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In recent decades, considerable advances have been made in assuring the safety of blood transfusion and organ transplantation. However, with the increasing movement of medical products of human origin across international boundaries, there is a need to enhance global norms and governance. These products, which include blood, organs, tissues, cells, human milk and faecal microbiota, are today crucial for health care but they also pose unique risks due to their human origin, such as disease transmission and graft failure. Moreover, the demand for medical products of human origin often exceeds supply, leading to dependence on international supply chains, and emerging technologies like cell and gene therapy present further challenges because of their unproven efficacy and long-term risks. Current regulatory mechanisms, especially in low- and middle-income countries, are insufficient. The World Health Organization (WHO) has both the mandate and experience to lead the development of international quality and safety standards, consistent product nomenclature, and robust traceability and biovigilance systems. An international, multistakeholder approach is critical for addressing the complexities of how medical products of human origin are used globally and for ensuring their safety. This approach will require promoting uniform product descriptions, enhancing digital communication systems and leveraging existing resources to support countries in establishing regulations for these products. As illustrated by World Health Assembly resolution WHA77.4 on transplantation in 2024, WHO's ongoing efforts to ensure the safe, efficient and ethical use of medical products of human origin worldwide provide the opportunity to galvanize international cooperation on establishing norms. [phrase omitted] Au cours des dernieres decennies, des progres considerables ont ete realises pour assurer la securite des transfusions sanguines et des transplantations d'organes. Cependant, avec l'augmentation de la circulation de produits medicaux d'origine humaine par-dela les frontieres internationales, il est imperatif de renforcer la gouvernance et les normes mondiales. Ces produits, parmi lesquels figurent le sang, les organes, les tissus, les cellules, le lait maternel et le microbiote fecal, sont aujourd'hui essentiels pour les soins de sante. Mais ils comportent egalement des risques particuliers en raison de leur origine humaine, comme la transmission de maladies et le rejet de greffe. En outre, la demande en produits medicaux d'origine humaine depasse souvent l'offre, ce qui engendre une dependance vis-a-vis des chaines d'approvisionnement internationales, tandis que des technologies emergentes telles que la therapie cellulaire et genique posent de nouveaux defis en raison de leur efficacite non demontree et des risques a long terme. Les mecanismes de reglementation actuels sont insuffisants, surtout dans les pays a revenu faible et intermediaire. LOrganisation mondiale de la Sante (OMS) possede a la fois le mandat et l'experience necessaires pour mener le developpement de normes internationales de qualite et de securite, d'une nomenclature coherente des produits, ainsi que de systemes de tracabilite et de biovigilance solides. Une approche internationale et multilaterale est cruciale pour gerer la complexite liee a l'utilisation de produits medicaux d'origine humaine dans le monde et garantir leur innocuite. Cette approche devra prevoir la mise en place de descriptions de produits uniformes, l'amelioration des systemes de communication numeriques et l'exploitation des ressources existantes afin d'aider les pays a definir des regles pour de tels produits. Comme l'illustre la resolution WHA77.4 de l'Assemblee mondiale de la Sante sur la transplantation, emise en 2024, les efforts constants de l'OMS visant a assurer la securite, l'efficacite et l'usage ethique des produits medicaux d'origine humaine a travers le monde represente l'occasion de stimuler la cooperation internationale en matiere d'etablissement des normes. [phrase omitted] En las ultimas decadas, se han realizado avances considerables para garantizar la seguridad de las transfusiones de sangre y los trasplantes de organos. Sin embargo, con el creciente movimiento de productos medicos de origen humano a traves de las fronteras internacionales, es necesario reforzar las normas y la gobernanza mundiales. Estos productos, que incluyen sangre, organos, tejidos, celulas, leche humana y microbiota fecal, son hoy cruciales para la asistencia sanitaria, pero tambien plantean riesgos unicos por su origen humano, como la transmision de enfermedades y el fracaso de los injertos. Ademas, la demanda de productos medicos de origen humano suele ser superior a la oferta, lo que hace depender de las cadenas de suministro internacionales, y las tecnologias emergentes, como la terapia celular y genetica, plantean nuevos desafios debido a su eficacia no demostrada y a sus riesgos a largo plazo. Los mecanismos reguladores actuales, en especial en los paises de ingresos bajos y medios, son insuficientes. La Organizacion Mundial de la Salud (OMS) tiene tanto el mandato como la experiencia para liderar el desarrollo de estandares internacionales de calidad y seguridad, nomenclatura coherente de productos y sistemas solidos de trazabilidad y biovigilancia. Para responder a la complejidad del uso global de los productos medicos de origen humano y garantizar su seguridad, es fundamental un enfoque internacional que incluya a todas las partes interesadas. Este enfoque requerira promover descripciones uniformes de los productos, reforzar los sistemas de comunicacion digital y aprovechar los recursos existentes con el fin de ayudar a los paises a establecer normativas para estos productos. Como se ilustra en la resolucion WHA77.4 de la Asamblea Mundial de la Salud sobre trasplantes en 2024, los esfuerzos en curso de la OMS para asegurar el uso seguro, eficiente y etico de los productos medicos de origen humano en todo el mundo brindan la oportunidad de impulsar la cooperacion internacional en el establecimiento de normas., Introduction In recent decades, substantial progress has been made in assuring the safety of blood transfusion and the transplantation of medical products of human origin, which are also referred to [...]

Catheter-associated infections may not be prevented by routine replacement of central vascular catheters every three days. Central vascular catheters are used in critically ill patients to administer fluids, nutrition and drugs. Among 160 patients who were catheterized for more than three days, 35 underwent catheter replacement at a new site every three days, 40 underwent guide wire-assisted catheter exchange at the same site every three days, 41 underwent catheter replacement at a new site only when necessary and 44 underwent guide wire-assisted catheter exchange only when necessary. Patients in all four groups had similar rates of bloodstream infection and bacterial colonization of the catheter. However, those who underwent catheter replacement at a new site were more likely to experience mechanical complications.

Medical products of human origin (MPHO) include blood, organs, bone marrow, cord blood, corneas, tissues, reproductive cells and milk derived from humans for therapeutic use. These materials, obtained from people [...]