and less restrictive to fill the elastomeric devices, but with no final gain in handling time. The repeated observation of cytotoxic leakage during syringe-spike connection/disconnection was the major factor that led to the trial being stopped. Corrective measures by the supplier on this issue are essential before considering its routine use. In addition, the announced cost of the captive syringes may also be an obstacle to its acquisition.

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