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This paper explores the legislative and operational commonalities and differences in Medical Products of Human Origin (MPHO) programs, including blood, hematopoietic cells, tissues and reproductive cells and human milk banking. The analysis includes ethical principles in donation and utilization, policies and legislation, public awareness and education, registries, guidelines in donor selection, safety and quality assurance, operational models and funding, infrastructure and human resources and biovigilance and evaluation of outcomes. Unlike other MPHO, the need for donor human milk (DHM) may be greatly reduced, that is, by ensuring optimal support for maternal lactation and breastfeeding. This should not be lost in the drive for wider and improved service provision. Nevertheless, increased overall demand for DHM is expected as a result of forthcoming international recommendations and also its increased use as the first‐choice supplement to a mother's own milk both within and beyond preterm, low‐birthweight and sick infant populations. Insight into current human milk banking highlights differences and gaps in practices that can benefit from further exploration and harmonization. Strong similarities with the ethical and operational principles underpinning donation and processing of the diverse MPHO suggest that legislating human milk banks within similar MPHO frameworks may bring additional safety and facilitate improved product quality. Moreover, that MPHO‐inspired models operating within attainable regulatory requirements may contribute to sustainable human milk banking activity and growth. Key messages: The strong similarities with the ethical, quality and safety expectations underpinning the donation and processing of the diverse Medical Products of Human Origin (MPHO) can be harnessed to provide additional safety levels and improved donor human milk (DHM) quality.MPHO‐inspired models operating within attainable regulatory requirements may contribute to sustainable human milk banking activity and growth.The need for DHM may be greatly reduced through optimal support for maternal lactation and breastfeedingCurrent global milk banking practices can benefit from expanded and harmonized, international guidance. [ABSTRACT FROM AUTHOR]

In the wake of the COVID‐19 global pandemic, self‐administered microsampling tools have reemerged as an effective means to maintain routine healthcare assessments without inundating hospitals or clinics. Finger‐stick collection of blood is easily performed at home, in the workplace, or at the point‐of‐care, obviating the need for a trained phlebotomist. While the initial collection of blood is facile, the diagnostic or clinical utility of the sample is dependent on how the sample is processed and stored prior to transport to an analytical laboratory. The past decade has seen incredible innovation for the development of new materials and technologies to collect low‐volume samples of blood with excellent precision that operate independently of the hematocrit effect. The final application of that blood (i.e., the test to be performed) ultimately dictates the collection and storage approach as certain materials or chemical reagents can render a sample diagnostically useless. Consequently, there is not a single microsampling tool that is capable of addressing every clinical need at this time. In this review, we highlight technologies designed for patient‐centric microsampling blood at the point‐of‐care and discuss their utility for quantitative sampling as a function of collection material and technique. In addition to surveying methods for collecting and storing whole blood, we emphasize the need for direct separation of the cellular and liquid components of blood to produce cell‐free plasma to expand clinical utility. Integrating advanced functionality while maintaining simple user operation presents a viable means of revolutionizing self‐administered microsampling, establishing new avenues for innovation in materials science, and expanding access to healthcare. [ABSTRACT FROM AUTHOR]

Context Until the last decade of the 20th century, France had no equivalent to the US Food and Drug Administration. In this paper we describe and interpret the complex series of events that led to the passage by the French Parliament in December 1992 of a law incorporating such an agency, the Agence du Médicament (literally, 'medicines agency'). The broad aim of this project was to learn how public health policy change comes about by detailed analysis of a specific instance. More specifically, we aimed to better understand the circumstances under which public health crisis leads to significant public health policy reform. Methods This paper is based on detailed analysis of primary documents (eg, archived French health ministry papers, recorded parliamentary debates, government reports, newspaper articles) and oral history interviews covering a period from 1988 to 1993. Thematic analysis of these materials was initially grounded in theories of organizational change, moving to constructs that emerged from the data themselves. Findings Policy entrepreneurs positioned to frame adverse events and seize opportunities are key to public health policy reform. However, whether these entrepreneurs will have the requisite institutional power is contingent both on political structure and on the power of competing institutional actors. Health crises may catalyze institutional reform, but our analysis suggests that whether reform occurs, or even whether adverse episodes are labeled as crises, is highly contingent on circumstances of history, political structure, and political ideology and is extremely difficult to predict or control. Conclusions Actors positioned to shape public health policy need to have a detailed understanding of the circumstances that facilitate or impede policy reform. Health crises are now more often global than not. Comparative, theoretically grounded, cross-national research that looks in detail at how different countries respond to similar health crises would be extremely valuable in informing both policymakers and researchers. [ABSTRACT FROM AUTHOR]

