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Evaluation of Closed-system Transfer Devices in Reducing Potential Risk for Surface Contamination Following Simulated
Scott Soefje1, Keith Rickabaugh2, Rahul Rajkumar3
1Mayo Clinic, Rochester, Minnesota. Soefje.Scott@mayo.edu.
International Journal of Pharmaceutical Compounding
|January 26, 2022
Summary
Needle-free closed-system transfer devices effectively prevent surface contamination from hazardous drugs like cyclophosphamide during compounding. Needle-based systems showed some contamination, highlighting the safety benefits of needle-free options for healthcare professionals.
Area of Science:
- Pharmaceutical Compounding and Drug Handling Safety
- Occupational Health and Safety in Healthcare
- Analytical Chemistry and Contamination Detection
Background:
- Hazardous drug handling poses significant occupational exposure risks for healthcare professionals.
- Closed-system transfer devices (CSTDs) are designed to mitigate these risks during drug preparation and administration.
- Evaluating the comparative effectiveness of different CSTD designs is crucial for optimizing safety protocols.
Purpose of the Study:
- To evaluate the effectiveness of a needle-free CSTD versus a needle-based CSTD in minimizing surface contamination.
- To assess contamination levels during simulated compounding, preparation, and administration of cyclophosphamide.
- To provide data supporting the selection of safer CSTD technologies for hazardous drug handling.
Main Methods:
- Three simulated trials of cyclophosphamide reconstitution, withdrawal, and IV bag preparation were conducted for both needle-free and needle-based CSTDs.
- Surface wipe samples were collected from the biological safety cabinet (workbench, grill, airfoil) and technician's gloves after each trial.
- Cyclophosphamide concentrations were quantified using high-performance liquid chromatography with dual-mass spectrometry.
Main Results:
- The needle-free CSTD demonstrated no detectable cyclophosphamide contamination on any tested surfaces or gloves across all three trials.
- The needle-based CSTD showed no contamination after the first trial, but detectable cyclophosphamide was found on the workbench in subsequent trials.
- No cyclophosphamide contamination was detected on the technician's gloves when using the needle-based CSTD.
Conclusions:
- The needle-free CSTD effectively prevented cyclophosphamide escape during simulated hazardous drug compounding and preparation.
- Needle-free CSTDs offer a superior solution for minimizing surface contamination compared to needle-based systems in this context.
- Needle-free closed-system transfer devices should be strongly considered for enhancing safety in hazardous drug handling.
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