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This report presents the recommendations of a WHO Expert Committee commissioned to coordinate activities leading to the adoption of international recommendations for the production and control of vaccines and other biological products used in medicine, and the establishment of international biological reference materials. Following a brief introduction, the report summarizes a number of issues brought to the attention of the Committee at its meeting held virtually in March 2024. Of particular relevance to manufacturers and national regulatory authorities are the discussions held on the development and adoption of new and revised WHO Recommendations, Guidelines and guidance documents. Following these discussions, the WHO document entitled Nonclinical and clinical evaluation of monoclonal antibodies and related products intended for the prevention or treatment of COVID-19 was adopted. Subsequent sections of the report provide information on the current status, proposed development and establishment of international reference materials in the areas of: biotherapeutics other than blood products; blood products and related substances; in vitro diagnostics; standards for use in high throughput sequencing technologies; and vaccines and related substances. A series of annexes is then presented which includes an updated list of all WHO Recommendations, Guidelines and other documents related to the manufacture, quality control and evaluation of biological products (Annex 1).
The Educational modules on clinical use of blood is to provide accessible learning materials that will assist prescribers of blood and other staff involved in clinical transfusion to make appropriate clinical decisions on transfusion and contribute to wider efforts to optimize clinical practice of transfusion. The target audience for this material includes medical staff and students across a range of clinical areas, nurses and midwives. It may also be useful for staff, including laboratory scientists or technicians who work in blood transfusion laboratories preparing or testing blood for transfusion, or managing inventories of blood products, or other settings where information about how blood is used may be relevant.
Much has been published on heart health, kidney health, and gut health. But how many of us are aware of our blood health? Is your blood as healthy as it should be? How would you even know? Blood Works is a fascinating new blood owners’ guide to help you care for the health of your most precious fluid—your blood. About 2 billion people globally are anemic, and almost as many suffer from iron deficiency without anemia. Many don’t even know they have it, just feeling tired, lethargic, and “foggy-headed.” Sound familiar? Over 600 million more suffer from acute or sometimes unrecognized chronic blood loss from causes such as heavy menstrual bleeding, obstetric hemorrhage, gastrointestinal bleeding, surgery, and trauma. Anemia, iron deficiency, and bleeding are signs of “blood failure” and have major negative health effects. Blood Works, with contributions from 48 leading international medical experts, is a must have book for all who want to look after their blood health. Your blood is the essential fluid that keeps you alive. Yet, while many of us know our cholesterol level and blood pressure, few of us are aware of our blood count. What we don’t know can affect our everyday quality of life and put us at risk if we have bleeding, an injury, or require hospitalization. Blood, and the vessels that contain it, make up the largest organ system in the body. Its balance and health must be maintained. For many decades, the treatment of first resort for anemia and blood loss has been blood transfusion, which is essentially a “liquid organ” transplant from another person. In heart failure or kidney failure, organ transplantation is not first-line treatment. In blood failure, blood “transplantation” should not be the first thing we reach for. Since the 1990s, scientific research has shown that the common use of blood transfusion is not the most effective treatment in many medical situations. It has been identified as one of the most overused treatments in modern medicine, costing billions of dollars, while causing changes in the recipient’s immune system that may increase the risk of complications and death. In October 2021, the World Health Organization called for the urgent global implementation of Patient Blood Management (PBM), stating “our own blood is still the best thing to have in our veins.” Blood Works is one of the most exciting books on blood health you will read. The book zooms in on why medical experts from around the world now recognize the need for fundamental change in the way a patient’s blood is managed. Known as PBM, Patient Blood Management places the person receiving treatment at the center of decisions involving their lifeblood. Its aim is to improve general health and treatment outcomes by managing and preserving a patient’s own blood while empowering them to share in making decisions. Meticulously researched and referenced, masterfully illustrated, and featuring personal stories from patients and their families, Blood Works is a compelling read. It will have a profound impact on your health and the health of your loved ones and is an invaluable resource for health care professionals.
This guidance document has been produced by the World Health Organization (WHO) to assist blood services in the development of national plans to respond to any disaster, major incident or emergency that threatens sufficiency or safety of the blood supply. Such situations can be caused by natural forces, by factors influenced by humans or directly caused by humans. This document is intended to guide the national blood service through the process of planning how to respond in a timely, controlled and appropriate way to emergencies. In the preparation of the document, WHO has tried to include the elements that blood services or providers might need to consider, providing some background on the reasons for their inclusion and guidance on different response options that may be available. The consequences of an emergency may include interruption of blood supply due to a shortage of blood donors, or to a disrupted supply of critical materials and equipment used in blood collection, component preparation and laboratory testing, resulting in reduced availability of blood and blood components. Although the demand for transfusion may decrease in some situations, transfusions continue to be necessary for clinical emergencies and for those patients reliant on long-term transfusion support. In contrast, some emergencies, for instance those resulting in multiple casualties, could lead to a rapid surge in demand for blood over a short time. The challenge is to maintain essential transfusion services as well as responding to the emergency. Preparedness, including business continuity planning, is essential for blood services to mitigate the impact of emergencies. Preparation should be underpinned by locally sensitive risk assessment using relevant data at the local or country level. However, it is not possible to predict the nature of every situation that could impact on the blood supply, and it is therefore expected that blood services will review the elements in this document as well as assessing their own situation, needs, capabilities and resources, along with any additional relevant country-specific factors, in the development of their own response plans. Planning should consider the concurrence and combinations of events and the response should be proportionate and coordinated with others. The aim is to maintain critical services and prepare for recovery. Staff training and support is key to resilience. It is acknowledged that as well as affecting the sufficiency and safety of blood supply, major incidents in countries undertaking transplantation may threaten the safety and sufficiency of the supply of other products of human origin, such as cells, tissues and organs. Increasingly, blood services are taking overall national responsibility for transplantation in their capacity as the organization responsible for the collection, processing, storage and supply of cells, tissues and organs. This approach is both sensible and appropriate, as the overall donor selection and screening processes are the same or very similar. This guidance document can therefore also be used to assist those bodies responsible for the provision of cells, tissues and organs to prepare for emergencies. Resilience to disasters and emergencies requires a commitment to the blood supply and transfusion system as an integral part of the health care system.