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Medical devices are used to diagnose, treat, or prevent a disease or abnormal physical condition without any chemical action in the body. They can also result in unintended incidents and other errors. This thesis was divided into three chapters: i) a systematic review on the recognition, reporting and resolution of incidents related to medical devices and other health technologies; ii) telephone interviews with physicians and registered nurses (RNs) to solicit information on the resolution, reporting and resolution of medical device-related incidents based on their professional experience; and iii) a case study to review the continuous quality improvement (CQI) data retrieved from the wireless smart infusion pump system at The Ottawa Hospital (TOH) and to propose a CQI data analysis process. The systematic review included 30 studies on factors that influence the recognition, reporting and resolution of incidents in hospitals and interventions to improve patient safety. Central themes that emerged for incident reporting were personal attitudes, awareness and perception of incident reporting systems, organizational culture, and feedback to healthcare professionals. In our telephone interviews, physicians and RNs attributed incident recognition to devices not operating based on the manufacturer’s instructions, and to the hospital staff’s knowledge of and professional experience with the use of the medical device, and clinical manifestations of patients. Suggestions to improve medical device safety surveillance centered on education and training to ensure that the staff is able to use the medical device properly and know what would be considered an error, and how to report these errors. The results of the systematic review and interviews helped to inform the design of a medical device surveillance framework in a hospital setting. Our case study assessed the Dose Error Reduction Software compliance and frequency of soft and hard limit alerts with wireless smart infusion pump systems over a one year period. A CQI data analysis process to monitor the performance of wireless smart infusion pumps is proposed. The findings of this doctoral thesis can contribute to the development of a medical device surveillance system that would help to improve health care delivery and patient safety in a health care institution.

Submitted by Nadir Basilio (nadirsb@uninove.br) on 2016-04-25T18:52:17Z No. of bitstreams: 1 Maria Aparecida dos Santos Traverzim.pdf: 1790311 bytes, checksum: 7a6d20dee6a1d5d6bad8e90842729788 (MD5) / Made available in DSpace on 2016-04-25T18:52:17Z (GMT). No. of bitstreams: 1 Maria Aparecida dos Santos Traverzim.pdf: 1790311 bytes, checksum: 7a6d20dee6a1d5d6bad8e90842729788 (MD5) Previous issue date: 2015-11-25 / Patient safety is one of the dimensions of quality that has received increasing attention in recent years. The incident detection in patient safety aims to improve the quality of patient care. Incidents and adverse events (AEs) of patient safety should be reported spontaneously contributing for the apprenticeship and to create barriers so that they would not be repeated, but the fear of prosecution and punishment cause its underreporting. The objective of this study was to evaluate the incidence of patient safety incidents in the perinatal period with the use of an extended check list. This research used the inductive method, empirical approach with exploratory, descriptive, cross and as a strategy action research. Population sample was composed by admitted patients in the perinatal unit from June 25th to July 25th, 2015.We evaluated in maternal registry for proper completion of partogram, the patient chart and newborn data. We looked for: uterine rupture, changing the delivery type, returning to the operating room during hospitalization or after discharge, instrumental delivery, complications in the postpartum period, maternal death. In the newborn chart we collected information on neonatal trauma due to childbirth; research proper fetal vitality; Apgar score less than 7, and death of newborns weighing more than 2,500 g, and mother / newborn (NB). For both we looked for the detection of failure to follow the clinical protocol and blood components transfusion. We also evaluated whether these components of the check list were related to incidents or EAs in health care assistance. The total number of patients studied in the period was 249 patients, and we detected 97 AEs (38.9%). Of EAs, 27 (27.8%) were detected by traditional trigger points and 70 (72.8%) extended check list. The Apgar score less than 7 at the fifth minute was detected in 11 (11.3%) of all EAs and seven newborns (7.2% of events) had some type of trauma due to childbirth, 4 NB (4, 1%) were admitted to the ICU with less than 24 hours of birth. It was noted that two patients (2%) had to undergo to further surgery and one of them is still in outpatient treatment in the unit. Two patients (2%) had lacerations third / fourth degree and one patient (1%) uterine rupture diagnosed at the time of cesarean section. In the extended check list we detected failure in medicines in 20.6% of all AEs. In this study we observed a high incidence of clinical protocols violation (39.2%). Nine patients (9.3%) had complications in the postpartum period, two (2.1%) required liaison and one patient (1%) anesthetic complications. / A segurança do paciente é uma dimensão de qualidade que tem recebido atenção crescente nos últimos anos. A detecção de incidentes na área tem como objetivo melhorar a qualidade da assistência. Os incidentes e eventos adversos (EAs) deveriam ser relatados espontaneamente para que haja aprendizado e criação de barreiras para que não se repetam; porém, o receio de processos judiciais e punições leva a subnotificação. O objetivo deste estudo é avaliar sua incidência no período perinatal com o uso de um check list ampliado. A pesquisa utilizou o método indutivo, abordagem empírica com caráter exploratório, descritivo e transversal, e como estratégia a pesquisa-ação. Foram averiguados os atendimentos prestados a pacientes internadas na unidade de medicina perinatal, no período de 25 de junho a 25 de julho de 2015, quanto ao preenchimento adequado do partograma, dados do prontuário materno e do recém-nascido (RN). Também foi averiguado se a mãe apresentou, durante a internação na unidade: rotura uterina, alteração da via de parto durante o procedimento, retorno à sala cirúrgica durante a internação ou pós-alta hospitalar, parto instrumental, intercorrências no período puerperal ou morte materna. Entre os RNs, verificou-se a ocorrência de trauma neonatal devido ao parto, Apgar menor que 7 e morte com peso superior a 2.500g, além de investigação da vitalidade fetal adequada. Para mãe e recem-nascido, verificou-se se foi seguido o protocolo clínico da instituição e transfusão de heomcomponentes. Também avaliamos se esses componentes do check list, quando presentes, estavam relacionados a incidentes ou EAs no atendimento. O total de pacientes estudadas no período foi de 249, sendo detectados 97 EAs (38,9%). Destes, 27 (27,8%) foram detectados pelos trigger points tradicionais e 70 (72,8%) pelo check list ampliado. O índice de Apgar menor que 7 no quinto minuto foi detectado em 11 (11,3%) do total de EAs e 7 RNs (7,2% dos eventos) apresentaram algum tipo de trauma devido ao parto. 4 RNs (4,1%) foram admitidos na UTI com menos de 24h de nascimento. Observou-se que duas pacientes (2%) tiveram que ser submetidas a nova intervenção cirúrgica e que uma delas ainda continua em tratamento ambulatorial na unidade. Duas (2%) apresentaram lacerações de terceiro/quarto grau e uma (1%), rotura uterina diagnosticada no momento da cesárea. No check list ampliado detectamos falhas de medicamentos como causa de 20,6% de todos os EAs. O número de inobservância de protocolos clínicos da instituição também se mostrou com elevada incidência (39,2%). Nove pacientes (9,3%) apresentaram intercorrências no puerpério, duas (2,1%) necessitaram de interconsulta e uma (1%) de intercorrência anestésica.

This thesis project examines the intertextuality between Cameron Awkward-Rich’s poetry collection Sympathetic Little Monster (2016) and earlier African American texts: Harriet Jacobs’ Incidents of a Slave Girl (1860) and Toni Morrison’s Sula (1973). Focusing on intertextuality and the trope of the train, this project analyzes Awkward-Rich’s collection which details how black bodies are still subjected to oppression and anti-black/anti-trans violence. His poems explore how black trans subjects are inhibited from reaching “arrival,” wholeness, and freedom in one’s representation and expression of their identity. White supremacy and constructs of race and gender attempt to dictate the speakers’ movements, possibilities, and mobility. Paying close attention to references to the past and the trope of the train, I examine how Awkward-Rich’s poetry interrogates black trans legibility, subjectivity, and subjugation. / Includes bibliography. / Thesis (M.A.)--Florida Atlantic University, 2020. / FAU Electronic Theses and Dissertations Collection

