Safety concerns about medical devices playing important role in health sciences and bioengineering research are rising day by day. Although there are specific standards regarding disposable medical materials, the information is updating with the toxicological studies. In this study, cytotoxic/genotoxic effects of chemicals leaking from serum infusion sets that have an important place in the clinic were investigated. Media containing leakage chemicals were prepared from equal samples taken from the plastic line sections of 13 different brands of serum infusion sets containing phthalates and the effects on the cultured cells were compared with the untreated control groups. To obtain leaking chemicals, extracting period was selected as 72 h, a routine set-change time in the clinic as indicated in various publications. Neutral red uptake and 3-(4,5-dimethylthiazol-2-yl)-2,5-diphenyltetrazolium bromide tests were performed in L929 cells to determine cytotoxicity, and cytokinesis blocked micronucleus technique was performed in lymphocytes to determine genotoxicity. Cytotoxic and genotoxic damage levels were compared by evaluating cell-viability rates relative to control, micronucleus frequency, and nuclear division index values. The results showed that all sets caused a decrease in cell viability revealing the effects both on lysosomal and mitochondrial activity and increase in micronucleus frequencies in general. The number of similar studies is extremely limited, and in this study in addition to the short-term effects of using the serum infusion sets, the information about the sample tests to determine the biosecurity of disposable medical materials is given.
Keywords: cytotoxicity; genotoxicity; micronucleus test; phthalates; serum infusion set.
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