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Master's Dissertation
DOI
10.11606/D.9.1985.tde-27052008-112629
Document
Author
Full name
Terezinha de Jesus Andreoli Pinto
E-mail
Institute/School/College
Knowledge Area
Date of Defense
Published
São Paulo, 1985
Supervisor
Committee
Saito, Takako (President)
Grecchi, Roberto
Magalhães, João Fernandes
Title in Portuguese
Controle de qualidade de produtos médico-hospitalares: característica de biocompatibilidade em materiais poliméricos
Keywords in Portuguese
Biocompatibilidade
Controle da qualidade
Polímeros
Abstract in Portuguese
Alguns correlatos, principalmente dispositivos para uso médico-hospitalar, não protéticos, produzidos e ou comercializados no Brasil foram submetidos à análise, visando averiguar algumas características relacionadas com a biocompatibilidade. Além disto, foi verificado o cumprimento legal dos fabricantes dos mesmos quanto à comercialização destes produtos. Foram amostrados 11 tipos de correlatos (cateter intravenoso, equipo de administração parenteral, escalpo, seringa hipodérmica, torneira três vias, sonda endotraqueal, bandeja de circulação extracorpórea, oxigenador sanguíneo, reservatório de cardiotomia, bainha urinária e preservativo), perfazendo 72 lotes. Além disto, 14 lotes de algumas matérias-primas foram submetidos à análise. As determinações analíticas para avaliação das amostras foram: toxicidade sistêmica aguda em camundongos, toxicidade intramuscular aguda em coelhos, citotoxicidade em cultura celular, esterilidade, endotoxinas e pH do extrato. Todos os produtos atenderam à exigência legal de comercialização, pelo menos no tocante ao nome do produto, identificação do ciclo produtivo industrial e nome do fabricante, dados que devem constar na embalagem do produto. Com relação às características dos produtos, 12 lotes dentre 72 acusaram citotoxicidade, seja pelo teste "in vivo" ou "in vitro". Frente a outras provas nenhuma amostra mostrou-se tóxica ou contaminada. Entre matérias-primas, 4 amostras dos 14 lotes acusaram resposta tóxica ou por provas "in vivo" ou "in vitro".
Title in English
Quality control of medical devices: biocompatibility features in polimeric materials
Keywords in English
Biocompatibility
Polymers
Quality control
Abstract in English
Some medical devices, mainly medical-hospital ones, not prosthetic ones, produced and or commercialized in Brazil were analysed with the purpose of verifying some features related to biocompatibility. Add to that, legal conformity of manufacturers referring to commercialization of this kind of products were checked. It was sampled 11 kinds of medical devices (intravenous catheter, infusion assembly, scalp, syringer, three way stopcock, tracheal tube, extra corporeal pack, blood oxygenator, cardiotomy reservoir,uro sheath and preservative), performing 72 lots. Also 14 raw material lots were tested. Analytical determinations for sample analysis were: acute systemic toxicity in mouse, acute intramuscular tissue toxicity, cell culture toxicity, sterility, endotoxins and pH of extraction medium. Whole products were in accordance with law requirements,at least referring to product name, production cycle identification and manufacturer's name on pack. Relating to product features, 12 of the 72 lots were citotoxic by "in vivo" or "in vitro" test. According to other kind of tests, neither of them was toxic or contaminated. Among raw material samples 4 of the 14 lots were toxic "in vivo" or "in vitro" tests.
 
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Publishing Date
2008-05-28
 
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