Rebecca Cardigan | Helen V. New | Lise Estcourt | Eugene Zhiburt | Rounak Dubey | Jesper Bengtsson | Magnus Jöud | Carlos Castillo | Joan Cid | Miquel Lozano | Dhana Gounder | Peter Flanagan | Sarah Morley | Gwen Clarke | Dana Devine | Salwa Hindawi | Aqeel AlOtaibi | Carolina Bonnet Bub | Jose Mauro Kutner | Toshiyuki Ikeda | Naoko Goto | Hitoshi Okazaki | Magali J. Fontaine | Jeremiah Pasion | Linda Song | Tom Latham | Jean-Louis Kerkhoffs | Masja de Haas | Jaap Jan Zwaginga | Birgit S. Gathof | Katharina Ommer | France Pirenne | Michel Raba | Anne Francois | James Daly | Tanya Powley | Nancy Dunbar

BACKGROUND:Immunoglobulin is an expensive and scarce resource and usage is increasing worldwide. Immunoglobulin is used to treat a variety of clinical conditions, particularly primary and acquired immunodeficiencies and immune-mediated neurological disorders. As immunoglobulin usage continues to increase, plasma collection must increase accordingly in order to sustain immunoglobulin production. The New Zealand Blood Service (NZBS) is the provider of immunoglobulin in New Zealand (NZ). Information regarding national immunoglobulin usage warrants analysis given the rise in usage.AIMS:To review immunoglobulin usage in NZ with a focus on the trend in the amount used, number of patients, clinical indications and compliance with international guidelines. A comparison with international immunoglobulin usage was performed. The impact on national plasma collection was reviewed.METHODS:Data on immunoglobulin usage, number of patients and plasma collection over the past decade were obtained from the NZBS Tableau database. Data from international literature were reviewed.RESULTS:Immunoglobulin usage in NZ has been increasing over the past decade, with an annual growth rate of 6.4%. The three main indications for immunoglobulin are primary immunodeficiency disorders, chronic inflammatory demyelinating polyneuropathy (CIDP) and acquired hypogammaglobulinaemia secondary to haematological malignancies. Prominent growth in usage is evident for CIDP and acquired hypogammaglobulinaemia. Immunoglobulin usage in NZ is low compared with other countries, such as Australia and the United States. There has been a marked increase in plasma donations in order to keep up with immunoglobulin demand.CONCLUSIONS:Immunoglobulin is a strategic resource and appropriate usage is critical to regulate demand.

Importance:Gamma irradiation of leukoreduced red blood cells (RBCs) prevents transfusion-associated graft-vs-host disease but also exacerbates storage lesion formation in RBCs. It is unknown whether freshly irradiated RBCs are more efficacious than irradiated and stored RBCs in preterm infants with high transfusion requirements.Objective:To examine whether transfusion of freshly irradiated vs irradiated and stored RBC components improves cerebral oxygen delivery in preterm infants with anemia.Design, Setting, and Participants:This single-center, double-blinded, proof-of-concept randomized clinical trial was conducted at the neonatal intensive care unit of Wellington Regional Hospital in Wellington, New Zealand, between December 1, 2017, and November 30, 2018. Participants were preterm infants (<34 weeks' gestation at birth) who were at least 14 days of age and had anemia. Participants underwent nonurgent transfusions, and these episodes were randomized to the intervention group (in which the infants received a transfusion of RBCs that were freshly irradiated on the day of transfusion) or control group (in which the infants received a transfusion of RBCs that were irradiated and stored for up to 14 days). Data were analyzed using the evaluable population approach.Intervention:Transfusion of freshly irradiated RBCs.Main Outcomes and Measures:The prespecified primary outcome was the change in cerebral regional oxygen saturation (crSO2) from baseline (immediately before) to immediately after the transfusion. The prespecified secondary outcomes were the change in cerebral fractional tissue oxygen extraction (cFTOE) at different time points (immediately after, 24 hours after, and 120 hours or 5 days after transfusion). Outcomes were measured by blinded clinicians using near-infrared spectroscopy. A covariate-adjusted linear mixed model was used to quantify mean treatment effects and account for multiple transfusions in some infants.Results:A total of 42 infants (mean [SD] gestational age, 26 [10] weeks and 3 days; 29 [69%] boys) were enrolled in the trial and underwent 64 transfusion episodes, which were randomized to the intervention (n = 31) or control (n = 33) group. Compared with infants in the control group, those in the intervention group showed a covariate-adjusted mean increase in crSO2 (2.0 percentage points; 95% CI, 1.2-2.8 percentage points) and a mean decrease in cFTOE (0.02; 95% CI, 0.01-0.04) immediately after transfusion. These differences were sustained up to 120 hours or 5 days after transfusion. There were negligible mean changes in crSO2 or cFTOE in infants in the control group at any of the follow-up time points.Conclusions and Relevance:Results of this trial showed that transfusion of freshly irradiated RBCs conferred a small advantage in cerebral oxygenation for at least 5 days after transfusion compared with transfusion of irradiated and stored RBC components. On-demand irradiation of RBC components may be considered to optimize oxygen delivery in the recipient, but this physiological finding requires further research.Trial Registration:ANZCTR Identifier: ACTRN12617001581358.