This paper challenges the traditional account of vulnerability in healthcare which conceptualizes vulnerability as a list of identifiable subpopulations. This list of 'usual suspects', focusing on groups from lower resource settings, is a narrow account of vulnerability. In this article we argue that in certain circumstances middle-class individuals can be also rendered vulnerable. We propose a relational and layered account of vulnerability and explore this concept using the case study of cord blood ( CB) banking. In the first section, two different approaches to 'vulnerability' are contrasted: categorical versus layered. In the second section, we describe CB banking and present a case study of CB banking in Argentina. We examine the types of pressure that middle-class pregnant women feel when considering CB collection and storage. In section three, we use the CB banking case study to critique the categorical approach to vulnerability: this model is unable to account for the ways in which these women are vulnerable. A layered account of vulnerability identifies several ways in which middle-class women are vulnerable. Finally, by utilizing the layered approach, this paper suggests how public health policies could be designed to overcome vulnerabilities. [ABSTRACT FROM AUTHOR]

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Biobanks for long-term research pose challenges to the legal and ethical validity of consent to participate. Different models of consent have been proposed to answer some of these challenges. This paper contributes to this discussion by considering the meaning and value of consent to participants in biobanks. Empirical data from a qualitative study is used to provide a participant view of the consent process and to demonstrate that, despite limited understanding of the research, consent provides the research participants with some level of control and a form of self determination that they value. Participation is framed as a moral act of a responsible citizen providing reinforcement of self identity. Consent symbolizes the trust invested in researchers and research institutions to use the biobank for the public good. The paper argues that consent continues to play an important role in biobank participation and that a participant view should inform proposals to modify consent processes. [ABSTRACT FROM AUTHOR]

Introduction: Blood‐based Alzheimer's disease (AD) biomarkers show promise, but pre‐analytical protocol differences may pose problems. We examined seven AD blood biomarkers (amyloid beta [Aβ]42${\rm{A\beta }}]{_{42}}$, Aβ40${\rm{A}}{{{\beta}}_{40}}$, phosphorylatedtau[p−tau181${\rm{phosphorylated\;tau\;[p - ta}}{{\rm{u}}_{181}}$, total tau [t‐tau], neurofilament light chain [NfL], Aβ4240,${\rm{A}}{{{\beta}}_{\frac{{42}}{{40}}}},$ and p−tau181Aβ42$\frac{{{\rm{p - ta}}{{\rm{u}}_{181}}}}{{{\rm{A}}{{{\beta}}_{42}}}}$) in three collection tube types (ethylenediaminetetraacetic acid [EDTA] plasma, heparin plasma, serum). Methods: Plasma and serum were obtained from cerebrospinal fluid or amyloid positron emission tomography‐positive and ‐negative participants (N = 38) in the Wisconsin Registry for Alzheimer's Prevention. We modeled AD biomarker values observed in EDTA plasma versus heparin plasma and serum, and assessed correspondence with brain amyloidosis. Results: Results suggested bias due to tube type, but crosswalks are possible for some analytes, with excellent model fit for NfL (R2${{\rm{R}}^2}\;$= 0.94), adequate for amyloid (R2${{\rm{R}}^2}\;$= 0.40‐0.69), and weaker for t‐tau (R2${{\rm{R}}^2}\;$= 0.04‐0.42) and p−tau181${\rm{p - ta}}{{\rm{u}}_{181}}$ (R2${{\rm{R}}^2}\;$= 0.22‐0.29). Brain amyloidosis differentiated several measures, especially EDTA plasma pTau181Aβ42$\frac{{{\rm{pTa}}{{\rm{u}}_{181}}}}{{{\rm{A}}{\beta _{42}}}}$ (d$d\;$= 1.29). Discussion: AD biomarker concentrations vary by tube type. However, correlations for some biomarkers support harmonization across types, suggesting cautious optimism for use in banked blood. [ABSTRACT FROM AUTHOR]