Work-related accidents emerge from potential hazards that can cause different negative outcomes in different situations. Human errors are specific actions that can either directly (active errors) or indirectly (latent errors) cause an accident in the workplace. Nowadays in order to establish an applicable system in the way of maintenance and preferment of a work environment without any accidents that are trying to develop the HSE system. In fact, this management system has been using as a significant tool to control and improve the performance of health and safety and the environment in all development programs of industries and organizations. In this term, one of the important perspectives of HSE management is Emotional Intelligence which deals with the management’s ability and safety performance in the workplace. The purpose of this study is to investigate the relationship between Emotional Intelligence and Occupational Health, Safety and Environment (HSE) management in the workplace, to reduce industrial incidents of human factors. Therefore, there is a requirement for a better understanding of how Emotional Intelligence factors influence health and safety performance in the workplace. A qualitative study has been done to achieve this purpose. In this case, data has been collected through eight semi-structured interviews with HSE managers and officers that participated from different industries around the world.  The main focus of this collection data was extracting the perspectives of the individual’s views. Afterward, to create a theory, the data has been analyzed according to different steps for a grounded analysis regarding discovering how the Emotional Intelligence factors of employees impact their health and safety performance in the workplace.   The results of this study have shown that there are mainly two areas to study which are key roles of Emotional Intelligence in safety performance and key roles for effective Healthy, Safety, and Environment management. It has shown that the key roles of Emotional Intelligence in safety performance is being able to manage your own and being able to deal with other’s emotions. Besides, key roles for effective Healthy, Safety, and Environment management only three factors have been important to improve the safety act which is being able to make the correct decision in the emergency situation’ and ability to prevent incidents at the workplace as well as the level of perception of risk. These results demonstrated that strong factors of Emotional Intelligence are vital to improve the health and safety performance at the workplace and the improvement of these abilities should be approached for the workplace.

Bakgrund: Sjuksköterskor riskerar dagligen att hamna i situationer som kan upplevas som kritiska. Syftet med denna systematiska litteraturstudie var därför att undersöka vilka händelser som sjuksköterskan upplever som kritiska och hur dessa händelser sedan upplevs och hanteras. Heideggers hermeneutiskt inriktade fenomenologi användes som teoretisk referensram i arbetet. Metod: Genom databaserna PubMed, CINAHL och Medline hittades 17 artiklar som var av intresse, efter kvalitetsgranskning valdes tio artiklar ut för att redovisas i arbetet. Resultat: Händelser som sjuksköterskan bland annat ansåg som kritiska var händelser som involverade barn, allvarligt skadade personer samt akuta händelser som kunde vara andnings- eller hjärtstopp. Upplevelsen av en sådan händelse var varierande, den kunde vara ledsam, sjuksköterskan kunde känna stor osäkerhet och gav en stark trötthet. För att hantera en sådan känsla tog sjuksköterskan till olika tekniker för att hantera situationen. Ett sätt för att minska ångesten var att skämta och använda humor, ett annat sätt var att söka stöd hos sina arbetskamrater. Samtidigt var det också viktigt att det fanns ett formellt stöd inom organisationen som sjuksköterskan kunde ta hjälp av ifall händelsen blev allt för övermäktig. Konklusion: Sjuksköterskan skall vara medveten om att kritiska händelser kan leda till allvarliga stressreaktioner och vara uppmärksam på ifall tecken på utbrändhet visas. / Background: Nurses risk every day to get into situations that could be perceived as critical. The purpose of this systematic literature review was to investigate the events, which the nurse feels are critical and how these events since perceived and handled. Heidegger's hermeneutic phenomenology was used as a focused theoretical framework of the work. Methods: The PubMed, CINAHL and Medline found 17 articles that were of interest, after the quality review was ten articles out for recognition at work. Results: Events that nurses in particular felt that was critical incidents involving children, serious injuries and emergencies that could be respiratory or cardiac arrest. The experience of such an event were varied, it could be tedious, the nurse could feel great uncertainty and gave a strong fatigue. To deal with such a sense took the nurse to the different techniques to handle the situation. One way to reduce the anxiety was making jokes and using humour, another way was to seek support from their colleagues. Meanwhile it was also important that there was a formal support of the organization that the nurse was able to enlist the help of whether the incident was too overpowering. Conclusion: The nurse must be aware that critical incidents can lead to severe stress reactions and be aware of if signs of burnout appear.

