2005D-0330
  

  
 Guidance for Industry and FDA Review Staff on Collection of Platelets by Automated Methods

  


  

  

  


  

  


  

  


  

  
FDA Comment Number : 
  

  
EC2
  



  

  
Submitter : 
  

  
Dr. Robertson Davenport
  

  
Date & Time: 
  

  
12/05/2005 05:12:52
  



  

  
Organization : 
  

  
University of Michigan
  



  

  
Category : 
  

  
Health Professional
  



  

  
Issue Areas/Comments 
  


  

  


  

  
GENERAL
  


  

  



  

  
GENERAL
  


  

  



  

  
 III. A. Donor Selection

Donors with more than 20 previous pheresis platelet donations have been shown to present an increased risk of bacterial contamination of the product. 

Perez, P., L. R. Salmi, et al. (2001). "Determinants of transfusion-associated bacterial contamination: results of the French Bacthem Case-Control Study." Transfusion 41(7): 862-872.

I recommend that individuals with more than 20 previous donations be permanently deferred as pheresis platelet donors. This would be the single most effective intervention available today to decrease the incidence of bacterial contamination.



VI. D. Product Performance Qualification

Knowledge of the actual platelet content of the product is essential for determination of effectiveness of transfusion and the selection of appropriate donors. 

Davenport RD. Blood components should be labeled for content. Transfusion 2005; 45:3-4.

Therefore, I urge that the platelet yield of all products be determined and the yield be part of the label.