Applying radio-frequency identification (RFID) technology in transfusion medicine

ISO/IEC 18000-3 mode 1 standard 13.56 MHz RFID tags have been accepted by the International Society for Blood Transfusion (ISBT) and the United States Food and Drug Administration (FDA) as data carriers to integrate with and augment ISBT 128 barcode data carried on blood products. The use of 13.56 MHz RFID carrying ISBT 128 data structures allows the global deployment and use of RFID, supporting both international transfer of blood and international disaster relief. The deployment in process at the BloodCenter of Wisconsin and testing at the University of Iowa Health Center is the first FDA-permitted implementation of RFID throughout in all phases of blood banking, donation through transfusion. RFID technology and equipment selection will be discussed along with FDA-required RF safety testing; integration with the blood enterprise computing system and required RFID tag performance. Tag design and survivability is an issue due to blood bag centrifugation and irradiation. Deployment issues will be discussed. Use of RFID results in significant return on investment over the use of barcodes in the blood center operations through labor savings and error reduction.     

Coding and traceability for cells,tissues and organs for transplantation

Modern transplantation of cells, tissues and organs has been practiced within the last century achieving both life saving and enhancing results. Associated risks have been recognized including infectious disease transmission, malignancy, immune mediated disease and graft failure. This has resulted in establishment of government regulation, professional standard setting and establishment of vigilance and surveillance systems for early detection and prevention and to improve patient safety. The increased transportation of grafts across national boundaries has made traceability difficult and sometimes impossible. Experience during the first Gulf War with miss-identification of blood units coming from multiple countries without standardized coding and labeling has led international organizations to develop standardized nomenclature and coding for blood. Following this example, cell therapy and tissue transplant practitioners have also moved to standardization of coding systems. Establishment of an international coding system has progressed rapidly and implementation for blood has demonstrated multiple advantages. WHO has held two global consultations on human cells and tissues for transplantation, which recognized the global circulation of cells and tissues and growing commercialization and the need for means of coding to identify tissues and cells used in transplantation, are essential for full traceability. There is currently a wide diversity in the identification and coding of tissue and cell products. For tissues, with a few exceptions, product terminology has not been standardized even at the national level. Progress has been made in blood and cell therapies with a slow and steady trend towards implementation of the international code ISBT 128. Across all fields, there are now 3,700 licensed facilities in 66 countries. Efforts are necessary to encourage the introduction of a standardized international coding system for donation identification numbers, such as ISBT 128, for all donated biologic products.     

Standardization of cellular therapy terminology,coding and labeling: a review

The 1990s saw rapid growth in international activity in hematopoietic cell transplantation. As national donor registries were established and international collaboration increased, a need to transfer cellular therapy products across national borders emerged. A lack of international standards for identification, terminology and labeling resulted in significant challenges for import and export. Twenty years of effort by a large group of experts supported by professional societies and accreditation bodies has today achieved a high degree of standardization. This review highlights the main landmarks in this journey and serves as a reminder of the importance of taking the “long view” when working toward international standardization. It demonstrates the need for continual maintenance and enhancement of standards to meet the changing needs of the cell therapy industry and highlights recent developments in ISBT 128.     

ISBT 128 coding and labeling for cellular therapy products

This paper describes the development of the ISBT 128 coding and labeling for cellular therapy products. It is published on behalf of the international Cellular Therapy Coding and Labeling Advisory Group (see )     

Barriers and enablers to introducing comprehensive patient blood management in the hospital

Patient Blood Management (PBM) is a patient-focused multidisciplinary and comprehensive concept that is designed to ensure the optimal, appropriate and safe use of blood and blood products, resulting in better outcome and safety for the recipients. The World Health Organization, in May 2010, adopted a resolution in favour of PBM, on the availability, safety and quality of blood products and their safe and rational use. However, several factors may enhance or hamper this process including health care personnel, available techniques and technologies, devices, standards, guidelines and documentation, quality systems as well as coordination, monitoring and evaluation. The implications in developing countries may have other peculiarities.     

Bioethics for clinicians: 16. Dealing with demands for inappropriate treatment

Demands by Patients or their Families for treatment thought to be inappropriate by health care providers constitute an important set of moral problems in clinical practice. A variety of approaches to such cases have been described in the literature, including medical futility, standard of care and negotiation. Medical futility fails because it confounds morally distinct cases: demand for an ineffective treatment and demand for an effective treatment that supports a controversial end (e.g., permanent unconsciousness). Medical futility is not necessary in the first case and is harmful in the second. Ineffective treatment falls outside the standard of care, and thus health care workers have no obligation to provide it. Demands for treatment that supports controversial ends are difficult cases best addressed through open communication, negotiation and the use of conflict-resolution techniques. Institutions should ensure that fair and unambiguous procedures for dealing with such cases are laid out in policy statements.     

