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Challenges in accessibility to CE marked medical devices within the European Union
Get PDFIntroduction: The European Union (EU) has introduced the 2017/745 Medical Devices Regulation (MDR), and the 2017/746 In Vitro Diagnostic
Medical Devices Regulation (IVDR). These regulations introduced challenges to pharmacists and stakeholders, such as medical
device manufacturers and importers. The need for competence building1 in medical devices regulatory compliance through
pharmacy education was identified.Aims: To identify challenges faced by stakeholders, brought about by the implementation of the current EU Regulations, 2017/475
MDR and 2017/746 IVDR.peer-reviewe
A framework for integrated safety in safety-management systems in healthcare
No full textPurpose – Notwithstanding increased patient safety initiatives, adverse events and their impact on those involved continue. The strategic approaches adopted to manage safety by other high-intensity, high-risk and complex industries, such as aviation, have led to an increase in the systems approach for safety management in healthcare organisations. Professional expertise from members of the European Researchers’ Network for Second Victims (ERNST) highlighted that safety and the second victim phenomenon are interconnected across the healthcare ecosystem, extending beyond individual healthcare organisations. Design/methodology/approach – Evidence from different sources, mainly the literature and practitioner professional expertise, was iteratively aggregated and analysed using theoretical systems-based approaches to conceptualise a framework for integrated safety in safety management systems in health. Findings – A cross-sectional view of the healthcare organisation affected by adverse events was presented as a baseline. The whole system (system levels) approach, representing the healthcare system at the micro-, meso- and macro-level, adapting the model for integrated care, was then adopted. A safety-generating culture was considered to integrate and network across the levels of the healthcare system. The “system” (processes) approach, also considering external factors, was incorporated. This iterative conceptualisation led to a proposed framework for integrated safety. This framework was applied to systematically make recommendations for actions to support safety across the healthcare ecosystem. Originality/value – Aggregation of evidence from the literature, together with expertise from professionals and iterative conceptualisation across models adopting the systems approach, led to a comprehensive framework for integrated safety in safety-management systems.peer-reviewe
Abstract citation ID: ckaf161.776
No full textThis presentation will outline other examples of international policies aimed at protecting children and adolescents from being targets of tech companies, with a specific focus on the new social media age restrictions in Norway and Australia. In Norway, the government has ramped up its campaign towards enforcing a strict minimum age limit on social media use. It has been proposed that Norway's Personal Data Act which aims at protecting children from harmful content they may encounter online, will be raised from a minimum of 13 to 15 years of age. In 2024, the Australian Parliament passed the Online Safety Amendment (Social Media Minimum Age) Bill 2024, to amend the Online Safety Act 2021. This new Bill establishes a minimum age for social media use and an obligation on providers of an age-restricted social media platform to take reasonable steps to prevent age-restricted users from having an account with the platform. According to this Bill, age-restricted user means an Australian child who has not reached 16 years. In this presentation, the practicalities and challenges in implementing this Bill, will be outlined, based on the initial 12-month experience since its enactment.peer-reviewe
The unseen role of AI in everyday decision-making
No full textPURPOSE: The aim of this article is to analyze the applications of artificial intelligence in less
visible aspects of human life, with particular emphasis on travel, social media, online
shopping, and digital entertainment.DESIGN/METHODOLOGY/APPROACH: The study reviews scientific literature on algorithms used in
these areas, including methods of machine learning, deep learning, and natural language
processing.FINDINGS: The results indicate that AI significantly enhances the personalization of user
experiences, thereby improving the efficiency of interactions across various digital systems.PRACTICAL IMPLEMENTATION: The conclusions highlight the growing importance of AI in
everyday life, as well as its potential for further automation and optimization of user
processes.ORIGINALITY/VALUE: The findings indicate that AI substantially improves the personalization of
user experiences and enhances the efficiency of interactions with digital systems. The study
underscores the increasing role of AI in daily practices and points to its potential for further
automation and optimization of user-related processes.peer-reviewe
Bottlenecks in advancing and applying multiomic data integration — common data resources as rate-limiting drivers — the high-impact use case of atherosclerotic cardiovascular disease
