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 
  


  

  


  

  
GENERAL
  


  

  



  

  
GENERAL
  


  

  



  

  
 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.