malaria deferral for travel to mexico

[dalangsfor]

The latest cdc map/guidelines indicate there is a small risk in Quintano Roo. Cancun and Cozumel are located there. There is no stipulation in the latest guideline regarding urban vs. rural travel. Previously there was a stipulation about small foci near the guatemala and belize borders. Does anyone have a guideline they would be willing to share regarding Quintana Roo?

Thank you

[cbaldwin]

Here is a link to the latest FDA draft guideline on Malaria, published June 2012:

http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceReguatoryInformation/Guidances/Blood/ucm077061.htm

It states:

You may accept a donor who is a resident of a non-endemic country and who has traveled to the Mexican states of Quintana Roo or Jalisco without any deferral for malaria risk. However, we recommend that you defer for one year after the last departure from a malaria-endemic area a donor who is a resident of a non-endemic country and who has traveled to or through any of the malaria-endemic areas in Mexico other than the states of Quintana Roo and Jalisco. 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.

[cbaldwin]

I just noticed my link will not take you to the guidance....sorry. I copied it from the address bar that appeared when I had the guidance open. If you just type in "FDA Guidance for Malaria Deferral" in a search engine, the link to the guidance will pop up.

[dalangsfor]

Thank you for your reply. Do you acceptable even though it is a draft guidance?

[cbaldwin]

Thank you for your reply. Do you acceptable even though it is a draft guidance?

I hope someone with more knowledge of FDA guidances and regulation will chime in here.

I do know that this is what the FDA says about draft guidances: Draft regulations and guidances are documents that have been proposed, but FDA has not made a decision as to whether the proposal will be adopted in whole, in part, or not at all. Each FDA draft document lists how to submit comments to the agency concerning the draft.

Donor centers follow approved and published FDA regulations and AABB standards for donor qualification. For situations that are hazy or not specifically addressed by the FDA or AABB, the medical director of a donor center will make a policy (and this is just my observation). Usually these policies are very conservative. Often donor centers have donor qualification policies that are more conservative than the FDA regulations or AABB standards.

The donor center where I donate blood accepts donors who have recently traveled to Quintana Roo, as long as they stayed in urban areas and did not travel far into rural environments.