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Irving A, Simmonds P, Irving W, Thomas S, Neuberger J. Quantifying the impact of a novel virus on the economic value of pathogen reduction technology for platelets. Transfusion 2025; 65:310-317. [PMID: 39699313 DOI: 10.1111/trf.18115] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 09/28/2024] [Revised: 12/03/2024] [Accepted: 12/07/2024] [Indexed: 12/20/2024]
Abstract
BACKGROUND Pathogen reduction technology (PRT) is an intervention designed to proactively reduce the amount of known and unknown pathogens in donated blood. As current screening for known pathogens is highly effective, some previous evaluations have found that the value of PRT largely hinges on a previously unknown pathogen, most likely a novel virus, emerging and entering the blood supply. In such situations, the risk of emergence can and should be modeled and presented transparently in the cost-effectiveness results for deliberation by decision-makers. STUDY DESIGN AND METHODS We built a Markov cohort model assessing the economic value of introducing PRT for platelets in the United Kingdom. Input data were obtained from the existing PRT literature, national sources, or by conservative assumption. The primary objective of the study was to demonstrate methods for modeling and presenting the risk of emergence of a novel virus, using alternative time-to-emergence scenarios in the probabilistic sensitivity analysis. RESULTS As expected, PRT will be more cost-effective the sooner the novel virus emerges after the introduction of PRT. In the base-case cost scenario, the deterministic ICER was £270 K/QALY gained if the virus emerged immediately and rose to £3.3 M/QALY gained if the virus emerged after 25 years. DISCUSSION At current prices, PRT is unlikely to be cost-effective when judged against thresholds for medicines and treatments. Given significant additional willingness-to-pay for blood safety, PRT is only likely to be cost-effective if a novel virus that causes chronic infection with significant morbidity and mortality emerges very soon after the introduction of PRT.
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Affiliation(s)
- Adam Irving
- Centre for Health Economics, Monash Business School, Monash University, Melbourne, Victoria, Australia
- Transfusion Research Unit, School of Public Health and Preventive Medicine, Monash University, Melbourne, Victoria, Australia
| | - Peter Simmonds
- Nuffield Department of Medicine, University of Oxford, Oxford, UK
| | - William Irving
- NIHR Nottingham Biomedical Research Centre, Nottingham University Hospitals NHS Trust, Nottingham, UK
- The University of Nottingham, Nottingham, UK
| | - Stephen Thomas
- Joint Professional Advisory Committee, London, UK
- NHS Blood and Transplant, London, UK
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2
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Schenberg K, Hoad VC, Harley R, Bentley P. Managing the risk of transfusion-transmitted malaria from Australian blood donations: Recommendation of a new screening strategy. Vox Sang 2024; 119:945-952. [PMID: 39048116 DOI: 10.1111/vox.13706] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 01/29/2024] [Revised: 05/17/2024] [Accepted: 05/23/2024] [Indexed: 07/27/2024]
Abstract
BACKGROUND AND OBJECTIVES To reduce the risk of transfusion-transmitted malaria (TTM) from transfusible components, Australia tests for malaria antibodies in both travellers returning from and former residents of malaria-endemic areas. The testing is performed a minimum of 120 days after last potential exposure. TTM is an extremely rare event and managing the risk adds considerable complexity. The objectives of this study were to analyse various testing and deferral strategies, considering the risk, donation numbers and operational complexities. MATERIALS AND METHODS A residual risk model was developed to calculate the risk of TTM in five testing/deferral strategies. Australian blood donor data from 2020 and 2021 were used and incorporated the incidence of parasitaemia, Plasmodium species and the malaria enzyme immunoassay test's failure rate. Donor and donation loss or gain and an operational assessment were performed. RESULTS The current model's estimated risk of TTM is 1 in 67.9 million transfused units. Testing residents with a 120-day plasma restriction for visitors without testing was found to have the same estimated risk, with an expected increase of 342 donations per year, significant cost savings and a 62% reduction in the number of donors requiring assessment. CONCLUSION A strategy that involves testing residents of malaria areas only and a 120-day plasma travel restriction would not significantly increase the risk of TTM, is operationally simpler, costs less and results in a small increase in donations.
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Affiliation(s)
- Katia Schenberg
- Faculty of Health and Medical Sciences, University of Western Australia, Perth, Western Australia, Australia
| | - Veronica C Hoad
- Australian Red Cross Lifeblood, Melbourne, Victoria, Australia
- School of Population and Global Health, University of Western Australia, Perth, Western Australia, Australia
| | - Robert Harley
- Australian Red Cross Lifeblood, Melbourne, Victoria, Australia
| | - Peter Bentley
- Faculty of Health and Medical Sciences, University of Western Australia, Perth, Western Australia, Australia
- Australian Red Cross Lifeblood, Melbourne, Victoria, Australia
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3
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Roy Choudhury A, Hoad VC, Seed C, Bentley P. Is dual testing for hepatitis C necessary? Modelling the risk of removing hepatitis C antibody testing for Australian blood donations. Vox Sang 2023; 118:480-487. [PMID: 37183505 PMCID: PMC10952898 DOI: 10.1111/vox.13430] [Citation(s) in RCA: 1] [Impact Index Per Article: 0.5] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 12/15/2022] [Revised: 03/08/2023] [Accepted: 03/23/2023] [Indexed: 05/16/2023]
Abstract
BACKGROUND AND OBJECTIVES Parallel testing of blood donations for hepatitis C virus (HCV) antibody and HCV RNA by nucleic acid testing (NAT) has been standard practice in Australia since 2000. Meanwhile, NAT technologies have improved, and HCV has become a curable disease. This has resulted in a significant reduction in the risk and clinical consequences of HCV transmission through transfusion. This study aimed to estimate the residual risk (RR) under various testing options to determine the optimal testing strategy. MATERIALS AND METHODS A developed deterministic model calculated the RR of HCV transmission for four testing strategies. A low, mid and high estimate of the RR was calculated for each. The testing strategies modelled were as follows: universal dual testing, targeted dual testing for higher risk groups (first-time donors or transfusible component donations) and universal NAT only. RESULTS The mid estimate of the RR was 1 in 151 million for universal dual testing, 1 in 111 million for targeted dual testing of first-time donors, 1 in 151 million for targeted dual testing for transfusible component donations and 1 in 66 million for universal NAT only. For all testing strategies, all estimates were considerably less than 1 in 1 million. CONCLUSION Antibody testing in addition to NAT does not materially change the risk profile. Even conservative estimates for the cessation of anti-HCV predict an HCV transmission risk substantially below 1 in 1 million. Therefore, given that it is not contributing to blood safety in Australia but consuming resources, anti-HCV testing can safely be discontinued.