In today's modern world, Cyber-Physical Systems (CPS) have gained widespread prevalence, offering tremendous benefits while also increasing society's dependence on them. Given the direct interaction of CPS with the physical environment, their malfunction or compromise can pose significant risks to human life, property, and the environment. However, as the complexity of CPS rises due to heightened expectations and expanded functional requirements, ensuring their trustworthy operation solely during the development process becomes increasingly challenging. This thesis introduces and delves into the novel concept of the 'Protective Shell' – a real-time safeguard actively monitoring CPS during their operational phases. The protective shell serves as a last line of defence, designed to detect abnormal behaviour, conduct thorough analyses, and initiate countermeasures promptly, thereby mitigating unforeseen risks in real-time. The primary objective of this research is to enhance the overall safety and security of CPS by refining, partly implementing, and evaluating the innovative protective shell concept. To provide context for collaborative systems working towards higher objectives — common within CPS as system-of-systems (SoS) — the thesis introduces the 'Emergence Matrix'. This matrix categorises outcomes of such collaboration into four quadrants based on their anticipated nature and desirability. Particularly concerning are outcomes that are both unexpected and undesirable, which frequently serve as the root cause of safety accidents and security incidents in CPS scenarios. The protective shell plays a critical role in mitigating these unfavourable outcomes, as conventional vulnerability elimination procedures during the CPS design phase prove insufficient due to their inability to proactively anticipate and address these unforeseen situations. Employing the design science research methodology, the thesis is structured around its iterative cycles and the research questions imposed, offering a systematic exploration of the topic. A detailed analysis of various safety accidents and security incidents involving CPS was conducted to retrieve vulnerabilities that led to dangerous outcomes. By developing specific protective shells for each affected CPS and assessing their effectiveness during these hazardous scenarios, a generic core for the protective shell concept could be retrieved, indicating general characteristics and its overall applicability. Furthermore, the research presents a generic protective shell architecture, integrating advanced anomaly detection techniques rooted in explainable artificial intelligence (XAI) and human machine teaming. While the implementation of protective shells demonstrate substantial positive impacts in ensuring CPS safety and security, the thesis also articulates potential risks associated with their deployment that require careful consideration. In conclusion, this thesis makes a significant contribution towards the safer and more secure integration of complex CPS into daily routines, critical infrastructures and other sectors by leveraging the capabilities of the generic protective shell framework.:1 Introduction 1.1 Background and Context 1.2 Research Problem 1.3 Purpose and Objectives 1.3.1 Thesis Vision 1.3.2 Thesis Mission 1.4 Thesis Outline and Structure 2 Design Science Research Methodology 2.1 Relevance-, Rigor- and Design Cycle 2.2 Research Questions 3 Cyber-Physical Systems 3.1 Explanation 3.2 Safety- and Security-Critical Aspects 3.3 Risk 3.3.1 Quantitative Risk Assessment 3.3.2 Qualitative Risk Assessment 3.3.3 Risk Reduction Mechanisms 3.3.4 Acceptable Residual Risk 3.4 Engineering Principles 3.4.1 Safety Principles 3.4.2 Security Principles 3.5 Cyber-Physical System of Systems (CPSoS) 3.5.1 Emergence 4 Protective Shell 4.1 Explanation 4.2 System Architecture 4.3 Run-Time Monitoring 4.4 Definition 4.5 Expectations / Goals 5 Specific Protective Shells 5.1 Boeing 737 Max MCAS 5.1.1 Introduction 5.1.2 Vulnerabilities within CPS 5.1.3 Specific Protective Shell Mitigation Mechanisms 5.1.4 Protective Shell Evaluation 5.2 Therac-25 5.2.1 Introduction 5.2.2 Vulnerabilities within CPS 5.2.3 Specific Protective Shell Mitigation Mechanisms 5.2.4 Protective Shell Evaluation 5.3 Stuxnet 5.3.1 Introduction 5.3.2 Exploited Vulnerabilities 5.3.3 Specific Protective Shell Mitigation Mechanisms 5.3.4 Protective Shell Evaluation 5.4 Toyota 'Unintended Acceleration' ETCS 5.4.1 Introduction 5.4.2 Vulnerabilities within CPS 5.4.3 Specific Protective Shell Mitigation Mechanisms 5.4.4 Protective Shell Evaluation 5.5 Jeep Cherokee Hack 5.5.1 Introduction 5.5.2 Vulnerabilities within CPS 5.5.3 Specific Protective Shell Mitigation Mechanisms 5.5.4 Protective Shell Evaluation 5.6 Ukrainian Power Grid Cyber-Attack 5.6.1 Introduction 5.6.2 Vulnerabilities in the critical Infrastructure 5.6.3 Specific Protective Shell Mitigation Mechanisms 5.6.4 Protective Shell Evaluation 5.7 Airbus A400M FADEC 5.7.1 Introduction 5.7.2 Vulnerabilities within CPS 5.7.3 Specific Protective Shell