title: In vitro toxicity of infusion sets depends on their composition, storage time and storage conditions.
abstract: Disposable medical devices release toxic leachables during their clinical use. Specifically, the individual parts of the infusion sets (the drip chamber, tube, flashball and injection site) are composed of numerous chemical compounds that can reach the patients' systemic circulation and induce local and systemic toxic effects. We aimed to reveal the relative in vitro toxicity of infusion sets from the leading vendors that are used in Israel, and to determine its dependence on their design and storage time/conditions. We found that leachates of the rubber parts were more toxic than those of the other parts of the infusion sets. The measured toxicity was affected by the experimental settings: the cells, medium composition, exposure duration, and the type of assay applied for toxicity assessment. We recommend to use the capillary endothelium cells for in vitro toxicity testing of the infusion sets, and refrain from the use of the MTT test which is insufficiently reliable, and can lead to artefacts and incorrect conclusions. Further investigation is needed to identify the toxic leachables from the individual parts of the infusion sets, and to reveal the risk of their toxicity during the clinical use of the infusion sets.
authors.affiliation: Department of Clinical Biochemistry and Pharmacology, The Faculty of Health Sciences, Ben-Gurion University of the Negev, Beer Sheva, Israel.
authors.forename: Luba
authors.initials: L
authors.lastname: Kozlovskaya
authors.affiliation: Drug and Medical Equipment Research & Quality Control Laboratory, Israeli Defense Forces Medical Corps, Israel.
authors.forename: Hen
authors.initials: H
authors.lastname: Popilski
authors.affiliation: Drug and Medical Equipment Research & Quality Control Laboratory, Israeli Defense Forces Medical Corps, Israel.
authors.forename: Pavel
authors.initials: P
authors.lastname: Gorenbein
authors.affiliation: Department of Clinical Biochemistry and Pharmacology, The Faculty of Health Sciences, Ben-Gurion University of the Negev, Beer Sheva, Israel. Electronic address: davidst@bgu.ac.il.
authors.forename: David
authors.initials: D
authors.lastname: Stepensky
mesh_terms: D000818:Animals; D002460:Cell Line; D002470:Cell Survival; D042783:Endothelial Cells / Q000187:drug effects; D004869:Equipment Safety; D007263:Infusions, Parenteral / Q000295:instrumentation*; D051379:Mice; D012408:Rubber / Q000633:toxicity
chemical_list: D012408:Rubber
keywords: Disposable medical devices; Forced degradation experiments; In vitro toxicity analysis; Infusion sets; Natural and synthetic rubber latex; Toxic leachables