Publications by authors named "Jay Epstein"

45 Publications

A WHO tool for risk-based decision making on blood safety interventions.

Transfusion 2021 Feb 25;61(2):503-515. Epub 2020 Dec 25.

Center for Biologics Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA.

Background: Risk-based decision making is increasingly recognized as key to support national blood policy makers and blood operators concerning the implementation of safety interventions, especially to address emerging infectious threats and new technology opportunities. There is an urgent need for practical decision support tools, especially for low- and middle-income countries that may not have the financial or technical capability to develop risk models. WHO supported the development of such a tool for blood safety. The tool enables users to perform both a quantitative Multi-Criteria Decision Assessment and a novel step-by-step qualitative assessment.

Study Design And Methods: This paper summarizes the content, functionalities, and added value of the new WHO tool. A fictitious case study of a safety intervention to reduce the risk of HIV transmission by transfusion was used to demonstrate the use and usefulness of the tool.

Results: Application of the tool highlighted strengths and weaknesses of both the quantitative and qualitative approaches. The quantitative approach facilitates assessment of the robustness of the decision but lacks nuances and interpretability especially when multiple constraints are taken into consideration. Conversely, while unable to provide an assessment of robustness, the step-by-step qualitative approach helps structuring the thought process and argumentation for a preferred intervention in a systematic manner.

Conclusion: The relative strengths and weaknesses of the quantitative and step-by-step qualitative approach to risk-based decision making are complementary and mutually enhancing. A combination of the two approaches is therefore advisable to support the selection of appropriate blood safety interventions for a particular setting.
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http://dx.doi.org/10.1111/trf.16231DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7898802PMC
February 2021

Plasma-based COVID-19 treatments in low-and middle-income countries and the risk of transfusion-transmitted infections.

NPJ Vaccines 2020 Nov 3;5(1):103. Epub 2020 Nov 3.

Graduate Institute of Biomedical Materials and Tissue Engineering & International PhD Program in Biomedical Engineering, College of Biomedical Engineering, Taipei Medical University, Taipei, Taiwan.

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http://dx.doi.org/10.1038/s41541-020-00256-6DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7642349PMC
November 2020

Use of COVID-19 convalescent plasma in low- and middle-income countries: a call for ethical principles and the assurance of quality and safety.

Vox Sang 2021 01 24;116(1):13-14. Epub 2020 Jun 24.

Graduate Institute of Biomedical Materials and Tissue Engineering, College of Biomedical Engineering, Taipei Medical University, Taipei, Taiwan.

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http://dx.doi.org/10.1111/vox.12964DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7283681PMC
January 2021

Points to consider in the preparation and transfusion of COVID-19 convalescent plasma.

Vox Sang 2020 08 14;115(6):485-487. Epub 2020 May 14.

Graduate Institute of Biomedical Materials and Tissue Engineering, College of Biomedical Engineering, Taipei Medical University, Taipei, Taiwan.

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http://dx.doi.org/10.1111/vox.12939DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7264781PMC
August 2020

Recovered plasma for fractionation: call for quality standards to end wastage.

Vox Sang 2020 Feb 24;115(2):213-214. Epub 2019 Nov 24.

Association Luxembourgeoise des Hémophiles, Luxembourg City, Luxembourg.

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http://dx.doi.org/10.1111/vox.12871DOI Listing
February 2020

Improving haemophilia therapy in developing countries: virus-safe cryoprecipitate.

Vox Sang 2019 08 10;114(6):635-636. Epub 2019 Jun 10.

College of Biomedical Engineering, Taipei Medical University, Taipei, Taiwan.

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http://dx.doi.org/10.1111/vox.12794DOI Listing
August 2019

Crisis in the Sustainability of the U.S. Blood System.

N Engl J Med 2018 01;378(3):305-306

Food and Drug Administration, Silver Spring, MD

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http://dx.doi.org/10.1056/NEJMc1714807DOI Listing
January 2018

Crisis in the Sustainability of the U.S. Blood System.

N Engl J Med 2017 10;377(15):1485-1488

From the Department of Transfusion Medicine, National Institutes of Health, Bethesda, MD (H.G.K.); and the American National Red Cross Biomedical Services (J.C.H.) and the Office of Blood Research and Review, Center for Biologics Evaluation and Research, Food and Drug Administration (J.S.E.) - both in Washington, DC.

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http://dx.doi.org/10.1056/NEJMsb1706496DOI Listing
October 2017

Serotherapy for patients with severe influenza.

Lancet Respir Med 2017 06 15;5(6):462-464. Epub 2017 May 15.

