The Use of Contact Tracing Technologies for Infection Prevention and Control Purposes in Nosocomial Settings: A Systematic Literature Review.

BACKGROUND: Pandemic management and preparedness are more needed than ever before and there is widespread governmental interest in learning from the COVID-19 pandemic in order to ensure the availability of evidence-based Infection Prevention and Control measures. Contact tracing is integral to Infection Prevention and Control, facilitating breaks in the chain of transmission in a targeted way, identifying individuals who have come into contact with an infected person, and providing them with instruction/advice relating to testing, medical advice and/or self-isolation. AIM: This study aims to improve our understanding of the use of contact tracing technologies in healthcare settings. This research seeks to contribute to the field of Infection Prevention and Control by investigating how these technologies can mitigate the spread of nosocomial infections. Ultimately, this study aims to improve the quality and safety of healthcare delivery. METHODS: A systematic literature review was conducted, and journal articles investigating the use of contact tracing technologies in healthcare settings were retrieved from databases held on the OvidSP platform between March and September 2022, with no date for a lower limit. RESULTS: In total, 277 studies were retrieved and screened, and 14 studies were finally included in the systematic literature review. Most studies investigated proximity sensing technologies, reporting promising results. However, studies were limited by small sample sizes and confounding factors, revealing contact tracing technologies remain at a nascent stage. Investment in research and development of new testing technologies is necessary to strengthen national and international contact tracing capabilities. CONCLUSION: This review aims to contribute to those who intend to create robust surveillance systems and implement infectious disease reporting protocols.

A 3D-printed condom intrauterine balloon tamponade: Design, prototyping, and technical validation.

Post-partum haemorrhage is among the main causes of (preventable) mortality for women in low-resource settings (LRSs), where, in 2017, the mortality ratio was 462 out of every 100 000 live births, over 10 times higher than for high-resource settings. There are different treatments available for post-partum haemorrhage. The intrauterine balloon tamponade is a medical device that proved to be a simple and cost-effective approach. Currently, there are several balloon tamponades available, with different design and working principles. However, all these devices were designed for high-resource settings, presenting several aspects that could be inappropriate for many lower-income countries. This paper presents the results of a preclinical study aiming at informing the design, prototyping and validation of a 3D-printed intrauterine balloon tamponade concept, contributing towards the United Nation's Sustainable Development Goal 3: Good health and Well-being. Frugal engineering concepts and contextualised design techniques were applied throughout, to define the design requirements and specifications. The performance of the final prototype was validated against the requirements of the UK National Health System (NHS) technical guidelines and relevant literature, measuring the water leak and pressure drop over time, both open air and in a approximate uterus model. The resulting prototype is made up of six components, some of which are easy to retrieve, namely a water bottle, a silicone tube and an ordinary condom, while others can be manufactured locally using 3D printers, namely a modified bottle cap, a flow stopper and a valve for holding the condom in place. Validation testing bore promising results with no water or pressure leak open air, and minimal leaks in the approximate uterus model. This demonstrates that the 3D printed condom-based intrauterine balloon tamponade is performing well against the requirements and, when compared to the state of the art, it could be a more appropriate and more resilient solution to low-resource settings, as it bypasses the challenges in the supply of consumables and presents a greener option based on circular economy.

Clearing the Fog: A Scoping Literature Review on the Ethical Issues Surrounding Artificial Intelligence-Based Medical Devices.

The use of AI in healthcare has sparked much debate among philosophers, ethicists, regulators and policymakers who raised concerns about the implications of such technologies. The presented scoping review captures the progression of the ethical and legal debate and the proposed ethical frameworks available concerning the use of AI-based medical technologies, capturing key themes across a wide range of medical contexts. The ethical dimensions are synthesised in order to produce a coherent ethical framework for AI-based medical technologies, highlighting how transparency, accountability, confidentiality, autonomy, trust and fairness are the top six recurrent ethical issues. The literature also highlighted how it is essential to increase ethical awareness through interdisciplinary research, such that researchers, AI developers and regulators have the necessary education/competence or networks and tools to ensure proper consideration of ethical matters in the conception and design of new AI technologies and their norms. Interdisciplinarity throughout research, regulation and implementation will help ensure AI-based medical devices are ethical, clinically effective and safe. Achieving these goals will facilitate successful translation of AI into healthcare systems, which currently is lagging behind other sectors, to ensure timely achievement of health benefits to patients and the public.