The safety net of the safety net: how federally qualified health centers "subsidize" Medicaid managed care

In this article, I examine the impact of neoliberalism and welfare reform on the delivery of Medicaid, specifically how the advent of Medicaid managed care (MMC) has been wrought with contradictions, placing increased burdens on primary safety-net organizations and impacting the many communities they serve. I argue that federally qualified health centers (FQHCs) operate as a primary safety net among safety-net providers, supporting and subsidizing New Mexico's MMC program financially and administratively. By presenting ethnographic data, I will demonstrate how FQHCs pay many of the hidden financial and institutional costs of the shift to managed care. Such findings uncover paradoxes inherent to neoliberal ideologies and privatization, raising questions about the efficacy of a managed care system for Medicaid as well as the future of the health care safety net and access to health care for the diverse populations it serves.     

Major Concerns in Developing Countries: Applications of the Precautionary Principle in Ecuador

Ecuador is a Latin American country with one of the biggest biodiversities. At the same time, social and environmental problems are also big. Poverty, political and social problems as well as questions like old transport systems, imported hazards from industrialized countries and lack of information and weak health care systems are the framework of this situation. The most common problems are the use of heavy metals in many activities without safety and health protection, a low technological oil production during two decades, intensive use of pesticides in agriculture, and some other chemical risks. A limited capacity to develop prevention strategies, reduced technical and scientific skills, and the absence of a reliable information and control system, lead to a weak response mechanism. The Precautionary Principle could help to stimulate prevention, protection and to have a new tool to improve the interest in environment and health problems. Reinforcing the presence of international organizations like WHO and ILO, establishing bridges among scientific organizations from developed and developing countries and introducing the Precautionary Principle in the legislation and daily practices of industry and agriculture could lead to an improvement in our environment and health.     

Identified and unidentified challenges for reproductive biotechnologies regarding infectious diseases in animal and public health.

The aim of the present paper is to review the known and theoretical risks for in vivo derived and in vitro produced embryos as well as for nuclear transferred or transgenic embryos in terms of animal diseases or diseases of public health consequence. For in vivo derived embryos, a considerable number of experiments and scientific investigations have resulted in recommended guidelines and procedures that ensure a high level of safety. The effectiveness of these measures has been validated by field experience with the safe transfer of several million embryos over the past three decades. In vitro produced embryos have several characteristics that differentiate them from the former, in particular a structure of the zona pellucida that results in a more frequent possible association of pathogens with the embryo. However, the guidelines prescribed by the IETS, the international standard setting body (OIE) and existing national regulatory frameworks are in place to minimize the risk of disease transmission. No specific public health risks have been identified to date with respect to in vivo or in vitro derived embryos. In regard to nuclear transferred and transgenic embryos, theoretical risks have been identified in relation to the potential effects on some intrinsic viruses such as endogenous retroviruses but very little targeted experimental work has been carried out on infectious diseases that could have adverse consequences on animal or human health. Although there has been no report of such adverse consequences associated with the limited number of animals produced to date by such reproductive technologies, a precautionary approach is warranted given the potential negative impacts and it would be prudent to restrict at this stage, the international movement of such "manipulated" embryos.     

The Need for Continuing Medical Education

Continuing medical education is an essential feature of the practice of modern medicine since it furnishes the means to maintain the doctor''s ability to provide quality patient care.To ensure that continuing medical education is provided efficiently and in the best quality, and utilized fully, it is necessary that: (1) the medical faculty inculcate in the student the concept of lifelong learning; (2) the practitioner adopt less time-consuming patterns of practice, to free more of his time for learning; (3) community hospital-based clinical teaching be provided universally; and (4) research be conducted to determine the best of current teaching methods and develop better ones. Conflicting efforts to meet these needs by practitioners (whose primary responsibility it is) and by organized medicine, specialty societies, voluntary health agencies and others have led to inefficient use of medical faculty teachers. The key parties in continuing medical education—practitioner and teacher—can learn best in medical school-administered programs, which need be supported by all other interested organizations.     

Donor vigilance: What are we doing about it?

Donor vigilance is the systematic monitoring of adverse reactions and incidents in blood donor care with a view to improving quality and safety for blood donors. Standard international definitions are available for surveillance purposes. In recent years advances have been made in determining risk factors for vasovagal and other adverse reactions to blood donation as well as in evaluating preventive measures. Blood establishments should record all adverse reactions in blood donors. Besides its use for individual donor care, this information can be reviewed within and between organisations to guide policy decisions and research for improving donor care.     

