Search results for: international patient safety goals

Authors: Noorulain Khalid, Unsaar Hayat, Muhammad Chaudhary, Christos Iosifidis, Felipe Dhawahir-Scala, Fiona Carley

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Dry eye disease (DED) is a common condition seen in the emergency eye department (EED) at Manchester Royal Eye Hospital (MREH). However, there is variability in the prescription of lubricating eye drops among different healthcare providers. The aim of this study was to develop an up-to-date, standardized algorithm for the prescription of lubricating eye drops in the EED at MREH based on international and national guidelines. The study also aimed to assess the impact of implementing the guideline on the rate of inappropriate lubricant prescriptions. Primarily, the impact was to be assessed in the form of the appropriateness of prescriptions for patients’ DED. The impact was secondary to be assessed through analysis of the cost to the hospital. Data from 845 patients who attended the EED over a 3-month period were analyzed, and 157 patients met the inclusion and exclusion criteria. After conducting a review of the literature and collaborating with the corneal team, an algorithm for the prescription of lubricants in the EED was developed. Three plan-do-study-act (PDSA) cycles were conducted, with interventions such as emails, posters, in-person reminders, and education for incoming trainees. The appropriateness of prescriptions was evaluated against the guidelines. Data were collected from patient records and analyzed using statistical methods. The appropriateness of prescriptions was assessed by comparing them to the guidelines and by clinical correlation with a specialized registrar. The study found a substantial improvement in the number of appropriate prescriptions, with an increase from 55% to 93% over the three PDSA cycles. There was additionally a 51% reduction in expenditure on lubricant prescriptions, resulting in cost savings for the hospital (approximate saving of £50/week). Theoretical importance: Appropriate prescription of lubricating eye drops improves disease management for patients and reduces costs for the hospital. The development and implementation of a standardized guideline facilitate the achievement of these goals. Conclusion: This study highlights the inconsistent management of DED in the EED and the potential lack of training in this area for healthcare providers. The implementation of a standardized, easy-to-follow guideline for lubricating eye drops can help to improve disease management while also resulting in cost savings for the hospital.

Keywords: lubrication, dry eye disease, guideline, prescription

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Authors: John Gaber, Youssef Ahmed, Hossam A. Gabbar, Jing Ren

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Accidents at Nuclear Power Plants (NPPs) occur due to various factors, notable among them being poor safety management and poor safety culture. During abnormal situations, the likelihood of human error is many-fold higher due to the higher cognitive workload. The most common cause of human error and high cognitive workload is mental fatigue. Electroencephalography (EEG) is a method of gathering the electromagnetic waves emitted by a human brain. We propose a safety system by monitoring brainwaves for signs of mental fatigue using an EEG system. This requires an analysis of the mental model of the NPP operator, changes in brain wave power in response to certain stimuli, and the risk factors on mental fatigue and attention that NPP operators face when performing their tasks. We analyzed these factors and developed an EEG-based monitoring system, which aims to alert NPP operators when levels of mental fatigue and attention hinders their ability to maintain safety.

Keywords: brain imaging, EEG, power plant operator, psychology

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Authors: Claudia Munoz, Henry Laniado

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In this research, the impact of outbound and return flight schedule preferences on airline choice for international trips is quantified. Several studies have used airline choice data to identify preferences and trade-offs of different air carrier service attributes, such as travel time, fare and frequencies. However, estimation of the effect return flight schedules have on airline choice for an international round-trip flight has not yet been studied in detail. The multinomial logit model found shows that airfare, travel time, arrival preference schedule in the outward journey, departure preference in the return journey and the schedule combination of round-trip flights are significantly affecting passenger choice behavior in international round-trip flights. it results indicated that return flight schedule preference plays a substantial role in air carrier choice and has a similar effect to outbound flight schedule preference. Thus, this study provides an analytical tool designed to provide a better understanding of international round-trip flight demand determinants and support carrier decisions.

Keywords: flight schedule, airline choice, return flight, passenger choice behavior

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Authors: Ali Akber Jaffri, Asad Naseem, Javeria Khan, Zubair Hamza, Ishtiaq

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The purpose of this study is to determine safety stock, maximum inventory level, reordering point, and reordering quantity by rearranging lot sizes for supplier and customer in MRO (maintenance repair operations) warehouse of Engro Polymers & Chemicals. To achieve the aim, physical analysis method and excel commands were carried out to elicit the customer and supplier data provided by the company. Initially, we rearranged the current lot sizes and MOUs (measure of units) in SAP software. Due to change in lot sizes, we have to determine the new quantities for safety stock, maximum inventory, reordering point and reordering quantity as per company's demand. By proposed system, we saved extra cost in terms of reducing time of receiving from vendor and in issuance to customer, ease of material handling in MRO warehouse and also reduce human efforts.

