Geospatial Mapping as a Guide for Resource Allocation Among Burn Centers in India.

Timely treatment is essential for optimal outcomes after burn injury, but the method of resource distribution to ensure access to proper care in developing countries remains unclear. We therefore sought to examine access to burn care and the presence/absence of resources for burn care in India. We surveyed all eligible burn centers (n = 67) in India to evaluate burn care resources at each facility. We then performed a cross-sectional geospatial analysis using geocoding software (ArcGIS 10.3) and publicly available hospital-level data (WorldStreetMap, WorldPop database) to predict the time required to access care at the nearest burn center. Our primary outcome was the time required to reach a burn facility within India. Descriptive statistics were used to present our results. Of the 67 burn centers that completed the survey, 45% were government funded. More than 1 billion (75.1%) Indian citizens live within 2 hours of a burn center, but only 221.9 million (15.9%) live within 2 hours of a burn center with both an intensive care unit (ICU) and a skin bank. Burn units are staffed primarily by plastic surgeons (n = 62, 93%) with an average of 5.8 physicians per unit. Most burn units (n = 53, 79%) have access to hemodialysis. While many Indian citizens live within 2 hours of a burn center, most centers do not offer ICU and skin bank services that are essential for modern burn care. Reallocation of resources to improve transportation and availability of ICU and skin bank services is necessary to improve burn care in India.

Cenário da doação de órgãos em uma macrorregional de Pernambuco / Escenario de la donación de órganos en una central de Pernambuco / Organ donation scenario in a transplantation center of Pernambuco

Objetivo conhecer o cenário da doação de órgãos e tecidos de uma macrorregional de transplantes situada em Pernambuco. Método estudo quantitativo, descritivo, retrospectivo e exploratório. Resultados suspeita de morte encefálica identificada em 524 prontuários de pacientes internados entre janeiro de 2013 e dezembro de 2017. A maioria dos potenciais doadores era do sexo masculino (63,6%), faixa etária entre 21 e 60 anos (55,9%); principais causas de morte encefálica foram acidente vascular encefálico (27,9%) e trauma cranioencefálico (19,5%). Maioria de internamentos (96,2%) em instituições públicas. Protocolos de morte encefálica totalizaram 86,8%. Predominou aceitação familiar (53,5%) para doação. Conclusão doação de órgãos e tecidos em uma macrorregional de transplantes era feita majoritariamente por indivíduos do sexo masculino, adultos jovens, atendidos em hospitais públicos e tendo como principal causa de morte o traumatismo crânio encefálico. Quanto ao aceite para doação, as entrevistas familiares foram positivas e, em grande parte, favoráveis à doação.

Objetivo conocer el escenario de donación de órganos y tejidos de un centro de trasplantes ubicado en Pernambuco. Método estudio cuantitativo, descriptivo, retrospectivo y exploratorio. Resultados sospecha de muerte cerebral identificada en 524 registros médicos de pacientes hospitalizados entre enero de 2013 y diciembre de 2017. La mayoría de los donantes potenciales eran varones (63,6%), de edad entre 21 y 60 años (55,9%); las principales causas de muerte cerebral fueron accidente cerebrovascular (27,9%) y traumatismo craneoencefálico (19,5%). La mayoría de las hospitalizaciones (96,2%) en instituciones públicas. Los protocolos de muerte cerebral totalizaron el 86,8%. Predominó la aceptación familiar (53,5%) para la donación. Conclusión la donación de órganos y tejidos en un centro de trasplante fue realizada principalmente por individuos masculinos, adultos jóvenes, tratados en hospitales públicos y con traumatismo craneoencefálico como la principal causa de muerte. En cuanto a la aceptación de la donación, las entrevistas familiares fueron positivas y, en gran parte, favorables a la donación.

Objective to know the scenario of organ and tissue donation of a transplantation center located in Pernambuco. Method quantitative, descriptive, retrospective and exploratory study. Results suspected brain death identified in 524 medical records of patients hospitalized between January 2013 and December 2017. Most potential donors were male (63.6%), age group between 21 and 60 years old (55.9%); main causes of brain death were stroke (27.9%) and head trauma (19.5%). Most of hospitalizations (96.2%) in public institutions. Total of brain death protocols 86.8%. Family acceptance (53.5%) for donation predominated. Conclusion mostly male individuals, young adults, treated in public hospitals and having traumatic brain injury as the main cause of death, were organ and tissue donors in a transplant center. As for donation acceptance, family interviews were positive and, in large part, in favor of donation.

