The Diaspora Human Genomics Institute Launches the Together for Change Initiative: A Transformative, Historic Partnership to Ensure Health Equity in a Time of Unprecedented Technological Advancements.

Human subjects research and drug and device development currently base their findings largely on the genetic data of the non-Hispanic White population, excluding People of Color. This practice puts People of Color at a distinct and potentially deadly disadvantage in being treated for sickness, disability, and disease, as seen during the COVID-19 pandemic. Major disparities exist in all chronic health conditions, including cancer. Data show that less than 2% of genetic information being studied today originates from people of African ancestry. If genomic datasets do not adequately represent People of Color, new drugs and genetic therapies may not work as well as for people of European descent. Addressing the urgent concern that historically marginalized people may again be excluded from the next technological leap affecting human health and the benefits it will bring will requires a paradigm shift. Thus, on behalf of underserved and marginalized people, we developed the Together for CHANGE (T4C) initiative as a unique collaborative public-private partnership to address the concern. The comprehensive programs designed in the T4C initiative, governed by the Diaspora Human Genomics Institute founded by Meharry Medical College, will transform the landscape of education and health care and positively affect global Black communities for decades to come.

Las normas técnicas para la formación en ingeniería biomédica, tecnología y administración en salud / Technical standards for the training in biomedical engineering, health technology and health management

Introducción: Los documentos normativos establecen el estado del arte relacionado con determinado campo del conocimiento. Existe una gran cantidad de normas relacionadas con los servicios de salud y su gestión, cuya aplicación es relevante en este sector. Objetivo: Exponer la importancia de las normas técnicas en la formación de los profesionales en ingeniería biomédica, tecnología y administración en salud. Desarrollo: Diferentes aspectos relacionados con el desempeño y las funciones de los profesionales en ingeniería biomédica, tecnología de la salud y administración en salud están recogidos en normas técnicas internacionales y en otras de carácter nacional, que resultan pertinentes y de gran utilidad para su formación en el nivel de grado y el posgrado. Conclusiones: Las profesiones abordadas requieren emplear los documentos normativos relacionados con sus funciones para contribuir con la calidad de los servicios de salud; de ahí la pertinencia de su incorporación en los planes de estudio de estas carreras(AU)

Introduction: Normative documents establish the state of the art related to a certain field of knowledge. There is a large number of standards related to health services and their management, whose application is relevant in this sector. Objective: To show the importance of technical standards in the training of professionals from the fields of biomedical engineering, health technology and health management. Development: Different aspects related to the performance and functions of professionals from the fields of biomedical engineering, health technology and health management are gathered in international and other national technical standards, relevant and useful for their training at the undergraduate and postgraduate levels. Conclusions: The addressed professions require the use of normative documents related to their functions in order to contribute to the quality of health services, hence the relevance of their incorporation into the curriculums of these major(AU)

The Isolation and Manufacture of GMP-Grade Bone Marrow Stromal Cells from Bone Specimens.

Bone marrow stromal cells (BMSCs, also known as bone marrow mesenchymal stem cells) are a plastic-adherent heterogeneous cell population that contain inherent skeletal progenitors and a subset of multipotential skeletal stem cells (SSCs). Application of BMSCs in therapeutic protocols implies its isolation and expansion under good manufacturing practices (GMP). Here we describe the procedures we have found to successfully generate practical BMSCs numbers, with preserved biological potency.

Swiss Fetal Transplantation Program and Non-enzymatically Isolated Primary Progenitor Cell Types for Regenerative Medicine.

Primary progenitor cell types adequately isolated from fetal tissue samples present considerable therapeutic potential for a wide range of applications within allogeneic musculoskeletal regenerative medicine. Progenitor cells are inherently differentiated and extremely stable in standard bioprocessing conditions and can be culture-expanded to establish extensive and robust cryopreserved cell banks. Stringent processing conditions and exhaustive traceability are prerequisites for establishing a cell source admissible for further cGMP biobanking and clinical-grade production lot manufacture. Transplantation programs are ideal platforms for the establishment of primary progenitor cell sources to be used for manufacture of cell therapies or cell-based products. Well-defined and regulated procurement and processing of fetal biopsies after voluntary pregnancy interruptions ensure traceability and safety of progeny materials and therapeutic products derived therefrom. We describe herein the workflows and specifications devised under the Swiss Fetal Progenitor Cell Transplantation Program in order to traceably isolate primary progenitor cell types in vitro and to constitute Parental Cell Banks fit for subsequent industrial-scale cGMP processing. When properly devised, derived, and maintained, such cell sources established after a single organ donation can furnish sufficient progeny materials for years of development in translational musculoskeletal regenerative medicine.

