Cytotoxicity Tests for Evaluating Medical Devices: An Alert for the Development of Biotechnology Health Products

Abstract

The risks and damages related to the use of products, technologies and services of sanitary interest can be due to defects or manufacturing failures. Certain products already contain a certain degree of risk, which requires strict quality control in their production, distribution and use, as well as in the disposal of their waste in the environment. With continuous development in science and technology, medical devices must undergo intradermal irritation and testing for sensitization, cytotoxicity, and acute systemic toxicity. In health care, biotechnology aims to provide technology-based products or processes related to energy, food, and health, which are capable of stimulating new businesses, expanding exports, integrating the value chain and stimulating new demands for innovative products and processes, taking into account health policies. The present article was prepared by a bibliographical survey of the electronic databases PubMed, Lilacs, and Bireme. Cell culture testing can be successfully employed, as it is reproducible, rapid, sensitive, and financially accessible for performing in vitro toxicity testing. Thus, it has been possible to optimize the development phase of new products by decreasing animal use or even replacing them in certain tests. Some in vitro assays validated by the Organization for Economic Cooperation and Development in the area of health products have already replaced animal testing.

Proangiogenic Hypoxia-Mimicking Agents Attenuate Osteogenic Potential of Adipose Stem/Stromal Cells

“…Therefore, we focused on developing a methodology to target a concentration-window that achieved the desired proangiogenic signaling while maintaining the cellular proliferation capacity even during prolonged exposure to the tested PHIs. The optimized concentrations for long-term treatment of AT-MSCs were estimated based on the accepted relative viability percentage of 70% [34,35]. Verification of the suitability of the optimized concentrations also involved cell cycle analysis and apoptosis assay.…”

Characterization and In Vitro Studies of Low Reflective Magnetite (Fe3O4) Thin Film on Stainless Steel 420A Developed by Chemical Method

“…Direct extract method according to ISO 10993-5 standard was used for invitro cytotoxicity assessment [23,24]. The L-929 cell line was used for the study.…”

“…Negative and positive controls gave grades 0 and 4 as expected. The three diluted extracts, 100%, 50%, and 25% of noncoated (control) and coated SS 420A samples have given a grade of 2, which is acceptable by ISO 10993-5 [23,24]. Figure 7A-F are the microscopic images of the L-929 cell line exposed for a duration of 24 h with 100%, 50% and 25% proportions of extracts of non-coated and coated SS 420A.…”

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“…The RBCs remain unlysed and settle to the bottom of the well to form a button. In a negative or nonreactive test, the complement remains free to interact with the blood cells causing them to lyse [30].…”

“…Lysis of these cells (seen as the development of a transparent red solution) is a negative result because it indicates that complement was not activated and that antibody was absent from the serum under test [3]. The complement test is a powerful tool to identify antibodies reacting with antigens, and it permits confirmation of exposure to a specific microorganism [30].…”