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Safe Cytotoxic Drug Preparation Using a Closed-system Transfer Device: Technical and Practical Evaluation of a New Device (Vialshield/Texium) Comparatively to a Reference One (Phaseal)

Author(s):  Garrigue Philippe,Montana Marc,Ventre Christophe,Savry Amadine,Gauthier-Villano Laurence,Pisano Pascale,Pourroy Bertrand

Issue:  Mar/Apr 2016 - Volume 20, Number 2
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Abstract:  Closed-system transfer devices enhance the drug handlers’ protection against hazardous drugs exposure by prohibiting the escape of liquid or vapor from the system. PhaSeal (Becton Dickinson), a reference closed-system transfer device, includes a vial protector with an expansion chamber, and an injector with an enclosed needle. VialShield (CareFusion) is another more recent closed-system transfer device including an expansion chamber and a non-return valve, designed to be used in association with Texium (CareFusion), a closed, needlefree male luer with its preassembled syringe. Evaluation of VialShield/Texium was done comparatively to a classic spike device (Spike Swan, Codan) and PhaSeal. Evaluation methods consisted in practical evaluation by pharmacy technicians (evaluation of ease to use by nine operators in practical conditions during a complete week of production), microbiological safety performance (by Media Fill Test), and leakage assessment (fluorescein, titanium tetrachloride smoke, and radioactive tracer). Results showed that 100% of those operators evaluated would be ready to use VialShield/Texium for daily use, whereas only 75% of them would be ready to use PhaSeal. The use of PhaSeal and VialShield/Texium increased the duration of preparations compared to Spike Swan. No microbiological growth was observed with any of the three devices. A leakage of smoke was observed only with Spike Swan. Fluorescein leakage assessment confirmed that PhaSeal is a performing closed system with a dry connection. Spike Swan showed fluorescein leaks. Fluorescein drops were visible on the connection sites of the VialShield/Texium. Nevertheless, no fluorescein was found on compress after connections swapping. Transfer performance, assessed using technetium-99m, was 98.1 ± 1.4%, 97.9 ± 1.1% and 97.0 ± 1.3% and dead volume of the devices, were 1.0 ± 0.8%, 1.7 ± 0.6%, and 3.0 ± 1.1% for Spike Swan, PhaSeal, and VialShield/Texium, respectively. VialShield/Texium appeared as a very interesting device with performances close to PhaSeal (except dry connection), with a higher satisfaction assessment from the operators.

Related Keywords: Philippe Garrigue, PharmD, Marc Montana, PharmD, PhD, Christophe Ventre, Amandine Savry, PharmD, PhD, Laurence Gauthier-Villano, PharmD, Pascale Pisano, PharmD, PhD, Bertrand Pourroy, PharmD, PhD, cytotoxic drug preparations, hazardous drug handling, closed system transfer devices, environmental contamination, PhaSeal, VialShield, Texium, ease of use, microbiological safety performance, media fill test, leakage assessment, transfer performance, pharmacy technician, production workflow

Related Categories: ENVIRONMENTAL , PARENTERALS, PEER-REVIEWED, QUALITY CONTROL

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