No full textDespite striking successes in identifying novel biomarkers for improved patient stratification and predicting disease progression, numerous challenges remain in the effective integration and exploitation of multiomic data in biomedical applications beyond cancer, for which most bioinformatics strategies are developed and validated. That focus on cancer severely limits the effective development and advancement of algorithms in machine learning and artificial intelligence that do not suffer degraded out-of-domain performance. Generalizability and interpretability of models, however, are also required for robust insights that may translate into clinical practice. Work across different independent datasets is critical for establishing models robust towards unwanted variation in assays, protocols, and cohort populations. Disease-specific context like ethnicity, socioeconomic background, sex, lifestyle, disease phase, and tissue type also strongly affect molecular profiles. We here discuss atherosclerotic cardiovascular disease (ASCVD) as a high-impact non-cancer use case for the challenges remaining in the development and application of the latest bioinformatics approaches to multiomics data integration. ASCVD remains the leading cause of death globally. Disease aetiology, progression, and therapy outcome depend on a complex interplay of genetic, environmental, and lifestyle factors. Integrating these diverse data types effectively remains a challenge but holds transformative potential for personalized medicine. Discovery and access to data of sufficient diversity and extent form key bottlenecks. We here compile a first comprehensive overview of key data sets in ASCVD to complement the established cancer-focused resources as a foundation for future effective development and application of state-of-the-art bioinformatics tools for multiomic data integration.peer-reviewe
Impact of European Union educational mobility on the employability of Polish youth and their social integration
No full textPURPOSE: The aim of the article is to analyze the impact of international educational
mobility, particularly the Erasmus+ program, on strengthening social security in Poland and
the European Union. The author focuses on the role of these initiatives in developing
competencies, promoting social integration, and counteracting exclusion and
marginalization.DESIGN/METHODOLOGY/APPROACH: The article applies the method of literature review and
analysis of strategic documents of the European Union concerning international educational
mobility and social security. The author uses quantitative data and reports from programs
such as Erasmus+ to illustrate the scale and scope of educational mobility in Poland
compared to other EU countries. The analysis is embedded within a broader socio-political
context and is based on available academic studies and institutional materials.FINDINGS: The analysis showed that international educational mobility significantly
contributes to strengthening social security by developing competencies, increasing
employment opportunities, and promoting social integration. Poland actively participates in
the Erasmus+ program, ranking 5th in the EU in terms of the number of funded projects in
2023. This mobility is growing not only in scale but also in quality supporting the
development of language, digital, and intercultural skills, thereby enhancing social and
economic resilience.PRACTICAL IMPLICATIONS: The results presented in the article shows that international
educational mobility has practical significance as a tool for strengthening social security,
integration, and employability. It can support educational and social policies, contributing to
socio-economic stability.ORIGINALITY/VALUE: The article offers an original perspective connection international
educational mobility with social security, highlighting its impact on integration,
employability, and stability. In the Polish context, it provides arguments for treating mobility
as a strategic tool of social policy.peer-reviewe
Optimizing maritime security strategies : a methodological approach using AHP and SWOT
No full textPURPOSE: The purpose of this paper is to propose the enhancement of SWOT analysis with
multicriteria decision-making technique (AHP). Therefore, the goal of applying this
combined method is to improve the quantitative aspect of strategic planning regarding the
best possible decision-making in the process of providing maritime security services in an
unstable geoeconomic and geopolitical environment.DESIGN/METHODOLOGY/APPROACH: Initially, a detailed presentation of the Strengths,
Weaknesses, Opportunities and Threats is made and reflected in the relevant SWOT table.
The AHP approach then achieves pairwise comparisons between factors and sub-criteria
SWOT in order to prioritize them using eigenvalue calculation.FINDINGS: Conclusions are drawn from this analysis regarding the weighting in relation to
the priority of each SWOT group. Thus, it is then concluded which factor from a particular
group is the most important due to the highest Overall Priority of Factor. And, of course, this
analysis also gives us the ranking in priorities of the other factors based on the Overall
Priority Factor. In addition, this analysis enables us to assess the consistency of our findings.PRACTICAL IMPLICATIONS: The practical implications relate primarily to the possibility for Law
Enforcemnts Agensies/Naval Forces and Shipping Companies as well to use the
methodology in question in effective decision -making management, in order to optimize
Maritime Security Strategies.ORIGINALITY/VALUE: The contribution is twofold: First, using SWOT's calculations of factors
and sub-criteria, an approach could be implemented regarding the support and
documentation of critical decisions at strategic and operational level, since each qualitative
element acquires a quantitative dimension in dealing with shipping risks and threats. Second,
the results of the work could be used to synthesize a set of appropriate alternative strategies