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Affiliation(s)
- Avijoy Roy Choudhury
- UWA Medical SchoolThe University of Western AustraliaPerthWestern AustraliaAustralia
| | | | - Clive Seed
- Australian Red Cross LifebloodPerthWestern AustraliaAustralia
| | - Peter Bentley
- UWA Medical SchoolThe University of Western AustraliaPerthWestern AustraliaAustralia
- Australian Red Cross LifebloodPerthWestern AustraliaAustralia
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4
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Krewski D, Saunders-Hastings P, Larkin P, Westphal M, Tyshenko MG, Leiss W, Dusseault M, Jerrett M, Coyle D. Principles of risk decision-making. JOURNAL OF TOXICOLOGY AND ENVIRONMENTAL HEALTH. PART B, CRITICAL REVIEWS 2022; 25:250-278. [PMID: 35980104 DOI: 10.1080/10937404.2022.2107591] [Citation(s) in RCA: 4] [Impact Index Per Article: 1.3] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Subscribe] [Scholar Register] [Indexed: 06/15/2023]
Abstract
Risk management decisions in public health require consideration of a number of complex, often conflicting factors. The aim of this review was to propose a set of 10 fundamental principles to guide risk decision-making. Although each of these principles is sound in its own right, the guidance provided by different principles might lead the decision-maker in different directions. For example, where the precautionary principle advocates for preemptive risk management action under situations of scientific uncertainty and potentially catastrophic consequences, the principle of risk-based decision-making encourages decision-makers to focus on established and modifiable risks, where a return on the investment in risk management is all but guaranteed in the near term. To evaluate the applicability of the 10 principles in practice, one needs to consider 10 diverse risk issues of broad concern and explore which of these principles are most appropriate in different contexts. The 10 principles presented here afford substantive insight into the process of risk management decision-making, although decision-makers will ultimately need to exercise judgment in reaching appropriate risk decisions, accounting for all of the scientific and extra-scientific factors relevant to the risk decision at hand.
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Affiliation(s)
- Daniel Krewski
- McLaughlin Centre for Population Health Risk Assessment, Faculty of Medicine, University of Ottawa, ON, Canada
| | - Patrick Saunders-Hastings
- McLaughlin Centre for Population Health Risk Assessment, Faculty of Medicine, University of Ottawa, ON, Canada
| | - Patricia Larkin
- McLaughlin Centre for Population Health Risk Assessment, Faculty of Medicine, University of Ottawa, ON, Canada
| | - Margit Westphal
- McLaughlin Centre for Population Health Risk Assessment, Faculty of Medicine, University of Ottawa, ON, Canada
| | | | - William Leiss
- McLaughlin Centre for Population Health Risk Assessment, Faculty of Medicine, University of Ottawa, ON, Canada
| | - Maurice Dusseault
- Department of Earth and Environmental Sciences, University of Waterloo, Waterloo, ON, Canada
| | - Michael Jerrett
- Department of Environmental Health Sciences, Fielding School of Public Health, UCLA, Los Angeles, CA, USA
| | - Doug Coyle
- School of Epidemiology and Public Health, University of Ottawa, ON, Canada
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5
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Prioli KM, Abersone I, Kopko PM, Herman JH, Custer B, Pizzi LT. Economic implications of FDA platelet bacterial guidance compliance options: Comparison of single-step strategies. Transfusion 2022; 62:365-373. [PMID: 34997763 PMCID: PMC9303536 DOI: 10.1111/trf.16778] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 05/21/2021] [Revised: 11/11/2021] [Accepted: 11/11/2021] [Indexed: 11/26/2022]
Abstract
BACKGROUND Bloodborne pathogens pose a major safety risk in transfusion medicine. To mitigate the risk of bacterial contamination in platelet units, FDA issues updated guidance materials on various bacterial risk control strategies (BRCS). This analysis presents results of a budget impact model updated to include 5- and 7-day pathogen reduced (PR) and large volumed delayed sampling (LVDS) BRCS. STUDY DESIGN AND METHODS Model base-case parameter inputs were based on scientific literature, a survey distributed to 27 US hospitals, and transfusion experts' opinion. The outputs include hospital budget and shelf-life impacts for 5- and 7-day LVDS, and 5- and 7-day PR units under three different scenarios: (1) 100% LVDS, (2) 100% PR, and (3) mix of 50% LVDS - and 50% PR. RESULTS Total annual costs from the hospital perspective were highest for 100% LVDS platelets (US$2.325M) and lowest for 100% PR-7 units (US$2.170M). Net budget impact after offsetting annual costs by outpatient reimbursements was 5.5% lower for 5-day PR platelets as compared to 5-day LVDS (US$1.663 vs. US$1.760M). A mix of 7-day LVDS and 5-day PR platelets had net annual costs that were 1.3% lower than for 100% 7-day LVDS, but 1.3% higher than for 100% 5-day PR. 7-day PR platelets had the longest shelf life (4.63 days), while 5-day LVDS had the shortest (2.00 days). DISCUSSION The model identifies opportunities to minimize transfusion center costs for 5- and 7-day platelets. Budget impact models such as this are important for understanding the financial implications of evolving FDA guidance and new platelet technologies.