Division of Infectious Diseases and International Health, University of Virginia School of Medicine, Charlottesville, VA 22908, USA. Electronic address:

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http://dx.doi.org/10.1016/S2213-2600(17)30173-XDOI Listing
June 2017

Assuring blood safety and availability: Zika virus, the latest emerging infectious disease battlefront.

Transfusion 2016 07;56(7):1669-72

Office of Blood Research and Review, Center for Biologics Evaluation and Research, Food and Drug Administration, Silver Spring, MD.

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http://dx.doi.org/10.1111/trf.13673DOI Listing
July 2016

Screening of Blood Donations for Zika Virus Infection - Puerto Rico, April 3-June 11, 2016.

MMWR Morb Mortal Wkly Rep 2016 Jun 24;65(24):627-8. Epub 2016 Jun 24.

Transfusion-transmitted infections have been documented for several arboviruses, including West Nile and dengue viruses (1). Zika virus, a flavivirus transmitted primarily by Aedes aegypti mosquitoes that has been identified as a cause of congenital microcephaly and other serious brain defects (2), became recognized as a potential threat to blood safety after reports from a 2013-2014 outbreak in French Polynesia. Blood safety concerns were based on very high infection incidence in the population at large during epidemics, the high percentage of persons with asymptomatic infection, the high proportion of blood donations with evidence of Zika virus nucleic acid upon retrospective testing, and an estimated 7-10-day period of viremia (3). At least one instance of transfusion transmission of Zika virus has been documented in Brazil after the virus emerged there, likely in 2014 (4). Rapid epidemic spread has followed to other areas of the Americas, including Puerto Rico.
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http://dx.doi.org/10.15585/mmwr.mm6524e2DOI Listing
June 2016

Maintaining a Safe Blood Supply in an Era of Emerging Pathogens.

J Infect Dis 2016 06 8;213(11):1676-7. Epub 2016 Mar 8.

Food and Drug Administration, Silver Spring, Maryland.

Coming shortly after outbreaks of dengue and chikungunya virus in related locations, the recent outbreak of Zika virus in the southern part of the western hemisphere is yet another reminder that infectious pathogens continue to emerge rapidly and can adversely affect public health, including the safety of the blood supply. In response to Zika virus, public health measures that rely largely on donor deferral and sourcing of blood from non-outbreak areas until a blood donor screening test becomes available have been implemented to address the safety of the blood supply in the United States. However, a more universal approach to ensuring blood safety in the setting of rapidly emerging infectious diseases is needed.
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http://dx.doi.org/10.1093/infdis/jiw089DOI Listing
June 2016

Hemolytic adverse events with immune globulin products: product factors and patient risks.

Transfusion 2015 Jul;55 Suppl 2:S2-5

Office of Blood Research and Review, Center for Biologics Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.

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http://dx.doi.org/10.1111/trf.13148DOI Listing
July 2015

Safeguarding immune globulin recipients against hemolysis: what do we know and where do we go?

Transfusion 2015 Jul;55 Suppl 2:S122-6

Office of Blood Research and Review, Center for Biologics Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland.

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http://dx.doi.org/10.1111/trf.13196DOI Listing
July 2015

Chikungunya virus: new risk to transfusion safety in the Americas.

Transfusion 2014 Aug;54(8):1911-5

Division of Vector-Borne Diseases, National Center for Emerging and Zoonotic Infectious Diseases, Centers for Disease Control and Prevention, Fort Collins, CO.

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http://dx.doi.org/10.1111/trf.12790DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6482831PMC
August 2014

Risk assessment for transmission of variant Creutzfeldt-Jakob disease by transfusion of red blood cells in the United States.

Transfusion 2014 Sep 1;54(9):2194-201. Epub 2014 Apr 1.

US Food and Drug Administration, Rockville, Maryland.

Background: Variant Creutzfeldt-Jakob disease (vCJD) is transmitted by blood transfusion. To mitigate the risk of transfusion-transmitted vCJD (TTvCJD), the US Food and Drug Administration has recommended deferral of potential at-risk blood donors, but some risk remains. We describe a quantitative risk assessment to estimate residual, postdeferral TTvCJD risk in the United States.

Study Design And Methods: We assumed that certain US donors may have acquired vCJD infection through dietary exposure to the agent of bovine spongiform encephalopathy during time spent in the United Kingdom, France, and other countries in Europe. Because of uncertainties regarding the prevalence of vCJD in the United Kingdom, we used both low and high UK prevalence estimates as model inputs. The model estimated the risk of infection from a transfusion in year 2011 and the cumulative risk from 1980 through 2011. The model was validated by comparing the model predictions with reported cases of vCJD.