Keywords: maintenance repair operation, maximum inventory, reorder quantity, safety stock

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Authors: Ugwu Blessing Nkiruka

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This paper seeks to examine Nigerian National Agency for the control of AIDS (NACA) and international response to the control of HIV/AIDS in Nigeria. The paper adopted the Functionalist theory alongside Liberalism and Idealism, but anchored extensively on functionalism. On the response of HIV/AIDS, Functionalist theory advocated for international corporation of both intergovernmental and non-governmental organisations as the basis for the reduction of the virus. the study adopted secondary source of data i.e journals, articles, newspapers and policy briefs to discuss the reduction of the pandemic (HIV/AIDS).This paper discovered that although HIV/AIDS is a global threat, especially to developing countries where the prevalence rate is still very high, yet international governmental and non-governmental organisation have been able to collaborate with National agencies like NACA in Nigeria and respond speedily through diverse initiatives and action plans to curb the spread of the virus. The study therefore recommends greater awareness on testing and early introduction of antiretroviral therapy, proper screening of blood before transfusion, absolute faithfulness among partners. Similarly, sharing of sharp objects like needles, knives and syringes should be avoided at all cost.

Keywords: HIV/AIDS, developing countries, Nigeria, international organizations, NACA

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Authors: Asifa Fitriani, Galih Prakoso

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This study aims to improve the design layout of a Micro, Small and Medium Enterprises (SMEs) to minimize material handling and redesigning the layout of production facilities based on the safety and health and standards of food production facilities. Problems layout in the one of chip making industry mushrooms in Indonesia is cross movement between work stations, work accidents, and the standard of facilities that do not conform with the standards of the food industry. Improvement layout design using CORELAP and 5S method to give recommendation and implementation of occupational health and safety standards of food production facilities. From the analysis, improved layout using CORELAP provide a smaller displacement distance is 155.84 meters from the initial displacement distance of 335.9 meters, and providing a shorter processing time than the original 112.726 seconds to 102.831 seconds. 5S method also has recommended the completion of occupational health and safety issues as well as the standard means of food production by changing the working environment better.

Keywords: Layout Design, Corelap, 5S

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Authors: Nadeem Akhtar, An Ran, Cornelius B. Pratt

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China’s President Xi' vision of Belt and Road Initiative, an infrastructural project of development and connectivity, is attracting international students to Chinese universities, with Pakistan and India among the top-10 countries of origin of those students (Ministry of Education China, 2018). An additional factor in international students’ interest in Chinese universities is their improving global rankings of Chinese universities. Against that backdrop, this study addresses two overarching questions: (a) What factors explain South Asian students’ study-away experiences, particularly in their multicultural environments? and (b) What role do new media play in their adaptation to that environment? This study is guided by Stephen’s (2011) theoretical model, which suggests that social networks influence immigrants’ interactions with host and home culture. The present study used a structured questionnaire distributed through both WeChat and other online platforms to international students studying in Chinese universities. Preliminary results are threefold: (a) that the frequency of use of social media is a predictor of the level of adjustment of the students to their multicultural environment; (b) that social engagement with their international-student peers is a moderating factor in their experiential outcomes; and (c) length of stay in Chinese universities, surprisingly, was not a predictor of adaptation. A major implication of these findings is that, even though social media tend to be criticized for contributing to anomie and to diminishing social capital among youths and millennials, they can be poignant tools for cultural adaptation, particularly among international students in China. It remains to be seen if such outcomes occur among international students in other countries or world regions.

Keywords: adaptation, China's Belt and Road Initiative, international students, social media

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Authors: K. Mardaleishvili, G. Loladze, G. Shatirishivili, D. Chakhunashvili, A. Vishnevskaya, Z. Kakabadze

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Benign osteoblastoma is a benign tumor of the bone, usually affecting the vertebrae and long tubular bones. It is a rarely seen tumor of the facial bones. The authors present a case of a 28-year-old male patient with a tumor in mandibular body. The lesion was radically resected and histological analysis of the specimen demonstrated features typical of a benign osteoblastoma. The defect of the jaw was reconstructed with titanium implants and decellularized and lyophilized cattle bone matrix with mesenchymal bone marrow stem cells transplantation. This presentation describes the procedures for rehabilitating a patient with decellularized bone scaffold in the region of the face, recovering the facial contours and esthetics of the patient.