A well-legislated and regulated blood transfusion service is a crucial component in assuring the safety of the blood supply within a country or state, although there are large differences among different jurisdictions on how this is addressed. Regulations should, but do not always, address issues of adequacy of supply and availability of blood within a state, as well as quality, safety and scientific developments. They are based in law, which should be explicit in statute, and are governed by guiding principles, often in practice a version of the precautionary principle and the principles and rules of good manufacturing practice. State regulatory agencies apply rules; these are often based on standards set by national accreditation or standards bodies, or by professional bodies within the field. The nature and scope of regulations may be influenced by forces inside or outside blood transfusion lobbying by professional groups, trade organizations, patient and groups and other interested bodies can apply pressure for change at the political and public level.

BackgroundThis multi‐national study evaluated changes in platelet (PLT) unit distributions at 12 national or regional blood collectors over a 10‐year period.MethodsData on the total number of PLT distributions, the collection method, that is apheresis vs whole blood‐derived (WBD), the PLT unit characteristics and post‐collection modifications were obtained from 12 national or regional blood collectors from 2008 through 2017. Individual WBD PLT units were converted to apheresis equivalent units (i.e. a dose of PLTs) by dividing by 4, the typical pool size; WBD units that were pooled before distribution were counted as a single dose.ResultsOverall at these 12 blood collectors, the total number of PLTs distributed in 2008 was 1 373 200, which rose by 10·2% to 1 513 803 in 2017. The Japanese Red Cross, which distributes only apheresis PLTs, had a 13·4% increase in the number of distributions between the years 2008 and 2017, while the other 11 blood collectors combined demonstrated a 6·8% increase in distributions between these two years. Between the years 2008 and 2017, the changes in the proportion of apheresis, platelet‐rich plasma and buffy coat PLT distributions were −29·9%, −70·7% and 80·0%, respectively.ConclusionThe number of PLT distributions increased during the 10‐year study period despite prophylactic PLT transfusion thresholds having remained fairly consistent over the last decade. Perhaps this increase is in part driven by increased administration of platelets to patients with massive haemorrhage or an increase in stem cell transplantation. The use of buffy coat PLTs is increasing at these collectors.

Purpose: Platelet lysate produced from platelet apheresis components has been proposed as an alternative to serum eye drops in the treatment of ocular surface disease. This study compared the effects of platelet lysate and serum on growth factor, cytokine and nanoparticle concentrations, and corneal epithelial cell proliferation. Methods: The concentration of growth factors, cytokines, and nanoparticles in platelet lysates manufactured from either fresh or expired platelet apheresis concentrations collected with Trima or Haemonetics technology was characterized and compared with those of allogeneic, autologous, and fetal calf serum. The ability to promote corneal epithelial cell proliferation and wound healing was tested in vitro. Results: Platelet lysate enriched the amount of transforming growth factor beta 1, platelet-derived growth factor -AB and -BB, fibroblast growth factor, and epidermal growth factor compared with the two sera groups. The concentrations of insulin-like growth factor 1, hepatocyte growth factor, and fibronectin were significantly lower than in sera. There were no differences in nanoparticle concentrations. There was no significant difference in corneal epithelial cell proliferation. Platelet lysateswere comparable to fetal calf serum in accelerating corneal epithelial wound healing in vitro. Conclusions: Fresh and expired platelet lysates from the Trima and Haemonetics systems had higher growth factor concentrations than sera. The ability of platelet lysates to promote corneal epithelial cell proliferation and wound healing was equivalent to sera. Translational Relevance: Platelet lysates may serve as an efficient and reliable source of human growth factors for the treatment of ocular surface diseases.

