Platelets, also known as thrombocytes, are very small cellular components of blood that are made in the bone marrow and survive in the circulatory system for an average of nine to 10 days. Considered a vital element of blood, platelets aid blood clotting by sticking to the lining of blood vessels, preventing possible day-to-day leakage as well as massive blood loss often associated with trauma. They are used to treat a condition called thrombocytopenia as well as for patients undergoing treatment for leukemia, cancer, aplastic anemia and marrow transplants, and can be collected either from donated whole blood or by plateletpheresis. Platelets collected by apheresis can be stored for only five days, unless the establishment is using an FDA-approved protocol that allows for seven-day storage.
AABB works on behalf of the transfusion medicine and cellular therapy community to ensure the safe and effective collection, processing and use of platelets. That work involves direct interaction with federal agencies, including the Food and Drug Administration and the Centers for Medicare and Medicaid Services, to ensure appropriate guidance, regulations and reimbursement for platelets.
FDA issued a draft guidance, "Bacterial Risk Control Strategies for Blood Collections Establishments and Transfusion Services to Enhance the Safety and Availability of Platelets for Transfusion," to replace the March 2016 draft guidance of the same title.
Members of the Food and Drug Administration’s Blood Products Advisory Committee heard presentations on the advantages and disadvantages of various strategies to control the risk of bacterial contamination in platelets, including the scientific evidence and the operational considerations involved. AABB, American Red Cross, and America’s Blood Centers presented a
joint statement updating the FDA on the current thinking of the organizations on the topic.
Jessica Jacobson, MD, Chair of the AABB Bacterial Contamination Work Group, gave a
BPAC on behalf of AABB regarding the results and conclusions of the 2017 Bacterial Risk Control Survey.
AABB, America's Blood Centers (ABC) and the American Red Cross (ARC) submitted
joint comments to provide additional information alerting the Food and Drug Administration (FDA) of concerns related to the March 2016 draft guidance, "Bacterial Risk Control Strategies for Blood Collection Establishments and Transfusion Services To Enhance the Safety and Availability of Platelets for Transfusion."
AABB, America’s Blood Centers and the American Red Cross submitted
joint comments to Food and Drug Administration officials on the “Bacterial Risk Control Strategies for Blood Collection Establishments and Transfusion Services To Enhance the Safety and Availability of Platelets for Transfusion” draft guidance.
Association Bulletin #14-04, “Clinical Recognition and Investigation of Suspected Bacterial Contamination of Platelets.”