Results: Using the low UK prevalence estimate, the model predicted a mean risk of 1 in 134 million transfusions, zero TTvCJD infections acquired in the year 2011, and zero cumulative clinical TTvCJD cases for the period spanning 1980 to 2011. With the high UK prevalence estimate, the model predicted a mean risk of 1 in 480,000 transfusions, six infections for 2011, and nine cumulative clinical cases from 1980 to 2011.

Conclusions: Model validation exercises indicated that predictions based on the low prevalence estimate are more consistent with clinical cases actually observed to date, implying that the risk, while highly uncertain, is likely very small.
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http://dx.doi.org/10.1111/trf.12637DOI Listing
September 2014

Blood system changes since recognition of transfusion-associated AIDS.

Transfusion 2013 Oct 27;53(10 Pt 2):2365-74. Epub 2013 Aug 27.

Center for Biologics Evaluation and Research, FDA, Rockville, Maryland.

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http://dx.doi.org/10.1111/trf.12373DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7169854PMC
October 2013

A telephone coaching intervention to improve asthma self-management behaviors.

Pediatr Nurs 2013 May-Jun;39(3):125-30, 145

St. Louis Children's Hospital Answer Line, St. Louis Children's Hospital, St. Louis, MO, USA.

Long recognizing that asthma, one of the most common chronic childhood diseases, is difficult to manage, the National Asthma Education Prevention Program developed clinical practice guidelines to assist health care providers, particularly those in the primary care setting. Yet, maintenance asthma care still fails to meet national standards. Therefore, in an attempt to improve and support asthma self-management behaviors for parents of children 5 to 12 years of age with persistent asthma, a novel nurse telephone coaching intervention was tested in a randomized, controlled trial. A detailed description of the intervention is provided along with parent satisfaction results, an overview of the training used to prepare the nurses, and a discussion of the challenges experienced and lessons learned.
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August 2013

Parents' experiences with pediatric care at retail clinics.

JAMA Pediatr 2013 Sep;167(9):845-50

Importance: Little is known about the use of retail clinics (RCs) for pediatric care.

Objective: To describe the rationale and experiences of families with a pediatrician who also use RCs for pediatric care.

Design And Setting: Cross-sectional study with 19 pediatric practices in a Midwestern practice-based research network.

Participants: Parents attending the pediatrician’s office.

Main Outcomes And Measures: Parents’ experience with RC care for their children.

Results: In total, 1484 parents (91.9% response rate) completed the self-administered paper survey. Parents (23.2%) who used the RC for pediatric care were more likely to report RC care for themselves (odds ratio, 7.79; 95% CI, 5.13-11.84), have more than 1 child (2.16; 1.55-3.02), and be older (1.05; 1.03-1.08). Seventy-four percent first considered going to the pediatrician but reported choosing the RC because the RC had more convenient hours (36.6%), no office appointment was available (25.2%), they did not want to bother the pediatrician after hours (15.4%), or they thought the problem was not serious enough (13.0%). Forty-seven percent of RC visits occurred between 8 am and 4 pm on weekdays or 8 am and noon on the weekend. Most commonly, visits were reportedly for acute upper respiratory tract illnesses (sore throat, 34.3%; ear infection, 26.2%; and colds or flu, 19.2%) and for physicals (13.1%). While 7.3% recalled the RC indicating it would inform the pediatrician of the visit, only 41.8% informed the pediatrician themselves.

Conclusions And Relevance: Parents with established relationships with a pediatrician most often took their children to RCs for care because access was convenient. Almost half the visits occurred when the pediatricians’ offices were likely open.
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http://dx.doi.org/10.1001/jamapediatrics.2013.352DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4019395PMC
September 2013

Pediatric providers' attitudes toward retail clinics.

J Pediatr 2013 Nov 28;163(5):1384-8.e1-6. Epub 2013 Jun 28.

Washington University in St Louis, St Louis, MO. Electronic address:

Objective: To describe pediatric primary care providers' attitudes toward retail clinics and their experiences of retail clinics use by their patients.

Study Design: A 51-item, self-administered survey from 4 pediatric practice-based research networks from the midwestern US, which gauged providers' attitudes toward and perceptions of their patients' interactions with retail clinics, and changes to office practice to better compete.