BACKGROUNDDetermination of blood donor hemoglobin (Hb) levels is a pre‐requisite to ensure donor safety and blood product quality. We aimed to identify Hb measurement practices across blood donation services and to what extent differences associate with low‐Hb deferral rates.METHODSAn online survey was performed among Biomedical Excellence for Safer Transfusion (BEST) Collaborative members, extended with published data. Multivariable negative‐binomial regression models were built to estimate adjusted associations of minimum donation intervals, Hb cut‐offs (high, ≥13.5 g/dL in men or ≥ 12.5 g/dL in women, vs. lower values), iron monitoring (yes/no), providing or prescribing iron supplementation (yes/no), post‐versus pre‐donation Hb measurement and geographical location (Asian vs. rest), with low‐Hb deferral rates.RESULTSData were included from 38 blood services. Low‐Hb deferral rates varied from 0.11% to 8.81% among men and 0.84% to 31.85% among women. Services with longer minimum donation intervals had significantly lower deferral rates among both women (rate ratio, RR 0.53, 95%CI 0.33‐0.84) and men (RR 0.53, 95%CI 0.31‐0.90). In women, iron supplementation was associated with lower Hb deferral rates (RR 0.47, 95%CI 0.23‐0.94). Finally, being located in Asia was associated with higher low‐Hb deferral rates; RR 9.10 (95%CI 3.89‐21.27) for women and 6.76 (95%CI 2.45‐18.68) for men.CONCLUSIONDifferences in Hb measurement and eligibility criteria, particularly longer donation intervals and iron supplementation in women, are associated with variations in low‐Hb deferral rates. These insights could help improve both blood donation service efficiency and donor care.

Clive R. Seed X , Jean-Pierre Allain X , Miquel Lozano X , Syria Laperche, Pierre Gallian, Sylvie Gross, So-Yong Kwon, Eun Young Oh, Jun Nyun Kim, Sze Sze Chua, Sally Lam, Ai Leen Ang, Wai-Chiu Tsoi, Patricia. E. Hewitt, Katy L. Davison X , Kate Tettmar, Niamh O’Flaherty, Fiona Boland, Padraig Williams, Louise Pomeroy, Silvano Wendel, Roberta Fachini, Patricia Santos Prado Scuracchio, Patricia Carminato, Margaret Fearon, Sheila F. O’Brien X , Gilles Delages, Philip Kiely X , Veronica C. Hoad X , Keiji Matsubayashi, Masahiro Satake, Rikizo Taira, Susan L. Stramer, Silvia Sauleda, Marta Bes, Maria Piron, Magdy El Ekiaby, Marion Vermeulen, Sne zna Levi cnik Stezinar, Polona Nograsek, Lisa M. Jarvis, Juraj Petrik, Richard Charlewood, Peter Flanagan, Piotr Grabarczyk, Aneta Kopacz, Magdalena Łeztowska, Michael Schmidt & Erhard Seifried

BACKGROUND AND OBJECTIVES:It is recognized that blood transfusion services have an ethical duty to obtain informed consent from their voluntary, non-remunerated donors. This right was most recently affirmed by the 2017 revision of the International Society of Blood Transfusion (ISBT) Code of Ethics. However, the constituent elements necessary to adequately inform such consent have not been definitively established. MATERIALS AND METHODS:This review evaluates the historical background to informed consent in medicine and as it has been applied to blood donation. The question of what information should be disclosed is then considered with regard to existing statutory requirements in both the United States and EU as well guidance from relevant international organizations. The emerging ethical issues around repurposing of donated blood for sale as recovered plasma and use in research are included in this analysis. RESULTS:A reasonable basis is found in the literature to advocate that valid informed consent of blood donors should encompass: the donation process itself and potential adverse effects, the need for pre-donation transfusion-transmissible infection (TTI) screening, potential non-transfusion uses of derived products, requirements to obtain and store personal information, the consequences that non-disclosure of such information may have for both the donor and the recipient and reassurance as to the confidentiality of this information. CONCLUSION:Informed consent is a key component of the duty of care between a blood service and its donor. We identify essential elements that should be present for such consent to be considered valid.