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Affiliation(s)
- Katherine M Prioli
- Center for Health Outcomes, Policy and Economics, Rutgers University, Piscataway, New Jersey, USA
| | - Ilze Abersone
- Center for Health Outcomes, Policy and Economics, Rutgers University, Piscataway, New Jersey, USA
| | - Patricia M Kopko
- Division of Transfusion Medicine, University of California San Diego, San Diego, California, USA
| | - Jay H Herman
- Division of Transfusion Medicine, Thomas Jefferson University, Philadelphia, Pennsylvania, USA
| | - Brian Custer
- Vitalant Research Institute, San Francisco, California, USA.,Department of Laboratory Medicine, UCSF, San Francisco, California, USA
| | - Laura T Pizzi
- Center for Health Outcomes, Policy and Economics, Rutgers University, Piscataway, New Jersey, USA
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6
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Janssen MP, Nuebling CM, Lery FX, Maryuningsih YS, Epstein JS. A WHO tool for risk-based decision making on blood safety interventions. Transfusion 2020; 61:503-515. [PMID: 33368381 PMCID: PMC7898802 DOI: 10.1111/trf.16231] [Citation(s) in RCA: 3] [Impact Index Per Article: 0.6] [Reference Citation Analysis] [Abstract] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 08/26/2020] [Revised: 10/22/2020] [Accepted: 11/25/2020] [Indexed: 11/28/2022]
Abstract
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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Affiliation(s)
- Mart P Janssen
- Transfusion Technology Assessment Group, Donor Medicine Research Department, Sanquin Research, Amsterdam, The Netherlands
| | - C Micha Nuebling
- Division of Major Policy Issues, Paul-Ehrlich-Institut, Langen, Germany
| | - François-Xavier Lery
- Technical Standards and Specifications Unit, Health Products Policy and Standards Department, WHO Headquarters, Geneva, Switzerland
| | - Yuyun S Maryuningsih
- Blood and Other Product of Human Origin, Health Products Policy and Standards Department, WHO Headquarters, Geneva, Switzerland
| | - Jay S Epstein
- Center for Biologics Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA
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7
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Matanhire TB, Lin SW. An economic reappraisal of hepatitis B virus testing strategy for blood donors in Taiwan. Vox Sang 2020; 116:564-573. [PMID: 33277934 DOI: 10.1111/vox.13045] [Citation(s) in RCA: 1] [Impact Index Per Article: 0.2] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 06/30/2020] [Revised: 11/11/2020] [Accepted: 11/15/2020] [Indexed: 12/26/2022]
Abstract
BACKGROUND AND OBJECTIVES Taiwan is among the few hepatitis B virus (HBV) high-endemic countries that implement universal mini-pool nucleic acid testing (MP-NAT) and hepatitis B surface antigen (HBsAg) testing together with confirmatory individual donor nucleic acid testing (ID-NAT) for its blood supply since 2013. The aim of this study was to reappraise the value of HBsAg test in Taiwan's HBV testing strategy. MATERIALS AND METHODS A Markov model was constructed, and cost-effectiveness analysis was conducted in order to reappraise the existing HBV screening strategy in Taiwan. RESULTS The incremental cost-effectiveness ratio (ICER) for the current testing strategy in Taiwan was estimated to be $US 443 154 per quality-adjusted life year (QALY) gained. This is almost six times the willingness-to-pay (WTP) threshold that reflects local preferences. CONCLUSION Universal HBsAg and MP-8-NAT together with confirmatory ID-NAT testing prevents a significant amount of HBV infections from entering the Taiwan blood supply. However, this comes at a disproportionate increase in cost.
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Affiliation(s)
- Tapiwa Blessing Matanhire
- Department of Industrial Management, National Taiwan University of Science and Technology, Taipei, Taiwan
| | - Shi-Woei Lin
- Department of Industrial Management, National Taiwan University of Science and Technology, Taipei, Taiwan.,Artificial Intelligence for Operations Management Research Center, National Taiwan University of Science and Technology, Taipei, Taiwan
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8
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Vermeulen M, van den Berg K, Sykes W, Reddy R, Ingram C, Poole C, Custer B. Health economic implications of testing blood donors in South Africa for HTLV 1 & 2 infection. Vox Sang 2019; 114:467-477. [PMID: 31131453 DOI: 10.1111/vox.12788] [Citation(s) in RCA: 2] [Impact Index Per Article: 0.3] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 12/11/2018] [Revised: 04/16/2019] [Accepted: 04/16/2019] [Indexed: 12/30/2022]
Abstract
BACKGROUND AND OBJECTIVES Currently, HTLV screening is not performed in South Africa (SA). This report describes an economic assessment (budget impact and cost-effectiveness) of implementing different HTLV screening strategies. METHODS A modified version of the Alliance of Blood Operators risk-based decision-making framework was used to assess the risk and consequences of HTLV in the blood supply in SA. We developed a deterministic model of the cost and consequences of four screening strategies: none, universal, all donors once and first time donors only assuming a transfusion-transmission (TT) efficiency of 10% and a manifestation of clinical disease of 6%. RESULTS Unscreened blood results in 3·55 symptomatic TT-HTLV cases and a total healthcare cost of Rand (R)3 446 950 (US Dollars (USD)229 800) annually. Universal screening would cost R24 000 000 (USD1 600 000) per annum and prevent 3·54 (99·8%) symptomatic TT-HTLV cases in the first year and 0·55 (98·4%) symptomatic TT-HTLV cases in the second year at a cost per TT-HTLV prevented of R6 780 000 (USD450 000) in year one and R43 254 000 (USD2 890 000) in year two. Screening all donors once would cost R16,200,000 (USD1 080 000) or R4 600 000 (USD306 000) per symptomatic TT-HTLV infection prevented in year one. Total costs decrease to R5 100 000 (USD340 000) in year 2 but the cost per TT-HTLV prevented increases to R10 700 000 (USD713 333). CONCLUSION This analysis contributed to the decision not to implement HTLV screening as the healthcare budget and particularly the budget for blood transfusion in SA is insufficient to provide appropriate treatment. Arguably, available resources can be more efficiently utilized in other healthcare programs.
