REGULATORY UPDATE: Updating the Circular with Bacterial Risk Control Strategy Language

May 26, 2021

The Food and Drug Administration requires an update to the Circular of Information when a blood center or transfusion service implements the December 2020 recommendations for bacterial risk control strategies for platelets stored at room temperature. The Circular of Information web page provides two options under the section, “FDA Required Updates to the Circular.” The Circular of Information Task Force developed a general statement that may be used for a range of strategies and platelet components. 

The second option, provided by FDA, may be considered if the blood center prefers to develop a statement describing the specific combination of risk control strategies that have been implemented. An example of such a statement is “To control the risk of bacterial contamination in platelets, [insert blood center name] uses either 1) pathogen reduction technology or 2) single-step, large volume, delayed sampling [LVDS] no sooner than 36-hour strategy for 5-day platelets and single-step LVDS no sooner than 48-hour strategy for 7-day platelets using the [insert name of microbial detection device] system with both aerobic and anaerobic cultures.”

Refer to the Circular of Information web page for detailed instructions, including the regulatory requirements and the User Guide for the Circular. Members may contact AABB’s Regulatory Affairs team for assistance at regulatory@aabb.org.