Scalable Manufacturing of Human Hematopoietic Stem/Progenitor Cells Exploiting a Co-culture Platform with Mesenchymal Stromal Cells.

In the context of hematopoietic cell transplantation, hematopoietic stem/progenitor cells (HSPC) from the umbilical cord blood (UCB) present several advantages compared to adult sources including higher proliferative capacity, abundant availability and ease of collection, non-risk and painless harvesting procedure, and lower risk of graft-versus-host disease. However, the therapeutic utility of UCB HSPC has been limited to pediatric patients due to the low cell frequency per unit of UCB. The development of efficient and cost-effective strategies to generate large numbers of functional UCB HSPC ex vivo would boost all current and future medical uses of these cells. Herein, we describe a scalable serum-free co-culture system for the expansion of UCB-derived CD34+-enriched cells using microcarrier-immobilized human bone marrow-derived mesenchymal stromal cells as feeder cells.

GMP-Compliant Adenoviral Vectors for Gene Therapy.

Recently, gene therapy as one of the most promising treatments can apply genes for incurable diseases treatment. In this context, vectors as gene delivery systems play a pivotal role in gene therapy procedure. Hereupon, viral vectors have been increasingly introduced as a hyper-efficient tools for gene therapy. Adenoviral vectors as one of the most common groups which are used in gene therapy have a high ability for humans. Indeed, they are not integrated into host genome. In other words, they can be adapted for direct transduction of recombinant proteins into targeted cells. Moreover, they have large packaging capacity and high levels of efficiency and expression. In accordance with translational pathways from the basic to the clinic, recombinant adenoviral vectors packaging must be managed under good manufacturing practice (GMP) principles before applying in clinical trials. Therein, in this chapter standard methods for manufacturing of GMP-compliant Adenoviral vectors for gene therapy have been introduced.

GMP-Grade Methods for Cardiac Progenitor Cells: Cell Bank Production and Quality Control.

Cardiac explant-derived cells (cEDC), also referred as cardiac progenitors cells (CPC) (Barile et al., Cardiovasc Res 103(4):530-541, 2014; Barile et al., Cardiovasc Res 114(7):992-1005, 2018), represent promising candidates for the development of cell-based therapies, a novel and interesting treatment for cardioprotective strategy in heart failure (Kreke et al., Expert Rev Cardiovasc Ther 10(9):1185-1194, 2012). CPC have been tested in a preclinical setting for direct cell transplantation and tissue engineering or as a source for production of extracellular vesicles (EV) (Oh et al., J Cardiol 68(5):361-367, 2016; Barile et al., Eur Heart J 38(18):1372-1379, 2017; Rosen et al., J Am Coll Cardiol 64(9):922-937, 2014). CPC cultured as cardiospheres derived cells went through favorable Phase 1 and 2 studies demonstrating safety and possible efficacy (Makkar et al., Lancet 379(9819):895-904, 2012; Ishigami et al., Circ Res 120(7):1162-1173, 2017; Ishigami et al., Circ Res 116 (4):653-664, 2015; Tarui et al., J Thorac Cardiovasc Surg 150(5):1198-1207, 1208 e1191-1192, 2015). In this context and in view of clinical applications, cells have to be prepared and released according to Good Manufacturing Practices (GMP) (EudraLex-volume 4-good manufacturing practice (GMP) guidelines-Part I-basic requirements for medicinal products. http://ec.europa.eu/health/documents/eudralex/vol-4 ; EudraLex-volume 4-good manufacturing practice (GMP) guidelines-Part IV-guidelines on good manufacturing practices specific to advanced therapy medicinal products. http://ec.europa.eu/health/documents/eudralex/vol-4 ). This chapter describes GMP-grade methods for production and testing of a CPC Master Cell Bank (MCB), consisting of frozen aliquots of cells that may be used either as a therapeutic product or as source for the manufacturing of Exo for clinical trials.The MCB production method has been designed to isolate and expand CPC from human cardiac tissue in xeno-free conditions (Andriolo et al., Front Physiol 9:1169, 2018). The quality control (QC) methods have been implemented to assess the safety (sterility, endotoxin, mycoplasma, cell senescence, tumorigenicity) and identity/potency/purity (cell count and viability, RT-PCR, immunophenotype) of the cells (Andriolo et al., Front Physiol 9:1169, 2018).