Keywords: facial bones, osteoblastoma, stem cells, transplantation

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Authors: Ling-Lang Huang

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Background: The holistic health care should ideally cover physical, mental, spiritual, and social aspects of a patient. With very constrained time in current clinical practice system, medical decisions often tip the balance in favor of evidence-based medicine (EBM) in comparison to patient's personal values. Even in the era of competence-based medical education (CBME), when scrutinizing the items of entrustable professional activities (EPAs), we found that EPAs of establishing doctor-patient relationship remained incomplete or even missing. This phenomenon prompted us to raise this project aiming at advocating value-based medicine (VBM), which emphasizes the importance of patient’s values in medical decisions. A true and effective doctor-patient communication and relationship should be a well-balanced harmony of EBM and VBM. By constructing VBM into current EPAs, we can further promote genuine shared decision making (SDM) and fix the missing link in holistic health care. Methods: In this project, we are going to find out EPA elements crucial for establishing an ideal doctor-patient relationship through three distinct pairs of doctor-patient relationships: patients with pulmonary arterial hypertension (relatively young but with grave disease), patients undergoing surgery (facing critical medical decisions), and patients with terminal diseases (facing forthcoming death). We’ll search for important EPA elements through the following steps: 1. Narrative approach to delineate patients’ values among 2. distinct groups. 3.Hermeneutics-based interview: semi-structured interview will be conducted for both patients and physicians, followed by qualitative analysis of collected information by compiling, disassembling, reassembling, interpreting, and concluding. 4. Preliminarily construct those VBM elements into EPAs for doctor-patient relationships in 3 groups. Expected Outcomes: The results of this project are going to give us invaluable information regarding the impact of patients’ values, while facing different medical situations, on the final medical decision. The competence of well-blending and -balanced both values from patients and evidence from clinical sciences is the missing link in holistic health care and should be established in future EPAs to enhance an effective SDM.

Keywords: value-based medicine, shared decision making, entrustable professional activities, holistic health care

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Authors: Ang Chia Hong, Julian Khoo Xubin, Burra Venkata Durga Kumar

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Distributed systems offer many benefits to the healthcare industry. From big data analysis to business intelligence, the increased computational power and efficiency from distributed systems serve as an invaluable resource in the healthcare sector to utilize. However, as the usage of these distributed systems increases, many issues arise. The main focus of this paper will be on security issues. Many security issues stem from distributed systems in the healthcare industry, particularly information security. The data of people is especially sensitive in the healthcare industry. If important information gets leaked (Eg. IC, credit card number, address, etc.), a person’s identity, financial status, and safety might get compromised. This results in the responsible organization losing a lot of money in compensating these people and even more resources expended trying to fix the fault. Therefore, a framework for a blockchain-based healthcare data management system for healthcare was proposed. In this framework, the usage of a blockchain network is explored to store the encryption key of the patient’s data. As for the actual data, it is encrypted and its encrypted data, called ciphertext, is stored in a cloud storage platform. Furthermore, there are some issues that have to be emphasized and tackled for future improvements, such as a multi-user scheme that could be proposed, authentication issues that have to be tackled or migrating the backend processes into the blockchain network. Due to the nature of blockchain technology, the data will be tamper-proof, and its read-only function can only be accessed by authorized users such as doctors and nurses. This guarantees the confidentiality and immutability of the patient’s data.

Keywords: distributed, healthcare, efficiency, security, blockchain, confidentiality and immutability

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Authors: Odd Ivar Haugen

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This paper explores the ontology of assurance in safety-critical systems, emphasising the importance of knowledge and confidence in system behaviour. Assurance is defined as providing grounds for justified confidence in system properties, such as safety and security. The paper discusses the main concepts of assurance, including system requirements, confidence, and justification. It discusses the CESM metamodel for understanding system behaviour and emergent properties. The paper also highlights the importance of objectivity in assessing the strength of knowledge and the role of verification in generating evidence as a part of the argumentation. The assurance case is presented as a systematic way to represent knowledge and support decision-making.

Keywords: assurance, CESM metamodel, confidence, emergent properties, knowledge, objectivity, risk, system behaviour, system safety

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Authors: Mehran Naghizaderokni, Asscar Janalizadechobbasty

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This paper explores probabilistic method for assessing the liquefaction potential of sandy soils. The current simplified methods for assessing soil liquefaction potential use a deterministic safety factor in order to determine whether liquefaction will occur or not. However, these methods are unable to determine the liquefaction probability related to a safety factor. A solution to this problem can be found by reliability analysis.This paper presents a reliability analysis method based on the popular certain liquefaction analysis method. The proposed probabilistic method is formulated based on the results of reliability analyses of 190 field records and observations of soil performance against liquefaction. The results of the present study show that confidence coefficient greater and smaller than 1 does not mean safety and/or liquefaction in cadence for liquefaction, and for assuring liquefaction probability, reliability based method analysis should be used. This reliability method uses the empirical acceleration attenuation law in the Chalos area to derive the probability density distribution function and the statistics for the earthquake-induced cyclic shear stress ratio (CSR). The CSR and CRR statistics are used in continuity with the first order and second moment method to calculate the relation between the liquefaction probability, the safety factor and the reliability index. Based on the proposed method, the liquefaction probability related to a safety factor can be easily calculated. The influence of some of the soil parameters on the liquefaction probability can be quantitatively evaluated.