Acceptable Weight Ranges for Research Tissue Procurement and Biorepositories, 2015-2017.

Background: The Cooperative Human Tissue Network, Midwestern Division, is a National Cancer Institute-funded program that provides quality research biospecimens to qualified investigators. Consented human tissues are procured according to researcher specifications for weight (size) and preservation type; weights of samples in significant demand and limited supply are negotiated. Weights of procured tissues are entered into a dedicated biospecimen database. This study seeks to provide guidance for acceptable tissue weights for researchers. Methods: Tissue weights by year and anatomic site were retrieved from the database for primary malignant tissues. The total number of tissues included was 5141. Statistical evaluation of data included the number of tissues for each year, anatomic site as well as minimum, maximum, average weights, standard deviation, and standard error. Anatomic sites with few tissues were excluded. Results: "Stock price" type graphs were constructed to show an average as "volume" with both full weight ranges and range that accommodated 80% of tissues. Average weight and number of sample trends varied by anatomic site. Tissues fell into four weight groups; 10 and 90 percentile boundaries were calculated for each. Smallest average research tissue weights for middle 80% were recorded for prostate and oropharynx (140 mg). Second weight group included tonsil, thyroid, breast, oral cavity, larynx, pancreas, salivary gland, skin, tongue, lung, and parotid (265 mg). The third group included stomach, cervix, colon, esophagus, endometrium, bone, brain, bladder, small bowel, uterus, liver, kidney lymph node, adrenal, and ovary (513 mg). The fourth and heaviest weight group included soft tissue tumors and spleen (1201 mg). Conclusions: Since tissue weights are not usually included in recommendations for research tissue procurement or for frozen tissues stored in biorepositories, we offer this data as a practical guide to researcher acceptable tissue weights for selected sites based on a 3-year researcher request and acceptance history.

Análisis de la relación solicitud-implante de injerto para trasplante osteomuscular / Analysis of the order-implantation relationship for musculoskeletal tissue transplantation

Objetivo: Analizar los pedidos solicitados a un banco musculoesquelético y evaluar el porcentaje de utilización de los tejidos. Material y métodos: Se analizaron 265 pedidos de tejido osteomuscular en el transcurso de un año. Exclusiones: 5 duplicaciones y 5 pedidos en los cuales no hubo disponibilidad para cubrir la necesidad. Se analizó la cantidad de cirugías en las que finalmente se utilizó el injerto. Resultados: De 255 pedidos solicitados, en 178 (70%) el injerto fue utilizado, mientras que en 77 (30%) el injerto no fue utilizado. De los 178 utilizados, en 23 (10%) hubo una devolución parcial. De los 77 pedidos de injerto no utilizado, en 32 (13%) la cirugía fue realizada sin necesidad de utilizar tejido de banco, mientras que en los 45 (17%) restantes la cirugía fue suspendida. Discusión: Un 30% de los injertos solicitados no fueron utilizados; un 17% debido a que la cirugía fue suspendida y un 13% porque el tejido fue devuelto, ya que la cirugía no lo requirió. En otro 10% hubo una devolución parcial del tejido. Con base en este análisis, consideramos que es importante tener una confirmación directa de la realización de la cirugía para evitar enviar tejido a cirugías suspendidas, ya que además del impacto económico, el banco debe asegurar un adecuado mantenimiento de la temperatura durante el transporte y almacenamiento en el centro trasplantológico, para evitar el descarte de dicho tejido, en caso de ser devuelto

Objective: To analyze orders requested from a musculoskeletal tissue bank and to evaluate the percentage of tissue implantation. Material and methods: Two hundred and sixty-five orders for musculoskeletal tissue were analyzed over the course of a year. Exclusions: 5 duplications and 5 orders for which there was no availability to cover the need. We analyzed the number of surgeries in which the graft was finally used. Results: Of a total of 255 orders, the graft was used in 178 (70%), and the graft was not used in 77 (30%). Of the 178 used, there was a partial refund in 23 (10%). Of the 77 orders not used, surgery was performed in 32 (13%) without the use of bank tissue, while surgery was discontinued in the remaining 45 (17%). Discussion: A non-utilization rate of 30% was identified, of which 17% was from surgery that was not performed and 13% from surgery that was performed, but the tissue was returned to the tissue bank, because it was not required. In a further 10% there was partial return of the tissue. Based on this analysis, we consider that it is important to have direct confirmation of the surgery to avoid sending tissue for discontinued surgeries, since in addition to the economic impact, the bank must ensure adequate temperature maintenance during transportation and storage in the transplantation centre, to avoid discarding said tissue if it is returned

Autism BrainNet: A network of postmortem brain banks established to facilitate autism research.