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Affiliation(s)
- Marion Vermeulen
- South African National Blood Service, Weltevreden Park, South Africa
| | | | - Wendy Sykes
- South African National Blood Service, Weltevreden Park, South Africa
| | - Ravi Reddy
- South African National Blood Service, Weltevreden Park, South Africa
| | | | - Colwyn Poole
- South African National Blood Service, Weltevreden Park, South Africa
| | - Brian Custer
- Vitalant Research Institute, San Francisco, CA, USA.,Department of Laboratory Medicine, University of California San Francisco, San Francisco, CA, USA
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9
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Prevention of transfusion-transmitted infections. Blood 2019; 133:1854-1864. [PMID: 30808637 DOI: 10.1182/blood-2018-11-833996] [Citation(s) in RCA: 151] [Impact Index Per Article: 25.2] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 11/20/2018] [Accepted: 02/03/2019] [Indexed: 01/10/2023] Open
Abstract
Since the 1970s, introduction of serological assays targeting virus-specific antibodies and antigens has been effective in identifying blood donations infected with the classic transfusion-transmitted infectious agents (TTIs; hepatitis B virus [HBV], HIV, human T-cell lymphotropic virus types I and II, hepatitis C virus [HCV]). Subsequently, progressive implementation of nucleic acid-amplification technology (NAT) screening for HIV, HCV, and HBV has reduced the residual risk of infectious-window-period donations, such that per unit risks are <1 in 1 000 000 in the United States, other high-income countries, and in high-incidence regions performing NAT. NAT screening has emerged as the preferred option for detection of newer TTIs including West Nile virus, Zika virus (ZIKV), and Babesia microti Although there is continual need to monitor current risks due to established TTI, ongoing challenges in blood safety relate primarily to surveillance for emerging agents coupled with development of rapid response mechanisms when such agents are identified. Recent progress in development and implementation of pathogen-reduction technologies (PRTs) provide the opportunity for proactive rather than reactive response to blood-safety threats. Risk-based decision-making tools and cost-effectiveness models have proved useful to quantify infectious risks and place new interventions in context. However, as evidenced by the 2015 to 2017 ZIKV pandemic, a level of tolerable risk has yet to be defined in such a way that conflicting factors (eg, theoretical recipient risk, blood availability, cost, and commercial interests) can be reconciled. A unified approach to TTIs is needed, whereby novel tests and PRTs replace, rather than add to, existing interventions, thereby ameliorating cost and logistical burden to blood centers and hospitals.
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10
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Leach Bennett J, Devine DV. Risk-based decision making in transfusion medicine. Vox Sang 2018; 113:737-749. [DOI: 10.1111/vox.12708] [Citation(s) in RCA: 10] [Impact Index Per Article: 1.4] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 11/16/2017] [Revised: 06/29/2018] [Accepted: 08/06/2018] [Indexed: 11/27/2022]
Affiliation(s)
| | - Dana V. Devine
- Canadian Blood Services; Ottawa ON Canada
- Centre for Blood Research; University of British Columbia; Vancouver BC Canada
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11
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Custer B, Zou S, Glynn SA, Makani J, Tayou Tagny C, El Ekiaby M, Sabino EC, Choudhury N, Teo D, Nelson K, Peprah E, Price L, Engelgau MM. Addressing gaps in international blood availability and transfusion safety in low- and middle-income countries: a NHLBI workshop. Transfusion 2018. [PMID: 29542130 DOI: 10.1111/trf.14598] [Citation(s) in RCA: 53] [Impact Index Per Article: 7.6] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 12/18/2022]
Abstract
In April 2017, a workshop sponsored by the National Heart, Lung, and Blood Institute, Division of Blood Diseases and Resources, and the Center for Translation Research and Implementation Science was held to discuss blood availability and transfusion safety in low- and middle-income countries (LMICs). The purpose of the workshop was to identify research opportunities for implementation science (IS) to improve the availability of safe blood and blood components and transfusion practices in LMICs. IS describes the late stages of the translational research spectrum and studies optimal and sustainable strategies to deliver proven-effective interventions. Regional working groups were formed to focus on opportunities and challenges in East Africa, Central/West Africa, Middle East and North Africa, Latin America and the Caribbean, Southeast Asia, Western Pacific Asia, Eastern Europe, and Central Asia. The need for an "adequate supply of safe blood" emerged as the major overriding theme. Among the regional working groups, common cross-cutting themes were evident. The majority of research questions, priorities, and strategies fell into the categories of blood availability, blood transfusion safety, appropriate use of blood, quality systems, health economics and budgeting, and training and education in IS. The workshop also brought into focus inadequate country-level data that can be used as the basis for IS initiatives. A mixed approach of needs assessment and targeted interventions with sufficient evidence base to move toward sustainment is an appropriate next step for blood availability and transfusion safety research in LMICs.