Keywords: liquefaction, reliability analysis, chalos area, civil and structural engineering

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Authors: Jasmin S. Nurkovic, Ljubisa Dj. Jovasevic, Zana C. Dolicanin, Zoran S. Bajin

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Ruptured muscles and tendons very often must be repatriated by open operation in young persons. In young, muscles are ruptured more often than tendons, at the sane time in older persons are more exposed to rupture than muscles. Ruptured of the calcaneus are the most present of all ruptures. Sometime the rupture is complete, but very often the incomplete rupture can be noticed. During six years, from 2006 to 2012, we treated nineteen male patients and three female patients with the rupture of tendon Achilles. The youngest patient was aged thirty two, and the oldest was also managed sixty four. The youngest female patient was forty one and the oldest was forty six. One of our patients who was under corticosteroid treatment did not take any part in sport activities but she was, as she told us, going for a long walk, the same was with other two patients one man and one woman. We had nineteen male patients age 32 to 64 and three female patients age 41, 44 and 46. Conservative treatment by cast was applied in five patients and very good results were in three of them. In two patients surgical treatment failed in patient’s age 53 and 64. Only one of all patients treated by surgery had healing problems because of necrotic changes of the skin where incision was made. One of our female patients age 45 was under steroid treatment for almost 20 years because of asthmatic problems. We suggested her wearing boots with 8cm long heels by day and by night eight weeks. The final results were satisfactory and all the time she was able to work and to walk. It was the only case we had with bilateral tendon rupture. After eight weeks the cast is removed and psychiatric treatment started, patient is using crutches with partial weight bearing over a period of two weeks. Quite the same treatment conservative treatment, only the cast is not removed after two but after four weeks. Everyday activities after the surgical treatment started ten weeks and sport activities can start after fourteen to sixteen weeks. An increased activity of our patient without previous preparing for forces activity can result, as we already see, with tendon rupture. Treatment is very long and very often surgical. We find that surgical treatment resulted as safer and better solution for patients. We also had a patient with spontaneous rupture of tendon during longer walking but this patient was under prolonged corticosteroid treatment.

Keywords: tendon, Achilles, rupture, sport

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Authors: Godwin Dennison, Edwin Cooper, George Theobald, Richard Dalton

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We report an unusual case of giant filiform polyposis in a patient with ulcerative colitis, causing a large stricture in the colon. A 62-year-old man was referred to the Bowel Cancer Screening Programme with a positive Faecal Immunochemical Test (FIT). He was known to have UC for 30 years. A CT scan showed a 9 cm stricture in the transverse colon suspicious of malignancy. A colonoscopy was attempted three times, and biopsies confirmed features of ulcerative colitis. A laparoscopic assisted transverse colectomy (Left hemicolectomy) was performed, and the histology revealed giant filiform polyposis. This should be considered in a UC patient presenting with signs of obstruction mimicking a carcinoma. Whilst it is a benign condition, because of the size of the lesion, it often causes obstruction, and surgery is indicated to relieve symptoms.

Keywords: giant inflammatory polyposis, filiform polyposis, ulcerative colitis, inflammatory bowel disease

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Authors: Addisu Teshama

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The existing criminal procedure law which is the main determinant of the phenomena of pre-trial detention is under revision in Ethiopia. The drafting work is completed and submitted for approval to the House of Peoples Representatives. The drafters of the draft law claim that the existing law is not in harmony with the constitutionally and internationally recognized principles pertinent to pretrial detention regulation. Further, the drafters allege that the drafting process is dictated by human rights principles recognized in the FDRE constitution and international human rights instruments ratified by Ethiopia. This article aims to the asses the plausibility of the claims of the drafters. For that purpose, this article uses the standards and guidelines articulated by international human rights standard setters as bench marks to juxtapose and judge the existing law and the draft criminal procedure and evidence code (DCrimPEC). The study found that the many aspects of the pre-trial detention law of Ethiopia are not in compliance with international law standards in the existing criminal procedure law. The DCrimPEC is aimed to harmonize the existing law with the constitution and international law standards. In this regard, the study found that the DCrimPEC has made significant changes on pre-trial detention policies which are not in harmony the principle of presumption of innocence. However, there are still gaps.

Keywords: pre-trial detention, right to personal liberty, right to bail, Ethiopia

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Authors: Nuhu Mohammed Gali, Kenichi Matsui

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Climate change poses a significant threat to agriculture and food security in Africa. The UNFCC recognized the need to address climate change adaptation in the broader context of sustainable development. African countries have initiated a governance system for adapting and responding to climate change in their Nationally Determined Contributions (NDCs). Despite the implementation limitations, Africa’s adaptation initiatives highlight the need to strengthen and expand adaptation responses. This paper looks at the extent to which South-South cooperation facilitates the implementation of adaptation actions between nations for agriculture and sustainable development. We conducted a literature review and content analysis of reports prepared by international organizations, reflecting the diversity of adaptation activities taking place in Sub-Saharan Africa. Our analysis of the connection between adaptation and nationally determined contributions (NDCs) showed that climate actions are mainstreamed into sustainable development. The NDCs in many countries on climate change adaptation action for agriculture aimed to strengthen the resilience of the poor. We found that climate-smart agriculture is the core of many countries target to end hunger. We revealed that South-South Cooperation, in terms of capacity, technology, and financial support, can help countries to achieve their climate action priorities and the Sustainable Development Goals (SDGs). We found that inadequate policy and regulatory frameworks between countries, differences in development priorities and strategies, poor communication, inadequate coordination, and the lack of local engagement and advocacy are some key barriers to South-South Cooperation in Africa. We recommend a multi-dimensional partnership, provisionoffinancialresources, systemic approach for coordination and engagement to promote and achieve the potential of SSC in Africa.