Background: Canine blood donors can be infected by various vector‐borne or other pathogens that could be an important cause of morbidity and death in transfusion recipients. Hypothesis/Objectives: To estimate and predict positivity to transmittable blood‐borne pathogens in blood units collected from blood donor dogs in Canada. Animals Six thousand one hundred and fifty blood units from 1914 active blood donors registered to the Canadian Animal Blood Bank (CABB) between March 2010 and December 2016. Methods: A registry‐based retrospective study. Blood units were screened by SNAP 4Dx/4Dx Plus and PCR panel tests. Information on blood donors and test results were extracted from multiple databases and collated. Logistic regressions were used to predict blood unit positivity. Results: Of 1779 blood units, 0.56% were antibody‐positive for Anaplasma phagocytophilum/platys and 0% for Ehrlichia canis/ewingii. After exclusion of antibody‐positive units to Anaplasma spp., 1.1% of 6140 blood units were PCR‐positive to Anaplasma phagocytophilum, Bartonella spp., Brucella canis, "Candidatus Mycoplasma haematoparvum," Mycoplasma haemocanis, or a combination of these pathogens. Babesia spp., Ehrlichia spp., and Leishmania spp. were not detected. Units from the first blood collection from a dog had higher odds of testing PCR‐positive (P <.001) for at least 1 pathogen than units from subsequent collections. Conclusions and Clinical Importance: Although our study indicates a low probability of detecting blood‐borne pathogen in blood units collected by this Canadian blood bank, the presence of positive units highlights the importance of the preemptive identification and screening of blood units from healthy blood donors for safe blood banking, especially in first‐time donors. [ABSTRACT FROM AUTHOR]

Summary: Genetic variation at HLA‐DRB1 is a risk factor for visceral leishmaniasis (VL) caused by Leishmania donovani. The single nucleotide polymorphism rs9271252 upstream of the DRB1 gene provides a perfect tag for protective versus risk HLA‐DRB1 four‐digit alleles. In addition to the traditional role of the membrane‐distal region of HLA class II molecules in antigen presentation and CD4 T‐cell activation, the membrane‐proximal region mediates 'non‐traditional' multi‐functional activation, differentiation, or death signals, including in DR‐expressing T cells. To understand how HLA‐DR contributes to disease pathogenesis, we examined expression at the protein level in circulating myeloid (CD14+, CD16+) and lymphoid (CD4+, CD8+, CD19+) cells of VL patients (pre‐ and post‐treatment) compared with endemic healthy controls (EHC). Although DR expression is reduced in circulating myeloid cells in active disease relative to EHC and post‐treatment groups, expression is enhanced on CD4+ DR+ and CD8+ DR+ T cells consistent with T‐cell activation. Cells of all myeloid and lymphoid populations from active cases were refractory to stimulation of DR expression with interferon‐γ (IFN‐γ). In contrast, all populations except CD19+ B cells from healthy blood bank controls showed enhanced DR expression following IFN‐γ stimulation. The rs9271252 genotype did not impact significantly on IFN‐γ‐activated DR expression in myeloid, B or CD8+ T cells, but CD4+ T cells from healthy individuals homozygous for the risk allele were particularly refractory to activated DR expression. Further analysis of DR expression on subsets of CD4+ T cells regulating VL disease could uncover additional ways in which pleiotropy at HLA DRB1 contributes to disease pathogenesis. Genetic variation at HLA‐DRB1 is a risk factor for visceral leishmaniasis caused by Leishmania donovani. The single nucleotide polymorphism rs9271252 upstream of the DRB1 gene provides a perfect tag for protective versus risk HLA‐DRB1 four‐digit alleles. Here we show that CD4+ T cells from individuals homozygous for the risk allele at rs9271252 are particularly refractory to activated DR expression. [ABSTRACT FROM AUTHOR]

To review information on cord blood banking and transplantation with respect to the author's studies, and in context of this field of investigation. Cord blood transplantation has been successfully used to treat a number of malignant and non-malignant disorders. However, this technique is still associated with limited numbers of cells for transplantation, and with delayed engraftment of neutrophils and platelets. The field of cord blood transplantation will benefit from enhanced and mechanistically based information on haematopoietic stem cell function and potential means to enhance its effectiveness are reviewed. This includes notions concerning possibility of retrieving more cells from the placenta and cord blood, to expand haematopoietic stem cells ex vivo and to increase efficiency of homing and engraftment of these cells. Also discussed are cryopreservation and long-term storage of cord blood haematopoietic and progenitor cells, and new laboratory findings and animal studies for non-haematopoietic uses of cord blood. [ABSTRACT FROM AUTHOR]