Transforming the Safety Net: Responses to Medicaid Managed Care in, Rural and Urban New Mexico

In this article we examine the impact of Medicaid managed care on safety net organizations in New Mexico and their ability to maintain their traditional mission of charity care. We address two particular areas of concern that have arisen in the literature on Medicaid managed care. First, analysts have debated under what circumstances safety net organizations are better positioned to survive under market competition without abandoning their social orientation. Second, analysts have suggested that populations in rural areas may be more disadvantaged under Medicaid managed care due to its intensification of already-existent barriers to access. By comparing the differential ability of safety net organizations in rural and urban New Mexico to buffer their patients from potentially harmful effects of Medicaid managed care, we identify factors that place these safety nets particularly at risk. We find that a rural location, lack of affiliation with a larger organization, and lack of recourse to charitable funding are "risk factors" determining who sinks—and who floats—in this new competitive health care system, [privatization of health care, Medicaid safety net organizations, managed care, resistance, ruralurban]     

Report of the FELASA Working Group on evaluation of quality systems for animal units

This report compares and considers the merits of existing, internationally available quality management systems suitable for implementation in experimental animal facilities. These are: the Good Laboratory Practice Guidelines, ISO 9000:2000 (International Organization for Standardization) and AAALAC International (Association for Assessment and Accreditation of Laboratory Animal Care International). Good laboratory practice (GLP) is a legal requirement for institutions undertaking non-clinical health and environmental studies for the purpose of registering or licensing for use and which have to be 'GLP-compliant'. GLP guidelines are often only relevant for and obtainable by those institutions. ISO is primarily an external business standard, which provides a management tool to master and optimize a business activity; it aims to implement and enhance 'customer satisfaction'. AAALAC is primarily a peer-reviewed system of accreditation which evaluates the organization and procedures in programmes of animal care and use to ensure the appropriate use of animals, safeguard animal well-being (ensuring state-of-the-art housing, management, procedural techniques, etc.) as well as the management of health and safety of staff. Management needs to determine, on the basis of a facility's specific goals, whether benefits would arise from the introduction of a quality system and, if so, which system is most appropriate. The successful introduction of a quality system confers peer-recognition against an independent standard, thereby providing assurance of standards of animal care and use, improving the quality of animal studies, and contributing to the three Rs-reduction, refinement and replacement.     

Chemical safety in animal care,use, and research

Chemical safety is an essential element of an effective occupational health and safety program. Controlling exposures to chemical agents requires a careful process of hazard recognition, risk assessment, development of control measures, communication of the risks and control measures, and training to ensure that the indicated controls will be utilized. Managing chemical safety in animal care and use presents a unique challenge, in part because research is frequently conducted in two very different environments--the research laboratory and the animal care facility. The chemical agents specific to each of these environments are typically well understood by the employees working there; however, the extent of understanding may not be adequate when these individuals, or chemicals, cross over into the other environment. In addition, many chemicals utilized in animal research are not typically used in the research laboratory, and therefore the level of employee knowledge and proficiency may be less compared with more routinely used materials. Finally, the research protocol may involve the exposure of laboratory animals to either toxic chemicals or chemicals with unknown hazards. Such animal protocols require careful review to minimize the potential for unanticipated exposures of the research staff or animal care personnel. Numerous guidelines and regulations are cited, which define the standard of practice for the safe use of chemicals. Key chemical safety issues relevant to personnel involved in the care and use of research animals are discussed.     

Perceptions of Health Communication,Water Treatment and Sanitation in Artibonite Department,Haiti, March-April 2012

The international response to Haiti’s ongoing cholera outbreak has been multifaceted, including health education efforts by community health workers and the distribution of free water treatment products. Artibonite Department was the first region affected by the outbreak. Numerous organizations have been involved in cholera response efforts in Haiti with many focusing on efforts to improve water, sanitation, and hygiene (WASH). Multiple types of water treatment products have been distributed, creating the potential for confusion over correct dosage and water treatment methods. We utilized qualitative methods in Artibonite to determine the population’s response to WASH messages, use and acceptability of water treatment products, and water treatment and sanitation knowledge, attitudes and practices at the household level. We conducted eighteen focus group discussions (FGDs): 17 FGDs were held with community members (nine among females, eight among males); one FGD was held with community health workers. Health messages related to WASH were well-retained, with reported improvements in hand-washing. Community health workers were identified as valued sources of health information. Most participants noted a paucity of water-treatment products. Sanitation, specifically the construction of latrines, was the most commonly identified need. Lack of funds was the primary reason given for not constructing a latrine. The construction and maintenance of potable water and sanitation services is needed to ensure a sustainable change.     

Balancing competing interests and obligations in mental health‐care practice and policy

It is often challenging for mental health‐care providers and health organizations to perform their various roles and to meet their varied obligations. In complex mental health‐care circumstances the concurrent application of relevant ethical principles and values often leads to the emergence of completing obligations that need to be carefully weighed and balanced in the making of care‐related decisions. Although some clinical circumstances, such as those potentially triggering the duty to warn, are adequately guided by existing rules based on legal precedents, there is a gap in decision‐making support in other mental health‐care domains. This article proposes that a set of targeted, decision‐making approaches be developed to assist in the handling of specific, challenging circumstances. By way of illustration, two novel approaches are introduced; that is, choosing to work within a moral relational space of optimal therapeutic engagement (at the micro level of clinical practice), and the use of a health policy development approach that instantiates deliberative engagement (at the meso and macro levels of health organization).     