Autism spectrum disorder (ASD or autism) is a neurodevelopmental condition that affects over 1% of the population worldwide. Developing effective preventions and treatments for autism will depend on understanding the genetic perturbations and underlying neuropathology of the disorder. While evidence from magnetic resonance imaging and other noninvasive techniques points to altered development and organization of the autistic brain, these tools lack the resolution for identifying the cellular and molecular underpinnings of the disorder. Postmortem studies of high-quality human brain tissue currently represent the only viable option to pursuing these types of studies. However, the availability of high-quality ASD brain tissue has been extremely limited. Here we describe the establishment of a privately funded tissue bank, Autism BrainNet, a network of brain collection sites that work in a coordinated fashion to develop an adequate library of human postmortem brain tissues. Autism BrainNet was initiated as a collaboration between the Simons Foundation and Autism Speaks, and is currently funded by the Simons Foundation Autism Research Initiative. Autism BrainNet has collection sites (nodes) in California, Texas, New York, and Massachusetts; an affiliated, international node is located in Oxford, England. All donations to this network become part of a consolidated pool of tissue that is distributed to qualified investigators worldwide to carry out autism research. An essential component of this program is a widespread outreach program that highlights the need for postmortem brain donations to families affected by autism, led by the Autism Science Foundation. Challenges include an outreach campaign that deals with a disorder beginning in early childhood, collecting an adequate number of donations to deal with the high level of biologic heterogeneity of autism, and preparing this limited resource for optimal distribution to the greatest number of investigators.

Design of a European code of conduct for brain banking.

The BrainNet Europe consortium, which is a consortium of 19 European brain banks, took the initiative to draft a series of documents to provide an ethical framework for brain banks to follow. The framework includes an ethical code of conduct, a model for brain bank regulations, and a toolkit containing several documents. The sources for the information included came from the laws, regulations, and guidelines (declarations, conventions, recommendations, guidelines, and directives) that had been issued by international key organizations, such as the Council of Europe, European Commission, World Medical Association, and World Health Organization. The code of conduct addresses fundamental topics such as the rights of the persons donating their tissue, the obligations of the brain bank with regard to respect and observance of such rights, informed consent, confidentiality, protection of personal data, collections of human biologic material and their management, and transparency and accountability within the organization of a brain bank. The code of conduct was ratified by all European brain banks in 2009. This chapter describes the process of establishing the code of conduct within the BrainNet Europe consortium and elaborates on three key aspects of the code of conduct, namely informed consent, genetics, and financial aspects in brain banking.

Bioprocessing automation in cell therapy manufacturing: Outcomes of special interest group automation workshop.

Phacilitate held a Special Interest Group workshop event in Edinburgh, UK, in May 2017. The event brought together leading stakeholders in the cell therapy bioprocessing field to identify present and future challenges and propose potential solutions to automation in cell therapy bioprocessing. Here, we review and summarize discussions from the event. Deep biological understanding of a product, its mechanism of action and indication pathogenesis underpin many factors relating to bioprocessing and automation. To fully exploit the opportunities of bioprocess automation, therapeutics developers must closely consider whether an automation strategy is applicable, how to design an 'automatable' bioprocess and how to implement process modifications with minimal disruption. Major decisions around bioprocess automation strategy should involve all relevant stakeholders; communication between technical and business strategy decision-makers is of particular importance. Developers should leverage automation to implement in-process testing, in turn applicable to process optimization, quality assurance (QA)/ quality control (QC), batch failure control, adaptive manufacturing and regulatory demands, but a lack of precedent and technical opportunities can complicate such efforts. Sparse standardization across product characterization, hardware components and software platforms is perceived to complicate efforts to implement automation. The use of advanced algorithmic approaches such as machine learning may have application to bioprocess and supply chain optimization. Automation can substantially de-risk the wider supply chain, including tracking and traceability, cryopreservation and thawing and logistics. The regulatory implications of automation are currently unclear because few hardware options exist and novel solutions require case-by-case validation, but automation can present attractive regulatory incentives.

The availability of allograft skin for large scale medical emergencies in the United States.

