Globally each year, millions of people suffer illness or lose their lives because the vaccines, medicines and diagnostic tests that they need are either unavailable or unaffordable – and this lack of access to medicine is acute in low- and middle-in-
come countries (LMICs). While the COVID-19 pan...demic laid this inequity bare, it also saw the pharmaceutical industry develop and bring new vaccines and treat- ments to market at unprecedented speed. As the world emerges from the worst
of this crisis, pharmaceutical companies are now at an important juncture, where lessons learned from the pandemic can prove pivotal in finding solutions to bridge long-standing gaps in access to medicine in LMICs.
more
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.
Digital publication you can download the English, French, Spanish and Russian version
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.
more
Biosafety involves the implementation of containment principles, technologies and practices to prevent unintentional exposure to biological agents. Biosecurity involves the protection, control and accountability of biological materials and information related to these materials and dualuse research,... to prevent their unauthorized access, loss, theft, misuse, diversion or intentional release.
more
HAT diagnosis relies on laboratory techniques because clinical signs and symptoms are unspecific. Serodiagnostic tests exist only for Tbg and are based on the detection of specific antibodies, thus they are not confirmatory of infection. With the current low disease prevalence, the positive predicti...ve value of serological tests is particularly low. Field-applicable tools include the card agglutination test for trypanosomiasis (CATT) used mainly in active screening by specialized mobile teams, and the rapid diagnostic tests that are more suitable for individual testing at point-of-care. Confirmation of Tbg infection requires microscopic examination of body fluids necessitating specific training. The best performing methods are laborious and reach 85–95% diagnostic sensitivity when performed by skilled personnel.
more
HAT diagnosis relies on laboratory techniques because clinical signs and symptoms are unspecific. Serodiagnostic tests exist only for Tbg and are based on the detection of specific antibodies, thus they are not confirmatory of infection. With the current low disease prevalence, the positive predicti...ve value of serological tests is particularly low. Field-applicable tools include the card agglutination test for trypanosomiasis (CATT) used mainly in active screening by specialized mobile teams, and the rapid diagnostic tests that are more suitable for individual testing at point-of-care.
more
Biosafety involves the implementation of containment principles, technologies and practices to prevent unintentional exposure to biological agents. Biosecurity involves the protection, control and accountability of biological materials and information related to these materials and dualuse research,... to prevent their unauthorized access, loss, theft, misuse, diversion or intentional release.
more
Biosafety involves the implementation of containment principles, technologies and practices to prevent unintentional exposure to biological agents. Biosecurity involves the protection, control and accountability of biological materials and information related to these materials and dualuse research,... to prevent their unauthorized access, loss, theft, misuse, diversion or intentional release.
more
Despite a historical association with poor tolerability, a comprehensive review on safety of antileishmanial chemotherapies is lacking. We carried out an update of a previous systematic review of all published clinical trials in visceral leishmaniasis (VL) from 1980 to 2019 to document any reported ...serious adverse events (SAEs).
more
8 January 2021
Sequencing enabled the world to rapidly identify SARS-CoV-2 and develop diagnostic tests and other tools for outbreak management. Continued genome sequencing supports the monitoring of the disease’s spread and evolution of the virus. Accelerated integration of genome sequencing int...o the practices of the global health community is required if we want to be better prepared for the future threats. This document provides guidance for laboratories on maximizing the impact of SARS-CoV-2 sequencing now and other emerging pathogens in the future.
more
The United Nations Commission on Life-Saving Commodities (UNCLSC, 2012) defined 13 health products to end preventable deaths of woman and children. One of those 13 products is the neonatal resuscitator, is indispensable medical device to save newborns from asphyxia at birth. For the efficient use of... neonatal resuscitation, training of healthcare professionals using neonatal resuscitation manikins is the most effective approach. Critical lifesaving trainings calls for the need of neonatal resuscitation manikins with the right features.
The purpose of the WHO Neonatal resuscitation manikin: technical specifications is to provide a minimum standard baseline to meet the increasing demand to procure good quality, affordable, accessible, and appropriate neonatal resuscitation manikins. Towards the development of this baseline, this document includes compilation of available scientific evidence from technical literature, international publications, expert reviews, and an industry survey which was conducted by WHO medical devices team.
more
To provide supply & equipment to collect, test and transfuse 50 blood bags.