Keywords: climate change, adaptation, food security, sustainable development goals

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Authors: Md. Shahriar Sabuz

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Different social factors influence individuals to migrate from their native lands. This qualitative study was designed to analyze the main social factors that have a significant role in the movement of people across borders. In this study, two research questions, i.e., ‘Which social factors of a country significantly influence the persons' decision to migrate from their homeland?’ and ’2: do different social factors of a country influence the process of international migration?" were formulated and relevant data were analyzed to get the logical answer to these two questions. Data analysis revealed that people migrate in large numbers due to deplorable and unsafe social conditions in their home countries. Sometimes migration occurs due to a lack of basic facilities in native countries. It is quite significant to know that these social conditions create a sense of deprivation and insecurity in individuals, and they move to other lands to get a sense of achievement and greater security for themselves and their whole families. This study is significant and distinct from previous studies in that it provides comprehensive information about the major social factors responsible for international migrations and their role in influencing an individual's proclivity to migrate. Besides this, it greatly opens new horizons of research and analysis for other researchers working on the agenda of international migration.

Keywords: International migration, social factors, income inequality, social discrimination

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Authors: Girma Y. Iyassu Menelik

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“The world is now like a global village!” so goes the saying that shows that due to development and technology the countries of the world are now closely linked. In the field of Human rights there is a close relationship in the way that rights are recognised and enforced. This paper will show that human rights have evolved from ancient times through important landmarks such as the Magna Carta, the French Declaration of Rights of Man and of the Citizen and the American Bill of Rights. The formation of the United Nations after the Second World War resulted in the need to codify and protect human rights. There are some rights which are so fundamental that they are found in international and continental instruments, national constitutions and domestic legislation. In the civil and political sphere they include the right to vote, to freedom of association, speech and assembly, right to life, privacy and fair trial. In the economic and social sphere you have the right to work, protection of the family, social security and rights to education, health and shelter. In some instance some rights can be suspended in times of public emergency but such derogations shall be circumscribed by the law and in most constitutions such limitations are subject to judicial review. However, some rights are so crucial that they cannot be derogated from under any circumstances and these include the right to life, recognition before the law, freedom from torture and slavery and of thought, conscience and religion. International jurisprudence has been developed to protect fundamental rights and avoid discrimination on the grounds of race, colour, sex, language or social origin. The elaborate protection system go to show that these rights have become part of the international order and they have universal application. We have now got to a stage where UDHR, ICCPR and ICESCR and have come to be regarded as part of an international bill of rights with horizontal and vertical enforcement mechanisms involving state parties, NGO’s , international bodies and other organs.

Keywords: rights, international, constitutional, state, judiciary

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Authors: Nuzhat Sultana M. B.

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Children are high-risk population in terms of food born illnesses. Food safety and security are the most important aspect of the success of midday meal programmes. Improper holding temperatures, cross-contamination and poor personal hygiene of food handlers are the main causes for the prevalence of pathogenic microbes in the food servicing areas. Two hundred and fifty preschool children in the age of 3 to 6 years from urban and rural anganwadies (pre school center) of Beed district were selected. Nutritional status of preschool children were assessed by anthropometrical and clinical measurement. The study assessed the food safety and security with the help of personal hygiene and other safety measures maintained by the food personnel working for midday meal programme, supplying mid meals to children in govt. anganwadies (pre school center). The hygiene level, sanitary condition and microbial quality of food and water, pathological health examination of food handlers were assessed with the help of checklist. A questionnaire was designed to evaluate knowledge, attitude, and practices of food handlers. Results of the study show that the nutritional and health status of rural and urban preschool children was very poor. Many of the food handlers were not aware of general knowledge and hygiene practices to be followed during food preparation areas. An intervention programme of education and importing training at workplaces has shown a positive impact on the outcome of safety and security practices and safe, hygienic practices of food handlers at workplace.