Mass injury events present a unique medical challenge. Effective communications and coordination of resources including trained personnel as well as supplies and equipment are critical in these emergent situations. In the U.S., the availability of allograft skin plays a lifesaving role in treatment of burn injuries. Maintaining an adequate and readily available supply of this precious resource is critical for treatment of multiple injuries in the event of a national emergency. Allograft skin has historically been a local resource but contraction and consolidation of tissue banks has given rise to a small number of more nationally focused skin suppliers. While distinctly separate and essentially competing entities, these organizations come together in times of crisis to serve patients in need. Emergency preparations must include the ability to monitor and coordinate the capabilities of these organizations to supply lifesaving tissue grafts in times of national and global disasters.

Brain banking for neurological disorders.

Brain banks are used to gather, store, and provide human brain tissue for research and have been fundamental to improving our knowledge of the brain in health and disease. To maintain this role, the legal and ethical issues relevant to the operations of brain banks need to be more widely understood. In recent years, researchers have reported that shortages of high-quality brain tissue samples from both healthy and diseased people have impaired their efforts. Closer collaborations between brain banks and improved strategies for brain donation programmes will be essential to overcome these problems as the demand for brain tissue increases and new research techniques become more widespread, with the potential for substantial scientific advances in increasingly common neurological disorders.

[Can one authorize oocyte donation in the Grand Duchy of Luxembourg?]. / Peut -on autoriser le don d'ovocytes au GDL?

In the case of early ovary extinction, the only way to have a child is either adoption or egg/embryo reception by donation. To day, egg donation is prohibited in Luxembourg by ministerial decision in 2003. Germ cell donation is part of artificial reproductive therapy. Oocyte donation, in particular, needs to be done by IVF treatment, which makes it more complicated then sperm donation What makes it more difficult is the fact that there are no oocyte bank yet. Today, prohibition encourages procreative tourism what only wealthy people can afford. Although donation programs are well established many questions arise about egg donation such as refunds, divulging information, women's age limit, health insurance participation.

Brain banks as key part of biochemical and molecular studies on cerebral cortex involvement in Parkinson's disease.

Exciting developments in basic and clinical neuroscience and recent progress in the field of Parkinson's disease (PD) are partly a result of the availability of human specimens obtained through brain banks. These banks have optimized the methodological, managerial and organizational procedures; standard operating procedures; and ethical, legal and social issues, including the code of conduct for 21st Century brain banking and novel protocols. The present minireview focuses on current brain banking organization and management, as well as the likely future direction of the brain banking field. We emphasize the potentials and pitfalls when using high-quality specimens of the human central nervous system for advancing PD research. PD is a generalized disease in which α-synuclein is not a unique component but, instead, is only one of the players accounting for the complex impairment of biochemical/molecular processes involved in metabolic pathways. This is particularly important in the cerebral cortex, where altered cognition has a complex neurochemical substrate. Mitochondria and energy metabolism impairment, abnormal RNA, microRNA, protein synthesis, post-translational protein modifications and alterations in the lipid composition of membranes and lipid rafts are part of these complementary factors. We have to be alert to the possible pitfalls of each specimen and its suitability for a particular study. Not all samples qualify for the study of DNA, RNA, proteins, post-translational modifications, lipids and metabolomes, although the use of carefully selected samples and appropriate methods minimizes pitfalls and errors and guarantees high-quality reserach.

SWOG Cooperative Group biorepository resource: access for scientific research studies.

SWOG (formerly the Southwest Oncology Group), a National Cancer Institute-supported cooperative group, conducts multi-institutional, multidisciplinary clinical trials for adult patients with cancer, covering a wide range of solid tumors and hematologic cancers. The group has amassed a large set of biospecimens, collected from patients in numerous studies over many years and linked to clinical data. SWOG is now actively promoting the use of this unique scientific resource by making it available to a much wider group of researchers. This biospecimen resource offers material for research on disease mechanisms, genomic changes associated with cancer progression, markers of response and resistance to therapies, diagnosis or detection of recurrence, and more. By collecting, storing, and distributing the specimens, SWOG provides the framework for translational scientists to complete the feedback loop from "bedside to bench." This article provides an overview of the group's biospecimen resources and guidelines for gaining access to them.

The current limitations on tissue banking from an academic perspective.

For research on human physiology and pathologies the most relevant results come from human tissue, necessitating the creation of more tissue banks. This need is acknowledged by academics, clinical researchers and the pharmaceutical industry. For academics, the major obstacles to establishing tissue banks are the somewhat cumbersome ethical procedures, a perceived lack of demand for human tissue and insufficient knowledge about supply and its demographic differences. The causes are inter-related: confusing and time-consuming ethics applications cause some researchers to avoid human tissue work and expend research efforts on animal studies, leading to a false presumption of a lower level of demand for human tissue. Lack of knowledge about why rates of donation are low, and why there are differences in donation for different organs, leads to an uncertainty about supply. This too poses a problem for tissue bank establishment, and further research into this area is required.

