A summary of the published clinical evidence of the effectiveness of the BD PhaSeal closed-system drug transfer device (CSTD)

Purpose. The primary objective of this study was to compare the levels of environmental contamination before and after the introduction of PhaSeal (closed-system drug transfer device) in two hospital pharmacies. Our secondary objective was to assess the impact of the device on the duration of drug preparation compared to procedures involving the use of needles and syringes. Methods. The study involved two French hospitals, which prepared antineoplastic chemotherapy using a biological safety cabinet and an isolator. Five skilled pharmacy technicians at each hospital prepared a total of 100 chemotherapy preparations using the standard procedure and 100 using the PhaSeal system. To control for possible contamination occurring in the course of the procedure, we used fluorescein which becomes fluorescent when exposed to UV light. To reply the second objective, we timed the duration of the different steps of the manipulation. Results. Our findings showed a major reduction in the contamination of the work environment when using the PhaSeal system for drug preparation. Reduction rates higher than 93% were obtained, whatever the type of protection used. On the duration of preparation, our results indicate that this duration would be approximately 1 h longer for the preparation of 100 samples. Conclusion. In conclusion, this study clearly establishes the benefit of using PhaSeal for protecting the staff members who work with hazardous agents. It also indicates that the duration of drug preparation is not impacted by the use of the