Toxicity assessment of extracts from infusion sets in cEND brain endothelial cells.
In vitro safety assessment of disposable medical devices, including infusion sets, is usually performed using L-929 mouse keratinocytes. However, cells of different origin (endothelial, lymphoid and myeloid cells) are also exposed to infusion sets' extractables during their clinical use. We studied whether the cEND mouse brain endothelial cells can be suitable for in vitro safety assessment of infusion sets. We analyzed infusion sets from different manufacturers that varied in design and storage time. cEND cells were incubated with extracts of individual parts of the infusion sets (tube, cup, latex), and relative toxicities were analyzed using MTT test, DCFH-DA-based analysis of reactive oxygen species formation, apoptosis and cell cycle analyses. We identified a pattern of yellowing of the infusion sets upon storage and revealed that it originated from the latex part. Extracts of the individual parts of the infusion sets, primarily of the latex, were toxic to the cEND cells leading to induction of apoptosis and cell death. We conclude that infusion sets release extractables that can be toxic to the endothelial cells of the patients that receive infusion. We suggest to use cEND cells for in vitro safety assessment of infusion sets and other medical devices that release extractables to the bloodstream.
Department of Pharmacology, Faculty of Health Sciences, Ben-Gurion University of the Negev, Beer Sheva, Israel.
George R
GR
Dakwar
Veronika
V
Kaplun
Lena
L
Kojukarov
Pavel
P
Gorenbein
Ilana
I
Schumacher
Diana
D
Kontorovich
Carola
C
Förster
Elie
E
Beit-Yannai
David
D
Stepensky
D000818:Animals; D017209:Apoptosis; D001921:Brain / Q000166:cytology / Q000378:metabolism; D002453:Cell Cycle; D002460:Cell Line; D004209:Disposable Equipment; D042783:Endothelial Cells / Q000378:metabolism*; D004869:Equipment Safety; D007260:Infusion Pumps / Q000009:adverse effects*; D007840:Latex / Q000737:chemistry / Q000633:toxicity; D051379:Mice; D017382:Reactive Oxygen Species / Q000378:metabolism*; D013997:Time Factors; D018675:Toxicity Tests / Q000379:methods*
D007840:Latex; D017382:Reactive Oxygen Species