Pre-term infants have one of the highest transfusion requirements within the hospital-setting. The vast majority of blood transfusions performed in Neonatal Intensive Care Units (NICUs) are for medically stable pre-term infants with anaemia of prematurity, with the aim of improving oxygen delivery to the vital organs during the crucial phase of growth and development. However, despite the frequency of transfusion in this population, the potential benefits and harms of 'top up' transfusion are not fully understood, leading to practice variation between clinicians, institutions and countries. Significant advances have been made in the prevention of anaemia of prematurity, with recent emphasis on optimising infants' circulatory volume at birth via placental transfusion and preserving infants' own blood volume through innovative minimal sampling techniques. More research is urgently needed to establish optimal transfusion thresholds for these high-risk pre-term infants, for whom benefits as well as adverse outcomes may have consequences that extend for decades throughout the recipients' life-course. In this review, we will discuss some of the consensus and controversies regarding optimal management of anaemia in pre-term infants and highlight potential areas for future research.

The ISBT Code of Ethics (the Code) identifies that blood donation should be voluntary and non‐remunerated (VNRD). Blood Services need to ensure that sufficient suitable donors are available to meet the clinical needs of the patients and hospitals that they support. In an increasingly busy world, Blood Services need to compete with other organizations promoting community health and well‐being in order to achieve this. Promotional and marketing activities are utilized to both attract new donors and to encourage repeat donation from regular donors. In designing programmes to improve recruitment and retention of donors, consideration needs to be given to both the effectiveness of the intervention and also whether the activities might inadvertently breach the principles underpinning VNRD. The available evidence relating to the effectiveness of incentives to donation is limited and there is a need for more active research in this area.

BACKGROUND: Culturing residual blood components after suspected septic transfusion reactions guides management of patients and cocomponents. Current practice, accuracy of provider vital sign assessment, and performance of the AABB culture criteria are unknown. A multicenter international study was undertaken to investigate these issues and develop improved culture criteria. STUDY DESIGN AND METHODS: Retrospective data for all transfusion reactions resulting in residual blood component culture in 2016 were collected from participating hospitals. The performance of the AABB culture criteria were assessed for detection of positive culture results. Modifications to the AABB criteria including 1) recommending culturing in the setting of isolated high fevers, 2) defining hypotension and tachycardia using objective parameters, and 3) incorporating antipyretic use were tested to determine if modifications improved performance. Modifications associated with improvement were incorporate into the BEST criteria. The AABB and the BEST criteria were then tested against a data set enriched for positive culture results to determine which criteria were superior. RESULTS: Data were collected from 20 centers encompassing 779,143 transfusions, 3,187 reported transfusion reactions, and 1,104 cultured components. There was marked variation in reaction reporting and culturing rates (0.0%-100.0%). Of 35 total positive component cultures, only one of 35 (2.9%) had concordant patient cultures; 12 of 34 (35.3%) did not have patient cultures performed. The BEST criteria had better sensitivity for detection of a positive culture result compared to the AABB criteria (74% vs. 41%), although specificity decreased (45% vs. 65%). CONCLUSION: Compared to the AABB criteria, the BEST criteria have improved sensitivity for positive culture detection.

BACKGROUND Wrong blood in tube (WBIT) errors are a preventable cause of ABO-mismatched RBC transfusions. Electronic patient identification systems (e.g., scanning a patient's wristband barcode before pretransfusion sample collection) are thought to reduce WBIT errors, but the effectiveness of these systems is unclear. STUDY DESIGN AND METHODS Part 1: Using retrospective data, we compared pretransfusion sample WBIT rates at hospitals using manual patient identification (n = 16 sites; >1.6 million samples) with WBIT rates at hospitals using electronic patient identification for some or all sample collections (n = 4 sites; >0.5 million samples). Also, we compared WBIT rates after implementation of electronic patient identification with preimplementation WBIT rates. Causes and frequencies of WBIT errors were evaluated at each site. Part 2: Transfusion service laboratories (n = 18) prospectively typed mislabeled (rejected) samples (n = 2844) to determine WBIT rates among samples with minor labeling errors. RESULTS Part 1: The overall unadjusted WBIT rate at sites using manual patient identification was 1:10,110 versus 1:35,806 for sites using electronic identification (p < 0.0001). Correcting for repeat samples and silent WBIT errors yielded overall adjusted WBIT rates of 1:3046 for sites using manual identification and 1:14,606 for sites using electronic identification (p < 0.0001), with wide variation among individual sites. Part 2: The unadjusted WBIT rate among mislabeled (rejected) samples was 1:71 (adjusted WBIT rate, 1:28). CONCLUSION In this study, using electronic patient identification at the time of pretransfusion sample collection was associated with approximately fivefold fewer WBIT errors compared with using manual patient identification. WBIT rates were high among mislabeled (rejected) samples, confirming that rejecting samples with even minor labeling errors helps mitigate the risk of ABO-incompatible transfusions.

