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Evaluation of Closed-system Transfer Devices in Reducing Potential Risk for Surface Contamination Following Simulated Hazardous-drug Preparation and Compounding

Author(s):  Soefje Scott, Rickabaugh Keith, Rajkumar Rahul, Wall Kathryn P

Issue:  Nov/Dec 2021 - Volume 25, Number 6
View All Articles in Issue

Page(s):  515-522

Note:  Electronic version includes errata or revisions.

Evaluation of Closed-system Transfer Devices in Reducing Potential Risk for Surface Contamination Following Simulated Hazardous-drug Preparation and Compounding Page 1
Evaluation of Closed-system Transfer Devices in Reducing Potential Risk for Surface Contamination Following Simulated Hazardous-drug Preparation and Compounding Page 2
Evaluation of Closed-system Transfer Devices in Reducing Potential Risk for Surface Contamination Following Simulated Hazardous-drug Preparation and Compounding Page 3
Evaluation of Closed-system Transfer Devices in Reducing Potential Risk for Surface Contamination Following Simulated Hazardous-drug Preparation and Compounding Page 4
Evaluation of Closed-system Transfer Devices in Reducing Potential Risk for Surface Contamination Following Simulated Hazardous-drug Preparation and Compounding Page 5
Evaluation of Closed-system Transfer Devices in Reducing Potential Risk for Surface Contamination Following Simulated Hazardous-drug Preparation and Compounding Page 6
Evaluation of Closed-system Transfer Devices in Reducing Potential Risk for Surface Contamination Following Simulated Hazardous-drug Preparation and Compounding Page 7
Evaluation of Closed-system Transfer Devices in Reducing Potential Risk for Surface Contamination Following Simulated Hazardous-drug Preparation and Compounding Page 8

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Abstract:  Closed-system transfer devices mitigate occupational exposure risks associated with hazardous-drug handling. This study was conducted in a controlled laboratory to evaluate the effectiveness of a needle-free and a needle-based closed-system transfer device in minimizing surface contamination during simulated compounding, preparation, and administration. A needle-based and a needle-free closed-system transfer device underwent three trials per system. Each trial included reconstituting cyclophosphamide in a vial, withdrawing cyclophosphamide from the vial, and pushing cyclophosphamide into an intravenous bag. After every trial, wipe samples were collected from five sources: biological safety cabinet workbench (left and right sides), biological safety cabinet grill, biological safety cabinet airfoil, and technicians’ gloves. Wipe samples were then analyzed using high-performance liquid chromatography with dual-mass spectrometry to measure cyclophosphamide concentrations. Surface contamination levels from 30 post-trial tests (15 per device) are reported, representing five different surface wipe samples from three trials for each device. Pre-trial samples of precleaned vials and work surfaces were obtained to ensure no cyclophosphamide contamination. Field blank samples were analyzed for quality-control purposes. Post-trial wipe sample analyses following each of the three needle- free trials did not detect cyclophosphamide on the biological safety cabinet workbench (both left/right), biological safety cabinet grill, biological safety cabinet airfoil, or the technician’s gloves. For the needle-based closed-system transfer device, the wipe sample analyses after the first trial showed no contamination; however, cyclophosphamide was detected on the right biological safety cabinet workbench at concentrations of 0.223 ng/cm2 and 0.021 ng/cm2, respectively, following the second and third trials. No cyclophosphamide was found on the technician’s gloves after any of the three needle- based closed-system transfer device trials. Based on surface contamination analyses, this study verified the ability of a needle-free closed-system transfer device in preventing the escape of cyclophosphamide during simulated compounding and preparation. Needle-free closed-system transfer devices warrant consideration for the handling of hazardous drugs.

Related Keywords: Scott Soefje, PharmD, MBA, BCOP, FCCP, FHOPA, Keith Rickabaugh, CIH, Rahul Rajkumar, MD, MPH, Kathryn P. Wall, PhD, closed-system drug transfer devices, surface contamination, occupational exposures, workplace exposure risk, needle, hazardous drugs, cyclophosphamide, antineoplastic agents, cancer chemotherapy, workplace surface sampling, engineering controls

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

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