FDA workshop on emerging infectious diseases: evaluating emerging infectious diseases (EIDs) for transfusion safety

Atreya, Chintamani D.; Nakhasi, Hira L.; Mied, Paul; Epstein, Jay S.; Hughes, James M.; Gwinn, Marta; Kleinman, Steven; Dodd, Roger Y.; Stramer, Susan L.; Walderhaug, Mark; Ganz, Peter; Goodrich, Raymond P.; Tibbetts, Clark; Asher, David M.

doi:10.1111/j.1537-2995.2011.03084.x

Cited by 21 publications

(18 citation statements)

References 84 publications

(153 reference statements)

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“…In contrast, cryopreservation enables storage of RBCs for years, which allows RBCs to be donated far in advance of the surgical procedure without affecting its quality. Although the benefit of preoperative autologous RBC transfusions is currently questioned, new pathogens keep emerging which could potentially threat the safety of allogenic RBC transfusions and the implementation of cryopreservation could make preoperative autologous RBC transfusions become a viable alternative.…”

Section: Utilization Of Cryopreserved Rbcsmentioning

confidence: 99%

Utilization and quality of cryopreserved red blood cells in transfusion medicine

Henkelman

Noorman²,

Badloe³

et al. 2014

Vox Sanguinis

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Cryopreserved (frozen) red blood cells have been used in transfusion medicine since the Vietnam war. The main method to freeze the red blood cells is by usage of glycerol. Although the usage of cryopreserved red blood cells was promising due to the prolonged storage time and the limited cellular deterioration at subzero temperatures, its usage have been hampered due to the more complex and labour intensive procedure and the limited shelf life of thawed products. Since the FDA approval of a closed (de) glycerolization procedure in 2002, allowing a prolonged postthaw storage of red blood cells up to 21 days at 2-6°C, cryopreserved red blood cells have become a more utilized blood product. Currently, cryopreserved red blood cells are mainly used in military operations and to stock red blood cells with rare phenotypes. Yet, cryopreserved red blood cells could also be useful to replenish temporary blood shortages, to prolong storage time before autologous transfusion and for IgA-deficient patients. This review describes the main methods to cryopreserve red blood cells, explores the quality of this blood product and highlights clinical settings in which cryopreserved red blood cells are or could be utilized.

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Section: Utilization Of Cryopreserved Rbcsmentioning

confidence: 99%

Utilization and quality of cryopreserved red blood cells in transfusion medicine

Henkelman

Noorman²,

Badloe³

et al. 2014

Vox Sanguinis

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“…While EIDs are not a new phenomenon, the frequency of reported outbreaks has increased in the last 20 years and experts predict that this will continue [17,18,21,26,[28][29][30]. To emphasize this point, the list of 21st century outbreaks already includes, in addition to ongoing outbreaks of West Nile virus (WNV) [31,32], severe acute respiratory syndrome corona virus (SARS-CoV) in China in 2002-3 [33,34], the reemergence of avian influenza virus H5N1 (A(H5N1) [35], chikungunya virus (CHIKV) on La Reunion island in 2005-07 followed by the Western Pacific region in 2012 and the Americas in 2013 [36][37][38][39], influenza A virus H1N1 ((A(H1N1)) [40], Middle East respiratory syndrome corona virus (MERS-CoV) in 2012 in the Middle East [41], influenza A virus H7N9 (A(H7N9)) in 2013 in China [42], ZIKV on Yap Is in 2007, the Western Pacific region in 2014 and the Americas in 2015-16 [43] and Ebola virus (EBOV) in West Africa in 2014-15 [44].…”

Section: Defining Emerging Infectious Diseasesand Why We Can Expect Mmentioning

confidence: 99%

“…However, over the last 20 years there has been an increasing awareness of the threat to blood safety from emerging infectious disease (EID) agents [12][13][14][15][16][17][18][19][20][21]. In this review we provide an overview of how EID agents can be defined, when they represent a potential risk to blood safety and how they differ from the classical transfusion-relevant agents.…”

mentioning

confidence: 99%

Emerging Infectious Diseases and Blood Safety: Modeling the Transfusion-Transmission Risk

Kiely

Gambhir

Cheng

et al. 2017

Transfusion Medicine Reviews

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While the transfusion-transmission (TT) risk associated with the major transfusion-relevant viruses such as HIV is now very low, during the last 20 years there has been a growing awareness of the threat to blood safety from emerging infectious diseases, a number of which are known to be, or are potentially, transfusion transmissible. Two published models for estimating the transfusion-transmission risk from EIDs, referred to as the Biggerstaff-Petersen model and the European Upfront Risk Assessment Tool (EUFRAT), respectively, have been applied to several EIDs in outbreak situations. We describe and compare the methodological principles of both models, highlighting their similarities and differences. We also discuss the appropriateness of comparing results from the two models. Quantitating the TT risk of EIDs can inform decisions about risk mitigation strategies and their cost-effectiveness. Finally, we present a qualitative risk assessment for Zika virus (ZIKV), an EID agent that has caused several outbreaks since 2007. In the latest and largest ever outbreak, several probable cases of transfusion-transmission ZIKV have been reported, indicating that it is transfusion-transmissible and therefore a risk to blood safety. We discuss why quantitative modeling the TT risk of ZIKV is currently problematic.

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“…We now recognize that in addition to classic TTIs that establish chronic infection, agents that cause acute transient infections may also be TTI at significant rates if there are large epidemics or recurrent seasonal transmission . Salient examples of EIDs where interventions were implemented in the United States include nationwide screening of donors for Trypanosoma cruzi using a one‐time antibody testing strategy, NAT testing for West Nile virus (WNV) and Zika virus (ZIKV), and testing for Babesia microti in endemic regions .…”

Section: Session 1: Blood‐borne Infectious Agents and Their Impact Onmentioning

confidence: 99%

“…The emergence of EIDs has proven to be unpredictable, as is their risk to blood safety . EIDs of concern span all pathogen classes, with 60% being from zoonotic sources.…”

Section: Session 1: Blood‐borne Infectious Agents and Their Impact Onmentioning

confidence: 99%

Proceedings of the Food and Drug Administration public workshop on pathogen reduction technologies for blood safety 2018 (Commentary, p. 3026)

et al. 2019

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FDA workshop on emerging infectious diseases: evaluating emerging infectious diseases (EIDs) for transfusion safety

Cited by 21 publications

References 84 publications

Utilization and quality of cryopreserved red blood cells in transfusion medicine

Utilization and quality of cryopreserved red blood cells in transfusion medicine

Emerging Infectious Diseases and Blood Safety: Modeling the Transfusion-Transmission Risk

Proceedings of the Food and Drug Administration public workshop on pathogen reduction technologies for blood safety 2018 (Commentary, p. 3026)

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