Does the use of a closed system transfer device (DTSC) for administration with elastomeric pumps allow a safe disconnection?

3 October 2019

E. Peyrilles1, H. Levert1, P. Sessink2, I. Madeleine Chambrin1, N. Jourdan Desrayaud1
1 Pharmacy, Saint-Louis Hospital, AP-HP, France.
2 Exposure Control Sweden AB, Backsippevägen 2, 475 37 Bohus-Björkö, Suède.

The administration of antineoplasic drugs represents a potential risk of chemical environmental contamination, especially when they are administered at home. All the guidelines concerning the protection of healthcare professionals recommend the use of DTSC. The objective of this study is to compare in vitro the potential chemical contamination during the disconnection of elastomeric pumps, with / without DTSC (Qimono® / Vygon laboratory).

Material and methods
30 elastomeric pumps of 5-FU were connected to a simulated vascular system (luer-lock (LL) female) using to 3 types of connections (10 elastomeric pumps per group): simple elastomeric pumps (LL male) (group A), elastomeric pumps + bidirectional valve (group B) and elastomeric pumps + DTSC (Qimomale® - Qimofemelle®) (group C). After the nurse pump disconnection, the chemical contamination was measured on the compresses, gloves and on a simulated patient arm surface. The analyses were performed by LC-MSMS method. The detection limit of 5-FU was 0.1 μg. The different groups were compared using the Kruskal-Wallis and Mann-Whitney tests.

The median total contamination of 5-FU (compress + glove + arm) was 158 μg for group A, 140 μg for group B and 95 μg for group C. Results were significantly different between groups A and C (p = 0.0173) and between groups B and C (p = 0.0065). There was no significant difference between groups A and B (p = 0.6232). Regarding gloves and arm contamination, there was no significant difference between the 3 groups. For compresses, the contamination was significantly lower in group C than in group A (p = 0.007) with a reduction of 60 %.

Discussion Conclusion
This is the first study to evaluate direct chemical contamination to which the manipulator is directly exposed. The results show that bidirectional valves do not significantly reduce contamination and therefore cannot be considered as DTSC. The evaluated DTSC significantly reduces global contamination. As there are currently not recommendations about the exposure threshold with a clinical impact, it is not possible to conclude about the impact of the residual chemical contamination. Furthermore, it should be noted, that the manipulation protocol of the study tended to maximize contamination (swabbing of connections). Finally, one other advantage of the Qimofemelle® connection is to be compatible with any male LL connection. This allows flushing and checking the blood reflux with a closed system in accordance with the central venous access guidelines.

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