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INTRODUCTION: D- Dimer levels from peripheral blood are increasingly used to assess various pathological conditions. Initially, an area for hematologists, now this analyte is evaluated more extensively from many specialties of medicine. Covid-19 infection has not only added a new dimension to D-Dimer level assessment in this disease but has also shed newer lights to the underlying pathophysiological mechanisms for its elevation in this disease. AREAS COVERED: Innate variability in measuring D- Dimer levels, Impact of various techniques in measuring D- Dimer, nonavailability of uniform controls and standards, molecular heterogeneity of the product, how it is produced. Reasons for raised D- Dimer in covid-19 infection. D- Dimer in other pathological states. Articles with relevant key words from 1990 searched in PubMed were utilized for review. EXPERT OPINION: : D-Dimer has important application in diagnosis, prognosis, management, and understanding various conditions. Its level can rise with increased coagulability of blood, sepsis, cytokine storm, snake bite, etc. Renal function, age influences its reference ranges. Units of measurement, its expression varies in different reports needing international standardization. In Covid-19 infection its levels correlate with stage of the disease, pathology, and complications.

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Magnetic resonance imaging (MRI) has become the gold standard for the diagnosis of many pathologies. Using MRI in patients with auditory implants can however raise concerns due to mutual interactions between the implant and imaging device, resulting in potential patient risks. Several implant manufacturers have been working towards more MRI safe devices. Older devices are however often labelled for more stringent conditions, possibly creating confusion with patients and professionals. With this myriad of different devices that are implanted in patients for lifetimes of at least 20 years, it is crucial that both patients and professionals have a clear understanding of the safety of their devices. This work aims at providing an exhaustive overview on the MRI safety of active auditory implants. The available industry standards that are followed by manufacturers are outlined and an overview of the latest scientific developments focusing on the last five years is provided. In addition, based on the analysis of the adverse events reported to the Food and Drug Administration (FDA) and in literature within the past ten years, a systematic review of the most commonly occurring issues for patients with auditory implants in the MRI environment is provided. Results indicate that despite the release of more MRI conditional active hearing implants on the market, adverse events still occur. An extensive overview is provided on the MRI safety of active auditory implants, aiming to increase the understanding of the topic for healthcare professionals and contribute to safer scanning conditions for patients.

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The present study aimed to review the current status and development of international standards in the domain of traditional Chinese medicine (TCM) diagnosis. Moreover, the roles and relevant work of different organizations in developing such standards were explored, and the difficulties and challenges encountered were analyzed. The study further elaborated on the approaches to establish a complete set of international standards on TCM diagnosis. It also provided a promising solution for the development of international standards on TCM diagnosis.

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As Traditional Chinese Medicine (TCM) becomes widely used in many countries around the world, global demand for intelligent and modernized medical devices of TCM is increasing. Medical devices of TCM have played an important role in diagnosis and treatment of disease. Standardization on medical devices of TCM cannot only be beneficial to ensuring the life safety of patients, but also to enhancing the effectiveness of diagnosis and treatment. This paper includes (1) classification and trends in medical devices of TCM; (2) status review on international standardization of medical devices of TCM; (3) key technical factors in developing international standards for medical devices of TCM and (4) prospects for international standardization development of medical devices of TCM.

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Chinese materia medica (CMM) is indispensable component of Traditional Chinese Medicine (TCM) therapy. With the widespread of TCM around the world, the quality control and safe use of CMM become a major concern. This paper introduces the role of ISO standards for industrial development and current development status of CMM standards in ISO/TC 249. Through the comparison of similarities and differences between CMM standards in ISO/TC 249 and pharmacopoeias of main stakeholders, this paper suggests strengthening standard formulation in the following areas to provide more appropriate documents to facilitate the international trade and promote the industrial development of CMM: (1) Develop standards to fill the blanks among the whole industry chain of CMM; (2) Develop standards for new forms of CMM and services; (3) Develop specification and grade standards for CMM with large quantity and high value.

