Date:       July 26, 1994

From:       Director, Center for Biologics Evaluation and         
            Research
            
Subject:    Recommendations for Deferral of Donors for Malaria    
            Risk          

To:         All Registered Blood Establishments

Transmission of malaria remains a rare, but medically serious
risk of transfusion.  Since 1958, blood establishments have
deferred donors based on exposure history and previous illness to
minimize this risk.  The current standards accepted by the Food
and Drug Administration (FDA), in use since 1974, are listed in
FDA's inspection guidelines, Instruction Booklet for Blood Bank
Inspection Checklist and Report, Form FDA-2609, May 1991.

Surveillance studies conducted by the Centers for Disease Control
and Prevention (CDC) since 1974 indicate no change in the
frequency of transfusion-transmitted malaria, estimated at 0.25
cases per million blood units collected, compared with the
experience under previous donor deferral practices (1). 
Nevertheless, recently obtained scientific data have led some
researchers and the American Association of Blood Banks to
reexamine the current standards (2,3) and propose revised
standards for donors at risk for malaria.

FDA's Blood Products Advisory Committee discussed the issue of
revising donor deferral standards for malaria at the June 29,
1993, meeting.  Consistent with the Committee's opinion, FDA's
recommendations for deferring blood donors at increased risk for
malaria follow:  

1.   Permanent residents of nonendemic countries who travel to an
     area considered endemic for malaria by the Malaria Branch,
     CDC, U.S. Department of Health and Human Services, should
     not be accepted as donors of whole blood and blood
     components prior to 1 year after departure from the endemic
     area. After 1 year after departure, such otherwise suitable
     prospective donors may be accepted provided that they have
     been free of unexplained symptoms suggestive of malaria and
     regardless of whether or not they have received antimalarial
     chemoprophylaxis. 

2.   Prospective donors who have had malaria should be deferred
     for 3 years after becoming asymptomatic.

3.   Immigrants, refugees, citizens, or residents of endemic
     countries should not be accepted as donors of whole blood or
     blood components prior to 3 years after departure from the 
     area. After the three year period, otherwise suitable
     prospective donors may be accepted if they have remained
     free of unexplained symptoms suggestive of malaria. 


These recommendations apply only to donations containing intact
red blood cells.  Donations used for preparing plasma, plasma
components or derivatives devoid of intact red blood cells are
excluded.

Because there are no approved tests to screen donated blood for
malaria, careful questioning is essential for identifying
prospective donors at risk for transmitting malaria.  Blood
establishment personnel should carefully elicit the necessary
information regarding travel and disease history in order to
defer those at risk.   When more than one deferral period applies
to a donor, the longest period of deferral should go into effect.

Blood establishments should promptly implement these
recommendations for all new donors.  

Questions about these recommendations may be directed to the
Division of Transfusion Transmitted Diseases, Telefax number
(301) 594-6989. 


                                 

                                 ____________________________
                                 Kathryn C. Zoon, Ph.D.



References:

1.   Guerrero I, Weniger B, Schultz M.  Transfusion malaria in
     the United States, 1972-1981.  Ann Intern Med 1983;99:221-
     226.
 
2.   Sazama K.  Prevention of transfusion-transmitted malaria: 
     Is it time to revisit the standards?  Transfusion
     1991;31:786-788.

3.   Nahlen B, Lobel H, Cannon S, Campbell C.  Reassessment of
     blood donor selection criteria for United States travelers
     to malarious areas.  Transfusion 1991;31:798-804.