美国同期血浆和成分血浆的概念及标准

Current considerations on the definitions and standards of US concurrent plasma and component plasma

近年来美国食品与药品管理局(FDA)采纳了美国血库协会(AABB)、美国血液中心(ABC)以及美国红十字血液系统(ARC)等机构关于开放血站分离血浆再利用途径的建议,考虑将美国国内得到许可的分离血浆再分类后用于血液制品生产,分别定义为同期血浆、成分血浆和未满足这2类标准的回收血浆。有关同期血浆和成分血浆的定义、标准等现已不断完善,这将为生产用血浆的来源开辟新的途径,也为我国开展回收血浆再利用提供了借鉴。

Since the adoption of the proposal on developing licensure requirements for recovered plasma for manufacture, FDA has been seeking advice on appropriate definitions and standards for two new licensed plasma products from recovered plasma, either by whole blood collection or by apheresis, which were each defined as concurrent plasma and component plas- ma. This article introduces FDA＇s current considerations of these newly licensed plasma products. It provides references to establish a pathway for recycling suitable but un - transfused plasma in order to manufacture into plasma products.