to protect international shipping activity in high-risk areas given geopolitical and geo-economic conditions.peer-reviewe
The genera Murexsul Iredale, 1915 and Muricopsis Bucquoy & Dautzenberg, 1882 in Maltese waters, with the description of a new species (Gastropoda : Muricidae)
No full textIn this study, the muricid gastropod species belonging the genera Murexsul Iredale, 1915 and
Muricopsis Bucquoy & Dautzenberg, 1882 that occur in Maltese waters are reviewed. The reviewed
determinations exclude Muricopsis inermis (Philippi, 1836) from the Maltese faunal checklist,
confirm the occurrence of Murexsul aradasii (Monterosato, 1883) and Muricopsis cristata (Brocchi,
1814), and recognise the presence of the newly recorded Muricopsis cevikeri Houart, 2000 and a
new species, formally described as Muricopsis vilhenae n. sp. The new species differs from the
sympatric M. cristata by bolder sculpture, a single prominent columellar knob, a consistently pale
violet aperture, a non-projecting siphonal canal, and a distinct animal colouration.peer-reviewe
Modeling exchange rate volatility in India in relation to COVID-19 and lockdown stringency : a wavelet coherence and quantile causality approach
No full textThe COVID-19 pandemic and the implementation of strict lockdown measures have significantly impacted various dimensions of the global economy. This study examines the impact of COVID-19 and lockdown stringency on exchange rate volatility in India using three core variables, i.e., COVID-19 cases, the lockdown stringency index, and exchange rate volatility. To achieve the above objectives, we have employed advanced econometric techniques, such as wavelet coherence and a hybrid non-parametric quantile causality framework, on the dataset spanning from 30 December 2020 to 24 January 2022. Robustness is assessed using Troster–Granger causality in quantiles and Breitung–Candelon Spectral Causality tests. The wavelet coherence analysis indicates that the initial outbreak of COVID-19 increased the exchange rate volatility, while the enforcement of stringent lockdowns in the later phases helped reduce this volatility. Similarly, the hybrid quantile causality results indicate that both COVID-19 cases and lockdown measures possess predictive power over exchange rate fluctuations. The robustness checks confirm these findings and establish a causal relationship between the pandemic, policy responses, and currency market behaviour. This study helps clarify the complex, nonlinear dynamics between pandemic-related variables and exchange rate volatility in emerging markets. Based on the aforementioned result, it is recommended that policymakers implement targeted lockdown strategies coupled with timely monetary interventions (such as foreign exchange reserve management or interest rate adjustments) to mitigate volatility and maintain currency stability during future pandemic-induced shocks.peer-reviewe
Coronary risk reduction intervention for siblings and offspring of patients with premature coronary heart disease : the criso project
No full textBackground: Preventive cardiology programmes often have limited success, with high-risk individuals maintaining suboptimal health practices. No existing programme on the island targets first-degree relatives of patients with premature coronary heart disease. This project aimed to develop and assess the feasibility, acceptability, and potential effectiveness of a preventive intervention. Design: A 12-month, single-centre RCT with 89 participants, randomly assigned to control (n=45) or intervention (n=44) groups. The intervention, delivered at the general hospital, included risk communication via an online calculator, motivational interviewing-style counselling, and 12 weekly goal-reinforcement calls. Controls received verbal lifestyle advice. Risk factors were assessed at baseline, 6, and 12 months. Feasibility was measured through recruitment/retention; acceptability via questionnaires and interviews with 24 intervention participants. Results: At 6 months, both groups showed significant improvements in diet, physical activity, blood pressure, and health literacy (p 0.05). Predictors of overweight, obesity, central obesity, and clustering of risk factors included underactivity and sedentarism (p < 0.05). Elevations in systolic (rs = 0.497, p = 0.001) and diastolic blood pressure (rs = 0.453, p = 0.002), Total-C ratio (rs = 0.532, p = 0.001), HbA1c (rs = 0.528, p = 0.001), Heart-Age (rs = 0.566, p = 0.001), and 10-year MI risk (rs = 0.604, p = 0.007) positively correlated with higher BMI. Reductions in waist circumference correlated with lower systolic blood pressure (p = 0.009), while weight changes improved HDL-C (p = 0.006). Systolic blood pressure and Total-C ratio were linked to better Heart-Age scores (p < 0.001) and lower 10-year MI risk (p = 0.006). Quality patient-clinician interactions included personalized feedback and free services. Key intervention components for behaviour change included clinician-guided results discussions, goal setting, reinforcement, and monitoring. Motivators for risk reduction included family history, ageing, and better outcomes, while challenges involved self-discipline, anxiety, addiction, and planning difficulties. Overcoming these challenges required awareness of benefits, simple enjoyable plans, a step-by-step approach, and goal prioritization. Conclusion: While between-group differences were non-significant, understanding motivators and clinician support is vital for behaviour change. Sustainable strategies focusing on patient-specific interventions are needed for improving preventive cardiology outcomes.peer-reviewe