AABB’s Association Bulletin, #21-02 - Considerations for Implementation of FDA Guidance on Bacterial Risk Controls for Platelets and AABB Bacterial Risk Reference Sheets were developed by experts from across AABB membership to assist members with FDA’s December 2020 Platelet guidance.
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.
The December 2020 Platelet guidance recommends that blood collectors and transfusion services implement “bacterial risk control strategies” to mitigate the risk of septic transfusion reactions caused by platelets stored at room temperature. The guidance provides options to support expiration from day 5 and up to day 7. Extending expiration beyond day 5 and up to day 7 requires the use of devices labeled as a “safety measure” and storage containers cleared or approved by FDA for 7-day storage.
FDA is currently discussing scientific considerations for cold stored (1 to 6 C) platelets products including product characterization, duration of storage and clinical indications for use including the clinical studies needed to support the indications for use of cold stored platelet products stored beyond the currently approved 3 days. Blood establishments interested in the use of cold stored platelets should discuss with FDA methods of preparation and storage.
Refer to the Circular of Information for Blood and Blood Components provided by your blood supplier, or the general information posted on AABB’s Circular of Information for Blood webpage, for indications, dosage and administration, contraindications, side effects and hazards, and description of available platelet components.
October 19, 2021
October 19, 2021
October 17, 2021