REGULATORY UPDATE: FDA Issues New Monkeypox Information for Blood Establishments

In response to concerns about the increase in monkeypox cases, the Food and Drug Administration released a new safety and availability communication today for the blood community, reiterating that existing safeguards provide sufficient protection against the potential for transfusion-transmission of monkeypox and ensure the continued safety and security of the blood supply. 
 
“Given the robustness of the existing safeguards for blood safety FDA does not recommend that blood establishments ask donors additional, specific questions about possible exposure to monkeypox virus,” the agency stated. “Further, FDA does not recommend using laboratory diagnostic tests to screen blood donors for monkeypox virus.” 
 
FDA reiterated that there have been “no reports of transmission of monkeypox virus through blood transfusion” and that “the risk of transfusion-transmission [of monkeypox] remains theoretical.”  
 
FDA said it will continue to monitor cases of monkeypox both in the U.S. and throughout the world and will provide updates to the blood community if needed.