Results: A total of 226 providers participated (50% response). Providers believed that retail clinics were a business threat (80%) and disrupted continuity of chronic disease management (54%). Few (20%) agreed that retail clinics provided care within recommended clinical guidelines. Most (91%) reported that they provided additional care after a retail clinic visit (median 1-2 times per week), and 37% felt this resulted from suboptimal care at retail clinics "most or all of the time." Few (15%) reported being notified by the retail clinic within 24 hours of a patient visit. Those reporting prompt communication were less likely to report suboptimal retail clinic care (OR 0.20, 95% CI 0.10-0.42) or disruption in continuity of care (OR 0.32, 95% CI 0.15-0.71). Thirty-six percent reported changes to office practice to compete with retail clinics (most commonly adjusting or extending office hours), and change was more likely if retail clinics were perceived as a threat (OR 3.70, 95% CI 1.56-8.76); 30% planned to make changes in the near future.

Conclusions: Based on the perceived business threat, pediatric providers are making changes to their practice to compete with retail clinics. Improved communication between the clinic and providers may improve collaboration.
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http://dx.doi.org/10.1016/j.jpeds.2013.05.008DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3812257PMC
November 2013

Immune globulins and thrombotic adverse events as recorded in a large administrative database in 2008 through 2010.

Transfusion 2012 Oct 12;52(10):2113-21. Epub 2012 Mar 12.

HealthCore, Inc, Alexandria, Virginia, USA.

Background: Thrombotic events (TEs) are rare but often serious adverse events that could occur after administration of immune globulin (IG) products. Our study objective was to assess occurrence of recorded TEs after administration of different US-licensed IG products and investigate potential risk factors using a large administrative database.

Study Design And Methods: This is a retrospective claims-based cohort study of individuals exposed to IG products from January 1, 2008, through September 30, 2010, using HealthCore's Integrated Research Database, a longitudinal health care database. IG products were identified by recorded Healthcare Common Procedure Coding System codes. TEs were ascertained via International Classification of Diseases, Ninth Revision, Clinical Modification diagnosis codes. Logistic regression was used to estimate odds ratios (ORs) and 95% confidence intervals (CIs) for same-day TEs by IG product, while controlling for confounders.

Results: Of 11,785 individuals exposed to IG products in the study period, 122 (1%) had TE(s) recorded on the same day as IG administration. TE rates per 1000 persons exposed ranged from 6.1 to 20.5 for different IG product groups. Vivaglobin users had an increased same-day TE risk compared to reference Gammagard Liquid users (OR, 3.56; 95% CI, 1.54-8.23). An increased TE risk was also found with older age (≥ 45 years), prior TE(s), and hypercoagulable state(s).

Conclusion: The study suggests potentially elevated TE rates for different IG products, including subcutaneous. It also identifies important recipient TE risk factors and suggests that risk-benefit profiles should be weighed before IG administration. The observed differences may be due to various factors such as dosage, administration rates, and product manufacturing processes that warrant further evaluation.
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http://dx.doi.org/10.1111/j.1537-2995.2012.03589.xDOI Listing
October 2012

Best practices in regulation of blood and blood products.

Authors:
Jay S Epstein

Biologicals 2012 May 27;40(3):200-4. Epub 2011 Nov 27.

Office of Blood Research and Review, Center for Biologics Evaluation and Research, US Food and Drug Administration, Rockville, MD 20852, USA.

The need for blood regulation arises from the inherent risks of blood transfusion, which are minimized through implementation of standards. Regulatory oversight is advocated by the World Health Organization (WHO) as an essential element of any blood system to ensure such standards are met. The WHO Blood Regulators Network has developed "Assessment Criteria for National Blood Regulatory Systems" that describe the legal authority and functions of a fully competent blood regulator. The core functions include licensing and/or registration of blood establishments, marketing approval of blood products, oversight of all associated substances and devices, control of clinical trials, access to an independent laboratory for product assessments, lot release, and hemovigilance systems. Regulatory policy-making for blood safety is needed to address emerging threats, to consider the risks and benefits of new products and technologies, and to respond to adverse events. Structured policy-making processes are essential to ensure that decisions are science-based, with appropriate consideration of relevant economic and social factors. Decision making is especially challenging in situations of scientific uncertainty, where prudent precautionary measures may be appropriate based on assessments of risk and feasibility of meaningful interventions. There is international interest in finding a common framework for addressing blood safety decisions.
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http://dx.doi.org/10.1016/j.biologicals.2011.11.002DOI Listing
May 2012

Progress in monitoring blood safety.

Transfusion 2010 Jul;50(7):1408-12

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http://dx.doi.org/10.1111/j.1537-2995.2010.02728.xDOI Listing
July 2010

Telephone coaching for parents of children with asthma: impact and lessons learned.

Arch Pediatr Adolesc Med 2010 Jul;164(7):625-30

Department of Medicine, Washington University School of Medicine, 660 S Euclid Ave, St Louis, MO 63110, USA.