Towards a common European ethical and legal framework for conducting clinical research: the GATEKEEPER experience.

This paper examines the ethical and legal challenges encountered during the GATEKEEPER Project and how these challenges informed the development of a comprehensive framework for future Large-Scale Pilot (LSP) projects. GATEKEEPER is a LSP Project with 48 partners conducting 30 implementation studies across Europe with 50,000 target participants grouped into 9 Reference Use Cases. The project underscored the complexity of obtaining ethical approval across various jurisdictions with divergent regulations and procedures. Through a detailed analysis of the issues faced and the strategies employed to navigate these challenges, this study proposes an ethical and legal framework. This framework, derived from a comparative analysis of ethical application forms and regulations, aims to streamline the ethical approval process for future LSP research projects. By addressing the hurdles encountered in GATEKEEPER, the proposed framework offers a roadmap for more efficient and effective project management, ensuring smoother implementation of similar projects in the future.

Pandemic Preparedness: A Scoping Review of Best and Worst Practices from COVID-19.

The COVID-19 pandemic highlighted the scale of global unpreparedness to deal with the fast-arising needs of global health threats. This problem was coupled with a crisis of governance and presented in the context of globally hitting climate crisis and disasters. Although such a pandemic was predictable due to the known effects of human intervention on the surrounding environment and its devastating secondary effects, such as climate change and increased zoonoses, most countries were unprepared to deal with the scale and scope of the pandemic. In this context, such as that of the climate crisis, the Global North and Global South faced several common challenges, including, first and foremost, the scarcity of resources required for health, policy, wellbeing and socioeconomic wellness. In this paper, we review the most recent evidence available in the literature related to pandemic preparedness and governance, focusing on principles and practices used during the COVID-19 pandemic, and we place it in the context of a European Parliament Interest Group meeting (this event took place on 21 March 2023 during the "European Health Tech Summit") to ground it within ongoing discussions and narratives of policy and praxis. The review identified key practices and principles required to better face future health threats and emergencies. Beyond health practices relying on technology and innovation, it is useful to mention the importance of contextualising responses and linking them to clear goals, improving the agreement between science and policymaking, thus building trust and enabling transparent communication with the general public based on clear ethical frameworks.

The use of smart environments and robots for infection prevention control: A systematic literature review.

BACKGROUND: Infection prevention and control (IPC) is essential to prevent nosocomial infections. This manuscript aims at investigating the current use and role of robots and smart environments on IPC systems in nosocomial settings METHODS: The systematic literature review was performed following the PRISMA statement. Literature was searched for articles published in the period January 2016 to October 2022. Two authors determined the eligibility of the papers, with conflicting decisions being mitigated by a third. Relevant data was then extracted using an ad-hoc extraction table to facilitate the analysis and narrative synthesis. RESULTS: The search strategy returned 1520 citations and 17 papers were included. This review identified 3 main areas of interest: hand hygiene and personal protective equipment compliance, automatic infection cluster detection and environments cleaning (ie, air quality control, sterilization). This review demonstrates that IPC practices within hospitals mostly do not rely on automation and robotic technology, and few advancements have been made in this field. CONCLUSIONS: Increasing the awareness of healthcare workers on these technologies, through training and involving them in the design process, is essential to accomplish the Health 4.0 transformation. Research priorities should also be considering how to implement similar or more contextualized alternatives for low-income countries.

COVID-19 preparedness and social dynamics in a Sub-Saharan Africa country, Benin.

This project aims to assess and analyse the perception and impact of the COVID-19 pandemic in Benin. The applied research methodology was interdisciplinary and combined field studies that used ethnographic and social research methods with coding and data analysis, leading to theoretical dilemmas, which were analysed from the viewpoint of bioethical reflection. Furthermore, biomedical engineering approaches were used to assess the preparedness to COVID-19. Despite the preparedness to COVID-19 due to the promoted governmental measures, a peculiar management of the pandemic emerged. The latter, although noteworthy, did not overcome the typical challenges of medical locations in low-resource settings. This, together with the controversial spread of information and local beliefs, caused significant economic and social consequences, exceeding the benefits related to the containment of the virus. This research highlights how the emotion of fear, in this specific situation, was herald of dramatic consequences, rather than having a heuristic and empowering effect.