Keywords: food, health, preschool children, safety, security

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Authors: Danijela Vuković, Radovan Čobanović, Milorad Plačkić

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The expansion of population imposes increase in usage of animal meat, on whose quality directly affects the quality of the feed that the animals are fed with. The selection of raw materials, hygiene during the technological process, various hydrothermal treatments, methods of mixing etc. have an influence on the quality of feed. Monitoring of the feed is very important to obtain information about the quality of feed and the possible prevention of animal diseases which can lead to different human diseases outbreaks. In this study parameters of feed safety were monitored. According to the mentioned, the goal of this study was to evaluate microbiological safety of feed (feedstuffs and complete mixtures). Total number of analyzed samples was 4399. Analyzed feed samples were collected in various retail shops and feed factories during the period of 44 months (from January 2013 untill September 2017). Samples were analyzed on Salmonella spp. and Clostridium perfringens in quantity of 50g according to Serbian regulation. All microorganisms were tested according to ISO methodology: Salmonella spp. ISO 6579:2002 and Clostridium perfringens ISO 7937:2004. Out of 4399 analyzed feed samples 97,5% were satisfactory and 2,5% unsatisfactory concerning Salmonella spp. As far as Clostridium perfringens is concerned 100% of analyzed samples were satisfactory. The obtained results suggest that technological processing of feed in Serbia is at high level when it comes to safety and hygiene of the products, but there are still possibilities for progress and improvement which only can be reached trough the permanent monitoring of feed.

Keywords: microbiology, safety, hygiene, feed

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Authors: Alaa Abdellatif, Gabrièle Breda

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Background. Advanced therapy medicinal products (ATMPs) are innovative therapies that mainly target orphan diseases and high unmet medical needs. ATMP includes gene therapy medicinal products (GTMP), somatic cell therapy medicinal products (CTMP), and tissue-engineered therapies (TEP). Since legislation opened the way in 2007, 25 ATMPs have been approved in the EU, which is about the same amount as the U.S. Food and Drug Administration. However, not all of the ATMPs that have been approved have successfully reached the market and retained their approval. Objectives. We aim to understand all the factors limiting the market access to very promising therapies in a systemic approach, to be able to overcome these problems, in the future, with scientific, regulatory and commercial innovations. Further to recent reviews that focus either on specific countries, products, or dimensions, we will address all the challenges faced by ATMP development today. Methodology. We used mixed methods and a multi-level approach for data collection. First, we performed an updated academic literature review on ATMP development and their scientific and market access challenges (papers published between 2018 and April 2023). Second, we analyzed industry feedback from cell and gene therapy webinars and white papers published by providers and pharmaceutical industries. Finally, we established a comparative analysis of the regulatory guidelines published by EMA and the FDA for ATMP approval. Results: The main challenges in bringing these therapies to market are the high development costs. Developing ATMPs is expensive due to the need for specialized manufacturing processes. Furthermore, the regulatory pathways for ATMPs are often complex and can vary between countries, making it challenging to obtain approval and ensure compliance with different regulations. As a result of the high costs associated with ATMPs, challenges in obtaining reimbursement from healthcare payers lead to limited patient access to these treatments. ATMPs are often developed for orphan diseases, which means that the patient population is limited for clinical trials which can make it challenging to demonstrate their safety and efficacy. In addition, the complex manufacturing processes required for ATMPs can make it challenging to scale up production to meet demand, which can limit their availability and increase costs. Finally, ATMPs face safety and efficacy challenges: dangerous adverse events of these therapies like toxicity related to the use of viral vectors or cell therapy, starting material and donor-related aspects. Conclusion. As a result of our mixed method analysis, we found that ATMPs face a number of challenges in their development, regulatory approval, and commercialization and that addressing these challenges requires collaboration between industry, regulators, healthcare providers, and patient groups. This first analysis will help us to address, for each challenge, proper and innovative solution(s) in order to increase the number of ATMPs approved and reach the patients

Keywords: advanced therapy medicinal products (ATMPs), product development, market access, innovation

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Authors: Efi Koutantou

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The foundation of successful therapy is the bond between the psychotherapist and the patient, Psychoanalysis would argue. The present study explores lived experiences of a psychotherapeutic relationship in different moments, initial and final with special reference to the transference love developed through the process. The fight between moments of ‘leaving a self’ behind and following ‘lines of flight’ in the process of creating a new subjectivity and ‘becoming-other’ will be explored. Moments between de-territorialisation – surpassing given constraints such as gender, family and religion, kinship bonds - freeing the space in favor of re-territorialisation – creation of oneself creation of oneself will also be analyzed. The generation of new possibilities of being, new ways of self-actualization for this patient will be discussed. The second part of this study will explore the extent to which this ‘transference love’ results for this specific patient to become ‘the discourse of the other’; it is a desideratum whether the patient finally becomes a subject of his/her own through his/her own self-exploration of new possibilities of existence or becomes alienated within the thought of the therapist. The way in which the patient uses or is (ab)used by the transference love in order to experience and undergo alienation from an ‘authority’ which may or may not sacrifice his/her own thought in favor of satisfying the therapist will be investigated. Finally, from an observer’s perspective and from the analysis of the results of this therapeutic relationship, the counter-transference will also be analyzed, in terms of an attempt of the analyst to relive and satisfy his/her own desires through the life of the analysand. The accession and fall of an idealized self will be analyzed, the turn of the transference love into ‘hate’ will conclude this case study through a lived experience in the therapeutic procedure; a relationship which can be called to be a mixture of a real relationship and remnants from a past object relationship.

