Decreto-Lei n.º 100/2011, de 29 de Setembro de 2011
Decreto-Lei n. 100/2011
de 29 de Setembro
O Decreto -Lei n. 267/2007, de 24 de Julho, estabelece o regime jurídico da qualidade e segurança do sangue humano e dos componentes sanguíneos, respectivas exigências técnicas, requisitos de rastreabilidade e notificaçáo de reacçóes e incidentes adversos graves e as normas e especificaçóes relativas ao sistema de qualidade dos serviços de sangue, com vista a assegurar um elevado nível de protecçáo da saúde pública, transpondo para a ordem jurídica nacional as Directivas n.os 2002/98/CE, do Parlamento Europeu e do Conselho, de 27 de Janeiro de 2003, 2004/33/CE, da Comissáo, de 22 de Março, 2005/61/CE, da Comissáo, de 30 de Setembro, e 2005/62/CE, da Comissáo, de 30 de Setembro.
O n. 2.4 do anexo XIV do referido diploma fixa entre outras coisas os níveis de pH mínimos (6,4) e máximos (7,4) para as unidades de plaquetas no fim do período de armazenamento, sendo que as unidades que náo respeitem os valores mínimos ou máximos estabelecidos têm de ser rejeitadas.
No entanto, dados científicos recentes e a experiência prática de campo demonstram que valores de pH superiores a 7,4 náo afectam a qualidade e a segurança das plaquetas armazenadas, sendo assim desnecessária a definiçáo de um valor máximo de pH para concentrados de plaquetas no fim do período de armazenamento.
A rejeiçáo de plaquetas que excedam o valor de pH máximo fixado no anexo XIV do referido diploma gera perdas consideráveis. Essas perdas podem aumentar...
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