Cytotoxicity Tests for Evaluating Medical Devices: An Alert for the Development of Biotechnology Health Products — Oak Academic Publishing
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Cytotoxicity Tests for Evaluating Medical Devices: An Alert for the Development of Biotechnology Health Products
National Institute of Quality Control in Health of the Oswaldo Cruz Foundation (INCQS/FIOCRUZ), Manguinhos, Brasil
,
Fluminense Federal University, Post-Graduation Program in Biotechnology, Niterói, Brazil
,
Quality and Metrology of the National Institute of Metrology, Quality and Technology, Directory of Metrology Applied to Life Sciences, Rio de Janeiro, Brazil
,
The Brazilian Branch of Institute of Biomaterials, Tribocorrosion and Nanomedicine (IBTN), Rio de Janeiro, Brazil
1 National Institute of Quality Control in Health of the Oswaldo Cruz Foundation (INCQS/FIOCRUZ), Manguinhos, Brasil
2 Fluminense Federal University, Post-Graduation Program in Biotechnology, Niterói, Brazil
3 Quality and Metrology of the National Institute of Metrology, Quality and Technology, Directory of Metrology Applied to Life Sciences, Rio de Janeiro, Brazil
4 The Brazilian Branch of Institute of Biomaterials, Tribocorrosion and Nanomedicine (IBTN), Rio de Janeiro, Brazil
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.
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