BACKGROUNDThere are many influences on a hospital's demand for plasma. Pharmaceuticals are now being administered for many indications instead of plasma, although trauma resuscitation now emphasizes increased and early intervention with plasma. This multinational study evaluated changes in blood center plasma unit distributions over a 10-year period. STUDY DESIGN AND METHODSData on the total number and the ABO groups of plasma unit distributions were obtained from nine American blood collectors (ABCs) and nine national or provincial blood services (NPBS) from 2007 through 2016. Plasma distributions to trauma hospitals by five ABCs and four NPBS were also analyzed. RESULTSThe overall number of plasma unit distributions from ABCs decreased by 23.1% from 2007 to 2016, but the relative proportion of distributed AB plasma units increased during the same period. The NPBS (excluding the Japanese Red Cross [JRC]) also had a 35.4% decrease in the overall number of plasma unit distributions with an increase in the relative proportion of AB plasma distributions between 2007 and 2016. The JRC, however, reported an increase in the overall number of plasma distributions by 13.5% in 2016 compared to 2007. The proportion of low-titer A plasma distributions increased to 1.6% of total plasma distributions by ABCs in 2016. There was a trend of distributing increasing proportions of group AB plasma units to trauma hospitals over the 10-year period. CONCLUSIONAlthough the number of plasma unit distributions has decreased at many blood collectors over time, the proportion of AB units has increased at both ABCs and NPBS.

AIM:Blood transfusion is one route of transmission of hepatitis E virus (HEV). The aim of this study was to assess both the prevalence of HEV antibodies and HEV infection in New Zealand blood donors.METHOD:To determine HEV seroprevalence, donor plasma samples (n=1,013) were tested for HEV antibodies using two commercially available ELISA kits, the Wantai HEV IgG ELISA and the MP Diagnostics HEV ELISA 4.0. To assess the prevalence of HEV infection, pooled plasma samples from individual plasma donors (n=5,000) were tested for HEV RNA using RT-qPCR. Samples that tested HEV antibody positive or gave an equivocal result with either ELISA were also tested for HEV RNA.RESULTS:The HEV seroprevalence in New Zealand blood donors was 9.7% using the Wantai HEV IgG ELISA and 8.1% using the MP Diagnostics HEV ELISA 4.0. The presence of HEV antibodies was significantly and positively correlated with increasing donor age. HEV RNA was not detected in any of the samples tested, indicating no evidence of current infection.CONCLUSION:This study, the largest to date to assess HEV seroprevalence in New Zealand, provides valuable baseline information on HEV seroprevalence and infection in New Zealand blood donors. The seroprevalence rate in New Zealand is similar to that reported in other developed countries.

AIMWe set out to evaluate the effectiveness of a new model of self management of haemochromatosis, whereby patients with stable ferritin control were discharged from the New Zealand Blood Service (NZBS) therapeutic venesection clinic and educated to manage their own venesection by regular blood donation and annual serum ferritin check by their general practitioner.METHODData regarding the frequency of blood donation and serum ferritin level were collected from the NZBS and Concerto records of haemochromatosis patients in the Wellington region who had been discharged back to the care of their general practitioner between January 2014 and June 2015.RESULTSOf the 107 patients, 93% continued to donate blood after discharge. A serum ferritin level was checked in 78% of patients by their general practitioner. The mean number of blood donations per year decreased after discharge, with a corresponding rise in the average ferritin level (difference 28 mcg/L; range 13-43 mcg/L; p<0.005).CONCLUSIONThe new model of self management was effective for the majority of patients who were discharged from the therapeutic venesection clinic. Longer follow up is required to assess the overall pattern of ferritin control in patients who self manage their haemochromatosis by regular blood donation.

