2004D-0198 Guidance for Industry: Acceptable Full-Length Donor History Questionnaire and Accompanying Materials for Use in Screening Human Donors of Blood and Blood Components
FDA Comment Number : EC6
Submitter : Mrs. Tracie Kroenert Date & Time: 12/08/2006 09:12:57
Organization : Mrs. Tracie Kroenert
Category : Individual Consumer
Issue Areas/Comments
GENERAL
GENERAL
In your full-length donor history questionnaire, I think you should create an addendum....you should address the current minimum age requirement for blood donation. Age 17 is too young to donate blood without parental permission. I believe that the FDA, American Red Cross and anyone who might have a mobile blood donation activity is setting themselves up for a law suit by taking blood from a minor. Children must be at least 18 to vote, be considered an adult, sign up for military service, etc. and at least 21 to drink. Therefore, the decision of giving blood should also be included in "adult decisions" at the age of 18. If a child gives blood, as my own did, at age 17, for the first time, and something goes wrong and the parent was not notified, I would hate to see the reprocussions. If changing the age is not an option, maybe you should change donation requirements...stating that the minor must discuss it with parents and prove that they have discussed it by a signature (not a permission signature) and even then, only allow them to donate at fixed headquarters or something similar. I realize how valuable blood donation is and why it is needed, but it is not needed at the expense of our children. Let them remain kids as long as they can! Please consider this when changing your full-length donor history questionnaire. Thank-you.