The WHO Global Antimicrobial Resistance and Use Surveillance System (GLASS) was launched in 2015 to foster AMR surveillance and inform strategies to contain AMR. The system started with surveillance of AMR in bacteria causing common human infections and has expanded its scope to include surveillance
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of antimicrobial consumption (AMC), invasive fungal infections, and a One Health surveillance model relevant to human health. To meet future challenges, it is in continuous evolution to enhance the quality and representativeness of data to inform the AMR burden accurately. As of the end of 2022, 127 countries, territories and areas participate in GLASS.
The fifth GLASS report, produced in collaboration with Member States, summarizes 2020 data on AMR rates in common bacteria from countries, territories, and areas. The report brings new features, including analyses of population testing coverage or AMR trends. For the first time, the report presents 2020 data on AMC at the national level. A new interactive dashboard allow users to explore AMR and AMC global data, country profiles and download the data.
This report marks the end of the early implementation phase of GLASS. In addition to presenting data collected through the latest data call, this report provides a summary of five years of national AMR surveillance data contributed to GLASS from its initiation, presents AMR findings in the context of progress of country participation in GLASS and in global AMR surveillance coverage and laboratory quality assurance systems at (sub)national level.
Patterns of antimicrobial consumption are presented by country with a particular focus on antibacterials. The report also presents the antimicrobial consumption according to the WHO AWaRe antibiotic classification, for penicillins and cephalosporines. From a One Health perspective, the report presents antimicrobial consumption data in the human sector expressed in tons to allow a comparison with antimicrobial consumption from other sectors (not included in this report).
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World Psychiatry. 2010 Jun;9(2):67-77.
The main recommendations are presented in relation to: the need for coordinated policies, plans and programmes, the requirement to scale up services for whole populations, the importance of promoting community awareness about mental illness to increase levels
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of help-seeking, the need to establish effective financial and budgetary provisions to directly support services provided in the community. The paper concludes by setting out a series of lessons learned from the accumulated practice of community mental health care to date worldwide, with a particular focus on the social and governmental measures that are required at the national level, the key steps to take in the organization of the local mental health system, lessons learned by professionals and practitioners, and how to most effectively harness the experience of users, families, and other advocates
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Spirometry is required as part of the comprehensive evaluation of both adult and paediatric individuals with suspected or confirmed respiratory diseases and occupational assessments. It is used in the categorisation of impairment, grading of severity, assessment of potential progression and response
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to interventions. Guidelines for spirometry in South Africa are required to improve the quality, standardisation and usefulness in local respiratory practice. The broad principles of spirometry have remained largely unchanged from previous versions of the South African Spirometry Guidelines; however, minor adjustments have been incorporated from more comprehensive international guidelines, including adoption of the Global Lung Function Initiative 2012 (GLI 2012) spirometry reference equations for the South African population.
All equipment should have proof of validation regarding resolution and consistency of the system. Daily calibration must be performed, and equipment quality control processes adhered to. It is important to have standard operating procedures to ensure consistency and quality and, additionally, strict infection control as highlighted during the COVID-19 pandemic.
Adequate spirometry relies on a competent, trained operator, accurate equipment, standardised operating procedures, quality control and patient co-operation. All manoeuvres must be performed strictly according to guidelines, and strict quality assurance methods should be in place, including acceptability criteria (for any given effort) and repeatability (between efforts).
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The Health Sector Development Plan 2015/16 - 2019/20 aims at accelerating movement towards Universal Health Coverage with essential health and related services needed for promotion of a healthy and productive life
The Virtual cGMP Training Marathon for Vaccine Manufacturing: Principles into Practice took place from 12 Sep to 10 Oct 2023 to continue to provide manufacturers & regulators with a comprehensive array of topics to build understanding of current WHO & international GMP standards, technological advan
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cements, industry practices and regulatory expectations specific to the vaccine manufacturing context. Some of the topics include computer system validation, data integrity, challenges in lyophilization and others. Real world examples and case studies will be used to show how to interpret current and recently new good manufacturing practices requirements from a practical point of view and to implement appropriate approaches.
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• provide scientific information on the safety, efficacy, and quality control/ quality assurance of widely used medicinal plants, in order to fac
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ilitate their appropriate use in Member States;
• provide models to assist Member States in developing their own mono- graphs or formularies for these or other herbal medicines; and
• facilitate information exchange among Member States.
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HIV testing programmes need to ensure that all clients who test for HIV are provided with correct diagnoses. The accuracy of HIV testing is critical to prevent misdiagnosis, as the consequences of giving an incorrect test result can be serious for clients, HIV testing services, HIV programmes and pu
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blic health.
With the evolution of global HIV epidemiology, HIV testing approaches must also evolve to maintain accuracy and efficiency in population-level diagnosis. Reports suggest that misdiagnosis of HIV status may occur when suboptimal testing algorithms and out-of-date testing strategies are used. As a result of changing epidemiology and declining HIV positivity in testing, WHO recommends all countries use a standard three-test strategy to ensure a PPV of at least 99%, minimizing false-positive misdiagnosis. The WHO-recommended HIV testing strategy, along with quality assurance measures such as retesting to verify a positive diagnosis prior to initiation of HIV treatment, is cost-effective as it prevents misdiagnosis and unnecessary initiation of costly lifelong treatment.