BACKGROUND:Typical practice is to transfuse group-specific plasma units; however, there are situations where group AB plasma (universal donor) is issued to group A, B, or O recipients. If demand for group AB plasma exceeds collections, there is potential for shortage. This project explored the patterns of group AB plasma utilization at hospitals around the world. STUDY DESIGN AND METHODS:The study had two phases: a survey that inquired about hospital group AB plasma inventory, policies, and transfusion practices and a retrospective review of 2014 calendar year data where participants submitted information on plasma disposition including ABO group of unit and recipient, transfusion location, and select indications. Recruitment occurred through snowball sampling. Descriptive analyses were performed. RESULTS:Survey data were received from 25 centers across 10 countries; of those, 15 participants contributed to the data collection component. These 15 centers transfused a total of 43,369 AB plasma units during the study period. Only 1496 of 5541 (27%) group AB plasma units were transfused to group AB recipients. Transfusion policies, practices, and patterns were variable across sites. CONCLUSION:Group AB plasma units are frequently transfused to non-AB recipients. Whether transfusing 73% of group AB plasma units to non-AB recipients is the ideal inventory management strategy remains to be determined.

BACKGROUND: Cryopreserved platelet (PLT) components stored at -80 degrees C in 5% to 6% dimethyl sulfoxide (DMSO) demonstrate enhanced hemostatic activity. Alterations in PLT surface glycoprotein expression and release of procoagulant microparticles during the freeze/thaw cycle result in PLT activation. Nothing is known of the effect of gamma irradiation on the in vitro quality of reconstituted cryopreserved PLTs.STUDY DESIGN AND METHODS: Gamma-irradiated (25-50 Gy) buffy coat-derived PLT components were either stored at room temperature for 7 days (the current expiry in New Zealand) or cryopreserved at -80 degrees C using 5% to 6% DMSO. Cryopreserved PLTs were thawed at 37 degrees C and reconstituted in ABO-identical plasma or PAS-E and compared to Day 7 gamma-irradiated liquid-stored PLTs. In vitro assays were performed to assess glycoprotein expression, PLT functionality and soluble cytokine release.RESULTS: Cryopreserved PLTs after thawing and reconstitution in ABO-matched plasma or PAS-E displayed differing recoveries (82.7 and 75.9%, respectively). Key expression levels of glycoproteins GPIb alpha (CD42b) and GPIIb (CD41a) were reduced. Cryopreserved PLTs retained the ability to form an effective functional clot, while showing accelerated initiation of clot formation (R-time) compared to Day 7 gamma-irradiated liquid-stored PLTs.CONCLUSION: Gamma-irradiated buffy coat-derived liquid-stored and cryopreserved PLTs have distinctly differing phenotypes. Cryopreserved PLTs reconstituted in ABO plasma have enhanced clot strength driven by coagulation factors and fibrinogen levels not present in PAS-E. Irradiated cryopreserved PLTs maintain a similar in vitro quality profile and hemostatic behavior to previously published, nonirradiated cryopreserved PLTs.

