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血液采集与不稳定血液成分:监管机构应该要求什么?

Blood collection and the labile blood components: what should the regulators ask for?

作者信息

Maniatis A, Adamides E

机构信息

Laboratory Hematology and Transfusion Medicine, University of Patras, Medical School, Greece.

出版信息

Vox Sang. 1998;74 Suppl 2:523-5. doi: 10.1111/j.1423-0410.1998.tb05468.x.

DOI:10.1111/j.1423-0410.1998.tb05468.x
PMID:9704493
Abstract

Efforts to promote the quality and safety of blood collection are underway in most European Union (EU) member states but the level of quality management continues to differ significantly not only between countries but also among Blood Collection Establishments (BCE's) within a country. The European Commission has asked for blood safety and self-sufficiency in the Community and has initiated action in this direction. What is sought is harmonization of practices in the transfusion chain but such cannot be accomplished solely through recommendations and directives given the sociocultural and economic differences among EU member states. Active support for the development of common standards and a common quality system as well as an inspection and accreditation system would certainly help. The goal of self-sufficiency should certainly be emphasized but may be difficult to achieve, given the unpredictability of factors that may affect demand and supply. Through bipartisan initiatives however, between the USA and EU, consensus regarding the issue of blood safety, could be reached.

摘要

大多数欧盟成员国正在努力提高采血的质量和安全性,但质量管理水平不仅在不同国家之间,而且在一个国家内的采血机构(BCE)之间仍存在显著差异。欧盟委员会要求实现共同体血液安全和自给自足,并已朝着这个方向采取行动。我们寻求的是输血链中操作的协调统一,但鉴于欧盟成员国之间的社会文化和经济差异,仅靠建议和指令是无法实现这一点的。积极支持制定共同标准、共同质量体系以及检查和认证体系肯定会有所帮助。自给自足的目标当然应该得到强调,但鉴于可能影响供需的因素具有不可预测性,这一目标可能难以实现。然而,通过美国和欧盟之间的两党倡议,可以就血液安全问题达成共识。

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