Guide on Cold-stored Platelets for Bleeding

FDA has posted a final guidance entitled “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.” The document is intended to provide a notice of exceptions and alternatives to certain requirements for blood and blood components. It is for use when responding to a public health need and addressing the urgent and immediate need for platelets for treating active bleeding when conventional platelets are not available, or their use is not practical. “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) is critical to assure that platelets are available to patients with active bleeding,” it says.