The Code of Ethics of the International Society of Blood Transfusion (ISBT) was first published in 19811. The Code has since been revised on two occasions, most recently in 2006. The main content however remains largely unchanged from the original version. The Code has been endorsed by the World Health Organization, International Federation of Red Cross and Red Crescent Societies and by the International Federation of Donor Organizations2. The current version of the Code is available on the ISBT website3. The opening statement of the current version of the Code identifies its objective as being “to define the ethical principles and rules to be observed in the field of Transfusion Medicine”. In the original version this was extended to identify that “these should form the basis of national legislation and regulation”1. The Code might thus be considered a tool for advocacy and, at least in part, to be aspirational in nature. It reflects the views of a professional society as to “what should be” and as such it is appropriate for it to challenge the status quo of the world we inhabit today. A key driver to the establishment of the Code was increasing concern from professionals involved in the field of transfusion of the impact of the development of the commercial plasma industry utilising plasma collected from individuals who received payment2. Over the ensuing 35 years the dominance of the commercial industry has increased significantly. The development of the Code was closely linked to the adoption of World Health Assembly resolution 28.72 on “utilization and supply of human blood and blood products”4. The principle of voluntary non remunerated donation (VNRD) is central to both of the documents. The original principles underpinning the development of the Code also align closely with principles of social cohesion and solidarity initially articulated by Titmuss in “the Gift Relationship”5. Interestingly the Nuffield Council for Bioethics has recently reviewed these issues and their findings are identified in their publication “Human bodies: donation for medicine and research”. The report observes that “whilst the claims made for altruism may be overblown, the notion of altruism underpinning important communal values expresses something very significant about the kind of society in which we wish to live”. The review acknowledged that other approaches, including payment, “are not necessarily unethical but may need to be subject to greater scrutiny because of the threat they may pose to wider communal values”6. The Board of ISBT has recently initiated a further review of the Code. This will be undertaken by the Society’s Standing Committee on Ethics (SCE) and any changes to the current version of the Code will require endorsement by the General Assembly. The review will aim to improve the overall clarity of the Code. The Code is currently presented as a series of statements. The ethical principles underpinning each of the statements are not however identified and it is not clear to which stakeholder they apply. The current review aims to address these concerns and to provide a framework which allows individual readers to understand better the intent of the Code and the obligations which apply to them. This process is currently at an early stage and it will likely be some time yet before a revised draft is available for consultation with the membership. In this issue of Blood Transfusion, Farrugia and Del Bo present their personal reflections on the Code with the aim of “establishing primacy through a synthesis”7. The Authors assert that the primary driver to the current review of the Code is to “address the tension with commercial plasmapheresis as a route to the manufacture of plasma products”. As identified above this is not the case. Not surprisingly however given Farrugia’s close association with the commercial plasma industry the reflections contained in the manuscript aim to legitimise the collection of paid plasma and the activities of the wider commercial industry within the Code. This is achieved by the introduction of a novel concept of a “paid supplier” of plasma. This concept builds on Farrugia’s previous proposal to promote a “plurality of routes towards donation as an appropriate paradigm in the heterogeneous landscape of blood and plasma supply”8. In outlining the concept the authors observe the contradictions in practice of voluntary blood and plasma collection agencies where incentives and benefits provided to donors might be considered to be the equivalent of payment and therefore fall outside of the altruistic focussed interventions in the intervention ladder developed by the Nuffield Council of Bioethics6. This is acknowledged and should be a source of concern for the proponents of VNRD2. This does not however in itself mean that the principle of VNRD should not continue to be a central component of a revised Code. The Code is currently structured in two sections with the first focussing on donors and the second on patients. Both have equal status within the Code. Farrugia and Del Bo argue for a paradigm shift whereby the patient is placed in the centre of all decisions and processes. I acknowledge that the primary reason for the existence of blood services is to benefit patients. Nonetheless the proposed approach fails to recognise the unique aspect of donation whereby one individual provides for another with no direct personal benefit. Issues of donor safety are therefore particularly important and under no circumstances should the donor be placed at unnecessary risk. Blood Services have a “duty of care” to the donor and issues relating to this should continue to play a central role in the Code. In my opinion, the health, safety and wellbeing of donors should never be subservient to the needs of patients. Farrugia and Del Bo also raise a question regarding the principle that “blood is a public resource and access should not be restricted” raising a concern that denial of access to commercial plasma products would have catastrophic implications for patients. This particular phrase needs to be considered in the context of the overall philosophy underpinning the Code. It focusses on the principle that “blood is a gift” and that therefore all members of a society should have equal access to the products derived from the gift based on clinical need and not simply the ability to pay. I believe that the intent is to assure social equity and justice around access rather than taking a specific view on access to commercial plasma products. The review of the Code is taking place in parallel with another initiative in which four professional organisations, including ISBT, that have “official relations” status with the World Health Organization are aiming to develop a set of ethical principles to guide the donation and procurement of Medical Products of Human Origin. It is interesting to note that the drivers to this initiative are in many ways similar to those that led to the development of the Code of Ethics in the 1970s and reflect concerns over payment for tissues and cells and the commercialisation of the products derived from them. Professionals have a responsibility to assert and advocate for what we believe to be right. Clearly in doing so we must be able to justify these assertions. The current review of the Code will aim to address both of these requirements. The outcome will reflect a consensus view of those in the Society and this will be achieved by internal debate and discussion. The synthesis promoted by Farrugia and Del Bo raises some interesting points which can be considered as part of this process. They acknowledge at the outset the tension that exists between advocates of VNRD and those supporting the commercial plasma industry. Their “synthesis” however aims to negate the debate by introduction of novel constructs that effectively sidestep the fundamental concerns. Ethics is primarily about moral principles and values and provides a framework to distinguish right from wrong. Personally, I am not convinced that their synthesis has achieved this.