2004D-0198 - Draft
FDA Comment Number : EC1
Submitter : Ms. Deborah Greene Date & Time: 09/07/2004 12:09:28
Organization : University of Iowa Hospitals
Health Care Association
Category :
Issue Areas/Comments
Our comments are as follows:

1. (p. A4-10) Under Donor Eligibility: should read Frequency of whole blood donation is a MAXIMUM of every 8 weeks; plasma, platelets, or leukapheresis is a MAXIMUM of every two days.

2. (p. A4-11) Under Donor Eligibility: A donor who has been exposed to a live virus via vaccination should not serve as a donor. Does this mean they can NEVER donate again? In the past that was a 2 or 4 week deferral, depending on the vaccine (AABB Std 5.4.1A, 9d)

3. (p. A4-26) Under Donor Eligibility: Better stated...1) any person with hemophilia or related clotting disorders WHO HAS BEEN TREATED WITH FACTOR CONCENTRATES

4. (p. A4-44) Under Donor Eligibility: Deos this include patiens with a history of CMV or EBV (mononucleosis) hepatitis? I believe we are accepting these donors now, although I can't find specific support for this in Standards. In any case, it makes medical sense to me to allow these individuals to donate.