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Massive blood loss and blood transfusion constantly occur in liver transplantation. Over the past two decades, the amount of blood transfusion during the perioperative period has been decreased dramatically along with the continual maturity of liver transplantation techniques. The goal of liver transplantation without blood transfusion has been achieved. Since bleeding and blood transfusion are correlated with poor prognosis after liver transplantation, reducing bleeding and unnecessary blood transfusion has become the key objective during perioperative period of liver transplantation. In this article, adverse effects of allogeneic blood transfusion during perioperative period of liver transplantation, coagulation function monitoring of patients with end-stage liver disease, blood transfusion management of liver transplant recipients and the strategies of reducing perioperative blood transfusion in liver transplantation were summarized, aiming to provide reference for reducing the requirement of blood transfusion during perioperative period of liver transplantation.

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Background: The prothrombin time may be used to monitor the plasma concentration of rivaroxaban. However, there is variability in the responsiveness of rivaroxaban to different thromboplastins. We aimed to develop a rivaroxaban-monitoring method using the prothrombin time to reduce the differences in the sensitivity among reagents. Methods: Rivaroxaban-spiked pooled normal plasma at a 0-1000 ng/ml concentration was used to generate a rivaroxaban-adjusted sensitivity index (SI) values, and was tested with three thromboplastins. The warfarin-adjusted international sensitivity index (ISI-warfarin), rivaroxaban-adjusted sensitivity index (SI-rivaroxaban), international normalized ratio (INR) calculated with ISI-warfarin, normalized ratio (NR) calculated with SI-rivaroxaban, and their coefficient of variances (CVs) were compared. The NR-rivaroxaban value was compared with the results of an anti-Xa assay. Results: The ISI-warfarin and SI-rivaroxaban using different thromboplastins were 1.02 and 1.88, respectively, with Thromborel S, 0.90 and 1.00 using Recombiplastin 2G, and 1.30 and 1.15 using Neoplastin CI-plus. Between-thromboplastin variability expressed as CV were 6.3%-25.1% when expressed as INR-warfarin and 1.7%-4.7% when expressed as NR-rivaroxaban. CVs for the NR-rivaroxaban with another laboratory were significantly lower than those for INR-warfarin. Anti-Xa assay v NR-rivaroxaban correlation coefficients were 0.97-0.99. Conclusion: Using a rivaroxaban-specific NR effectively minimises inter-thromboplastin variability. By utilizing a NR-rivaroxaban, standardized prothrombin time results could be rapidly obtained, especially useful in standardizing the therapeutic effect of rivaroxaban.

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BACKGROUND: Ocular trauma is an important cause of visual morbidity in children worldwide. Pediatric ocular trauma accounts for up to one third of all ocular trauma admissions, with significant economic implications for health care providers. It is estimated that 90% of all ocular trauma is preventable. Development of strategies to reduce the incidence and severity of pediatric ocular trauma requires an understanding of the epidemiology of these injuries and their characteristics. This will enable appropriate targeting of resources toward prevention and allow effective service planning. At present, there is no standardized methodology for the collection of global cross-sectional data in pediatric ocular trauma, and the ability to undertake detailed epidemiological and health-economic analyses is limited. Furthermore, it is difficult to draw international comparisons in incidence, etiology, and outcomes of pediatric ocular trauma due to the range of published reporting criteria. This study describes two novel questionnaires for standardized data collection in pediatric ocular trauma, which can be adopted across a range of health care settings internationally. METHODS: Two standardized data collection questionnaires have been developed from previously reported templates. The first enables collection of demographic and incident data on serious pediatric ocular trauma requiring hospitalization, and the second enables follow-up outcome data collection. Both the questionnaires are designed to collect primarily categorical data in order to increase ease of completion and facilitate quantitative analysis. These questionnaires enable acquisition of standardized data on the incidence, etiology, and outcomes of pediatric ocular trauma. DISCUSSION: These questionnaires enable collection of standardized data and are designed for global use across all health care settings. Through prospective data collection, epidemiological trends can be determined, allowing health care providers to develop collaborative global preventive strategies. Furthermore, the same questionnaires may be used in future studies to draw comparisons with baseline data, allowing assessment of the efficacy of targeted preventative interventions.

