FDA Workshop on “Emerging Infectious Diseases: Evaluation to Implementation for Transfusion and Transplantation Safety”. Day 1: “Evaluating Emerging Infectious Diseases (EIDs) for Transfusion Safety” May 11, 2010 Paul A. Mied, Ph.D. Update for the Blood Products Advisory Committee
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Day 1: “Evaluating Emerging Infectious Diseases (EIDs) for Transfusion Safety”
May 11, 2010
Paul A. Mied, Ph.D.
Update for the Blood Products Advisory Committee
July 26, 2010
To explore strategies for EID threat detection, intervention, and the prioritization of effort
1. How do we and should we characterize the risk to blood safety from an EID?
2.What are the criteria to prioritize EIDs that pose a threat to blood safety?
3.How should regulators, blood organizations, manufacturers, and other stakeholders develop a response to the threat from EIDs?
whose incidence in humans has increased within the past 20 years or whose incidence threatens to increase in the near future.
- human demographics, behavior, and sanitation
- closer human contact with wildlife and its habitat
- failure of control measures
- international travel and commerce
- microbial adaptation and change
- human susceptibility to infection
- climate and weather
needs to be disseminated in a timely fashion
- “to unite human and veterinary medicine
- to anticipate potential threats to blood safety
- to be vigilant for early detection
Improve predictive capability, coordination and communication through strong national and international partnerships”
- evaluation of transfusion-transmission of known agents
- may be very useful for that purpose for new and future EID agents
1. To describe known and potential EID agents for which transfusion transmission is documented or its potential exists, and no effective intervention exists;
2. To create fact sheets for the agents;
3. To prioritize agents as to their blood safety threat.
SFV: No TTD XMRV: No TTD?”
- expanding geographically
- regional testing is conceivable
- no transfusion transmission observed
- no known causative relationship to disease
- donor prevalence is unknown
- test methods have not been standardized
- literature is controversial: inconsistent findings for viral markers
“ Action should be taken even if its value cannot be proven; that is, even if there is only a theoretical risk of harm.
If risk is possible, then we must err on the side of caution.”
high Infectious Diseases
Influenza virus subtype H5N1
Science/EpidemiologyEID Agent Priority Matrix
Stramer et. al. 2009 Transfusion 49: Suppl.
1. Issue Identification: identify a possible risk to blood safety;
3. Risk Management: identify and analyze options, select and implement strategy, monitor results; surveillance
Question: “What is the appropriate vehicle or process to put this forum into action?”
Orthogonal process approach was suggested – combines NAT and PRT to cover the Window Period. Could Testing + Inactivation or Removal = Reduced Deferrals?”