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Affiliation(s)
- Brian Custer
- Blood Systems Research Institute, San Francisco, California.,Department of Laboratory Medicine, University of California at San Francisco, San Francisco, California
| | | | | | - Julie Makani
- Department of Haematology and Blood Transfusion, Muhimbili University of Health and Allied Sciences, Dar es Salaam, Tanzania
| | - Claude Tayou Tagny
- Faculty of Medicine and Biomedical Sciences, University of Yaounde I, Yaounde, Cameroon
| | | | - Ester C Sabino
- Instituto de Medicina Tropical e Faculdade de Medicina da Universidade de São Paulo, São Paulo, Brazil
| | | | - Diana Teo
- Health Sciences Authority, Singapore
| | - Kenrad Nelson
- Department of Epidemiology, Bloomberg School of Public Health, Johns Hopkins University, Baltimore, Maryland
| | - Emmanuel Peprah
- Center for Translation Research and Implementation Science, National Heart, Lung, and Blood Institute, National Institutes of Health, Rockville, Maryland
| | - LeShawndra Price
- Center for Translation Research and Implementation Science, National Heart, Lung, and Blood Institute, National Institutes of Health, Rockville, Maryland
| | - Michael M Engelgau
- Center for Translation Research and Implementation Science, National Heart, Lung, and Blood Institute, National Institutes of Health, Rockville, Maryland
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12
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Devine DV. Implementation of pathogen inactivation technology: how to make the best decisions? Transfusion 2018; 57:1109-1111. [PMID: 28425602 DOI: 10.1111/trf.14117] [Citation(s) in RCA: 3] [Impact Index Per Article: 0.4] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 02/22/2017] [Accepted: 02/22/2017] [Indexed: 11/30/2022]
Affiliation(s)
- Dana V Devine
- Canadian Blood Services, University of British Columbia, Vancouver, BC, Canada.,Centre for Blood Research and the Department of Pathology & Laboratory Medicine, University of British Columbia, Vancouver, BC, Canada
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13
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Babigumira JB, Lubinga SJ, Castro E, Custer B. Cost-utility and budget impact of methylene blue-treated plasma compared to quarantine plasma. BLOOD TRANSFUSION = TRASFUSIONE DEL SANGUE 2018; 16:154-162. [PMID: 27893348 PMCID: PMC5839612 DOI: 10.2450/2016.0130-16] [Citation(s) in RCA: 1] [Impact Index Per Article: 0.1] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Subscribe] [Scholar Register] [Received: 05/16/2016] [Accepted: 08/30/2016] [Indexed: 11/21/2022]
Abstract
BACKGROUND Methylene blue and visible light treatment and quarantine are two methods used to reduce adverse events, mostly infections, associated with the transfusion of fresh-frozen plasma. The objective of this study was to estimate and compare the budget impact and cost-utility of these two methods from a payer's perspective. MATERIALS AND METHODS A budget impact and cost-utility model simulating the risks of hepatitis B virus, hepatitis C virus, cytomegalovirus, a West Nile virus-like infection, allergic reactions and febrile non-haemolytic transfusion reactions achieved using plasma treated with methylene blue and visible light (MBP) and quarantine plasma (QP) was constructed for Spain. QP costs were estimated using data from one blood centre in Spain and published literature. The costs of producing fresh-frozen plasma from whole blood, apheresis plasma, and multicomponent apheresis, and separately for passive and active methods of donor recall for QP were included. Costs and outcomes over a 5-year and lifetime time horizon were estimated. RESULTS Compared to passive QP, MBP led to a net increase of € 850,352, and compared to active QP, MBP led to a net saving of € 5,890,425 over a 5-year period. Compared to passive QP, MBP increased the cost of fresh-frozen plasma per patient by € 7.21 and had an incremental cost-utility ratio of € 705,126 per quality-adjusted life-year. Compared to active QP, MBP reduced cost by € 50.46 per patient and was more effective. DISCUSSION Plasma collection method and quarantine approach had the strongest influence on the budget impact and cost-utility of MBP. If QP relies on plasma from whole blood collection and passive quarantine, it is less costly than MBP. However, MPB was estimated to be more effective than QP in all analyses.
