Articles / Άρθρα

MDCG 2019-16 is intended to assist practitioners in compliance with the Medical Device Regulation and the In-Vitro Device Regulation. This paper presents a gap analysis of MDCG 2019-16, identifying key gaps and proposing a robust set of recommendations to enhance the IoMT regulatory framework. This work has been undertaken by a selection of current (2023-2025) projects, all funded under the Horizon Europe call "Enhancing cybersecurity of connected medical devices": HORIZON-HLTH-2022-IND-13-01, and this paper summarizes observations and recommendations from across these projects. There is considerable consensus across the projects in many recommendation themes, notably; linking cybersecurity with patient safety and privacy; keeping the guidelines current; and usage recipes for the guidelines. The paper also suggests toolkit solutions to address some of the recommendations.

Global environmental and social change are pushing wildfire activity and impact beyond known trajectories. Here, we conducted a targeted review to distill five wildfire challenges that we argue form opportunities for their governance (research aim 1). We exemplified our arguments by drawing from the case of Cyprus (research aim 2), a small island country in the south-east European Mediterranean Basin at risk of extreme wildfire impact. Findings indicate that burning for social and ecological resource benefits, innovative management paradigms and anticipatory governance systems offer actionable solutions to the wildfire paradox and the limits of suppression. Local adaptive institutions and a reconceptualisation of wildfire as a risk and process beyond technocratic interpretations are necessary to account for broader social conditions shaping wildfire regimes and community impact. Governance systems that accommodate collective action have proven suitable to address multiple wildfire complexities linked with different socio-economic systems and values. A systematic literature review, policy review, and qualitative data collection on wildfire management in Cyprus track back to the initial framing. Our case study offers insights for tackling wildfires with actionable steps through overarching governance systems, and illustrates the potential for change in thinking of and acting on wildfire in flammable landscapes globally.

This paper investigates the views of practitioners on the decision-making influences and the transnational considerations affecting risk assessment (RA) for critical infrastructure (CI) and its protection (CIP). The investigation is based on a thematic analysis of the interviews of twelve RA practitioners. The analysis identified an overarching theme supporting the view that the team approach is the one true remedy to RA process shortcomings as well as five other themes: (1) the value of the human influence in RA; (2) transnationalism - an unfathomable notion; (3) consistency is no panacea to performance; (4) CI organizational RA-influencing forces; and (5) CI RA-enablers and impediments. The investigation suggests that the team approach to effective RA for CIP is considered as the absolute panacea in the eyes of practitioners although both insights from the current industry RA practice through the interviews themselves, and an investigation of relevant literature suggests that although this is warmheartedly recommended (a) there are no set rules and guidelines in its application, (b) it is not coordinated nor applied consistently, and (c) it is not an integral part of RA processes. Notwithstanding the reality that a team approach to RA for CIP is being contemplated by practitioners, albeit with lagging consistency and coordination, it is evident that additional research is necessary to broaden the understanding of its value.

Fire and explosion are one of the fatal causalities frequently encountered in maritime transportation. Due to technical or/and human error, fire and explosion can be occurred either in the cargo hold or deck of bulk carriers. According to the EMSA report (2022), fire and explosion causalities were ranked 4th on the top. Fire and explosion accidents onboard may pose hazards for human life and the maritime environment. In this context, performing a comprehensive risk assessment is of paramount importance for safer navigation, cargo operation, and the marine environment. This study aims to assess the risks, including human errors, of fire and explosion accidents in cargo holds and decks of bulk carriers under the fuzzy Bayesian networks (BN) approach. Since BN provides a robust tool for calculating the conditional probability of risk, fuzzy sets deal with uncertainty and ambiguity during expert judgments. The outcomes of the paper are expected to contribute to bulk carrier ship owners, safety superintendents, HSEQ managers, Master, Chief officers, and crew on-board ships to understand basic events that may cause fire and explosion and to improve safety at the operational level.