|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|
| 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.