Mitigation Mechanisms 5.7.4 Protective Shell Evaluation 5.8 Similarities between Specific Protective Shells 5.8.1 Mitigation Mechanisms Categories 5.8.2 Explanation 5.8.3 Conclusion 6 AI 6.1 Explainable AI (XAI) for Anomaly Detection 6.1.1 Anomaly Detection 6.1.2 Explainable Artificial Intelligence 6.2 Intrinsic Explainable ML Models 6.2.1 Linear Regression 6.2.2 Decision Trees 6.2.3 K-Nearest Neighbours 6.3 Example Use Case - Predictive Maintenance 7 Generic Protective Shell 7.1 Architecture 7.1.1 MAPE-K 7.1.2 Human Machine Teaming 7.1.3 Protective Shell Plugin Catalogue 7.1.4 Architecture and Design Principles 7.1.5 Conclusion Architecture 7.2 Implementation Details 7.3 Evaluation 7.3.1 Additional Vulnerabilities introduced by the Protective Shell 7.3.2 Summary 8 Conclusion 8.1 Summary 8.2 Research Questions Evaluation 8.3 Contribution 8.4 Future Work 8.5 Recommendation

The aim of the study was to describe and analyse leaming processes in a group of preschool students. My questions was; what do preschool students think about preschool teachers' attitude regarding meals? Do their attitudes and descriptions change during the time of education and if so, which are the contributory causes to this change? The investigation has a qualitative approach where ten students were interviewed on two different occasions with two years in between. The starting point for the interviews were nine cri tical incidents. In the analysis I found several different attitudes, which were brought together to six general attitudes witch I narned; "the Regulator", "the Considerator", "the Planner", "the Cooperator", "the Adaptor" and "the Persuader". The Considerator, the Planner, the Cooperator and the Adaptor all want to, in their own way, tum the meals into positive and joyful moments for all participants. These attitudes describe an active preschool teacher who plans and organises the meals based on the childs needs and abilities. The Regulator's and the Persuader's attitudes were based upon the will to reform the childs behaviour, which was seen upon as negative or less acceptable. The result shows that the attitudes somewhat differ between the two years, for exarnple does the Persuader deminishes while the Planner grows in nurnber. My analysis shows that there are several contributory causes to the students' change of attitude. These are; work experience, theoretical experience, literature studies, broadened understanding, possibilities to discussion, as well as the collaboration between theory and practice. When discussing the result, theories about competence and knowledge, especially the competence and knowledge of the preschool teacher, are considered. The learning process and effects from education, again especially focused on the education of preschool teachers, are also discussed. One conclusion is thai:" the learning process can either be facilitated or aggravated by the organisation of the education. Alternation between theoretical and practical elements &lt;luring the whole educational period is positive for the learning process, as well as creating several opportunities for reflection, and to create working methods which stimulate the visualisation of the students' own learning process. / <p>Licentiatavhandling</p>

Fire incidents are a central issue in Saudi civil defence. Despite detailed regulation concerning firefighting equipment dealing with dwelling fires, fires occur frequently. Globally, research on dwelling fire safety is relatively new. Most studies focus on human factors, incidence and causal issues. Few studies examine management or policy-making perspectives towards managing these individual agents. Thus, a detailed study on understanding the management of these factors for dwelling fires is long overdue. The study uses an inductive approach to investigate key management issues in reducing dwelling fires in Saudi Arabia. This qualitative study consisted of twelve indepth semi-structured interviews and four focus groups with senior managers of the Civil Defence Division dealing with fire safety. A sustainability-based framework is developed to map the critical issues in generating a long-term planning solution to policy and management of fire hazard and risk in Saudi Arabia. Critical drivers of this sustainability approach are good management, regulation, governance practices: especially accountability and transparency; reduction of tribalism, bureaucracy, and burns unit efficiency. However, given the modern environment of communications, information technology and communications, and in particular public education, are viewed as important mediators between drivers and sustainability. The critical role of knowledge generation is also positioned as a mediator. The framework proposed is a paradigm shift from merely managing fire incidents on a case by case basis to a proactive risk reduction strategy. This represents an original solution to managing fire hazards at a national level and an important contribution to the fire management literature.

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