Ethical tissue: a not-for-profit model for human tissue supply.

Following legislative changes in 2004 and the establishment of the Human Tissue Authority, access to human tissues for biomedical research became a more onerous and tightly regulated process. Ethical Tissue was established to meet the growing demand for human tissues, using a process that provided ease of access by researchers whilst maintaining the highest ethical and regulatory standards. The establishment of a licensed research tissue bank entailed several key criteria covering ethical, legal, financial and logistical issues being met. A wide range of stakeholders, including the HTA, University of Bradford, flagged LREC, hospital trusts and clinical groups were also integral to the process.

The impact of the International Atomic Energy Agency (IAEA) program on radiation and tissue banking in Uruguay: development of tissues quality control and quality management system in the National Multi-Tissue Bank of Uruguay.

BNOT was created and regulated in 1977 and started its operation in 1978 according to the Decree No. 86/1977. By the Decree 248/005 is transformed in the National Institute of Donation and Transplantation of Cells, Tissues and Organs (Instituto Nacional de Donación y Trasplante de Células, Tejidos y Organos--INDT). The organisation has been operating within the State University Medical School and the Public Health Secretary and it is the governmental organisation responsible for the regulation, policy and management of donation and transplantation in Uruguay. By the Decree 160/2006 is responsible for human cells and tissues regulation too. The participation of the INDT in the IAEA program facilitated the introduction of the radiation sterilisation technique for the first time in the country. The radiation sterilisation of tissues processed by INDT (ex BNOT), was initially carried out in the 60 Cobalt Industrial Plant in the National Atomic Energy Commission of Argentina and now is carried out in INDT, using a Gamma Cell 220 Excel, which was provided by the IAEA through the national project URU/7/005. The results of the implementation of tissues, quality control and quality management system, are showed.

Training tissue bank operators: the International Atomic Energy Agency (IAEA)/National University of Singapore (NUS) 10 years of experience.

National University of Singapore (NUS) was appointed by IAEA to become IAEA/NUS Regional Training Centre (RTC) for Asia and the Pacific region in September 1996. The Government of Singapore (represented by the Ministry of Environment) with the National Science and Technology Board as the funding agency awarded a grant of S$225,500 to build a new purpose-built tissue bank to be the Regional Training Centre. National University Hospital provided a space of 2,000 square feet for this purpose. The first Diploma Course was launched on 3 November 1997 with 17 candidates with the first NUS Diploma Examination being held in October 1998. Between November 1997 and April 2007, a total of nine courses were conducted by RTC with a total of 180 tissue bank operators, 133 from Asia and the Pacific region (13 countries including 2 from Iran), 14 from Africa (Algeria, Egypt, Libya, Egypt, South Africa and Zambia), 6 from Latin America (Brazil, Chile, Cuba, Peru and Uruguay), 9 from Europe (Greece, Slovakia, Poland, Ukraine) and 2 from Australia. The last batch (ninth batch) involved twenty students registered in April 2007 and will be due to sit for the terminal examination only in April 2008.

The impact of the International Atomic Energy Agency (IAEA) program on radiation and tissue banking in Singapore.

The National University Hospital (NUH) Tissue Bank was established in October 1988. The National University of Singapore (NUS) was officially appointed by IAEA to be the IAEA/NUS Regional Training Centre (RTC) for RCA Member States for training of tissue bank operators on September 18, 1996. In the first five years since its establishment the National University Hospital Tissue Bank concentrated its work on the sterile procurement and production of deep frozen femoral heads and were used in patients for bone reconstruction. The cost of producing these tissues were about SGD$ 250 per femoral head although cost fees were initially charged at SGD$ 50 per femoral head. The most important activity carried out by Singapore within the IAEA was training. Between November 1997 and April 2007, a total of nine courses were conducted by RTC with a total of 180 tissue bank operators registered, 133 from Asia and the Pacific region (13 countries, including 2 from Iran), 14 from Africa (Zambia, Libya, Egypt, Algeria, and South Africa), 6 from Latin America (Brazil, Chile, Cuba, Peru, and Uruguay), 9 from Europe (Greece, Slovakia, Poland, and Ukraine), and 2 from Australia. The last batch (ninth batch) involved 20 students registered in April 2007 and will be due to sit for the terminal examination in April 2008.