Brian Custer, Hany Kamel, Marj Bravo Peter Tomasulo Blood Systems, Inc.

1. Blood Center Experience with Double Red Cell Collections by Apheresis:Adverse Events and Impact on Capacity Brian Custer, Hany Kamel, Marj Bravo Peter Tomasulo Blood Systems, Inc. FDA Blood Products Advisory Committee August 2011

2. Blood Systems2010: Red Cells Collected – 1.1 Million, Platelets Collected –160,000Donor Panels Tested – 4.2 Million

3. 2RBC and WB Phlebotomy Time and LOC rates in Allogeneic Donations BSI data, Allogeneic Donations, April 2009 to September 2010

4. Methods • Study period: January 1 – December 31, 2007 • Reactions studied: • moderate and severe vasovagal reactions (combined into a single category) • Statistical analysis: • Logistic regression analyses that compared 2-RBC to WB donors. • We report risks of AR using a diverse set of predictors based on an adjusted logistic regression model constructed using manual stepwise deletion. Kamel et al. Adverse Reactions in Whole Blood and Automated 2-unit Red Cell Donations among 2RBC-eligible allogeneic male donors: a multivariate analysis.

5. Results – Experience, Age, Blood Volume and Collection Method Kamel et al. Adverse Reactions in Whole Blood and Automated 2-unit Red Cell Donations among 2RBC-eligible allogeneic male donors: a multivariate analysis.

6. Adverse Event Rate / Procedure Type Custer et al. Associations between Collection Procedure Type and Donor Adverse Events.

7. Comparison of Vasovagal Reactions Across Time Course of Automated and WB Donations

8. BSI data, Allogeneic Donations, April 2009 to September 2010

9. BSI data, April 2009 to September 2010

10. By Period: Summary of Adjusted Odds Ratios Across Time Course of Blood Odds Ratios and Confidence Intervals

11. Bravo et al. Vasovagal Reaction, Outside Medical Care and Injury Rates During/After Whole Blood and Automated Collections.

12. There are fewer LOC reactions and falls per donation with 2 rbc donations than with whole blood donations. The LOC reactions which occur with 2 RBC donations occur earlier

13. Custer et al. Donor adverse events: needle related injuries and vasovagal reactions are strongly associated.

14. RESULTS Factors associated with NRI (with VVR as a factor) Odds Ratios and 95% Confidence Intervals Custer et al. Donor adverse events: needle related injuries and vasovagal reactions are strongly associated.

15. RESULTS Factors associated with VVR (with NRI as a factor) Odds Ratios and 95% Confidence Intervals Custer et al. Donor adverse events: needle related injuries and vasovagal reactions are strongly associated.

16. VVR rate is higher for WB than for 2RBC or PP collections NRI rate is higher for 2RBC and PP collections Risk factors for VVR and NRI are not the same LOC and NRI are strongly associated VVR are influenced by NRI, EBV, age, donor history, donor race and procedure type NRI are influenced by VVR, donor weight and procedure type More likely that NRI  VVR than VVR  NRI Custer et al. Associations between Collection Procedure Type and Donor Adverse Events.

17. Collection Capacity

19. Estimated blood volume (EBV) and hemoglobin (Hgb) criteria among presenting donors BSI data, February 2010 to February 2011

22. Apheresis in a Disaster:Electric Power • Electric power needed to pump gasoline and diesel fuel • Not all BSI collection locations have generators • Not all generators can power apheresis devices • Most generators dedicated to refrigerators and computers • Bus mobiles have generators • WB throughput more rapid – capacity loading • Apheresis may be reserved for platelets

23. Summary • Fewer VVR, more NRI from 2 RBC apheresis • Possibly fewer injuries per procedure with 2 RBC • Reserve capacity is significant • Red cell apheresis has little benefit in “routine” emergencies • May help more in widespread prolonged disasters affecting donor availability (in which platelet apheresis would also be important) • Apheresis requires power

24. * e.g., jail>72 hrs, blood transfusion, ear/body piercing, needle stick, etc.