Objective: To determine whether an asthma coaching program can improve parent and child asthma-related quality of life (QOL) and reduce urgent care events.

Design: Randomized controlled trial of usual care vs usual care with coaching. Comparisons were made between groups using mixed models.

Setting: A Midwest city.

Participants: A community-based sample of 362 families with a child aged 5 to 12 years with persistent asthma.

Intervention: A 12-month structured telephone coaching program in which trained coaches provided education and support to parents for 4 key asthma management behaviors.

Main Outcome Measures: Parental and child QOL measured with a validated, interview-administered, 7-point instrument and urgent care events in a year (unscheduled office visits, after-hours calls, emergency department visits, or hospitalizations) determined by record audit.

Results: Parental asthma-related QOL scores improved by an average of 0.67 units (95% confidence interval [CI], 0.49 to 0.84) in the intervention group and 0.28 units (95% CI, 0.10 to 0.46) in the control group. The difference between study groups was statistically significant (difference, 0.38; 95% CI, 0.14 to 0.63). No between-group difference was found in the change in the child's QOL (difference, -0.17; 95% CI, -0.47 to 0.12) or in the mean number of urgent care events per year (difference, 1.15; 95% CI, 0.82 to 1.61). The proportion of children with very poorly controlled asthma in the intervention group decreased compared with the control group (difference, 0.34; 95% CI, 0.21 to 0.48).

Conclusions: A telephone coaching program can improve parental QOL and can be implemented without additional physician training or practice redesign.
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http://dx.doi.org/10.1001/archpediatrics.2010.91DOI Listing
July 2010

Alternative strategies in assuring blood safety: An overview.

Authors:
Jay S Epstein

Biologicals 2010 Jan 27;38(1):31-5. Epub 2010 Jan 27.

Office of Blood Research and Review, Center for Biologics Evaluation and Research, Food and Drug Administration, HFM-300, 1401 Rockville Pike, Rockville, MD 20852, USA.

Assuring transfusion safety is an essential element of health care in all countries, requiring government commitment, national policy and a legal framework. Fundamental safety strategies include selection of low risk donors, Good Manufacturing Practices in preparation of blood components, and appropriate clinical use including avoidance of unnecessary transfusions. Hemovigilance, including surveillance for known adverse events and sentinel reporting of unexpected adverse events, enhances safety through benchmarking to promote best practices and by enabling rapid responses to new threats. Preventing transmission of infectious diseases is a principal safety concern. Selection of low risk donors includes use of screening questions to elicit risk factors known to be associated with transmissible infections. Laboratory testing for specific infectious disease markers is an established strategy for interdicting contaminated donations. The sensitivity, specificity, and operational convenience of laboratory testing have improved over time and newer technologies are imminent. Donor screening and laboratory testing, while highly effective in reducing risk, cannot eliminate all risk from known agents and must be developed de novo to address emerging infections. In contrast, pathogen reduction technologies offer the possibility for robust inactivation of a broad spectrum of blood transmissible agents and provide an added safeguard against newly emerging infectious threats of most types. Current pathogen reduction methods also inactivate leukocytes, adding safety benefits similar to leukocyte removal and product irradiation. However, to date, concerns about the safety and efficacy of cellular blood components treated by pathogen reduction have prevented approval of these technologies in the U.S. and Canada. FDA is promoting clinical and basic scientific studies to clarify these issues and would consider alternative approaches to assuring blood safety if pathogen reduction technologies are proven to be safe and effective.
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http://dx.doi.org/10.1016/j.biologicals.2009.10.009DOI Listing
January 2010

Transfusion-transmitted babesiosis in the United States: summary of a workshop.

Transfusion 2009 Dec 10;49(12):2759-71. Epub 2009 Oct 10.

Office of Blood Research and Review, Center for Biologics Evaluation and Research, US Food and Drug Administration, Rockville, Maryland 20852, USA.

Infections of humans with intraerythrocytic parasites of the genus Babesia can be locally prevalent in diverse regions of the United States. Transfusion of blood and blood products collected from donors infected with Babesia may result in a serious illness that can be fatal. In September 2008, the Food and Drug Administration organized a public workshop to discuss the various aspects of transfusion-transmitted babesiosis in the United States including the possible strategies to identify and defer blood donors who may have been infected with Babesia. Discussions were also held on the biology, pathogenesis, and epidemiology of Babesia species. In this article, we summarize the scientific presentations and panel discussions that took place during the workshop.
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http://dx.doi.org/10.1111/j.1537-2995.2009.02429.xDOI Listing
December 2009