Bact/Alert BPA and BPN culture bottles from bioMérieux, Marcy-l’Etoile, France, have received FDA 510(k) clearance for large-volume delayed sampling (LVDS) of leukocyte-reduced apheresis platelets and leukocyte-reduced whole blood platelet concentrates with the Bact/Alert 3D and Bact/Alert Virtuo systems.
In September 2019, FDA released its final guidance regarding Bacterial Risk Control Strategies for Blood Collection Establishments and Transfusion Services to Enhance the Safety and Availability of Platelets for Transfusion.1 This guidance officially recognizes LVDS as an effective strategy to control the risk of bacterial contamination in platelets and extend their shelf life to 7 days with a single-step approach. The process results in improved safety as well as increased availability of these life-saving products.
Mark Miller, MD, bioMérieux.
Platelets are particularly prone to contamination since they are stored at room temperature. Routine testing for bacterial contamination is therefore critical to detect those units that are contaminated and could potentially cause harm to transfused patients. LVDS has already been implemented in several countries as an effective risk-reduction measure to increase the safety of the platelet supply while eliminating the need for further testing.
“FDA clearance for LVDS when using either of our two culture systems is an important step toward increasing patient safety and availability of precious life-saving platelets,” says Mark Miller, MD, executive vice president and chief medical officer at bioMérieux. “As we continually face a shortage of blood products, especially now due to the covid-19 pandemic, extending platelet shelf life with a single-step bacterial screening approach is critical and highly beneficial for patients in need.”
For more information, visit bioMérieux.
Reference
1. Bacterial Risk Control Strategies for Blood Collection Establishments and Transfusion Services to Enhance the Safety and Availability of Platelets for Transfusion; Guidance for Industry. Silver Spring, Md: Center for Biologcs Evaluation and Research, 2019. Available at: www.fda.gov/regulatory-information/search-fda-guidance-documents/bacterial-risk-control-strategies-blood-collection-establishments-and-transfusion-services-enhance. Accessed June 2, 2020.
