[Control of potential risk in blood establishments in Brazil: a strategy for regulating authorities]. / Controle de riscos potenciais em serviços de hemoterapia no Brasil: uma abordagem para autoridades reguladoras.

Objective To describe the sanitary status of Brazilian blood establishments (BE) assessed by the national health surveillance system in 2013. Method In the present descriptive study, the sanitary profile of BE was assessed using the Blood Establishment Potential Risk Assessment Method (Método de Avaliação de Risco Potencial de Serviços de Hemoterapia, MARPSH), developed by the National Sanitary Surveillance Agency (Anvisa). The MARPSH involves the evaluation of 471 structure and process items to produce an assessment of potential risk associated with critical control points in the blood cycle (vein-to-vein). Based on this assessment, BE are classified into five risk categories: low, medium-low, medium, medium-high, and high. The results were analyzed regarding the type of service (considering all levels, from coordinating centers to collection units), type of financing (public/private) and geographic region. Results Of the existing BE, 1 212 (60%) were assessed in 2013. Of these, 81% met ≥ 70% of the sanitary requirements (satisfactory status, corresponding to medium, medium-low, and low risk categories). Transfusion agencies (hospital units with the role of storing, running compatibility tests between donors and recipients, and transfusing blood components) and public establishments had the highest number of non-conformity structure and process items. Conclusion The use of the MARPSH facilitated the assessment of BE in Brazil and revealed objective opportunities for improvement. These gaps should be addressed by regulating authorities, especially in public services.

Transfusion-related acute lung injury (TRALI): A Canadian blood services research and development symposium.

Since the first description of transfusion-related acute lung injury (TRALI) more than 2 decades ago, we have only recently begun to learn how this disorder may occur and how to prevent it. Scientists from around the world have made great strides in identifying the possible causes of this condition. Blood banks and transfusion services have risen to the challenges of prevention. Recent introduction of restricting most plasma products to those obtained from male donors only has greatly reduced the incidence of TRALI worldwide. Scientists have recently identified the gene and protein for the human neutrophil antigen-3a associated with most mortality due to TRALI, and this presents an opportunity for a screening assay to prevent future TRALI-associated deaths. Finally, animal models of TRALI have provided insight into the possible mechanisms of this disorder and can be used to explore potential treatment modalities.

Blood conservation strategies in major orthopaedic surgery: efficacy, safety and European regulations.

Several major orthopaedic surgical procedures may result in significant blood loss and the need for allogeneic blood transfusion (ABT). However, overall concerns about adverse effects of ABT have prompted the review of transfusion practice and the search for transfusion alternatives to decrease or avoid the use of ABT. These strategies include the correction of perioperative anaemia, pharmacological and non-pharmacologic measures to reduce blood loss, preoperative autologous blood donation and perioperative red blood cell salvage. We have reviewed the efficacy and safety of these strategies and where appropriate offer evidence-based recommendations on their use in orthopaedic surgery. We also reviewed the European regulations on ABT alternatives. Pharmacological alternatives need to be used with a total adherence to European regulations in their legal and off-label use. The administration and use of pharmacological agents to stimulate erythropoiesis or reduce blood loss needs to be within the context of attempting to use allogenic blood in a rational manner. As for autologous blood, European Directives cover preoperative autologous blood donation, but not its clinical use, and perioperative red blood cell salvage devices, but not the product yielded by them. Therefore, the development of quality standards and good practice guidelines for perioperative red blood cell salvage, as well as its inclusion in the haemovigilance programme, is urgently needed. Finally, it is noteworthy that some recommendations given for ABT alternatives are not supported by a high level of evidence and that the goal of performing major orthopaedic surgical procedures without the use of ABT may be better accomplished by combining several of these techniques within a defined algorithm.

Potential impact of AUSFTA on Australia's blood supply.

