APIB243886242 - CME/CMLE - FDA Guidance for Bacterial Risk Control Strategies-APIB243886242

APIB243886242 - Educational Activity

Pdf Summary

This educational commentary by Dr. William S. Crews Jr. reviews the FDA's 2020 final guidance on bacterial risk control strategies to improve the safety and availability of platelet transfusions. Bacterial contamination poses the greatest infectious risk in platelet transfusion, with contamination rates from 1 in 1,000 to 1 in 2,500 platelet units and serious potential for septic transfusion reactions. In response, the FDA mandated implementation of risk control strategies by October 2021.<br /><br />Key historical advances include diversion of the initial collection volume to reduce skin flora contamination significantly and the requirement since 2004 for bacterial detection testing using aerobic culture systems. Recent developments comprise pathogen reduction technology (using amotosalen and UVA light) and rapid bacterial detection tests, enhancing safety and operational flexibility.<br /><br />The FDA guidance outlines multiple approved bacterial risk mitigation pathways, grouped into single-step and two-step approaches. Single-step strategies include large volume delayed sampling (LVDS) at either 36 or 48 hours post-collection, which determines product dating as 5 or 7 days respectively, and pathogen reduction performed within 24 hours, which removes need for bacterial testing but requires significant investment. Two-step strategies combine primary culture testing with secondary testing (either a second culture or rapid test), enabling 7-day product dating and improved detection sensitivity but requiring coordination between blood centers and hospitals.<br /><br />Most bacterial testing (~85%) is performed at blood centers for operational efficiency and cost reasons; only a minority of hospitals conduct secondary testing. Costs vary significantly between strategies, with hospitals paying $596-685 per unit for LVDS platelets and additional expenses when doing secondary testing. Facilities transfusing large volumes (over 5,000 units annually) achieve better cost efficiencies.<br /><br />Implementation challenges include staffing, training, quality control, and geographic factors affecting shelf life and testing logistics. Centralized testing at blood centers helps smaller hospitals maintain compliance despite limited resources. Partnerships and hub-and-spoke models can mitigate challenges. Flexibility to adopt emerging technologies and evolving regulations remains crucial.<br /><br />In conclusion, the FDA guidance has driven substantial improvements in platelet transfusion safety through adaptable bacterial risk control strategies. Success hinges on facility size, resources, geographic location, and collaboration between blood centers and hospitals. Continuing evaluation of clinical outcomes and cost-effectiveness will optimize these evolving practices to enhance patient safety.

Keywords

FDA 2020 guidance

bacterial risk control

platelet transfusion safety

bacterial contamination

pathogen reduction technology

large volume delayed sampling (LVDS)

aerobic culture testing

rapid bacterial detection

two-step testing strategies

blood center and hospital collaboration