Evaluation of Brazilian medical devices using agar diffusion cytotoxicity assay

Revista Brasileira de Hematologia e Hemoterapia

Mirian N. P. Vidal²  Claudia Aiub¹  Shirley Abrantes¹  Helena P. S. Zamith¹ 

[1],Fundação Oswaldo CruzRio de Janeiro RJ

关键词: Cytotoxicity;    L929 cells;    latex;    medical devices;    PVC;    Citotoxicidade;    células L929;    látex;    dispositivos médicos;    PVC;   

DOI  :  10.1590/S1516-84842009000200009

来源: SciELO

【 摘 要 】

Over the last decades, governmental actions and mechanisms created to protect consumer rights have been linked to a growing effort to guarantee the quality and reliability of products. Samples of condoms (latex), medical devices and blood bags (PVC - polyvinyl chloride) have been tested using the agar diffusion assay. This assay evaluates the cytotoxicity induced by biomaterials by measuring the biological reactivity of mammalian cell cultures in contact with these materials. PVC is used in the production of medical devices because of its specific properties, such as flexibility, obtained after the addition of plasticizers (phthalates), which can cause toxicity even at low doses. Latex is a natural elastomer used for surgical gloves and condoms with a formulation that includes dispersion of liquid latex and chemicals, such as antioxidants and a vulcanizing accelerator, both of which are able to induce cytotoxicity. Samples were analyzed by the National Institute of Quality Control in Health - INCQS of the Oswaldo Cruz Foundation (Fiocruz) in accordance with the governmental sanitary surveillance actions on respect to the quality control. We observed an increase in the quality of the products in relation to the results of the agar diffusion assay during the period between 2000 and 2007. This situation, together with other actions, reflects in an improvement in the quality of products that can be translated in the health of the population.

【 授权许可】

CC BY-NC-ND   
 All the contents of this journal, except where otherwise noted, is licensed under a Creative Commons Attribution License