The new Collection testing and transfusion kit 2021 is specially designed for emergency settings where blood transfusion is crucial. It contains all the necessary supply & equipment needed to collect blood, test it agains...t HIV, Malaria, Hep B and C, and syphilis, make sure of the blood grouping, and ensure transfusion.
The equipment such as blood bags, IV transfusion set and vacutainer blood collection tubes are from BD or Fresenius Kabi, also available as single item in the WHO catalogue.
more
Interim Guidance, 12 July 2021; This tool was developed to assess present and surge capacities for the treatment of COVID-19 in health facilities. It allows health facilities to assess the availability and status of stockout of critical COVID-19 medicines, equipment and supplies on site and to ident...ify areas that need further attention to enable the facility to respond effectively to the pandemic. The tool encompasses key components that are essential to managing COVID-19 in a hospital setting, including:
health workforce (numbers, absences, COVID-19 infections, staff vaccinated for COVID-19 health workforce management, training and support);
medicines and medical supplies for management of COVID-19;
IPC capacities (protocols, safety measures, guidelines) and the availability of personal protective equipment (PPE) for staff;
diagnostic testing, imaging and patient monitoring devices and supplies
medical equipment for management of COVID-19, including O2 administration;
COVID-19 vaccine readiness ;
beds and space capacity.
more
6 July 2021. The “WHO consolidated guidelines on tuberculosis. Module 3: Diagnosis - Rapid diagnostics for tuberculosis detection 2021 update” is the latest document replacing the one issued in 2020. Three new nucleic acid amplification test (NAAT) classes are endorsed by WHO and included in the... latest consolidated guideline
more
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.
more
The second edition of the joint WHO, WIPO and WTO
publication “Promoting Access to Medical Technologies
and Innovation: Intersections between public health,
intellectual property and trade” (the Trilateral Study),*
published in 2020, included a special insert mappi...ng the
challenges posed by the COVID-19 pandemic in relation
to the integrated health, trade and IP policy framework set
out in the study. The Trilateral Study and the special insert
were designed to serve as background reference for policy-
makers in the widest sense – lawmakers, government
officials, delegates to international organizations, non-
governmental organizations (NGOs) and researchers
who seek a comprehensive presentation of the full range
of issues, including institutions and legal concepts with
which they may be unfamiliar. It is also designed to serve
as a factual resource for the three organizations’ technical
cooperation activities.
This update revises the information contained in that
insert in the light of more recent developments as of
30 August 2021. Further updates will be made to reflect
subsequent developments.
more
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
more
The development of this target product profile (TPP) was led by the WHO Department of Control of Ne-
glected Tropical Diseases (NTD) following standard WHO guidance for TPP development. In order to
identify and prioritize diagnostic needs, a WHO NTD Diagnostics Technical Advisory Group (DTAG)
was... formed, and different subgroups were created to advise on specific NTDs, including a subgroup
working on the human African trypanosomiasis (HAT) diagnostic innovation needs. This group of in-
dependent experts included leading scientists, public health officials and endemic-country end-user rep-
resentatives. Standard WHO Declaration of Interest procedures were followed. A landscape analysis of
the available products and of the development pipeline was conducted, and the salient areas with unmet
needs were identified
more
23 March 2021
The meeting addressed the last key area, that is, determining the best method or combination of diagnostic methods for a control programme for S. stercoralis infections in humans.
Dr Montresor’s presentation highlighted that while there is currently no “gold standard” for the... diagnosis of S. stercoralis, there is a felt urgency to optimize diagnostic regimens that are currently available, and in the context of population-based testing (as opposed to individual focused diagnostics in clinical settings).
In other words, the diagnostic test(s) should have good accuracy, but we should remember that in public health we do not aim at individual diagnosis: rather, we need a tool that should help to estimate the prevalence in a population.
more
This publication provides information for identifying, classifying, marking, labelling, packaging, documenting and refrigerating infectious substances for transportation and ensuring their safe delivery.
The document provides practical guidance to facilitate compliance with applicable international... regulations for the transport of infectious substances by all modes of transport, both nationally and internationally, and include the changes
more
Orientações para a vigilância em saúde, no que se refere aos aspectos epidemiológicos e laboratoriais da vigilância genômica da covid-19