Dunbar Nancy M, Dumont Larry J, Szczepiorkowski Zbigniew M
Department of Pathology and Laboratory Medicine, Dartmouth-Hitchcock Medical Center, Lebanon, New Hampshire.
Department of Medicine, Dartmouth-Hitchcock Medical Center, Lebanon, New Hampshire.
Transfusion. 2016 Jun;56(6):1262-6. doi: 10.1111/trf.13577. Epub 2016 Mar 28.
Regulations surrounding blood components are designed to maintain safety, purity, and potency of products used for transfusion and further manufacture. These regulations evolve in response to risks and available options to reduce risk. Recent updates to the Code of Federal Regulations require transfusion services to take steps to control bacterial contamination of platelets (PLTs) using Food and Drug Administration (FDA)-approved or cleared devices and to identify contaminating organisms and notify the donor if the organism is likely to represent an endogenous infection. The recently published FDA draft guidance describing bacterial testing to enhance the safety and availability of PLTs outlined the steps for hospital transfusion services to extend apheresis PLT dating for up to 7 days. Newly cleared storage containers and a bacterial detection device labeled as a "safety measure" now provide the opportunity for hospital transfusion service to implement routine use of Day 6 and Day 7 PLTs. As one of the first adopters of this approach, we provide a detailed description of our own implementation process including the required update to our FDA registration, supplier agreement modification, laboratory information system changes, and process modifications necessary to support this practice change.
围绕血液成分的法规旨在确保用于输血和进一步制造的产品的安全性、纯度和效力。这些法规会根据风险和降低风险的可用选项而不断演变。最近对《联邦法规法典》的更新要求输血服务机构采取措施，使用美国食品药品监督管理局（FDA）批准或认可的设备控制血小板（PLT）的细菌污染，并识别污染微生物，若该微生物可能代表内源性感染，则通知献血者。最近发布的FDA指导草案描述了加强PLT安全性和可用性的细菌检测，概述了医院输血服务机构将单采血小板保存期延长至7天的步骤。新获批的储存容器和一款标记为“安全措施”的细菌检测设备，现在为医院输血服务机构提供了实施第6天和第7天血小板常规使用的机会。作为最早采用这种方法的机构之一，我们详细描述了我们自己的实施过程，包括对FDA注册的必要更新、供应商协议修改、实验室信息系统变更以及支持这种实践变更所需的流程修改。