Negative-pressure wound therapy in the military: lessons learned

The utilization of negative pressure for medicinal purposes dates back to 600 bc. The U.S. military has been engaged in continuous overseas combat operations since 2001. Negative-pressure wound therapy has been in use in the treatment of casualties from these operations since 2004. It represents a new standard of practice in combat wound care; it promotes granulation tissue formation and creates mechanical forces supporting wound contraction, facilitating definitive wound closure. This article describes (1) the use of negative-pressure wound therapy in combat casualty care, (2) inherent challenges of its use in theater of operations and across the echelons of care, (3) modifications of this wound therapy to meet military-specific needs, and (4) future directions with this novel wound care modality.     

Nitrogen Dioxide Sterilization in Low-Resource Environments: A Feasibility Study

Access to sterilization is a critical need for global healthcare, as it is one of the prerequisites for safe surgical care. Lack of sterilization capability has driven up healthcare infection rates as well as limited access to healthcare, especially in low-resource environments. Sterilization technology has for the most part been static and none of the established sterilization methods has been so far successfully adapted for use in low-resource environments on a large scale. It is evident that healthcare facilities in low-resource settings require reliable, deployable, durable, affordable, easily operable sterilization equipment that can operate independently of scarce resources. Recently commercialized nitrogen dioxide (NO₂) sterilization technology was analyzed and adapted into a form factor suitable for use in low-resource environments. Lab testing was conducted in microbiological testing facilities simulating low-resource environments and in accordance with the requirements of the international sterilization standard ANSI/AAMI/ISO 14937 to assess effectiveness of the device and process. The feasibility of a portable sterilizer based on nitrogen dioxide has been demonstrated, showing that sterilization of medical instruments can occur in a form factor suitable for use in low-resource environments. If developed and deployed, NO₂ sterilization technology will have the twin benefits of reducing healthcare acquired infections and limiting a major constraint for access to surgical care on a global scale. Additional benefits are achieved in reducing costs and biohazard waste generated by current health care initiatives that rely primarily on disposable kits, increasing the effectiveness and outreach of these initiatives.     

Therapeutic bacteriophages as a rescue treatment for drug-resistant infections – an in vivo studies overview

Bacteriophages, highly prevalent in all environments, have found their use in medicine as an alternative or complement to antibiotics. The therapeutic use of bacteriophages was particularly popular in the 1920s and 1930s, until the discovery and introduction of antibiotics. Due to the dynamic growth of antibiotic resistance among bacterial strains, numerous international institutions (such as the FDA) have declared the search for novel treatment modalities to be of the highest priority. To date, bacteriophage therapy has not been registered for general use in Western countries. The regulation of biological medicinal products (within medicinal product regulation) does not contain a specific documentation frame for bacteriophages (only for vaccines, blood derived products, etc.) which, as active substances, need to meet specific requirements. Recently, the FDA allowed bacteriophage therapy to be used in the United States, via the Emergency Investigational New Drug scheme; clinical trials to compare the safety and efficacy of bacteriophage therapy are also permitted. To date, several therapeutic products of this type have made it to phase I or II; some clinical programmes have also been completed. This article cites numerous animal model studies and registered clinical trials, showing the safety and effectiveness of bacteriophage therapy, including infections caused by bacterial strains resistant to antibiotic treatment.     

Making the health care system 'safe' for persons with HIV infection or AIDS.

If health care reform is implemented in states and nationally, the safety of this process needs to be examined for persons with human immunodeficiency virus (HIV) infection or the acquired immunodeficiency syndrome (AIDS). Reform should assure ongoing prevention and transmission control of HIV and continuous coverage of medical costs for persons ill with HIV or AIDS. These persons currently benefit from various state and federal categoric programs designed to assure access to preventive and personal care services. Washington State has passed health care reform legislation that envisions integrating these programs to provide a system of population-based and personal health care. This legislation was analyzed using existing epidemiologic and entitlement information about persons with HIV infection or AIDS in the state to assess its effect. The relationship between public health and personal care services will be a central concern for those with HIV infection or AIDS, and complete coverage of this group may be achieved relatively late in the process of implementing health care reform. Health personnel planning under health care reform will affect the delivery of HIV- and AIDS-related services. Including treatment of AIDS in the basic benefit package merits particular attention. These issues parallel those being faced by the nation as a whole as it seeks to ensure epidemic disease control and compassionate care for long-term disabling illness if health care reform is implemented.