Interim guidance, 6 October 2021
Direct detection of SARS-CoV-2 viral proteins (antigens) in nasal swabs and other respiratory secretions using lateral flow immunoassays (also known as rapid diagnostic tests, RDTs) offers a faster and less expensive method to test for SARS-CoV-2 than the reference ...method, nucleic acid amplification tests (NAATs). This interim guidance offers recommendations on the priority uses of antigen-detecting rapid diagnostic tests (Ag-RDTs) in specific populations and settings, including (i) for primary case detection in symptomatic individuals suspected to be infected and asymptomatic individuals at high risk of COVID-19, (ii) for contact tracing, (iii) during outbreak investigations and (iv) to monitor trends of disease incidence in communities. Ag-RDTs meeting minimum performance requirements can be used outside of clinical and laboratory settings, including in communities, by trained operators in accordance with instructions. The guidance additionally provides recommendations on implementation, product selection and storage.
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Prepared by the Independent Panel for Pandemic Preparedness and Response for the WHO Executive Board, January 2021
“The world was not as prepared as it should have been, and it must do better,” concludes a WHO panel reviewing the pandemic response "
Reports of antimicrobial-resistant (AMR) microorganisms are increasing globally, threatening to render existing treatments ineffective against many infectious diseases. In Africa, AMR has already been documented to be a problem for human immunodeficiency virus (HIV) and the pathogens that cause mala...ria, tuberculosis (TB), typhoid, cholera, meningitis, gonorrhoea and dysentery. Recognizing the urgent need for action, the 2016 United Nations (UN) General Assembly approved a resolution to ensure sustained and effective global action to address AMR.
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New England Journal of Medicine
April 9, 2021
DOI: 10.1056/NEJMoa2104840
This publication is based on the list of clinical interventions selected from clinical guidelines on prevention, screening, diagnosis, treatment, palliative care, monitoring and end of life care. This publication addresses medical devices for six types of cancer: breast, cervical, colorectal, leukem...ia, lung and prostate. The first section defines the global increase in cancer cases, the global goals to manage NCDs and the WHO activities related to these goals. The second section presents the methodology used for the selection of medical devices that support clinical interventions required to screen, diagnose, treat and monitor cancer stages, as well as the provision of palliative care, based on evidence-based information. The third section lists the priority medical devices required to manage cancer in seven different units of health care services: 1. Vaccination, clinical assessment and endoscopy, 2. Medical imaging and nuclear medicine, 3. Surgery, 4. Laboratory and pathology, 5. Radiotherapy, 6. Systemic therapy and 7. Palliative and end of life care
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Pharmaceutical regulators are at the forefront of ensuring that only safe and effective medicines are authorized and available in the market. This document builds on the recommendations in the above publication and has been prepared to specifically assist national medicines regulatory authorities to... understand the nature and extent of oxytocin quality issues and to provide key technical information and quality requirements for oxytocin products in dossier assessments. Furthermore, this document also presents recommendations on other regulatory actions needed to ensure that only quality-assured oxytocin products are authorized and made available to women.
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Ghana's attempt to regulate health care waste management started in 2002 with the development of guidelines on health care waste manage-ment by the Environmental Protection Agency (EPA). In 2006, the Ghana Health Service (GHS) also developed the Health Care Waste Management Policy and Guidelines as ...a single document.
Although awareness on Health Care Waste Management (HCWM) has improved in recent years, there is the need for a systematic approach to improve on effective segregation, safe collection, and storage, as well as ultimate treatment before disposal.
This guideline seeks to ensure that HCW is managed effectively in compliance with existing International Conventions that Ghana is a signatory to, national laws and regulations, and others to be passed in future.
Recommendations for better management of HCW in the nation's health care facilities have been presented in this document. Also, standard operating procedures (SOPs) have been developed to provide
guidance to various levels of the health facilities.
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This new plan has been developed to build on successes made and lessons learnt from implementation of the two initial plans and to provide a short to medium term strategic anchor against which preparedness and response plans to the corona virus disease COVID-19 epidemic in the country should focus o...n for the period June 2021 to June 2022.
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The portable diagnostic imaging technology covered by this document will serve not only the pressing demands for tuberculosis screening and triage but also other diseases. Therefore, the requirements, accessories, hardware and software packages listed in the following specifications are described in... detail in order to serve also other pathologies and conditions, like trauma and pneumonia.
Through the definition of "minimum technical requirements", this document is recommended to support decision-making regarding the selection, incorporation, allocation and use of portable X-ray systems and is intended for health care providers, managers of imaging departments, procurement and regulatory agencies, policymakers and planning officers in ministries of health, as well as biomedical engineering professionals, medical physicists, the private health sector, medical device industry and intergovernmental and international agencies.
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In many conflicts around the world, more children die from diseases linked to unsafe water than from direct violence. UNICEF is releasing Water Under Fire volume 3, a report that highlights the issues children face in accessing water in times of war. The report demonstrates the humanitarian impact o...n children through case studies from Iraq, State of Palestine, Syria, Yemen, and Ukraine. Attacks on water, sanitation services and staff must stop.
