SunCoast Blood Centers, Sarasota, FL, United States
Background/Case Studies: Malaria exposure donor deferrals significantly reduce the donor pool in many U.S. regions, especially during seasonal travel peaks. The U.S. Food and Drug Administration (FDA) now permits collection of apheresis platelets or plasma from donors at risk of malaria due to travel, if components undergo pathogen reduction (PR) with an FDA-approved device. FDA has proposed extending this to donors deferred for malaria-risk due to prior residency. As of 2023, more than half of all apheresis platelets distributed in the U.S. are pathogen reduced. This study describes the implementation of a PR-based pathway to accept malaria-risk donors, focusing on feasibility, process controls, and indicators of operational success.
Study
Design/Methods: A process map (Figure A) was developed to identify eligible donors, ensure appropriate component collection, and adhere to PR process requirements. The blood establishment computer system (BECS) was configured with process controls that permit only platelet collection from malaria-risk donors found otherwise eligible via the Uniform Donor History Questionnaire. Safeguards ensure that: (a) only products intended for PR were collected (i.e. apheresis platelets with no concurrent products), (b) all products underwent PR treatment, and (c) any untreated components were quarantined and prevented from being distributed. Production and discard rates were tracked over 12 months.
Results/Findings: Ten donors who would otherwise have been deferred for malaria travel risk were accepted during the study period. Each donation was successfully PR-treated, resulting in one or more transfusable platelet units. No products were discarded due to PR processing issues. No deviations or compliance issues were identified.
Conclusions: Routine acceptance of malaria-risk donors when treating platelets with PR is demonstrated as operationally feasible, with no product loss and good staff compliance. The initial number of reinstated donors was modest as it was limited to those with recent travel to malaria-endemic areas. The approach, however, has clear potential for broader adoption to address longer and recurring deferrals related to prior residency in endemic regions; currently 90 individuals are in the center’s database, representing an immediately accessible donor pool. As FDA guidance evolves to permit the use of PR for residency-based deferrals, this approach may offer a scalable pathway to reinstate and retain donors who would otherwise be excluded long-term, while avoiding the cost of malaria testing. Given that apheresis donors at this center average 5.9 donations annually and yield approximately 2 platelet products per donation, even modest re-engagement of this population could materially strengthen platelet availability without compromising safety.
