Leakage from closed-system transfer devices as detected by a radioactive tracer

A study of leakage from selected closed-system transfer devices (CSTDs) under experimental conditions is described.

Three CSTDs (the ChemoClave, OnGuard, and PhaSeal systems) were tested. Nine manufacturer-trained oncology pharmacists and pharmacy technicians volunteered to participate in an experiment to determine the degree of leakage of a liquid test agent (a radioactive technetium isotope [(99m)Tc] diluted in normal saline) during CSTD-assisted transfer of liquid from vials to syringes per standard practices. After such transfers, alcohol prep pads (n = 135 for each system) were used to wipe CSTD points of entry and assessed for the presence of (99m)Tc. Comparisons among participants and devices were conducted via analysis of variance (ANOVA), with the a priori level of significance set at 0.05.

ANOVA results indicated significant differences among devices in leakage of the test solution, with the PhaSeal device having the lowest geometric mean leakage (0.1 nL; 95% confidence interval [CI], 0-0.2 nL), followed by the OnGuard (1.5 nL; 95% CI, 1.1-1.9 nL) and ChemoClave (35.6 nL; 95% CI, 29.1-43.6 nL) devices; each pairwise comparison was significant (p < 0.001). Despite several major limitations, the research supports the use of CSTDs to help protect health care workers, as recommended by federal authorities and professional groups including the American Society of Health-System Pharmacists.

The volume of leakage was significantly less with PhaSeal than with OnGuard and ChemoClave when pharmacists and pharmacy technicians used the three CSTDs and (99m)Tc as a tracer.