Social Engagement in the Fight Against COVID-19 in the Urban and Peri-Urban Areas of Cotonou (Benin, Sub-saharan Africa): Acceptability of the Vaccination and Tracking Program.

Introduction: This article aims at investigating social engagement in the fight against the COVID-19 pandemic in low-resource settings (LRSs). In particular, it focuses on Benin (Sub-Saharan Africa), and reports the results of a field study that investigated the local people's acceptance of the vaccine and the tracking program. Methods: This project is the product of a collaboration between the ABSPIE (Applied Biomedical and Signal Processing E-Health) Lab of the University of Warwick (UK) and the LAMA (Laboratoire d'Antropologie Medical Appliqué) of the University of Abomey Calavi (Benin). This international multidisciplinary collaboration brought together engineers, sociologists, anthropologists, and bioethicists. In light of the aims of the project, a qualitative methodology was deemed appropriate. The research team prepared two questionnaires that provided the basis for semi-structured interviews that took place between June and August 2021. Results: The research team interviewed 34 Beninese respondents, comprising people aged 60+ (with multiple comorbidities), who were primarily healthcare workers and/or traditional therapists. The results of this work highlight the fact that there is widespread reticence about the vaccination program in Benin, both due to local beliefs and uncertainty about governmental management. In this study, we uncovered several local reasons interfering with the involvement of the population in the vaccination campaign against COVID-19, e.g., the existence of traditional medical practices considered as valid alternatives to vaccines, and many beliefs showing a fear of neo-colonialism hidden in the pandemic threat. Yet, another hindrance can be traced to shortcomings in the management of the vaccination campaign which resulted in obstacles to the implementation of the program. Conclusions: This work does not intend to denounce any governmental effort or foster a regressive mindset, but shows how the overall confusion (defined by the World Health Organization as infodemic) linked to the pandemic and its management has caused even more dramatic consequences in LRSs. In addition, the paper proposes a specific framework for the interpretation and management of bioethical and biomedical issues in LRSs that the authors are validating in their current research.

Biomedical engineering and ethics: reflections on medical devices and PPE during the first wave of COVID-19.

In March 2019, the World Health Organization (WHO) declared that humanity was entering a global pandemic phase. This unforeseen situation caught everyone unprepared and had a major impact on several professional categories that found themselves facing important ethical dilemmas. The article revolves around the category of biomedical and clinical engineers, which were among those most involved in dealing with and finding solutions to the pandemic. In hindsight, the major issues brought to the attention of biomedical engineers have raised important ethical implications, such as the allocation of resources, the responsibilities of science and the inadequacy and non-universality of the norms and regulations on biomedical devices and personal protective equipment. These issues, analyzed one year after the first wave of the pandemic, come together in the appeal for responsibility for thought, action and, sometimes, even silence. This highlights the importance of interdisciplinarity and the definitive collapse of the Cartesian fragmentation of knowledge, calling for the creation of more fora, where this kind of discussions can be promoted.

A framework for designing medical devices resilient to low-resource settings.

BACKGROUND: To date (April 2021), medical device (MD) design approaches have failed to consider the contexts where MDs can be operationalised. Although most of the global population lives and is treated in Low- and Middle-Income Countries (LMCIs), over 80% of the MD market share is in high-resource settings, which set de facto standards that cannot be taken for granted in lower resource settings. Using a MD designed for high-resource settings in LMICs may hinder its safe and efficient operationalisation. In the literature, many criteria for frameworks to support resilient MD design were presented. However, since the available criteria (as of 2021) are far from being consensual and comprehensive, the aim of this study is to raise awareness about such challenges and to scope experts' consensus regarding the essentiality of MD design criteria. RESULTS: This paper presents a novel application of Delphi study and Multiple Criteria Decision Analysis (MCDA) to develop a framework comprising 26 essential criteria, which were evaluated and chosen by international experts coming from different parts of the world. This framework was validated by analysing some MDs presented in the WHO Compendium of innovative health technologies for low-resource settings. CONCLUSIONS: This novel holistic framework takes into account some domains that are usually underestimated by MDs designers. For this reason, it can be used by experts designing MDs resilient to low-resource settings and it can also assist policymakers and non-governmental organisations in shaping the future of global healthcare.