Keywords: alienation, authority, counter-transference, hate, transference love

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Authors: Vera Lúcia Raposo

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Medical devices are products used for medical purposes and aimed to operate in the human body, sometimes even inside the human body. Therefore, they can become particularly risky products, and some of the injuries caused by medical devices can have serious effects on the person’s health or body, even leading to death. Because they fit in the category of 'products' as described in Article 2 of Council Directive 85/374/EEC of 25 July 1985, concerning liability for defective products, the liability of the manufacturer of medical devices follows the rules of strict liability as long as one of the defects covered by the directive is at stake. The directive is not concerned with the product’s efficiency, but instead with the product’s safety, although in what regards medical devices (the same being valid for drugs) the two concepts frequently go together, and a lack of efficiency can result in a lack of safety. In the particular case of medical devices, the most debatable defects are the ones related with erroneous or non-existing information and the so-called development defects. This paper analyses how directive 85/374/EEC applies to medical devices, which defects are covered by its regulation, and which criteria can be used to evaluate the product’s safety. Some issues are still to be clarified, even though the decisions from the European Court of Justice and from national courts are valuable tools to understand the scope of directive 85/374/EEC in what regards medical devices.

Keywords: medical devices, producer’s liability, product safety, strict liability

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Authors: Wendy Ampadu, Ray Diezmos, Hassan Malik, Jeremy Hyslob

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There are several technologies out there for use as high-level switches as part of a system for shutting down flow to a vessel. Given that the asphalt truck loading poses issues such as poor visibility, coating, condensation, and fumes, a solution that is robust enough to last in these conditions is often needed in industries. Furthermore, the design of the loading arm, rack, and process equipment should allow for the safety of workers. The objective of this report includes the redesign of structures for use at loading facilities and selecting an overflow technology protection from hot bitumen. The report is based on loading facilities at a Canadian bitumen production company. The engineering design approach was used to create multiple redesign concepts for the loading dock system. Research on overfill systems was also completed by surveying the existing market for technologies and securing quotes from over 20 Canadian and United States instrumentation companies. A final loading dock redesign and level transmitter for overfill protection solution were chosen.

Keywords: bitumen, reliability engineering, safety system, process safety management, asphalt, loading docks, tanker trucks

Procedia PDF Downloads 155

Authors: Mannan Mridha, Usama Gazay, Kosovare V. Aslani, Hugo Linder, Alice Ravizza, Carmelo de Maria

Abstract:

In most developing countries, although the vast majority of the people are living in the rural areas, the qualified medical doctors are not available there. Health care workers and paramedics, called village doctors, informal healthcare providers, are largely responsible for the rural medical care. Mishaps due to wrong diagnosis and inappropriate medication have been causing serious suffering that is preventable. While innovators have created many devices, the vast majority of these technologies do not find applications to address the needs and conditions in low-resource settings. The primary motive is to address the acute lack of affordable medical technologies for the poor people in low-resource settings. A low cost smart medical device that is portable, battery operated and can be used at any point of care has been developed to detect breathing rate, electrocardiogram (ECG) and arterial pulse rate to improve diagnosis and monitoring of patients and thus improve care and safety. This simple and easy to use smart medical device can be used, managed and maintained effectively and safely by any health worker with some training. In order to empower the health workers and village doctors, our device is being further developed to integrate with ICT tools like smart phones and connect to the medical experts wherever available, to manage the serious health problems.

Keywords: e-health for low resources settings, health awareness education, improve patient care and safety, smart and affordable medical device

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Authors: Maziar Yazdani, Ahmad Khodaee, Fatemeh Hajizadeh

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The purpose of this research was analysis of the reliability of the signaling system in the railway and planning repair and maintenance of its subsystems. For this purpose, it will be endeavored to introduce practical strategies for activities control and appropriate planning for repair and preventive maintenance by statistical modeling of reliability. Therefore, modeling, evaluation, and promotion of reliability of the signaling system appear very critical. Among the key goals of the railway is provision of quality service for passengers and this purpose is gained by increasing reliability, availability, maintainability and safety of (RAMS). In this research, data were analyzed, and the reliability of the subsystems and entire system was calculated and with emphasis on preservation of performance of each of the subsystems with a reliability of 80%, a plan for repair and preventive maintenance of the subsystems of the signaling system was introduced.

Keywords: reliability, modeling reliability, plan for repair and preventive maintenance, signaling system

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Authors: Naseer Ahmad Bhat

Abstract:

Jammu and Kashmir Public Safety Act, 1978 provides for administrative detention in Jammu and Kashmir, a disputed region between India & Pakistan, since 1947. This paper shall critically analyse the working of PSA (Public Safety Act) in this J&K since 1978, since its inception. Detentions under this Act traverse between the security of the State and Liberty of citizens but over decades, has this Act served its purpose in Kashmir or not shall be analysed in this paper. J&K PSA is used to detain political workers, Over-Ground Workers and Stone Pelters who pose a direct threat to the ‘security of the State.’ Detentions under J&K PSA are a good measure in the hands of Security agencies to bring calm during periods of turmoil, but it has socio-economic consequences for detainees as well as families. This paper shall highlight the Socio-Economic impact of detentions under J&K PSA on individuals and families.