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Affiliation(s)
- Joseph B. Babigumira
- Global Medicines Program, Department of Global Health, University of Washington, Seattle, United States of America
- Pharmaceutical Outcomes Research and Policy Program, Department of Pharmacy, University of Washington, Seattle, United States of America
| | - Solomon J. Lubinga
- Global Medicines Program, Department of Global Health, University of Washington, Seattle, United States of America
- Pharmaceutical Outcomes Research and Policy Program, Department of Pharmacy, University of Washington, Seattle, United States of America
| | - Emma Castro
- Community Blood Transfusion Centre, Valencia, Spain
| | - Brian Custer
- Blood Systems Research Institute, San Francisco, United States of America
- Department of Laboratory Medicine, UCSF, San Francisco, United States of America
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14
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Janssen MP, van Hulst M, Custer B. An assessment of differences in costs and health benefits of serology and NAT screening of donations for blood transfusion in different Western countries. Vox Sang 2017. [DOI: 10.1111/vox.12543] [Citation(s) in RCA: 11] [Impact Index Per Article: 1.4] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 12/21/2022]
Affiliation(s)
- M. P. Janssen
- Julius Center for Health Sciences and Primary Care; UMC Utrecht; Utrecht The Netherlands
- Transfusion Technology Assessment Department; Sanquin Research; Sanquin Blood Supply Foundation; Amsterdam The Netherlands
| | - M. van Hulst
- Department of Clinical Pharmacy and Toxicology; Martini Hospital; Groningen The Netherlands
- Department of PharmacoTherapy, -Epidemiology & -Economics; Department of Pharmacy; University of Groningen; Groningen The Netherlands
| | - B. Custer
- Blood Systems Research Institute; San Francisco CA USA
- Department of Laboratory Medicine; UCSF; San Francisco CA USA
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15
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Custer B, Janssen MP, Hubben G, Vermeulen M, van Hulst M. Development of a web-based application and multicountry analysis framework for assessing interdicted infections and cost-utility of screening donated blood for HIV, HCV and HBV. Vox Sang 2017; 112:526-534. [PMID: 28597489 DOI: 10.1111/vox.12538] [Citation(s) in RCA: 9] [Impact Index Per Article: 1.1] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 11/20/2016] [Revised: 03/06/2017] [Accepted: 04/25/2017] [Indexed: 01/20/2023]
Abstract
BACKGROUND AND OBJECTIVES Most countries test donations for HIV, HCV and HBV using serology with or without nucleic acid testing (NAT). Cost-utility analyses provide information on the relative value of different screening options. The aim of this project was to develop an open access risk assessment and cost-utility analysis web-tool for assessing HIV, HCV and HBV screening options (http://www.isbtweb.org/working-parties/transfusion-transmitted-infectious-diseases/). An analysis for six countries (Brazil, Ghana, the Netherlands, South Africa, Thailand and USA) was conducted. MATERIALS AND METHODS Four strategies; (1) antibody assays (Abs) for HIV and HCV + HBsAg, (2) antibody assays that include antigens for HIV and HCV (Combo) + HBsAg, (3) NAT in minipools of variable size (MP NAT) and (4) individual donation (ID) NAT can be evaluated using the tool. Country-specific data on donors, donation testing results, recipient outcomes and costs are entered using the online interface. Results obtained include the number infections interdicted using each screening options, and the (incremental and average) cost-utility of the options. RESULTS In each of the six countries evaluated, the use of antibody assays is cost effective or even cost saving. NAT has varying cost-utility depending on the setting, and where adopted, the incremental cost-utility exceeds any previously defined or proposed threshold in each country. CONCLUSION The web-tool allows an assessment of infectious units interdicted and value for money of different testing strategies. Regardless of gross national income (GNI) per capita, countries appear willing to dedicate healthcare resources to blood supply safety in excess of that for other sectors of health care.
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Affiliation(s)
- B Custer
- Blood Systems Research Institute, San Francisco, CA, USA.,Department of Laboratory Medicine, University of California San Francisco, San Francisco, CA, USA
| | - M P Janssen
- Julius Center for Health Sciences and Primary Care, UMC Utrecht, Utrecht, The Netherlands.,Transfusion Technology Assessment Department, Sanquin Research, Sanquin Blood Supply Foundation, Amsterdam, The Netherlands
| | | | - M Vermeulen
- South African National Blood Service, Johannesburg, South Africa
| | - M van Hulst
- Department of PharmacoTherapy, Epidemiology & Economics, University of Groningen, Groningen, The Netherlands.,Department of Clinical Pharmacy and Toxicology, Martini Hospital, Groningen, The Netherlands
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16
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Kramer K, Verweij MF, Zaaijer HL. Are there ethical differences between stopping and not starting blood safety measures? Vox Sang 2017; 112:417-424. [DOI: 10.1111/vox.12525] [Citation(s) in RCA: 8] [Impact Index Per Article: 1.0] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 01/05/2017] [Revised: 03/03/2017] [Accepted: 03/27/2017] [Indexed: 11/28/2022]
Affiliation(s)
- K. Kramer
- Department of Blood-borne Infections (BOI); Sanquin Blood Supply Foundation; Amsterdam the Netherlands
- Department of Communication, Philosophy and Technology (CPT); Wageningen University and Research; Wageningen the Netherlands
| | - M. F. Verweij
- Department of Communication, Philosophy and Technology (CPT); Wageningen University and Research; Wageningen the Netherlands
| | - H. L. Zaaijer
- Department of Blood-borne Infections (BOI); Sanquin Blood Supply Foundation; Amsterdam the Netherlands
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17
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Kramer K, Zaaijer HL, Verweij MF. The Precautionary Principle and the Tolerability of Blood Transfusion Risks. THE AMERICAN JOURNAL OF BIOETHICS : AJOB 2017; 17:32-43. [PMID: 28207362 DOI: 10.1080/15265161.2016.1276643] [Citation(s) in RCA: 12] [Impact Index Per Article: 1.5] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Subscribe] [Scholar Register] [Indexed: 05/28/2023]
Abstract
Tolerance for blood transfusion risks is very low, as evidenced by the implementation of expensive blood tests and the rejection of gay men as blood donors. Is this low risk tolerance supported by the precautionary principle, as defenders of such policies claim? We discuss three constraints on applying (any version of) the precautionary principle and show that respecting these implies tolerating certain risks. Consistency means that the precautionary principle cannot prescribe precautions that it must simultaneously forbid taking, considering the harms they might cause. Avoiding counterproductivity requires rejecting precautions that cause more harm than they prevent. Proportionality forbids taking precautions that are more harmful than adequate alternatives. When applying these constraints, we argue, attention should not be restricted to harms that are human caused or that affect human health or the environment. Tolerating transfusion risks can be justified if available precautions have serious side effects, such as high social or economic costs.