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In 2015, to advance the global and national response to antimicrobial resistance (AMR), the World Health Assembly issued resolution WHA68.7 calling for all Member States to develop AMR national action plans that address the five objectives of the World Health Organization Global Action Plan (GAP) by... May 2017. The WHO GAP provides a framework to support countries in developing their national action plans on AMR. To operationalize and accelerate implementation of national action plans on AMR, WHO has developed a costing and budgeting tool and accompanying user guide. The purpose is to support countries in costing prioritized activities of an operational plan linked to their AMR national action plan, and identify existing funding and funding gaps to promote resource mobilization and sustainable implementation. The target audience of the publication are national policy makers and designated costing coordinators for national action plans on AMR.
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Über SARS-CoV-2-Testsysteme informieren das Bundesinstitut für Arzneimittel und Medizinprodukte (BfArM) und das Paul-Ehrlich-Institut. Die Informationen ergänzen sich, den rechtlichen Rahmen bietet u.a. die Coronavirus-Testverordnung-TestV.
Das BfArM bietet eine Liste von Antigen-Tests zum dir...ekten Erregernachweis des Coronavirus SARS-CoV-2 an. In dieser Liste befinden sich diejenigen Tests, die sich laut Herstellerangaben gemäß den Vorgaben des Medizinproduktegesetzes (MPG) rechtmäßig in Europa bzw. Deutschland in Verkehr befinden und alle vom Paul-Ehrlich-Institut in Abstimmung mit dem Robert Koch-Institut (RKI) festgelegten Mindestkriterien für Antigen-Tests erfüllen.
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Saving Lives: Universal access to Trauma Services in Kenya
Laboratory Safety Handbook. Global edition
Las pruebas de cultivo y sensibilidad a fármacos son necesarias especialmente para los pacientes con riesgo de tuberculosis resistente a los medicamentos y para vigilar su respuesta al tratamiento. Si bien el cultivo y las pruebas de sensibilidad son ca...da vez más accesibles, la infraestructura para realizarlos es compleja y requiere equipos especializados y costosos. Con vistas a garantizar que el personal de laboratorio realice su trabajo de forma correcta y segura, este manual ofrece una guía práctica mediante textos sencillos e ilustraciones claras que ayudan a comprender los problemas de seguridad conexos. De ahí la importancia de su publicación en español para la red de laboratorios nacionales y supranacionales que apoya la Organización Panamericana de la Salud en la Región de las Américas.
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n the countries of the Region of the Americas, there are different forms of organization of health services at the first level of care. Some countries include certain laboratory, dental and diagnostic imaging practices in the first level of care, while other countries centralize these practices in t...he second and third levels of care. Consequently, so that the List of Priority Medical Devices (LPMD) could be adapted to these different forms of organization of health systems in the region of the Americas, modular lists were developed that complement the main list. In this way, to use the LPMD, only those modules that are planned to be offered in a first-level care center are selected, and it is those lists that are analyzed.
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PlosOne May 7, 2012 https://doi.org/10.1371/journal.pone.0036735 ; Safe drinking water is critical for health. Household water treatment (HWT) has been recommended for improving access to potable water where existing sources are unsafe. Reports of low adherence to HWT may limit the usefulness of thi...s approach, however.
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PlosOne December 10, 2014 https://doi.org/10.1371/journal.pone.0111913
Plastic pollution is ubiquitous throughout the marine environment, yet estimates of the global abundance and weight of floating plastics have lacked data, particularly from the Southern Hemisphere and remote regions. Here we re...port an estimate of the total number of plastic particles and their weight floating in the world's oceans from 24 expeditions (2007–2013) across all five sub-tropical gyres, costal Australia, Bay of Bengal and the Mediterranean Sea conducting surface net tows (N = 680) and visual survey transects of large plastic debris (N = 891). Using an oceanographic model of floating debris dispersal calibrated by our data, and correcting for wind-driven vertical mixing, we estimate a minimum of 5.25 trillion particles weighing 268,940 tons. When comparing between four size classes, two microplastic <4.75 mm and meso- and macroplastic >4.75 mm, a tremendous loss of microplastics is observed from the sea surface compared to expected rates of fragmentation, suggesting there are mechanisms at play that remove <4.75 mm plastic particles from the ocean surface.
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PNAS 119 (8) e2113947119 | https://doi.org/10.1073/pnas.2113947119
Environmental exposure to active pharmaceutical ingredients (APIs) can have negative effects on the health of ecosystems and humans. While numerous studies have monitored APIs in rivers, these employ different analytical methods, m...easure different APIs, and have ignored many of the countries of the world. This makes it difficult to quantify the scale of the problem from a global perspective. Furthermore, comparison of the existing data, generated for different studies/regions/continents, is challenging due to the vast differences between the analytical methodologies employed. Here, we present a global-scale study of API pollution in 258 of the world’s rivers, representing the environmental influence of 471.4 million people across 137 geographic regions. Samples were obtained from 1,052 locations in 104 countries (representing all continents and 36 countries not previously studied for API contamination) and analyzed for 61 APIs. Highest cumulative API concentrations were observed in sub-Saharan Africa, south Asia, and South America. The most contaminated sites were in low- to middle-income countries and were associated with areas with poor wastewater and waste management infrastructure and pharmaceutical manufacturing. The most frequently detected APIs were carbamazepine, metformin, and caffeine (a compound also arising from lifestyle use), which were detected at over half of the sites monitored. Concentrations of at least one API at 25.7% of the sampling sites were greater than concentrations considered safe for aquatic organisms, or which are of concern in terms of selection for antimicrobial resistance. Therefore, pharmaceutical pollution poses a global threat to environmental and human health, as well as to delivery of the United Nations Sustainable Development Goals.
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