Workshop on Leukocyte Reduction of Blood and Blood Components: An Update


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Workshop on Leukocyte Reduction of Blood and Blood Components: An Update

  • Alan E. Williams, Ph.D.

  • Division of Blood Applications

  • OBRR/CBER/FDA

  • July 20, 2005


Workshop Goals:

  • Review new evidence regarding leukocyte reduction for non-targeted recipient populations. (Assume accepted medical value of leukocyte reduction for targeted recipient populations)

  • Update on leukoreduction failures and adverse events

    • Incomplete filtration
    • Incomplete WBC removal
    • Recipient adverse events
    • Blood establishment experiences
  • Practical, effective process control



Morning Agenda:

    • Welcome and Introduction
    • Jay S. Epstein, M.D.
    • Director, Office of Blood Research and Review, (OBRR), CBER, FDA
  • U.S. Regulatory Considerations and International Policies Regarding Leukocyte Reduction



Morning Agenda (cont.):

  • Recent Studies Addressing the Value of Pre-storage Leukoreduction for Non-Targeted Recipients

    • Robertson Davenport, MD, University of Michigan
  • The Yale-New Haven Hospital Universal Leukocyte Reduction Program



Morning Agenda (cont.):

  • The Impact of Pre-storage Leukoreduction Among Transfused Trauma Patients

    • Avery Nathans, MD, PhD, MPH , Univ of Washington
  • Adverse Events and Manufacturing Failures Associated with Leukoreduction.

    • David Stroncek, MD, Department of Transfusion Medicine, NIH
    •  
  • Questions for morning speakers and Open Public Hearing



Afternoon Agenda:

  • Practical Aspects of Pre-storage Leukoreduction in a Blood Establishment, including Use of Pooled Samples for Enumeration of Residual Leukocytes

    • Timothy Malone, Florida Blood Services
  • Practical Aspects of Pre-storage Leukoreduction in Blood Establishments

    • Dan Waxman, M.D., America’s Blood Centers
    • Fred Walker, Ph.D. American National Red Cross
    •  


Afternoon Agenda (cont.):

  • FDA Current Considerations: Pre-Storage Leukoreduction: Process Validation, Quality Assurance and Monitoring, Processing, Testing, and Licensure

    • Alan Williams, PhD and Sharyn Orton, PhD, Division of Blood Application, OBRR, CBER
    •  
    • Questions for Afternoon Speakers and Open Public Hearing


Afternoon Agenda (cont.):

    • Panel Discussion:
    • Dana Devine, Ph.D.
    • Larry Dumont,Ph.D.
    • Celso Bianco, MD
    • Michael Busch, MD Ph.D.
    • Harvey Klein MD
    • Gary Moroff, Ph.D.
    • Moderator: Alan E. Williams, Ph.D.


Afternoon Agenda (cont.):

  • Prion Reduction by Filtration

  • Luisa Gregori, Ph.D. University of Maryland

  • Pall Leukotrap Affinity Filtration System:Update

  • Jerry Ortolano, PhD, Pall Corporation




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