Evaluation of Brazilian medical devices using agar diffusion cytotoxicity assay

Vidal, M. N. P.; Aiub, Cláudia Alessandra Fortes; Abrantes, Shirley de Mello Pereira; Zamith, Helena Pereira da Silva

doi:10.1590/s1516-84842009000200009

Cited by 3 publications

(4 citation statements)

References 7 publications

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“…Latex cytotoxicity is well documented on the scientific literature [4], and several authors already employed it as a positive control in toxicity assays [5][6][7][8]. The present study focused on accessing the cytotoxicity obtained in test of three different sources of this material.…”

Section: Resultsmentioning

confidence: 97%

Evaluation of Commercial Latex as a Positive Control for <i>In Vitro</i> Testing of Bioceramics

Lourenço

Côrtes

Costa

et al. 2014

KEM

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Several tests for the biological evaluation of bioceramic materials and medical devices are provided in specific international standards, where in vitro tests have a major role. Tests involving exposure of cells in culture require the use of validated positive controls, which, in the same preparation and treatment conditions, present a substantial and well-known cytotoxicity. The present work aimed to test and validate 3 different sources of low cost, commercially available latex, as positive controls in cytotoxicity tests for bioceramic materials performed by indirect exposure. The tested origins for latex samples were: surgical gloves without powder, 100% pure amber latex hospital-grade tourniquets and 60 % latex White tubing. MC3T3-E1 murine pre-osteoblasts in culture were exposed to conditioned media (extracts) of each material tested, along with sintered stoichiometric hydroxyapatite bioceramics, and polystyrene beads as negative control. Cell viability was determined by XTT and Crystal Violet Exclusion tests. Concentration curves of the extracts were performed to obtain the DC50. Only the 100% pure amber latex tubing was proven to be cytotoxic, with cell survival less than 5%. This material did not affected neighboring groups at the same experimental system. Moreover, latex samples showed great repeatability in different tests against latex and biomaterials, with consistent toxicity under 20% cell survival as shown in 3 different cell viability parameters. We conclude that fragments of latex ambar tubing are suited as effective positive controls in tests of medical bioceramic materials.

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Section: Resultsmentioning

confidence: 97%

Evaluation of Commercial Latex as a Positive Control for <i>In Vitro</i> Testing of Bioceramics

Lourenço

Côrtes

Costa

et al. 2014

KEM

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“…Since the 22 nd USP review, the agar diffusion test has been introduced as an in vitro biological reactivity assay to assess the safety of plastics for medical use [15,47,48].…”

Section: In Vitro Cytotoxicity Assay By the Agar Diffusion Methods (Inmentioning

confidence: 99%

“…Conversely, medical devices are medical equipment and products made from metal, rubber, glass or fabrics [11][12][13][14][15].…”

Section: Relationship Between Biotechnology and Medical Devicesmentioning

confidence: 99%

“…Therefore, special attention should be paid to the following: a) Selection of the used materials, particular regarding their toxicity, and where applicable, flammability b) Compatibility of the used materials and compatibility between materials and biological tissues, cells and body fluids, according to the intended use of the medical device Health products must be designed, manufactured and packaged in a way that minimizes the risk presented by contaminants and residues to people involved in their transport, storage, and use, as well as to patients, considering the intended purpose of the product. Special attention should be paid to exposed tissues and the duration and frequency of exposure [15,18]. Health products must be designed and manufactured in a way that the risks associated with derivative substances released from these products are reduced to a minimum [19].…”

Section: Safety and Efficacy Of Health Productsmentioning

confidence: 99%

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

Vidal¹,

Granjeiro²

2017

JBiSE

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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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Agar difusion cytotoxicity assay for medical devices evaluation

Bueno¹

2009

Rev. Bras. Hematol. Hemoter.

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Evaluation of Brazilian medical devices using agar diffusion cytotoxicity assay

Cited by 3 publications

References 7 publications

Evaluation of Commercial Latex as a Positive Control for <i>In Vitro</i> Testing of Bioceramics

Evaluation of Commercial Latex as a Positive Control for <i>In Vitro</i> Testing of Bioceramics

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

Agar difusion cytotoxicity assay for medical devices evaluation

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