Blood, a living tissue circulating throughout the human body, is comprised of red blood cells, white blood cells, platelets and plasma. Although often collected as whole blood and separated into major components prior to transfusion, automated collections have become common practice whereby the components that are needed for transfusion are the only ones collected.
In the U.S., the collection, testing, preparation, storage and transport of blood and blood components is governed by FDA regulations and guidance documents. On behalf of the transfusion medicine community and as part of ongoing collaborative efforts, AABB works directly with FDA and through government advisory committees to ensure the safe and effective collection and transfusion of blood products. In addition, AABB works with other federal agencies, including the Center for Medicare and Medicaid Services, to achieve adequate reimbursement for blood and blood products.
AABB, America's Blood Centers (ABC) and the American Red Cross (ARC) submitted joint comments to the Food and Drug Administration in response to the agency's January 2017 draft guidance, “Labeling of Red Blood Cell Units with Historical Antigen Typing Results.” The organizations expressed support for the draft recommendations to label red blood cells based on the results of historical antigen testing from two previous donations, without requiring antigen-typing the current donation.
The Food and Drug Administration issued a draft guidance,
Labeling of Red Blood Cell Units with Historical Antigen Typing Results, with recommendations on using historical antigen typing results performed previously by blood collectors.
AABB posted an
updated list of components on the Circular of Information webpage following the approval for platelets collected in 100 percent plasma to be further processed using Pathogen Reduction Technology (PRT). The list updates the interim language and includes information that automated collections, further processed using PRT, must be collected on platforms that have received specific FDA approval for that purpose.
The Food and Drug Administration
posted new approvals for the SOLX System (Haemonetics’ Leukotrap Whole Blood System(CPD). SOLX is manufactured by Hemerus Medical, LLC. In addition to the more traditional red blood cells, fresh frozen plasma and Plasma Frozen Within 24 Hours After Phlebotomy (PF24), Haemonetics received FDA approval to hold whole blood collections at room temperature for up to 24 hours after collection. This approval will enable blood establishments to manufacture Plasma Frozen Within 24 Hours After Phlebotomy Held at Room Temperature Up to 24 Hours After Phlebotomy (PF24RT24) without affecting the 42-day shelf-life of the AS-7 Red Cells, Leukocytes Reduced. To view the complete listing of approved components, it is necessary to access the document titled
SOLX System - Instructions for Use.
Pathogen reduction interim language for use in the November 2013 Circular of Information was found acceptable by the FDA and posted on the AABB website. The
interim language developed by AABB’s Circular of Information Task Force and its FDA liaisons will be incorporated at a later date into the Further Processing section of the Circular of Information for the Use of Human Blood and Blood Components. The language describes further processing of blood components using pathogen reduction technology. Suggested methods for inserting interim language into the Circular include use of an adhesive label or an ink stamp. The version date of the Circular should not be changed.
FDA issued a
final rule that requires written notification to the agency of a permanent discontinuance or interruption in biological products manufacturing that is likely to lead to supply disruptions in the United States. The requirements apply to blood establishments that manufacture a significant percentage of the U.S. blood supply [600.82(f)]. “Based on 2011 NBCUS data, this would be more than 1.5 million units of whole blood annually or approx. 125,000 units per month.” The rule is effective Sept. 8, 2015.
analysis of the Final Rule, “Requirements for Blood and Blood Components Intended for Transfusion or for Further Manufacturing Use” is now available online. An attachment to the analysis — prepared for educational purposes only — depicts amended sections of Title 21 of the Code of Federal Regulations (CFR). High profile revisions to the CFR include FDA’s decision to raise the minimum hemoglobin requirement for male donors to 13.0 g/dL and the new section on control of bacterial contamination of platelets. The final rule, reflected in updated sections of the CFR, becomes effective on May 23, 2016.