Australia is largely self-sufficient in its supply of safe, fresh blood products because of the goodwill of non-remunerated, volunteer donors, plus rigorous testing and processing standards. CSL Limited is the sole provider of plasma fractionation services in Australia, enjoying exclusive rights under the Plasma Fractionation Agreement with the Australian Government. In the Australia-United States Free Trade Agreement (AUSFTA), Australia agreed to review its current contract with CSL Limited, and to recommend to the states and territories that the process be opened up to overseas tender. Overseas tenders for off-shore fractionation services are likely to be highly competitive due to their low manufacturing costs and accumulated expertise. Off-shore fractionation could compromise the safety of Australia's blood supply through delays in processing and transportation, issues related to quality control, and even the siphoning of stock to overseas markets. This could compromise the long-term care of Australian patients and create a serious national security risk in the event of a terrorist attack or natural disaster. Australia's AUSFTA obligation to recommend changes does not equate to an obligation to actually proceed. The states and territories should carefully consider whether such changes would be in our national interest. The long-term security of the Australian people in the current security environment is dependent on continuance of an on-shore fractionation plant and appropriate back-up facilities.

Using a technological community framework to manage new medical technologies. The case of umbilical cord blood (UCB) banking.

A technological community framework can be used to explain and manage new medical technologies. It describes emergence, commercialization, and standardization of an innovation or technology within the context of its whole network (or community) of stakeholders. This framework is used to illustrate the emergence, commercialization, and standardization of a relatively new medical technology--umbilical cord blood (UCB) banking. Umbilical cord blood may prove to be a source of stem cells for bone marrow transplant that is safer, more accessible, and less expensive than current sources of stem cells. The technological community framework can signal potential problems as the technology emerges, and help healthcare delivery systems and providers to effectively assess and manage the technology. The framework can also be applied to other medical technologies and innovations.

[Preoperative autologous blood donation and disposition. Possibilities and prerequisites]. / Präoperative Eigenblutspende und-bereitstellung. Möglichkeiten und Voraussetzungen.

Preoperative blood deposit can help to avoid the risks of homologous blood transfusions. However, it is necessary that prerequisites concerning medicine standard, organisation, technical questions and administrative aspects have to be fulfilled.

I Congreso iberoamericano de bancos de sangre y medicina transfusional. Memoria / I Iberoamerican congress of banks of blood and transfussional medicine. Memory

La presente memoria del "I Congreso Iberoamericano de Bancos de Sangre y Medicina Transfusional" es el resultado del esfuezo que realiza la Secretaría de Salud, a través del Centro Nacional de la Transfusión Sanguínea y de los Centros Estatales de la Transfusión Sanguínea, en la revisión, actualización y difusión de las acciones desarrolladas y de los conocimientos obtenidos en la captación, manejo y uso de la sangre. Esta memoria condensa, por un lado, los principales logros alcanzados por los Centros Nacional y Estatales de la Transfusión Sanguínea durante 1990 en lo tocante a captación y análisis y transfusión de sangre, y, por otro, recopila varios trabajos de investigación, relativos a la sangre y la transfusión sanguínea, agrupados bajo los siguientes temas: enfermedades infecciosas transmisibles por vía sanguínea, medicina transfusional, inmuno hematología, feresis, autotransfusión, estudios en donadores, factor VIII-hemofilia, anemias por deficiencia de hierro y enfermedad de chagas

[Duties and responsibilities of hospital services in reference to autotransfusion practice as provided by the May 4, 1990 law No. 107]. / Compiti e responsabilità dei servizi ospedalieri in riferimento alla pratica autotrasfusionale prevista dalla legge 4 maggio 1990, n. 107.

The Authors report the aims of the law 4/5/90 n. 107, as regards to the "diffusion" of autotransfusion practices, pointing out the responsibilities of hospital services named by the law. These services are immunohematology and transfusion services, sanitary directions, surgery divisions and anesthesiology services, with reference to articles 5,6 and 16. Finally, they point the forensic medical problems concerning the possibility of an homologous use of predeposited blood.