The U.S. Food and Drug Administration’s (FDA) published a guidance on June 23rd titled “Alternative Procedures for the Manufacture of Cold-Stored Platelets Intended for the Treatment of Active Bleeding when Conventional Platelets Are Not Available or Their Use Is Not Practical.” According to the agency the guidance document “provide[s] a notice of exceptions and alternatives to certain requirements in Title 21 of the Code of Federal Regulations (CFR) regarding blood and blood components. This notice is being issued under 21 CFR 640.120(b) to respond to a public health need and address the urgent and immediate need for platelets for the treatment of active bleeding when conventional platelets are not available, or their use is not practical.”
The agency provided “recommendations to blood establishments for the manufacture and labeling of cold-stored platelets (CSP). The guidance also discusses the need for additional data on the efficacy of CSP, in particular, to address whether their use is supported when conventional platelets are available, and their use is practical. For the purposes of this guidance, conventional platelets include all platelets (as defined in 21CFR 640.20) intended for transfusion and stored at 20 to 24°C. Conventional platelets are also referred to as room-temperature platelets (RTP). Platelets stored continuously at 1 to 6°C within a specified time after collection are referred to in this guidance as CSP.”
The agency further explained that the guidance aims to assist with “maintaining platelet availability in the face of logistical challenges (e.g., in military, prehospital, or austere settings) or other threats to blood availability (e.g., mass casualty events or public health emergencies). [It] is critical to assure that platelets are available to patients with active bleeding.” America’s Blood Centers will continue to provide updates regarding the guidance and its advocacy efforts as they become available.