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6ER-012 Evaluation of the effect of closed system transfer device syringe adaptor connection in the isolator on cytotoxic residue contamination during intravenous administration
  1. L Knowles
  1. University of Manchester, Faculty of Medical and Human Sciences, Manchester, UK


Background and Importance The European Biosafety Network recommends that cytotoxic drug surface contamination in pharmacy and patient wards not exceed 0.1 ng/cm2. Among other mitigations, closed system transfer devices (CSTDs) are recommended in several guidances in the US, Europe, and UK for reduction of surface contamination. In the UK, CSTDs are not part of standard cytotoxic preparation procedures in isolators, but the NHS recommends the use of CSTD syringe adaptors (SAs) with syringes used for intravenous administration. At University Hospitals Birmingham, standard practice is to connect Luer caps in the isolator and remove them for administration.

Aim and Objectives The aim was to determine if the addition of a CSTD SA in the isolator reduces cytotoxic residue contamination during intravenous bolus administration.

Material and Methods Surface contamination of syringes, gauze pads placed at the administration site, and nurses’ gloves were compared between two procedures: connecting AMD hub caps in the isolator and removal in the ward vs. connecting Tevadaptor SA Locks (SALs) in the isolator during preparation.

In a negative pressure isolator, 25 cyclophosphamide syringes were prepared with hub caps and 25 with SALs. Syringes were wiped with 50% methanol prior to removal from the isolator. In the ward, syringes were swabbed. Gauze pads placed under connection sites for bolus administration were collected. Following administration, nurses’ gloves were swabbed. Cyclophosphamide on swabs and gauze pads was quantified by LC/MS.

When SALs replaced hub caps median cyclophosphamide contamination decreased from 8.29 ng to 0.62 ng on syringes, from 384.82 ng to 0.01 ng on gauze pads, and from 1.11 ng to 0.00 ng on gloves. When hub caps were used, 12/25 syringes, 19/25 gauze pads, and 2/25 gloves exceeded the recommended limit of 0.1 ng/cm2, while with SAL, no samples exceeded this limit.

Conclusion and Relevance Addition of Tevadaptor SALs to syringes in the isolator reduced cytotoxic residue on syringe surfaces, nurses’ gloves, and on connect/disconnect, compared to the addition of standard hub caps. Thus, Tevadaptor SALs are beneficial in reducing cytotoxic drug exposure to nurses administering IV syringes and may reduce the risk of mutagenic adverse events.

References and/or Acknowledgements Partial funding provided by B. Braun Medical and Simplivia Healthcare Ltd.

Conflict of Interest Conflict of interest.

Corporate sponsored research or other substantive relationships:

The author has no conflict of interest. to declare. Elana Slutsky Smith, who assisted with the submission process, is employed by Simplivia Healthcare, Ltd., the manufacturer of the Tevadaptor CSTD.

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