Evaluation of the effect of closed system transfer device syringe adaptor connection in the isolator on cytotoxic residue contamination during intravenous administration.

Abstract

IntroductionThe European Biosafety Network recommends that cytotoxic drug surface contamination in pharmacies and patient wards not exceed 0.1 ng/cm². Among other mitigations, closed system transfer devices (CSTDs) are recommended in the US, Europe, and UK for the reduction of surface contamination. Although in the UK CSTDs are not part of standard cytotoxic preparation procedures in isolators, CSTD syringe adaptors are recommended for use with syringes for intravenous administration. We investigated whether the addition of a CSTD syringe adaptor in the isolator reduces cytotoxic residue contamination during intravenous bolus administration.MethodsTwenty-five cyclophosphamide syringes were prepared with hub caps and twenty-five with SIMPLIVIA^® (formerly Tevadaptor/OnGuard^®) Syringe Adaptor Locks (SALs) in an isolator. Surface contamination of syringes, gauze pads placed at the administration site, and nurses' gloves was compared between the practice of connecting hub caps in the isolator and removing them in the ward versus connecting SALs in the isolator during preparation. Cyclophosphamide contamination was quantified by liquid-chromatography mass spectrometry.ResultsUse of SALs compared to standard hub caps led to statistically significant reduction in cyclophosphamide contamination on the syringes (2.41 ± 0.89 ng versus 33.42 ± 8.48 ng, p = 0.0007), the swabs used for connect/disconnect (0.01372 ± 0.01 ng versus 655.80 ± 190.18 ng, p = 0.001), and nurses' gloves (0.0009 ± 0.0009 ng versus 8.31 ± 3.94 ng, p = 0.04). When hub caps were used, 48% of syringes, 76% of gauze pads, and 8% of gloves exceeded the recommended limit of 0.1 ng/cm², while no samples exceeded this limit with SAL.ConclusionsThe implementation of CSTD syringe adaptors was beneficial for reducing cytotoxic drug exposure to nurses administering intravenous syringes.