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Managing recalls and withdrawals of blood components.
Transfusion Medicine Reviews ( IF 2.7 ) Pub Date : 2004-01-01 , DOI: 10.1016/j.tmrv.2003.10.005
Glenn Ramsey 1
Affiliation  

Donor centers are issuing a growing number of recalls and market withdrawals to hospital transfusion services about blood components. More than 1 in 2,000 units were recalled in the late 1990s in the United States. The most common reason for these notices from donor centers is postdonation donor information. Most of these units had been transfused, and many present a "risk of a risk" (ie, a problem might have been present that might have affected the recipient). A few regulations and standards address recalls in general terms, but transfusion services generally have wide discretion in the management of specific common recall problems. The Food and Drug Administration (FDA) is now including posttransfusion evaluations in its guidelines for emerging infectious threats to the blood supply. We suggest that hospital transfusion services should have standard operating procedures for managing recalls and that the hospital transfusion committee and the quality management program should provide local input or oversight. Using the FDA's categories of donor center biological product deviations, we provide recommendations to consider for when to notify the recipient's physician, after postdonation information is received about a previously transfused blood component. More study of this important everyday issue in transfusion medicine is highly desirable.

中文翻译:

管理血液成分的召回和撤回。

捐献中心正在就血液成分向医院输血服务部门发出越来越多的召回和市场撤回通知。在1990年代后期,美国召回了2,000多个单位中的1个。捐赠中心发出这些通知的最常见原因是捐赠后的捐赠者信息。这些单位大多数已被输血,许多单位存在“风险风险”(即可能存在可能影响接收者的问题)。一些法规和标准以通用术语解决召回问题,但是输血服务通常在管理特定的常见召回问题方面拥有广泛的酌处权。美国食品药品监督管理局(FDA)现在将输血后评估纳入其针对血液供应的新发传染性威胁的指南中。我们建议医院输血服务部门应具有用于管理召回的标准操作程序,并且医院输血委员会和质量管理计划应提供本地意见或监督。使用FDA的供体中心生物产品偏差类别,我们提供建议,考虑在收到有关先前输血成分的信息后,何时通知接受者的医生。迫切需要对输血医学中这一重要的日常问题进行更多的研究。在收到有关先前输血成分的捐赠信息后,我们提供建议,考虑何时通知接收者的医生。迫切需要对输血医学中这一重要的日常问题进行更多的研究。在收到有关先前输血成分的捐赠信息后,我们提供建议,考虑何时通知接收者的医生。迫切需要对输血医学中这一重要的日常问题进行更多的研究。
更新日期:2019-11-01
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