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FDA Bacterial Risk Control Strategies for Blood Collection Establishments and Transfusion Services to Enhance the Safety and Availability of Platelets for Transfusion

蒋千琴 11/3/2021 浏览 285 FDA U.S

标准简介

Bacterial Risk Control Strategies for Blood Collection Establishments and Transfusion Services to Enhance the Safety and Availability of Platelets for Transfusion[附网盘链接]是Food&Drug Administration发布的FDA标准，适用于U.S。

标准截图

Bacterial Risk Control Strategies for Blood Collection Establishments and Transfusion Services to Enhance the Safety and Availability of Platelets for Transfusion[附网盘链接]
Bacterial Risk Control Strategies for Blood Collection Establishments and Transfusion Services to Enhance the Safety and Availability of Platelets for Transfusion[附网盘链接](截图)

 

标准文档说明

标准文档类型为Bacterial Risk Control Strategies for Blood Collection Establishments and Transfusion Services to Enhance the Safety and Availability of Platelets for Transfusion[附网盘链接]高清PDF版本（文字版），标准文档内可进行搜索，可以复制原文，可粘贴。

标准部分原文

Bacterial Risk Control Strategies for Blood Collection Establishments and Transfusion Services to Enhance the Safety and Availability of Platelets for Transfusion Guidance for Industry This guidance represents the current thinking of the Food and Drug Administration (FDA or Agency) on this topic. It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations. To discuss an alternative approach, contact the FDA staff responsible for this guidance as listed on the title page. I. INTRODUCTION We, FDA, are issuing this guidance document to provide you, blood collection establishments and transfusion services, with recommendations to control the risk of bacterial contamination of 1

room temperature stored platelets intended for transfusion. The recommendations in this guidance apply to all platelet products stored at room temperature in plasma or additive solutions, including platelets manufactured by automated methods (apheresis platelets), and Whole Blood derived (WBD) single and pooled (pre-storage and post-storage) platelets. Additionally, this guidance provides licensed blood establishments with recommendations on how to report implementation of manufacturing and labeling changes under Title 21 of the Code of Federal Regulations (CFR) 601.12. This guidance updates the final guidance of the same title dated September 2019. The September 2019 guidance finalized the draft guidance of the same title dated December 2018. We received numerous comments from blood collection establishments requesting an extension of the implementation timeframe because of various unforeseen challenges, including responding to the COVID-19 public health emergency. Consequently, we have extended the recommended implementation timeframe in section VI. of the guidance. In addition, we clarified the recommendations for submission of information in a prior approval supplement submission in section IV.A.2.f. and g. of the guidance. We also removed a footnote regarding the lack of appropriately labeled devices for implementation of the large volume, delayed sampling no sooner than 48 hours strategy for a 7-day dating period in section III.B.1.b. of the guidance because of a recent device clearance. 1

Cold storage (1 to 6°C) of platelet products as a strategy to control bacterial risk is outside the scope of this guidance document. However cold storage of platelets may be found acceptable by FDA as an approach to assure that the risk of bacterial contamination is adequately controlled. Blood establishments should discuss with FDA methods of preparation and storage of cold-stored platelets.

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