Isolation, Culture, Cryopreservation, and Preparation of Umbilical Cord-Derived Mesenchymal Stem Cells as a Final Cellular Product Under Good Manufacturing Practices-Compliant Conditions.

Mesenchymal stem cells have gained popularity in cell-based therapies due to their regenerative capabilities, immunomodulation properties, and paracrine activity through trophic factors. It is of utmost importance to establish clinical-grade procedures for the preparation of the mesenchymal stem cells for clinical applications. Here, we describe detailed procedures for isolation, culture, cryopreservation, and preparation of mesenchymal stem cells derived from umbilical cord as a final product under good manufacturing practices-compliant conditions.

El uso de túneles y otras tecnologías para la desinfección de humanos utilizando rociado de productos químicos o luz UV-C, 5 de mayo del 2020 / Recommendations to expand access to hand washing and its proper use / O uso de túneis e outras tecnologias para desinfecção de humanos usando aspersão de produtos químicos ou radiação UV-C, 8 de maio de 2020

El uso de túneles u otras estructuras físicas (cabinas, gabinetes, puertas) con rociado de productos para la desinfección, los dispositivos de pulverización y la radiación UV-C (200-280 nm) no se recomiendan para humanos.

Promoting handwashing is essential to minimize transmission of SARS-COV-2, the virus that causes COVID-19, and to save lives. One of the most commons ways of transmission of SARS-COV-2 is from contaminated hands touching the mouth, nose and eyes. The virus can also be transferred from one surface to another through contaminated hands. Free access and mandatory use of handwashing stations would help to minimize SARS-COV-2 transmission and save lives.

O uso de túneis ou outras estruturas físicas (cabines, armários, portas) com dispositivos para aspersão ou radiação UV-C (200-280 nm) não é recomendável para pessoas.

Guia de contratação de serviços e aquisição de soluções em tecnologia da informação para a gestão estadual do SUS / Guide to contracting services and acquiring information technology solutions for SUS state management

Diante da necessidade de informações atualizadas e disponíveis para o planejamento e monitoramento das ações, bem como da troca de informações clínicas entre os diversos pontos de atenção com vistas à continuidade do cuidado, torna-se cada vez mais importante a informatização dos diversos serviços de saúde. Multiplicam-se assim as demandas não só para a contratação e aquisição de equipamentos, adequação da infraestrutura e conectividade, como também para o desenvolvimento de sistemas, aplicativos e outras soluções na área de tecnologia da informação para a gestão estadual. A estruturação da gestão da Tecnologia da Informação vem se mostrando um grande desafio nas Secretarias Estaduais de Saúde (SES), situação que vem sendo evidenciada nos debates realizados nas reuniões da Câmara Técnica de Informação e Informática em Saúde do Conass. O Conselho Nacional de Secretários de Saúde publica este "Guia de Contratação de Serviços e Aquisição de Soluções em Tecnologia da Informação para a Gestão Estadual do SUS", no sentido de apoiar as equipes das SES, disponibilizando informações, esclarecendo normas e processos e orientando quanto à organização necessária para a gestão da área nas SES. Buscou-se, na organização deste manual, apresentar os temas de forma prática, apresentando os problemas e pontos a serem observados com maior cuidado nos processos de aquisição e contratação de soluções na área de Tecnologia da Informação em uma secretaria de saúde. Nesse sentido, foi fundamental contar com a contribuição e consultoria de André Luís de Almeida em sua elaboração. A experiência e as lições apreendidas por André, que, por muitos, anos coordenou a área na Secretaria de Saúde do Estado de São Paulo, estão presentes em todos os capítulos deste livro.