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Affiliation(s)
- Koen Kramer
- a Sanquin Blood Supply Foundation and Wageningen University and Research Center
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18
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Rebulla P, Vaglio S, Beccaria F, Bonfichi M, Carella A, Chiurazzi F, Coluzzi S, Cortelezzi A, Gandini G, Girelli G, Graf M, Isernia P, Marano G, Marconi M, Montemezzi R, Olivero B, Rinaldi M, Salvaneschi L, Scarpato N, Strada P, Milani S, Grazzini G. Clinical effectiveness of platelets in additive solution treated with two commercial pathogen-reduction technologies. Transfusion 2017; 57:1171-1183. [DOI: 10.1111/trf.14042] [Citation(s) in RCA: 59] [Impact Index Per Article: 7.4] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 09/28/2016] [Revised: 12/13/2016] [Accepted: 12/20/2016] [Indexed: 12/21/2022]
Affiliation(s)
- Paolo Rebulla
- Blood Transfusion Service, Foundation IRCCS Ca' Granda Ospedale Maggiore Policlinico; Milan Italy
| | - Stefania Vaglio
- Italian National Blood Center, National Institute of Health; Rome Italy
| | - Francesco Beccaria
- Blood Transfusion Service and Hematology 1; IRCCS San Martino University Hospital; Genoa Italy
| | - Maurizio Bonfichi
- Blood Transfusion Service and Hematology; IRCCS Policlinico San Matteo; Pavia Italy
| | - Angelo Carella
- Blood Transfusion Service and Hematology 1; IRCCS San Martino University Hospital; Genoa Italy
| | - Federico Chiurazzi
- Blood Transfusion Service and Hematology; Federico II University Hospital; Naples Italy
| | - Serelina Coluzzi
- Blood Transfusion Service and Hematology; Umberto I Hospital; Rome Italy
| | - Agostino Cortelezzi
- Hematology, Foundation IRCCS Ca' Granda Ospedale Maggiore Policlinico and University of Milan; Milan Italy
| | - Giorgio Gandini
- Blood Transfusion Service and Hematology; University Hospital; Verona Italy
| | - Gabriella Girelli
- Blood Transfusion Service and Hematology; Umberto I Hospital; Rome Italy
| | - Maria Graf
- Blood Transfusion Service and Hematology; Federico II University Hospital; Naples Italy
| | - Paola Isernia
- Blood Transfusion Service and Hematology; IRCCS Policlinico San Matteo; Pavia Italy
| | - Giuseppe Marano
- Italian National Blood Center, National Institute of Health; Rome Italy
| | - Maurizio Marconi
- Blood Transfusion Service, Foundation IRCCS Ca' Granda Ospedale Maggiore Policlinico; Milan Italy
| | - Rachele Montemezzi
- Blood Transfusion Service and Hematology; University Hospital; Verona Italy
| | - Barbara Olivero
- Blood Transfusion Service, Foundation IRCCS Ca' Granda Ospedale Maggiore Policlinico; Milan Italy
| | - Marianna Rinaldi
- Blood Transfusion Service and Hematology; University Hospital; Verona Italy
| | - Laura Salvaneschi
- Blood Transfusion Service and Hematology; IRCCS Policlinico San Matteo; Pavia Italy
| | - Nicola Scarpato
- Blood Transfusion Service and Hematology; Federico II University Hospital; Naples Italy
| | - Paolo Strada
- Blood Transfusion Service and Hematology 1; IRCCS San Martino University Hospital; Genoa Italy
| | - Silvano Milani
- Laboratory of Medical Statistics and Biometry, Department of Clinical Sciences and Community Health; University of Milan; Milan Italy
| | - Giuliano Grazzini
- Italian National Blood Center, National Institute of Health; Rome Italy
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19
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Seed CR, Kiely P, Hoad VC, Keller AJ. Refining the risk estimate for transfusion-transmission of occult hepatitis B virus. Vox Sang 2016; 112:3-8. [PMID: 27564651 DOI: 10.1111/vox.12446] [Citation(s) in RCA: 14] [Impact Index Per Article: 1.6] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 06/19/2016] [Revised: 08/01/2016] [Accepted: 08/01/2016] [Indexed: 12/11/2022]
Abstract
BACKGROUND AND OBJECTIVES We previously published a model to estimate the residual risk (RR) for occult hepatitis B infection (OBI) in the absence of universal anti-HBc testing. To incorporate new information on the epidemiology of OBI, we describe model refinements and estimate a more accurate HBV RR due to OBI in Australia. MATERIALS AND METHODS In our original model, the OBI risk, p(OBI), was defined by the rate of 'non-detection' by the HBV DNA screening test in use, p(NAT non-detection), and the average infectivity of blood components from OBI donors, p(transmission). We revised the model by integrating three refinements: that donations with anti-HBs levels of >10 IU/l, or donations solely for manufactured plasma products, be excluded from the risk calculation, and an updated estimate of p(transmission). RESULTS Refining our OBI RR model resulted in a more than 10-fold reduction in the reported RR risk to recipients from OBI in our donor population. Based on the use of a common data set, the mean OBI RR risk decreased from 1 in 374 354 donations (95% CI: 1 in 191 940-1 072 681) to 1 in 3 984 033 (95% CI: 1 in 1 146 188-65 268 257) for the refined model. CONCLUSION Our model refinements provide a more realistic measure of the HBV RR in the donor population. Unlike the previous model, the new model demonstrates that the risk of HBV due to OBI in the Australian blood donor population is negligible, and further potentially cost-ineffective risk management strategies are not currently warranted.