Symptoms of mental health problems among Italian adolescents in 2017-2018 school year: a multicenter cross-sectional study.

BACKGROUND: Identifying individual and contextual factors that influence adolescent well-being is a research priority. This study aimed to assess the prevalence of symptoms of mental health problems and some related factors in Italian adolescents in 2017-2018. METHODS: The present study was a cross-sectional survey among 3002 students aged 15-16 years who resided in two Italian provinces, in North and South Italy. Symptoms of mental health problems were assessed using the SDQ and CES-DC, and students' risk-taking behaviors and school climate perception were assessed. All information was collected anonymously. Logistic regression models were used to assess the associations of tobacco and alcohol use, screen time, bullying, and school climate with symptoms of mental health problems. RESULTS: One student out of five reported symptoms of mental health problems, with a more than double proportion among girls than boys (28.7% vs 10.4% with depressive symptoms, respectively). Thirty percent and 40% of students smoked tobacco or drank alcoholic beverages at least once in the past month, and more than 40% reported being victims or authors of bullying in the past 6 months. Smoking behavior, alcohol consumption, screen time, bullying, and negative school climate had 1.2- to 3.3-fold increased odds of symptoms of mental health problems without substantial differences between sexes and geographical areas. CONCLUSIONS: Tobacco and alcohol use, screen time, bullying, and school climate were independently associated with symptoms of mental health problems in a large sample of 15-16-year-old Italian adolescents without substantial gender and geographical differences.

The role of ethics in science: a systematic literature review from the first wave of COVID-19.

This paper proposes a systematic literature review on ethics and CoviD-19, aiming to understand the impact and the perception of the pandemic during the first wave (January-June 2020) and the consequences one year later. PubMed was systematically searched up May 2020 to identify studies that took into consideration various ethical issues that have been arising from the Covid-19 outbreak. The eligibility of the papers was determined by two authors, who screened the results mediated by a third author. In order to facilitate the screening, the titles were divided into five sub-thematic macro-areas, namely allocation, policy, specialist, clinical trials, and technology and, when possible, per geographical area. Specifically, a posteriori, we decided to focus on the papers referring to policies and technology, as they highlighted ethical issues that are not overused and worthy of particular attention. Thus, 38 studies out of 233 met our inclusion criteria and were fully analysed. Accordingly, this review touches on themes such as fairness, equity, transparency of information, the duty of care, racial disparities, the marginalisation of the poor, and privacy and ethical concerns. Overall, it was found that despite the increased awareness of interdisciplinarity and the essential reference to ethics, many scientific articles use it with little competence, considering it only a "humanitarian" enrichment. In fact, as we understand, reflecting a year after the outbreak of the pandemic, although Covid-19 is leading scientists to increasingly recognise the importance of ethical issues, there is still a lot of confusion that could be helped by establishing international guidelines to act as a moral compass in times of crisis. SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1007/s12553-021-00570-6.

The Inadequacy of Regulatory Frameworks in Time of Crisis and in Low-Resource Settings: Personal Protective Equipment and COVID-19.

COVID-19 pandemic is plaguing the world and representing the most significant stress test for many national healthcare systems and services, since their foundation. The supply-chain disruption and the unprecedented request for intensive care unit (ICU) beds have created in Europe conditions typical of low-resources settings. This generated a remarkable race to find solutions for the prevention, treatment and management of this disease which is involving a large amount of people. Every day, new Do-It-Yourself (DIY) solutions regarding personal protective equipment and medical devices populate social media feeds. Many companies (e.g., automotive or textile) are converting their traditional production to manufacture the most needed equipment (e.g., respirators, face shields, ventilators etc.). In this chaotic scenario, policy makers, international and national standards bodies, along with the World Health Organization (WHO) and scientific societies are making a joint effort to increase global awareness and knowledge about the importance of respecting the relevant requirements to guarantee appropriate quality and safety for patients and healthcare workers. Nonetheless, ordinary procedures for testing and certification are currently questioned and empowered with fast-track pathways in order to speed-up the deployment of new solutions for COVID-19. This paper shares critical reflections on the current regulatory framework for the certification of personal protective equipment. We hope that these reflections may help readers in navigating the framework of regulations, norms and international standards relevant for key personal protective equipment, sharing a subset of tests that should be deemed essential even in a period of crisis.