Regulation on introducing process of the highly difficult new medical technologies: A survey on the current status of practice guidelines in Japan and overseas.

Since serious problematic cases regarding the technical safety of technically demanding operations were reported in Japan, the Ministry of Health, Labor and Welfare issued new regulations on June 10, 2016 requiring each hospital to check the status of informed consent, skill of surgery team and governance system of the surgical unit, when the highly difficult new medical technologies were introduced to a hospital. In order to firmly establish this new system for highly difficult new medical technologies, it is very important and informative to survey the current situation for guidelines and consensus regarding introduction of medical technology with special skills in Japan and overseas. Based on the survey of questionnaires, document retrieval, and expert interviews, we found that documentation related to the introduction process of highly difficult medical technologies is very rare, and the regulations were mainly issued by academic societies. Moreover, even if such documentation existed, the quality of the regulations is poor and not sufficient enough to perform surgical practice safely. Therefore, for medical practitioners, comprehensive and concrete regulations should be issued by the government or ministry to legally follow in regard to technically demanding operations. A new practice guideline was proposed by our special research group to regulate the introduction process of highly difficult new medical technologies in hospitals in Japan. This guideline, gained understanding from relevant academic societies, provided a comprehensive view on the interpretation of "high difficulty new medical technology" prescribed by the law and show the basic idea at a preliminary examination from the viewpoints of "Surgeon's requirement", "Guidance system", "Medical safety" , and "Informed consent". These efforts will contribute to the improvement of the quality of guidelines regarding "highly difficult new medical technology".

Combining usability evaluations to highlight the chain that leads from usability flaws to usage problems and then negative outcomes.

Poor usability of health technology is thought to diminish work system performance, increase error rates and, potentially, harm patients. The present study (i) used a combination of usability evaluation methods to highlight the chain that leads from usability flaws to usage problems experienced by users and, ultimately, to negative patient outcomes, and (ii) validated this approach by studying two different discharge summary production systems. To comply with quality guidelines, the process of drafting and sending discharge summaries is increasingly being automated. However, the usability of these systems may modify their impact (or the absence thereof) in terms of production times and quality, and must therefore be evaluated. Here, we applied three successive techniques for usability evaluation (heuristic evaluation, user testing and field observation) to two discharge summary production systems (underpinned by different technologies). The systems' main usability flaws led respectively to an increase in the time need to produce a discharge summary and the risk of patient misidentification. Our results are discussed with regard to the possibility of linking the usability flaws, usage problems and the negative outcomes by successively applying three methods for evaluating usability (heuristic evaluation, user testing and in situ observations) throughout the system development life cycle.

Un dilema ético actual: ¿Ensañamiento terapéutico o adecuación del esfuerzo terapéutico? / A current ethical dilemma: therapeutic savageness or adequate therapeutic effort?

La medicina está estrechamente relacionada con el uso cada vez más de modernas tecnologías, muy sofisticadas y poderosas, que ofrecen posibilidades sin precedentes, en cuanto a la prolongación de la vida. En consecuencia, surgen y abundan nuevos conflictos de carácter ético. La práctica de la adecuación del esfuerzo terapéutico continúa siendo un tema de reflexión médica vigente, demandado no solo por la comunidad científica, sino también por toda la sociedad. El trabajo tiene como objetivo fundamental realizar una breve reflexión teórica, desde un análisis ético acerca del desarrollo alcanzado por la ciencia y la tecnología a partir de la Revolución Científico Técnica y de su influencia en el campo de la medicina, específicamente en las unidades de atención al paciente grave, ante los problemas éticos que ocasiona este avance científico - tecnológico y el poder que se le otorga al equipo de salud que labora en este tipo de unidades para decidir entre la vida o la muerte, entre el ensañamiento terapéutico y la adecuación del esfuerzo terapéutico (AU).