This implementation guide provides practical advice on switching to a three-test strategy and instituting other measures that can help national HIV programmes deliver high-quality, accurate HIV testing services and ensure that misdiagnosis is minimized.
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Thesis presented in partial fulfilment of the requirements for the degree of Master of Nursing Science in the Faculty of Health Sciences at Stellenbosch University.
The mobile clinic health care services fulfil an essential role in delivering primary health care to the dwellers in the rural commun
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ities of the Western Cape. However, occupational health and safety, as well as quality assurance are issues that need to be addressed urgently. It is thus recommended that policy makers take cognizance of the specific needs of every individual mobile clinic team.
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Medical devices are used for the prevention, diagnosis and treatment of illness and diseases and for rehabilitation. WHO developed guidance on medical device donation in 2011, which has been now reviewed, with new evidence, new references on considerations for medical device solicitation and provisi
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on, risks associated with inappropriate donations, the responsibilities of donors and recipient, and the steps they should follow before, during and after a donation. It includes three sections: description of major problems that may be faced during the donation process, listing of best practices for donors and recipients and addressing situations requiring special attention. It also has three annexes for further reading: the criteria for the acceptability of a donation, literature review on donations of medical devices between 2010 and 2023 and a flyer. This document is intended to improve the quality of medical devices donations, including medical equipment, single-use medical devices and in-vitro diagnostics, to provide maximum benefit to all stakeholders. The considerations can be used to develop institutional or national policies and regulations for medical devices donations. This document is intended for use by any organization, expert or practitioner involved in the donation, procurement, management of medical devices, including health workers, biomedical engineers, health managers, policymakers, donors, nongovernmental organizations and academic institutions.
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Annex 5, WHO Technical Report Series 1010, 2018
Reference Manual for Programme Managers on Accreditation Process
Session V: Regulatory & quality assurance aspects
Update on prequalification of ARVs and regional harmonisation of medicine registration
Deusdedit K. Mubangizi
Group Lead, Inspections, WHO-PQT
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E-mail: mubangizid@who.int
Acknowledgements:
• Matthias Stahl
• Milan Smid
• Antony Fake
• Jacqueline Sawyer
• Iveta Streipa
D-Building – UNAIDS
Kofi A. Annan Meeting Room
Wednesday, 9 March 2016 11:15 – 11:30
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This field guide is designed for use by FHI 360 staff and partner organizations responsible for ensuring quality clinical services, at both facility and non-facility levels. The guide provides general information on how to organize, implement and fo
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llow up on quality assurance/quality improvement clinical facility and service assessments.
The accompanying checklists are intended to be used with the clinical facility assessment guide.
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Through the USAID-funded Organized Network of Services for Everyone’s Health (ONSE) Activity, MSH is assisting Malawi’s National Malaria Control Program to provide high-quality malaria services at the facility and community levels in 10 district
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s, covering nearly a third of the country.
Our team in Malawi share recent results on strengthening malaria services through Outreach Training and Supportive Supervision (OTSS).
Designed to provide ongoing support to clinicians, data, and laboratory staff, OTSS combines a standardized checklist with targeted mentorship and supportive supervision to identify areas for improvement and strengthen clinical and diagnostic services in health facilities.
This webinar shares lessons learned on how the application of OTSS, as part of broader quality assurance systems, impacts staff performance and improves the provision and quality of malaria services.
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This policy document is to guide the Traditional, Complimentary and Alternative Medicine practices in Rwanda. The various elements examined under the policy include, legislation and regulatory control, registration, manufacture, procurement and supply management, rational use,
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quality assurance, co-ordination, monitoring and evaluation of Traditional, Complementary and Alternative Medicine practices.
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The document, "Sustainable Management of Radiotherapy Facilities and Equipment," by WHO and IAEA, provides guidelines for managing radiotherapy equipment and facilities to ensure effective and safe cancer treatment. It covers essential aspects like preventive and corrective maintenance, funding, inf
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rastructure, and staffing requirements for sustainable operation. The document aims to support radiotherapy departments, especially in low-resource settings, by outlining strategies for equipment procurement, maintenance, and replacement, emphasizing safety, quality assurance, and optimal patient care.
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This guidance addresses rationale, risk-based scenarios, practical considerations prior to adoption of the self-testing products, quality assurance, safety and ethical considerations, and data manag
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ement considerations for COVID-19 self-testing. The Africa CDC recommends the use of rapid antigen self-testing within two key scenarios. The first includes testing for case identification within scenarios with a high risk of infection, including symptomatic cases and contacts of a confirmed case. The second scenario involves general screening within scenarios of low or unknown risk exposure allowing for self-care such as before gatherings with at-risk individuals and prior to participation in events involving members of different households. Within these scenarios, a positive test result indicates likelihood of current infection, while a negative test result indicates a lower risk of active infection, though it does not rule out infection altogether. All positive cases should be managed following the national COVID-19 management protocol of Member States.ssur
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