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With the enactment of the Nagoya Protocol, biological resources are now increasingly considered as assets of an individual country, instead of as the common property of mankind. As worldwide interest for securing biological resources intensifies, research resource centers (RRCs), which collect, preserve, and provide resources and their information to academia and industries, are gathering more attention. The Asian Network of Research Resource Centers (ANRRC) strives for conservation and effective use of bioresources and their data by connecting resource centers of Asia, a continent with the greatest diversity of life. Since its foundation in 2009, the Network has significantly expanded to encompass 103 RRCs of 14 countries. Through the Network, member countries discuss opportunities for resource exchange and research collaboration and share biobanking information and regulations of different countries for international harmonization of resource management. ANRRC also contributes to developing of International Standards of biobanks and biological resources as a liaison to the International Organization for Standardization technical committee 276 Biotechnology.

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OBJECTIVE: The aim of the investigation was to contribute to the ongoing discussion at the international standardization committee on how to artificially age dental resin composite cements. METHODS: Indirect tensile strength (n=30) of a dual-cured resin composite cement (Panavia F2.0) was measured to evaluate the effect of water storage at 37°C or thermal cycling (5°C/55°C/1min) for up to 64 days. The influence of water temperature (5-65°C) after 16 days and the effect of 1 day water storage at 37°C prior to aging were assessed. Storage in air at 37°C served as control. RESULTS: Thermal cycling affected the indirect tensile strength most, followed by water storage at 55°C, whereas water storage at 37°C had only little influence. Major deterioration occurred before day 4 (≈6000 cycles). A 1-day pre-treatment by water storage at 37°C prior to thermal cycling attenuated the effect of aging. SIGNIFICANCE: For the material investigated, thermal cycling for 4 days is the most efficient aging procedure. A 1-day water storage at 37°C prior to thermal cycling is recommended to allow complete polymerization. A 4-day water storage at 55°C may be considered as a viable alternative to thermal cycling.

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The awareness of the impact of human activities in society and environment is known as "Social Responsibility" (SR). It has been a topic of growing interest in many enterprises since the fifties of the past Century, and its implementation/assessment is nowadays supported by international standards. There is a tendency to amplify its scope of application to other areas of the human activities, such as Research, Development and Innovation (R + D + I). In this paper, a model of quantitative assessment of Social Responsibility in Environmental Science and Technology (SR EST) is described in detail. This model is based on well established written standards as the EFQM Excellence model and the ISO 26000:2010 Guidance on SR. The definition of five hierarchies of indicators, the transformation of qualitative information into quantitative data and the dual procedure of self-evaluation and external evaluation are the milestones of the proposed model, which can be applied to Environmental Research Centres and institutions. In addition, a simplified model that facilitates its implementation is presented in the article.

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Many countries have developed standard strategy under the tendency of the economic globalization.TCM international standardization faces more and more competitions.This article analyzes the competitors and competitive status of TCM international standardization by the research methods of competitive intelligence,competitor analysis and SWOT analysis,and puts forward corresponding strategic measures in details.

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The demands for Traditional Chinese Medicine(TCM)standardization are rising internationally,but the development for TCM intemational standards is confronted with competence.In this context,the authors analyzed the competing status of intemationalized TCM standardization from 3 aspects:1.It is the key point for competition that obtaining leadership in the international organization and dominant position in developing important intemational standards:2.Integrating technical development and intellectual property with intemational standards has been gradually formed;3.Striving to make breakthrough in the development of TCM international standards on the basis of TCM Chinese national standards.The authors recommend that international standards be initiated from TCM service standards.TCM products quality standards and TCM process standards.

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Conclusions1)The present situation of teaching English for medical purposes (EMP) in Japanese medical schools is chaotic.2)We need a standardized EMP curriculum and standardized national and international EMP goals.3) Based on Ministry of Education funding, a free Internet platform for EMP educational materials has been established and could be used to develop a national standardized EMP program.