Evaluation of cancer drug infusion devices prior to the implementation of a compounding robot

Author:

Caron Guillaume1,Vasseur Michèle12ORCID,Courtin Justin1,Masse Morgane12,Décaudin Bertrand12ORCID,Genay Stéphanie12,Odou Pascal12,Simon Nicolas12

Affiliation:

1. Institut de Pharmacie, CHU Lille, Lille, France

2. Université de Lille, CHU Lille, ULR 7365 – GRITA – Groupe de Recherche sur les formes Injectables et les Technologies Associées, Lille, France

Abstract

Introduction Compounding robots are increasingly being implemented in hospital pharmacies. In our hospital, the recent acquisition of a robot (RIVATM, ARxIUM) for intravenous cancer drug compounding obliged us to replace the previously used infusion devices. The objective of the present study was to assess and qualify the new intravenous sets prior to their use in our hospital and prior to the implementation of the compounding robot. Materials and Methods The ChemoLockTM (ICU Medical) was compared with the devices used previously for compounding (BD PhaSealTM, Becton-Dickinson) and infusion (Connect-ZTM, Codan Medical). The connection/disconnection of infusion devices to/from 50 mL infusion bags was tested with a dynamometer (Multitest-i, Mecmesin). Leakage contamination was visualized by a methylene blue assay and was quantified in simulated pump infusions with 20 mg/mL quinine sulfate ( N = 36/group); after the analytical assay had been validated, quinine was detected by UV-spectrophotometry at 280 and 330 nm. Groups were compared using chi-squared or Mann–Whitney U tests. Results The connection/disconnection test showed that although all the devices complied with the current standard, there was a statistically significant difference in the mean ± standard deviation compression force (51.5 ± 11.6 for the Connect-ZTM vs. 60.3 ± 11.7 for the ChemoLockTM; p = 0.0005). Leaks were detected in 32 (29.1%) of the 110 tests of the ChemoLockTM. The contamination rates were also significantly different: 13.9% for the BD PhaSealTM versus 75.0% for the ChemoLockTM; p < 0.0001). Discussion/conclusion Our results showed that the new infusion device complied with current standards. However, the presence of contamination emphasizes the need for operators to use the recommended personal protective equipment. Further studies of contamination with cancer drugs are required.

Publisher

SAGE Publications

Subject

Pharmacology (medical),Oncology

Reference18 articles.

1. Que retenir dans la prise en charge des cancers en 2022 ?

2. Agence Nationale de Sécurité des Médicaments et des produits de santé. Bonnes Pratiques de Préparation. Edition 2022. Available at: https://ansm.sante.fr/documents/reference/bonnes-pratiques-de-preparation (accessed 22 December 2022).

3. US Pharmacopeia. USP General chapter <800> Hazardous drugs—handling in healthcare settings. Available at: www.usp.org (accessed 22 December 2022).

4. ISOPP Standards for the Safe Handling of Cytotoxics

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