La medicina está estrechamente relacionada con el uso cada vez más de modernas tecnologías, muy sofisticadas y poderosas, que ofrecen posibilidades sin precedentes, en cuanto a la prolongación de la vida. En consecuencia, surgen y abundan nuevos conflictos de carácter ético. La práctica de la adecuación del esfuerzo terapéutico continúa siendo un tema de reflexión médica vigente, demandado no solo por la comunidad científica, sino también por toda la sociedad. El trabajo tiene como objetivo fundamental realizar una breve reflexión teórica, desde un análisis ético acerca del desarrollo alcanzado por la ciencia y la tecnología a partir de la Revolución Científico Técnica y de su influencia en el campo de la medicina, específicamente en las unidades de atención al paciente grave, ante los problemas éticos que ocasiona este avance científico - tecnológico y el poder que se le otorga al equipo de salud que labora en este tipo de unidades para decidir entre la vida o la muerte, entre el ensañamiento terapéutico y la adecuación del esfuerzo terapéutico (AU).

Diagnosis and Treatment of Acute Retinal Necrosis: A Report by the American Academy of Ophthalmology.

PURPOSE: To evaluate the available evidence in peer-reviewed publications about the diagnosis and treatment of acute retinal necrosis (ARN). METHODS: Literature searches of the PubMed and Cochrane Library databases were last conducted on July 27, 2016. The searches identified 216 unique citations, and 49 articles of possible clinical relevance were reviewed in full text. Of these 49 articles, 27 were deemed sufficiently relevant or of interest, and they were rated according to strength of evidence. An additional 6 articles were identified from the reference lists of these articles and included. All 33 studies were retrospective. RESULTS: Polymerase chain reaction (PCR) testing of aqueous or vitreous humor was positive for herpes simplex virus (HSV) or varicella zoster virus (VZV) in 79% to 100% of cases of suspected ARN. Aqueous and vitreous specimens are both sensitive and specific. There is level II and III evidence supporting the use of intravenous and oral antiviral therapy for the treatment of ARN. Data suggest that equivalent plasma drug levels of acyclovir can be achieved after administration of oral valacyclovir or intravenous acyclovir. There is level II and III evidence suggesting that the combination of intravitreal foscarnet and systemic antiviral therapy may have greater therapeutic efficacy than systemic therapy alone. The effectiveness of prophylactic laser or early pars plana vitrectomy (PPV) in preventing retinal detachment (RD) remains unclear. CONCLUSIONS: Polymerase chain reaction testing of ocular fluid is useful in supporting a clinical diagnosis of ARN, but treatment should not be delayed while awaiting PCR results. Initial oral or intravenous antiviral therapy is effective in treating ARN. The adjunctive use of intravitreal foscarnet may be more effective than systemic therapy alone. The role of prophylactic laser retinopexy or early PPV is unknown at this time.

Investigación en salud como política pública en Colombia: balance y perspectivas / On health research as public policy in Colombia: assessment and perspectives

Este ensayo plantea algunos elementos de análisis sobre la investigación en salud en Colombia, como una política pública que se ha configurado desde 1990 con la normatividad instaurada sobre Ciencia y Tecnología. Una serie de ajustes institucionales se llevaron a cabo y se crearon el Programa y el Consejo Nacional de Ciencia y Tecnología de la Salud, además de la institucionalización de la convocatoria como mecanismo de selección de proyectos de investigación y asignación de recursos, de acuerdo con las necesidades y prioridades de los actores del Sistema Nacional de Ciencia y Tecnología. Aunque no ha habido mayores transformaciones posteriores en la gestión de la investigación en salud, excepto la creación del Fondo de Investigación en Salud en 2001, se han venido desarrollando algunas capacidades y, por supuesto, ha habido esfuerzos para formular una política de investigación de salud. Esta tarea, aún pendiente, podría por fin tener una oportunidad con la Ley Estatutaria en Salud, aprobada en 2015.(AU)

This essay presents some elements of analysis for thinking about health research in Colombia as a public policy, something which was formed starting in 1990 with the establishment of Science and Technology regulations. A set of institutional adjustments was carried out which led to the creation of the National Program of Health Science and Technology and the National Council of Health Science and Technology. In addition, it led to the institutionalization of calls for research proposals as a mechanism for selecting research projects and assigning resources in accordance with the needs and priorities of the National System of Science and Technology. Since then, there have been no major changes in the public management of health research, with the exception of the Health Research Fund, created in 2001. However, some efforts have been made to develop some capacities and -so far unsuccessfully- to formulate a national policy on health research. The Statutory Health Act approved in 2015 could be an important opportunity to realize and implement this policy decision.(AU)