The country profiles incorporate facts indicating the national status of medical devices in areas such as: medical device policies, regulations, incorporation, lists, inventories, nomenclature, health technology assessment, management, and biomedical engineering resources. This publication is int...ended for use as a reference by decision-makers in Ministries of Health, nongovernmental organizations and academic institutions involved in health technology at the district, national, regional, or global levels.
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4th edition
The WHO Laboratory Biosafety Manual (LBM) has been in broad use at all levels of clinical and public health laboratories, and other biomedical sectors globally, serving as a de facto global standard that presents best practices and sets trends in biosafety.
LBM encouraged countries t...o accept and implement basic concepts in biological safety and to develop national codes of practice for the safe handling of biological agents in laboratories within their geographical borders.
This fourth edition of the manual builds on the risk assessment framework introduced in the third edition. A thorough, evidence-based and transparent assessment of the risks allows safety measures to be balanced with the actual risk of working with biological agents on a case-by-case basis.
This novel evidence- and risk-based approach will allow optimised resource use and sustainable laboratory biosafety and biosecurity policies and practices that are relevant to their individual circumstances and priorities, enabling equitable access to clinical and public health laboratory tests and biomedical research opportunities without compromising safety.
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For several years, agencies supporting preparedness and response to cholera outbreaks have supplied medicines and medical devices through the Interagency Diarrhoeal Disease Kits (IDDK).
In an effort to better align the presentation and content of the kits to field needs, the composition of the ch...olera kits has been reviewed by WHO and its partners in 2015 and again in 2020. The content of all modules have been slightly revised with no changes except for the cholera laboratory check list.
The revised cholera kits 2020 are designed to help prepare for a potential cholera outbreak and to support the first month of the initial response for 100 cases. The overall package consists of six different kits, each divided in several modules.
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A manual for health care providers.
This manual provides expert guidance on the laboratory techniques and procedures used in the diagnosis of Buruli ulcer, a disease caused by Mycobacterium ulcerans. Aimed at laboratory technicians and scientists working on this disease, the manual details the exac...t procedures to follow when performing a range of diagnostic tests. Recommended procedures, intended for use throughout the health system, are presented at levels appropriate for peripheral, district and central services and in accordance with the varying resources, skills and equipment typically found in countries where Buruli ulcer is endemic.
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Manuel destiné au personnel de santé. Le présent manuel est un guide spécialisé sur les techniques et les méthodes de laboratoire à utiliser pour le diagnostic de l’ulcère de Buruli, une maladie provoquée par Mycobacterium ulcerans. Destiné aux techniciens et aux scientifi ques de labora...toire travaillant sur cette maladie, le présent manuel décrit les méthodes exactes à mettre en oeuvre pour réaliser un certain nombre de tests diagnostiques. Les procédures recommandées, utilisables dans l’ensemble du système de santé, sont adaptées aux services périphériques, des districts et centraux et ce, conformément aux ressources, compétences et matériel variables que l’on trouve classiquement dans les pays où l’ulcère de Buruli est endémique.
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The objective of the 2022 Compendium is to compile and highlight emerging innovative health technologies for low-resource settings. It presents a snapshot of technologies that are solutions to an unmet medical/health technology need or are likely to improve health outcomes and the quality of life. H...ealth technologies in the Compendium underwent WHO evidence-based assessments focused on the life cycle of health technology innovations for low-resource settings.
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A total of 18 laboratories from 13 countries participated in the four rounds of EQA: 10 laboratories from eight African endemic countries, four of which participated in all four rounds and three in three rounds. The overall results showed that the median performance of these laboratories improved ov...er the four rounds. However, the proportion of laboratories reporting false–positive cases remains high and indicates a problem of specificity probably due to contamination. The proportion of laboratories reporting both false–positive and false–negative results raises the issue of the quality of the data reported by WHO in Africa as well as the results of the studies carried out in these different laboratories in various countries.
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In 2009, WHO’s Second International Conference on Buruli Ulcer Control and Research resolved to strengthen the capacity of national laboratories to confirm cases of the disease, but advised that “efforts are still needed to develop simple diagnostic tools usable in the field as well as disabilit...y prevention methods”.
In 2013, WHO and the Foundation for Innovative New Diagnostics convened a meeting of Buruli ulcer experts in Geneva, Switzerland (9) at which two priority unmet needs in diagnosis were identified:
a diagnostic test for early detection of Buruli ulcer in symptomatic patients with sufficient positive predictive value to put patients on appropriate treatment; and
a screening test at the primary health care or community level for symptomatic patients with ulcer
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Policy Brief. 24 June 2022. This policy brief, one of two on the updated hepatitis C (HCV) guidelines, focuses on the new recommendations on simplified service delivery for a public health approach to HCV testing, care and treatment. These recommendations include decentralization, integration and ta...sk-sharing, in addition to the use of point-of-care (POC) HCV viral load assays and reflex viral load testing.
