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Analysis of Guidance for Industry: Recommendations for Donor Questioning, Deferral, Reentry and Product Management to Reduce the Risk of Transfusion-Transmitted Malaria – 8/19/13

The guidance for industry titled "Recommendations for Donor Questioning, Deferral, Reentry and Product Management to Reduce the Risk of Transfusion-Transmitted Malaria," announced Aug. 19, 2013, supersedes the Food and Drug Administration memorandum of July 26, 1994, titled "Recommendations for Deferral of Donors for Malaria Risk." The recommendations apply to the collection of whole blood and all blood components except source plasma and have a 12-month implementation deadline, Aug. 19, 2014.

The guidance document provides definitions that are incorporated in the recommendations. For the first time, FDA has defined "residence" — for purposes of the guidance — as a continuous stay of longer than five years in a country or countries having any malaria-endemic area. "Malaria-endemic area" is defined as any area(s) with malaria where the Centers for Disease Control and Prevention recommends anti-malarial chemoprophylaxis in travelers in the most current version of The Yellow Book — "CDC Health Information for International Travel" — at the time the donor is screened. This revision is one of the more striking differences between the new guidance document and the 1994 memorandum that recommended deferral based on recognition by CDC of any malaria activity in an area — without the qualification that malaria chemoprophylaxis be recommended for travelers to the area.

The recommendations include a deferral from blood donation of three years for history of malaria — illness or a positive laboratory test — and residency in a malaria-endemic country, and one year for travel to or through a malaria-endemic area — where the duration of travel is more than 24 hours — for residents of non-endemic countries. When calculating the length of deferral from blood donation for individuals who have traveled to malaria-endemic areas and are prior residents of malaria-endemic countries, the number of consecutive years the donor has resided in non-endemic countries after departing the malaria-endemic country must be considered. If this period is less than three consecutive years, the donor will be deferred from blood donation for three years after travel to a malaria-endemic area. When the donor has lived at least three consecutive years in non-endemic countries, the deferral from blood donation is only one year after travel to a malaria-endemic area.

Recommendations regarding product retrieval and quarantine as well as the notification of consignees are focused on in-date cellular products collected from a donor who should have been deferred. An additional recommendation addresses cellular components collected from a donor with a clinical history of malaria. In this instance, if the component is distributed and transfused, FDA encourages notification of the recipient's physician of the need to monitor for possible malaria infection for a period of three months post-transfusion. Acellular components that have not been distributed should be quarantined; there are no recommendations for consignee notification of distributed components.

The agency provides recommendations for licensed blood establishments to report revisions of their donor history questionnaires and associated materials. The changes are considered major and are reported under 21 CFR 601.12(b) as a prior approval supplement. However, if establishments implement the revised AABB Donor History Questionnaire (DHQ) and materials, once they are revised and found acceptable by the agency, the implementation of the questionnaire and accompanying materials would be considered minor changes if implemented without modification and in their entirety. Reporting use of the revised AABB DHQ would occur in the Annual Report under 21 CFR 601.12(d).

1994 FDA Memorandum

2013 FDA Guidance Document

 

Terms used in the recommendations are defined in the guidance, Section III Definitions:
Malaria - An infectious disease caused by a parasitic protozoan of the genus Plasmodium. Malaria diagnosis in a prospective donor is based on a positive laboratory test indicating Plasmodium infection, or a determination of a history of malaria made by the blood establishment’s Medical Director.
Malaria-endemic area - Any areas 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) at the time the donor is screened.
Malaria-endemic country - Any country having an area or areas with malaria where CDC recommends anti-malarial chemoprophylaxis in travelers in The Yellow Book at the time the donor is screened. A country that has any malaria-endemic areas should be considered to be malaria-endemic in its entirety.
Residence in a malaria-endemic country - For purposes of this guidance, residence is defined as a continuous stay of longer than 5 years in a country or countries having any malaria-endemic area (see definition above).
Travel to a malaria-endemic area - Any travel to or through a malaria-endemic area or areas, as identified by CDC (see definition above). The duration of travel to a malaria-endemic area is defined as more than 24 hours to less than 5 years.

 

Section IV. Recommendations for donor management
Questionnaires should assess for the following risk (utilizing the definitions in section III):

Permanent residents of nonendemic countries who travel to an area considered endemic for malaria by the Malaria Branch, CDC, US 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.

  • A history of travel to a malaria-endemic area in the past one year;

 Defer for 1 year after the last departure from a malaria-endemic area a donor who is a resident of a non-endemic country. After the 1-year deferral period, the donor may be eligible to donate, provided the donor has been free from malaria during this period and meets all other donor eligibility criteria.

  

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

  • A history of malaria in the past three years;

Defer for 3 years. If the donor has remained free of malaria symptoms for a 3-year period while residing in a non-endemic country, the Medical Director may decide to accept the donor, provided the donor meets all other donor eligibility criteria

  

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.

  • A history of prior residence in a malaria-endemic country;

Defer for 3 years. After the 3-year deferral period, the donor may be eligible to donate provided the donor has been free from malaria during this period and meets all other donor eligibility criteria.

  • A history of travel to a malaria-endemic area in the past three years, if previously a resident of a malaria-endemic country

Defer for 3 years after a visit to a malaria-endemic area a donor who is a prior resident of a malaria-endemic country and who has been a resident of non-endemic countries for less than 3 consecutive years. After the 3-year deferral period, the donor may be eligible to donate, provided the donor has been free from malaria during this period and meets all other donor eligibility criteria.

Defer for 1 year a prior resident of a malaria-endemic country who returns to a malaria-endemic area after residence for 3 years consecutively in non-endemic countries. The deferral period begins when the donor returns to the non-endemic country. After the 1-year deferral period, the donor may be eligible to donate, provided the donor has been free from malaria during this period and meets all other donor eligibility criteria.

No particular recommendations for product quarantine or disposition. The recommendations applied only to donations containing intact red blood cells.

Section IV. Recommendations for product management when blood has been collected from a donor who should have been deferred:

 

Quarantine any undistributed in-date cellular blood components collected from the donor

 

When products were distributed, notify consignees to retrieve and quarantine in-date cellular blood components from a donor with a clinical history of malaria, or malaria-risk associated with travel or prior residence.

  • If cellular blood components from a donor with a clinical history of malaria were transfused FDA encourages a process whereby the consignee notifies the transfusion recipient’s physician  regarding the need for monitoring the recipient for 3 months post-transfusion
 

Undistributed acellular products should be quarantined. Based on risk assessment there is no recommendation to notify consignees of distributed acellular products.

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