Effectiveness of a Closed-System Transfer Device in Reducing Surface Contamination in a New Antineoplastic Drug-Compounding Unit: A Prospective, Controlled, Parallel Study

Abstract

BackgroundThe objective of this randomized, prospective and controlled study was to investigate the ability of a closed-system transfer device (CSTD; BD-Phaseal) to reduce the occupational exposure of two isolators to 10 cytotoxic drugs and compare to standard compounding devices.Methods and FindingsThe 6-month study started with the opening of a new compounding unit. Two isolators were set up with 2 workstations each, one to compound with standard devices (needles and spikes) and the other using the Phaseal system. Drugs were alternatively compounded in each isolator. Sampling involved wiping three surfaces (gloves, window, worktop), before and after a cleaning process. Exposure to ten antineoplastic drugs (cyclophosphamide, ifosfamide, dacarbazine, 5-FU, methotrexate, gemcitabine, cytarabine, irinotecan, doxorubicine and ganciclovir) was assessed on wipes by LC-MS/MS analysis. Contamination rates were compared using a Chi2 test and drug amounts by a Mann-Whitney test. Significance was defined for p<0.05. Overall contamination was lower in the “Phaseal” isolator than in the “Standard” isolator (12.24% vs. 26.39%; p < 0.0001) although it differed according to drug. Indeed, the contamination rates of gemcitabine were 49.3 and 43.4% (NS) for the Standard and Phaseal isolators, respectively, whereas for ganciclovir, they were 54.2 and 2.8% (p<0.0001). Gemcitabine amounts were 220.6 and 283.6 ng for the Standard and Phaseal isolators (NS), and ganciclovir amounts were 179.9 and 2.4 ng (p<0.0001).ConclusionThis study confirms that using a CSTD may significantly decrease the chemical contamination of barrier isolators compared to standard devices for some drugs, although it does not eliminate contamination totally.

A decontamination process adding a tensioactive agent and isopropanol to a closed-system drug transfer device for better control of isolator contamination. A prospective, parallel study

“…The assay used was the same as that described in a previous study which compared the contamination of isolators after using standard or BD-Phaseal devices [ 6 ]. Sampling was carried out daily with 100 μl water for injection and 5×5 cm compresses (ref.…”

“…The risks associated with occupational exposure to antineoplastic drugs can be genotoxic effects or a decrease in reproductive functioning [ 3 , 4 ]. Several sources of contamination have been determined in hospital settings: in pharmacies, notably on the external surface of commercial vials [ 5 ], during the compounding process [ 6 ], inside isolators [ 7 ] and in medical wards (e.g. preparations coming from the pharmacy and patients’ excreta) [ 8 ].…”

“…Recently, we have demonstrated that using a CSTD (BD-Phaseal, Becton-Dickinson, France) leads to a 50% reduction in the number of samples contaminated by ten cytotoxic drugs when compared to standard compounding devices (needles and mainly spikes) [ 6 ]. Although our results showed a significant difference in favor of the CSTD, residual contamination was still observed, as in other studies [ 14 – 16 ].…”

Occupational exposure to cytotoxic drugs: the importance of surface cleaning to prevent or minimise exposure

“…Closed-system drug transfer devices serve to prevent transfer of contamination from these objects to outside surfaces (4). The benefits of closed drug transfer systems have already been demonstrated by Sessink et al (46) and Simon et al (47), but the latter also noted that the device could not completely prevent chemical contamination.…”

Overcoming Challenges of Implementing Closed System Transfer Device Clinical In-Use Compatibility Testing for Drug Development of Antibody Drug Conjugates

“…[1][2][3][4][5][6] Since the introduction of these devices in early 2000, there have been multiple studies demonstrating their effectiveness at reducing leakage and associated surface contamination in the health care setting. [7][8][9][10][11][12][13][14][15][16][17][18][19][20][21][22][23] Swab or wipe tests using a range of surrogate drugs have clearly shown lower contamination levels on isolator surfaces, gloves, prep mats, and the surface of infusions when drug is prepared with a CSTD. 7,23 Other studies report leakage rates that vary based on device as well as device and surrogate agent dependent reductions in contamination.…”