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he Framework sets the requirements for facilities handling High Consequence Agents and Toxins (HCATs) and guides the implementation of laboratory biosafety and biosecurity practices associated with the design, commissioning, routine operation safe and secure biocontainment laboratories.
The Global guidance framework for the responsible use of the life sciences: mitigating biorisks and governing dual-use research (the framework) aims to provide values and principles, tools and mechanisms to support Member States and key stakeholders to mitigate and prevent biorisks and govern dual-u...se research.
The framework adopts the One health approach and focuses on the role that responsible life sciences research can play in preventing and mitigating risks caused by accidents, inadvertent or deliberate misuse with the intention to cause harm to humans, nonhuman animals, plants and agriculture, and the environment.
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Quarta Edição.
Esta quarta edição do manual se baseia no esquema de avaliação de risco apresentado na terceira edição. Uma avaliação completa, baseada em evidências e transparente dos riscos permite que as medidas de segurança sejam equilibradas com o risco real de trabalhar com agentes... biológicos, caso a caso. Isso permitirá que os países implementem políticas e práticas de biossegurança e biosseguridade laboratoriais economicamente viáveis e sustentáveis que sejam relevantes para suas circunstâncias e prioridades individuais.A necessidade de atualizar as diretrizes de biossegurança de laboratórios internacionais faz parte de uma iniciativa mais ampla para globalizar a biossegurança e enfatizar os princípios e as abordagens que são acessíveis a países que tenham ampla gama de recursos financeiros, técnicos e regulatórios
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This document is a guide defining requirements for quality and safety for malaria rapid diagnostic testing services to safeguard the quality of the results, the safety of the operators and patients and that of the environment for use by national malaria control programmes, regulators, implementers a...nd rapid diagnostic providers.
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The WHO BioHub Biosafety & Biosecurity: criteria and operational modalities sets out the requirements to which laboratories wishing to receive biological materials as part of this international exchange system should abide, to ensure safe and secure operations. These provisions are in accordance wit...h the recommendations of the WHO Laboratory Biosafety Manual 4th edition (LBM4), adopting an evidence- and risk-based approach to enable scalable and adaptable biosafety provisions and actions, proportionate to the assessed risk
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To meet the need for laboratory diagnosis to be integrated in community care, the new 2022 Update describes point-of-care tests that can be performed both in district laboratories and peripheral healthcare facilities by non-specialist staff. Also included are recently developed self-tests.
The meeting was held from 26 to 27 March 2018 to review and discuss the following topics:
Advances and challenges in the use of fTLC, and new approaches to detecting mycolactone using monoclonal antibodies (mAbs).
The status of development of rapid diagnostic tests (RDTs) targeting the M...UL_3720 protein.
The role of PCR as a reference test, and hurdles in providing a confirmatory diagnosis and in establishing a quality assurance programme.
New molecular tools with potential for implementation at a level lower than in the national or regional reference laboratory, such as loop-mediated isothermal amplification (LAMP) and recombinase polymerase amplification (RPA).
The need to harmonize and standardize methods for collection and preparation of specimens, so samples can be referred for diagnosis and stored for evaluation of new diagnostic tests in optimal conditions.
Barriers to accessing early diagnosis and treatment, including coordination at the programme level, and lack of adequate diagnostic tools.
Defining target product profiles (TPPs) to guide the development of new diagnostic tools that can be applied at different levels of the health system. Participants agreed that two TPPs would be developed to address the current gaps: (i) a rapid test for BU diagnosis at the primary health-care level; and (ii) a test for diagnosis of BU that can also assist in treatment monitoring and differential diagnosis at the district hospital or reference centre.
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GDF is the largest global provider of quality-assured tuberculosis (TB)
medicines, diagnostics, and laboratory supplies to the public sector.
Since 2001, GDF has facilitated access to high-quality TB care in over 130
countries, providing treatments to over 30 million people with TB and procuring
...
and delivering more than $200 million worth of diagnostic equipment
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The World Health Organization’s (WHO) global report for the year 2019 indicates that sub-Saharan Africa (SSA) has a very high maternal mortality rate (MMR) with a 2017 point estimate of 542 (UI 498 to 649) maternal deaths per 100 000 live births, accounting for approximately 66% of estimated globa...l maternal deaths. Despite recent improvements, current analysis confirms that millions of mothers and children are still dying every year because of severe anaemia due to insufficient blood supply. The lack of blood to treat severe perinatal haemorrhage contributes to up to 72% of maternal deaths (2,3). Similarly, delayed transfusion has been associated with increased infant mortality in cases of paediatric malaria-associated anaemia (4,5). Indeed, safe and reliable blood and blood products remain unavailable to many people living in the world’s poorest countries, particularly in SSA. While the need for blood is universal, there is a significant imbalance between developing and industrialized countries accessing safe blood.
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