America’s Blood Centers (ABC) encourages the Food and Drug Administration (FDA) to continue to assess the impact of the Final Guidance issued on Bacterial Risk Control Strategies for Blood Collection Establishments and Transfusion Services to Enhance the Safety and Availability of Platelets for Transfusion Guidance for Industry. While the Final Guidance took an important step in allowing for an extended implementation period, significant operational complexities remain that could affect patient access to platelets, especially in rural and underserved communities.
“Hospitals and the patients they serve rely on independent blood centers to collect and distribute a continual, robust supply of blood components, including platelets,” said Kate Fry, MBA, CAE, ABC’s Chief Executive Officer. “ABC appreciates the continued opportunity to work with the FDA to ensure patient access to life-saving transfusions. We are fully committed to the safety of the U.S. blood supply and wholeheartedly share the FDA’s goal of reducing the risk of bacterial contamination in platelets while ensuring a robust supply of this essential blood component.”
Currently there is no FDA approved system available for the large volume, delayed sampling (LVDS) option for a 7-day dating period included in the Guidance. As such, ABC encourages the FDA to expeditiously approve a technology to allow blood centers sufficient time to consider this option and time for the ramp-up required by the manufacturer to meet potential market needs. Additional risk-control strategies should be approved that demonstrate safety and promote maximum flexibility.
ABC looks forward to continuing to work with FDA on our shared goal of minimizing the risk of bacterial contamination of platelets without negatively impacting platelet availability.