Malaria is a serious and sometimes fatal disease that can caused by any of the following four Plasmodium species: P. falciparum; P. malariae; P. ovale; or P. vivax. About 1,500 cases of malaria are diagnosed in the United States each year, the vast majority of which are found among travelers and immigrants returning from countries where malaria transmission occurs, such as sub-Saharan Africa and South Asia. People who contract malaria typically become very sick with high fevers, shaking chills and flu-like illness. Although malaria can be fatal, illness and death from this disease usually can be prevented.
What actions should be taken to reduce the risk of transfusion-transmitted malaria?
Transfusion-transmitted malaria occurs rarely, but remains a serious concern for transfusion recipients. In the absence of a licensed donor screening test, FDA guidance recommends deferral of donors who have had an infection or a possible exposure to malaria, to reduce the risk of transfusion-transmitted malaria in the U.S. FDA’s current guidance, Recommendations for Donor Questioning, Deferral, Reentry and Product Management to Reduce the Risk of Transfusion-Transmitted Malaria (first issued in 2013 and updated in August of 2014), defines the exposure for residence in or travel to malaria-endemic countries and areas.
A donor’s accurate travel history should be documented on the donor history questionnaire for evaluation during the screening process. AABB’s Donor History Task Force maintains flowcharts for the full-length and abbreviated donor history questionnaires, consistent with FDA recommendations, to assist with donor eligibility decisions, including timeframes of exposure in malaria-endemic countries and areas. FDA recommends:
- Using the CDC website to identify risks associated with residence in or travel of a donor to a Malaria-endemic country or area - defined as any country or area “with malaria where CDC recommends anti-malarial chemoprophylaxis in travelers in the most current version of the CDC Health Information for International Travel,” commonly known as The Yellow Book (Yellow Book Homepage).
- Accessing the Malaria Information by Country Table in the Malaria chapter of The Yellow Book for the most current recommendations on anti-malarial chemoprophylaxis in malaria-endemic countries.
AABB provides guidance to blood establishments while working with public health officials to monitor malaria outbreaks in nonendemic areas. On occasion, the CDC issues a malaria outbreak notice along with a recommendation for travelers to the affected area to take malaria chemoprophylaxis after which AABB evaluates the alert and notifies members of the outbreak through "AABB Weekly Report" and/or "AABB News Flash" (see Malaria Alerts). Blood collection facilities should follow updates for new CDC recommendations or subscribe for notifications from CDC.
A working group of the AABB Transfusion-Transmitted Diseases Committee monitors the risk for malaria in U.S. blood donors to propose a strategy to help ensure a safe and adequate blood supply.
AABB posted an
analysis of the guidance for industry titled “Recommendations for Donor Questioning, Deferral, Reentry and Product Management to Reduce the Risk of Transfusion-Transmitted Malaria.”