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Affiliation(s)
- C R Seed
- Australian Red Cross Blood Service, Perth, WA, Australia
| | - P Kiely
- Australian Red Cross Blood Service, Melbourne, Vic., Australia
| | - V C Hoad
- Australian Red Cross Blood Service, Perth, WA, Australia
| | - A J Keller
- Australian Red Cross Blood Service, Perth, WA, Australia
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20
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Walsh GM, Shih AW, Solh Z, Golder M, Schubert P, Fearon M, Sheffield WP. Blood-Borne Pathogens: A Canadian Blood Services Centre for Innovation Symposium. Transfus Med Rev 2016; 30:53-68. [PMID: 26962008 PMCID: PMC7126603 DOI: 10.1016/j.tmrv.2016.02.003] [Citation(s) in RCA: 12] [Impact Index Per Article: 1.3] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 01/19/2016] [Accepted: 02/18/2016] [Indexed: 12/19/2022]
Abstract
Testing donations for pathogens and deferring selected blood donors have reduced the risk of transmission of known pathogens by transfusion to extremely low levels in most developed countries. Protecting the blood supply from emerging infectious threats remains a serious concern in the transfusion medicine community. Transfusion services can employ indirect measures such as surveillance, hemovigilance, and donor questioning (defense), protein-, or nucleic acid based direct testing (detection), or pathogen inactivation of blood products (destruction) as strategies to mitigate the risk of transmission-transmitted infection. In the North American context, emerging threats currently include dengue, chikungunya, and hepatitis E viruses, and Babesia protozoan parasites. The 2003 SARS and 2014 Ebola outbreaks illustrate the potential of epidemics unlikely to be transmitted by blood transfusion but disruptive to blood systems. Donor-free blood products such as ex vivo generated red blood cells offer a theoretical way to avoid transmission-transmitted infection risk, although biological, engineering, and manufacturing challenges must be overcome before this approach becomes practical. Similarly, next generation sequencing of all nucleic acid in a blood sample is currently possible but impractical for generalized screening. Pathogen inactivation systems are in use in different jurisdictions around the world, and are starting to gain regulatory approval in North America. Cost concerns make it likely that pathogen inactivation will be contemplated by blood operators through the lens of health economics and risk-based decision making, rather than in zero-risk paradigms previously embraced for transfusable products. Defense of the blood supply from infectious disease risk will continue to require innovative combinations of surveillance, detection, and pathogen avoidance or inactivation.
A symposium on blood-borne pathogens was held September 26, 2015, in Toronto, Canada. Transmission-transmitted infections remain a threat to the blood supply. The residual risk from established pathogens is small; emerging agents are a concern. Next generation sequencing and donor-free blood are not yet practical approaches. Pathogen inactivation technology is being increasingly used around the world. Health economic concerns will likely guide future advances in this area.
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Affiliation(s)
- Geraldine M Walsh
- Centre for Innovation, Canadian Blood Services, Hamilton, Ottawa, and Vancouver, Canada
| | - Andrew W Shih
- Medical Services and Innovation, Canadian Blood Services, McMaster University, Hamilton, Canada; Pathology and Molecular Medicine, McMaster University, Hamilton, Canada
| | - Ziad Solh
- Medical Services and Innovation, Canadian Blood Services, McMaster University, Hamilton, Canada; Pathology and Molecular Medicine, McMaster University, Hamilton, Canada
| | - Mia Golder
- Centre for Innovation, Canadian Blood Services, Hamilton, Ottawa, and Vancouver, Canada
| | - Peter Schubert
- Centre for Innovation, Canadian Blood Services, Hamilton, Ottawa, and Vancouver, Canada; Centre for Blood Research, University of British Columbia, Canada; Department of Pathology and Laboratory Medicine, University of British Columbia, Canada
| | - Margaret Fearon
- Medical Services and Innovation, Canadian Blood Services, McMaster University, Hamilton, Canada; Pathology and Laboratory Medicine, University of Toronto, Canada
| | - William P Sheffield
- Centre for Innovation, Canadian Blood Services, Hamilton, Ottawa, and Vancouver, Canada; Pathology and Molecular Medicine, McMaster University, Hamilton, Canada.
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21
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Bennett JL. Making good policy decisions: a discipline we cannot afford to ignore. Transfusion 2015; 55:2775-7. [DOI: 10.1111/trf.13382] [Citation(s) in RCA: 3] [Impact Index Per Article: 0.3] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 09/14/2015] [Accepted: 09/14/2015] [Indexed: 11/29/2022]
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22
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Kramer K, Verweij MF, Zaaijer HL. An inventory of concerns behind blood safety policies in five Western countries. Transfusion 2015; 55:2816-25. [DOI: 10.1111/trf.13254] [Citation(s) in RCA: 11] [Impact Index Per Article: 1.1] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 03/30/2015] [Revised: 06/17/2015] [Accepted: 06/17/2015] [Indexed: 11/29/2022]
Affiliation(s)
- Koen Kramer
- Department of Blood-borne Infections; Sanquin Blood Supply Foundation; Amsterdam
- the Department of Communication, Philosophy, and Technology; Wageningen University and Research Center; Wageningen the Netherlands
| | - Marcel F. Verweij
- the Department of Communication, Philosophy, and Technology; Wageningen University and Research Center; Wageningen the Netherlands
| | - Hans L. Zaaijer
- Department of Blood-borne Infections; Sanquin Blood Supply Foundation; Amsterdam
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