Evaluation of Brazilian medical devices using agar diffusion cytotoxicity assay

Detalhes bibliográficos
Autor(a) principal: Vidal,Mirian N. P.
Data de Publicação: 2009
Outros Autores: Aiub,Claudia, Abrantes,Shirley, Zamith,Helena P. S.
Tipo de documento: Artigo
Idioma: eng
Título da fonte: Revista brasileira de hematologia e hemoterapia (Online)
Texto Completo: http://old.scielo.br/scielo.php?script=sci_arttext&pid=S1516-84842009000200009
Resumo: 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.
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spelling Evaluation of Brazilian medical devices using agar diffusion cytotoxicity assayCytotoxicityL929 cellslatexmedical devicesPVCOver 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.Associação Brasileira de Hematologia e Hemoterapia e Terapia Celular2009-04-01info:eu-repo/semantics/articleinfo:eu-repo/semantics/publishedVersiontext/htmlhttp://old.scielo.br/scielo.php?script=sci_arttext&pid=S1516-84842009000200009Revista Brasileira de Hematologia e Hemoterapia v.31 n.2 2009reponame:Revista brasileira de hematologia e hemoterapia (Online)instname:Associação Brasileira de Hematologia e Hemoterapia e Terapia Celular (ABHHTC)instacron:ABHHTC10.1590/S1516-84842009000200009info:eu-repo/semantics/openAccessVidal,Mirian N. P.Aiub,ClaudiaAbrantes,ShirleyZamith,Helena P. S.eng2009-05-25T00:00:00Zoai:scielo:S1516-84842009000200009Revistahttp://www.rbhh.org/pt/archivo/https://old.scielo.br/oai/scielo-oai.phpsbhh@terra.com.br||secretaria@rbhh.org1806-08701516-8484opendoar:2009-05-25T00:00Revista brasileira de hematologia e hemoterapia (Online) - Associação Brasileira de Hematologia e Hemoterapia e Terapia Celular (ABHHTC)false
dc.title.none.fl_str_mv Evaluation of Brazilian medical devices using agar diffusion cytotoxicity assay
title Evaluation of Brazilian medical devices using agar diffusion cytotoxicity assay
spellingShingle Evaluation of Brazilian medical devices using agar diffusion cytotoxicity assay
Vidal,Mirian N. P.
Cytotoxicity
L929 cells
latex
medical devices
PVC
title_short Evaluation of Brazilian medical devices using agar diffusion cytotoxicity assay
title_full Evaluation of Brazilian medical devices using agar diffusion cytotoxicity assay
title_fullStr Evaluation of Brazilian medical devices using agar diffusion cytotoxicity assay
title_full_unstemmed Evaluation of Brazilian medical devices using agar diffusion cytotoxicity assay
title_sort Evaluation of Brazilian medical devices using agar diffusion cytotoxicity assay
author Vidal,Mirian N. P.
author_facet Vidal,Mirian N. P.
Aiub,Claudia
Abrantes,Shirley
Zamith,Helena P. S.
author_role author
author2 Aiub,Claudia
Abrantes,Shirley
Zamith,Helena P. S.
author2_role author
author
author
dc.contributor.author.fl_str_mv Vidal,Mirian N. P.
Aiub,Claudia
Abrantes,Shirley
Zamith,Helena P. S.
dc.subject.por.fl_str_mv Cytotoxicity
L929 cells
latex
medical devices
PVC
topic Cytotoxicity
L929 cells
latex
medical devices
PVC
description 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.
publishDate 2009
dc.date.none.fl_str_mv 2009-04-01
dc.type.driver.fl_str_mv info:eu-repo/semantics/article
dc.type.status.fl_str_mv info:eu-repo/semantics/publishedVersion
format article
status_str publishedVersion
dc.identifier.uri.fl_str_mv http://old.scielo.br/scielo.php?script=sci_arttext&pid=S1516-84842009000200009
url http://old.scielo.br/scielo.php?script=sci_arttext&pid=S1516-84842009000200009
dc.language.iso.fl_str_mv eng
language eng
dc.relation.none.fl_str_mv 10.1590/S1516-84842009000200009
dc.rights.driver.fl_str_mv info:eu-repo/semantics/openAccess
eu_rights_str_mv openAccess
dc.format.none.fl_str_mv text/html
dc.publisher.none.fl_str_mv Associação Brasileira de Hematologia e Hemoterapia e Terapia Celular
publisher.none.fl_str_mv Associação Brasileira de Hematologia e Hemoterapia e Terapia Celular
dc.source.none.fl_str_mv Revista Brasileira de Hematologia e Hemoterapia v.31 n.2 2009
reponame:Revista brasileira de hematologia e hemoterapia (Online)
instname:Associação Brasileira de Hematologia e Hemoterapia e Terapia Celular (ABHHTC)
instacron:ABHHTC
instname_str Associação Brasileira de Hematologia e Hemoterapia e Terapia Celular (ABHHTC)
instacron_str ABHHTC
institution ABHHTC
reponame_str Revista brasileira de hematologia e hemoterapia (Online)
collection Revista brasileira de hematologia e hemoterapia (Online)
repository.name.fl_str_mv Revista brasileira de hematologia e hemoterapia (Online) - Associação Brasileira de Hematologia e Hemoterapia e Terapia Celular (ABHHTC)
repository.mail.fl_str_mv sbhh@terra.com.br||secretaria@rbhh.org
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