Keywords: detentions, Kashmir, public safety act, liberty, security

Procedia PDF Downloads 228

Authors: Anna Wszołek

Abstract:

For a very long time, the doctor-patient relationship had a paternalistic character. The events of the II World War, as well as fast development of the biotechnology and medicine caused an important change in that relationship. Human beings and their dignity were put in the centre of philosophical and legal debate. The increasing frequency of clinical trials led to the emergence of bioethics, which dealt with the topic of the possibilities and boundaries of such research in relation to individual’s autonomy. Thus, there was a transformation from a paternalistic relationship to a more collaborative one in which the patient has more room for self-determination. Today, patients are more and more aware of their rights and the obligations placed on doctors and the health care system, which is linked to an increase in medical malpractice claims. Unfortunately, these claims are not always justified. There is a strong concentration around the topic of patient’s good, however, at the other side there are doctors who feel, on the example of Poland, they might be easily accused and sued for medical malpractice even though they fulfilled their duties. Such situation may have a negative impact on the quality of health care services and patient’s interests. This research is going to present doctor’s perspective on the topic of medical malpractice allegations. It is supposed to show possible damage to a doctor’s reputation caused by frivolous and weakly justified medical malpractice accusations, as well as means to protect this reputation.

Keywords: doctor's reputation, medical malpractice, personal rights, unjustified allegations

Procedia PDF Downloads 91

Authors: Ava Zarif Sanayei, Sedigheh Sina

Abstract:

During fluoroscopically guided procedures, healthcare workers, especially radiology trainees, are at risk of exposure to elevated radiation exposure. It is vital to prioritize their safety in such settings. However, there is limited data on their monthly or annual doses. This study aimed to evaluate the equivalent dose to the eyes of the student trainee, utilizing LiF: Mg, Ti (TLD-100) chips at the radiology department of a hospital in Shiraz, Iran. Initially, the dosimeters underwent calibration procedures with the assistance of ISO-PTW calibrated phantoms. Following this, a set of dosimeters was prepared To determine HP(3) value for a trainee involved in the main operation room and controlled area utilized for two months. Three TLD chips were placed in a holder and attached to her eyeglasses. Upon completion of the duration, the TLDs were read out using a Harshaw TLD reader. Results revealed that Hp(3) value was 0.31±0.04 mSv. Based on international recommendations, students in radiology training above 18 have an annual dose limit of 0.6 rem (6 mSv). Assuming a 12-month workload, staff radiation exposure stayed below the annual limit. However, the Trainee workload may vary due to different deeds. This study's findings indicate the need for consistent, precise dose monitoring in IR facilities. Students can undertake supervised internships for up to 500 hours, depending on their institution. These internships take place in health-focused environments offering radiology services, such as clinics, diagnostic imaging centers, and hospitals. Failure to do so might result in exceeding occupational radiation dose limits. A 0.5 mm lead apron effectively absorbs 99% of radiation. To ensure safety, technologists and staff need to wear this protective gear whenever they are in the room during procedures. Furthermore, maintaining a safe distance from the primary beam is crucial. In cases where patients need assistance and must be held for imaging, additional protective equipment, including lead goggles, gloves, and thyroid shields, should be utilized for optimal safety.

Keywords: annual dose limits, Hp(3), individual monitoring, radiation protection, TLD-100

Procedia PDF Downloads 74

Authors: Ljubica Milanović Glavan, Vesna Bosilj Vukšić, Dalia Suša

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In order to gain a competitive advantage, many companies are focusing on reorganization of their business processes and implementing process-based management. In this context, assessing process performance is essential because it enables individuals and groups to assess where they stand in comparison to their competitors. In this paper, it is argued that process performance measurement is a necessity for a modern process-oriented company and it should be supported by a holistic process performance measurement system. It seems very unlikely that a universal set of performance indicators can be applied successfully to all business processes. Thus, performance indicators must be process-specific and have to be derived from both the strategic enterprise-wide goals and the process goals. Based on the extensive literature review and interviews conducted in Croatian company a conceptual framework for process performance measurement system was developed. The main objective of such system is to help process managers by providing comprehensive and timely information on the performance of business processes. This information can be used to communicate goals and current performance of a business process directly to the process team, to improve resource allocation and process output regarding quantity and quality, to give early warning signals, to make a diagnosis of the weaknesses of a business process, to decide whether corrective actions are needed and to assess the impact of actions taken.

Keywords: Croatia, key performance indicators, performance measurement, process performance

Procedia PDF Downloads 673