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.

Scoping Meta-Review of Methods Used to Assess Artificial Intelligence-Based Medical Devices for Heart Failure.

Artificial intelligence and machine learning (AI/ML) are playing increasingly important roles, permeating the field of medical devices (MDs). This rapid progress has not yet been matched by the Health Technology Assessment (HTA) process, which still needs to define a common methodology for assessing AI/ML-based MDs. To collect existing evidence from the literature about the methods used to assess AI-based MDs, with a specific focus on those used for the management of heart failure (HF), the International Federation of Medical and Biological Engineering (IFMBE) conducted a scoping meta-review. This manuscript presents the results of this search, which covered the period from January 1974 to October 2022. After careful independent screening, 21 reviews, mainly conducted in North America and Europe, were retained and included. Among the findings were that deep learning is the most commonly utilised method and that electronic health records and registries are among the most prevalent sources of data for AI/ML algorithms. Out of the 21 included reviews, 19 focused on risk prediction and/or the early diagnosis of HF. Furthermore, 10 reviews provided evidence of the impact on the incidence/progression of HF, and 13 on the length of stay. From an HTA perspective, the main areas requiring improvement are the quality assessment of studies on AI/ML (included in 11 out of 21 reviews) and their data sources, as well as the definition of the criteria used to assess the selection of the most appropriate AI/ML algorithm.

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.

A robotic arm for safe and accurate control of biomedical equipment during COVID-19.

Purpose: Hospital facilities and social life, along with the global economy, have been severely challenged by COVID-19 since the World Health Organization (WHO) declared it a pandemic in March 2020. Since then, countless ordinary citizens, as well as healthcare workers, have contracted the virus by just coming into contact with infected surfaces. In order to minimise the risk of getting infected by contact with such surfaces, our study aims to design, prototype, and test a new device able to connect users, such as common citizens, doctors or paramedics, with either common-use interfaces (e.g., lift and snack machine keyboards, traffic light push-buttons) or medical-use interfaces (e.g., any medical equipment keypad). Method: To this purpose, the device was designed with the help of Unified Modelling Language (UML) schemes, and was informed by a risk analysis, that highlighted some of its essential requirements and specifications. Consequently, the chosen constructive solution of the robotic system, i.e., a robotic-arm structure, was designed and manufactured using computer-aided design and 3D printing. Result: The final prototype included a properly programmed micro-controller, linked via Bluetooth to a multi-platform mobile phone app, which represents the user interface. The system was then successfully tested on different physical keypads and touch screens. Better performance of the system can be foreseen by introducing improvements in the industrial production phase. Conclusion: This first prototype paves the way for further research in this area, allowing for better management and preparedness of next pandemic emergencies.

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.

3D-printed activated charcoal inlet filters for oxygen concentrators: A circular economy approach.

As of May 2021, the current COVID-19 pandemic is still plaguing the world, challenging all the countries and their health systems, globally. In this context, conditions typical of low-resource settings surfaced also in high-resource ones (e.g., the lack of essential medical equipment, of resources etc.), while exacerbating in the already resource-scarce settings, because of COVID-19. This is the case of oxygen concentrators that are one of the first-line medical devices for treating COVID-19 patients. Since the beginning of 2020, their demand has been rapidly growing worldwide, aggravating the situation for low-resource settings, where the availability of devices providing oxygen-enriched air was already scarce. In fact, due to their delicacy, the lack of spare parts and of an appropriate health technology management system, oxygen concentrators can often be found broken or not working properly in these settings. The underlying problems have deep roots. The current regulatory frameworks and standards, which are set by high-income countries, are too stringent, and do not take into account the limited resources of poorer settings. Thus, they are often inapplicable in such settings. One of the main issues affecting the oxygen concentrators, is that related to the filters, which are designed to filter out dust, particles, bacteria, and to be used in medical locations complying with international standards (e.g., the air filtration level in a surgical theatre in Italy is at 99.97%). When used in low-resource settings, which do not comply with these standards and face several challenges (e.g., dust), these filters have a much-reduced lifespan. For these reasons, this paper aims to present the redesign of the inlet filter of an oxygen concentrator, which is used to prevent gross particles to enter the device. The redesign is based on a reverse engineering approach, and on the use of 3D-printing along with activated charcoal. After testing the filtration efficiency with a particle counter, the filter design has been refined through several iterations. The final prototype performs particularly well when filtering particles above 1 µm (with a filtration efficiency of 64.2%), and still has a satisfactory performance with any particle size over 0.3 µm (with a filtration efficiency of 38.8%). Following the United Nations Sustainable Development Goals, this project aims to empower local communities, and start a positive trend of self-sustained supply chain of simple spare parts for medical devices, leveraging on frugal engineering, 3D-printing, locally produced activated charcoal, and circular economy.

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.

Electrodes in external electrohysterography: a systematic literature review.

BACKGROUND: In low-income countries, pregnant women do not have easy access to health care, especially in rural and peri-urban areas. In this context, they can be surprised by the uterine contractions that precede childbirth and sometimes find themselves giving birth at home or on the way to the nearest health facility (located miles away from their home). In view of the development of an external uterine electrohysterogram acquisition system for labour prediction, a review of the literature on electrodes and their characteristics is necessary. METHODS: A comprehensive literature review was conducted to collate information on the use of electrodes in external EHG recording and their characteristics. RESULTS: Wet electrodes based on Ag/AgCl redox chemistry are the most common type of electrodes for EHG, employed in different configurations on the pregnant woman's abdomen. All positioning configurations are around the vertical median axis if they are not placed directly on it. Positioning below the navel seems to be the most efficient. The number of source, reference, and ground electrodes used varies from one author to another, as does the distance between the electrodes. CONCLUSION: Two well-positioned source electrodes on the vertical median axis, with ground electrode on the right side of the hip and reference one on the left side, are able to generate a good external EHG recording signal. The minimum allowed inter-electrode distance is approximately 17.5 to 25mm.

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.

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.

Endovascular Treatment versus Medical Therapy for Hypertensive Patients with Renal Artery Stenosis: An Updated Systematic Review.

The benefit of balloon angioplasty, with or without stenting, for the treatment of patients with renal artery stenosis remains controversial. A number of randomized controlled trials have attempted to determine its efficacy but the matter remains unclear. A 2014 Cochrane review, which combined data from 8 trials, showed homogeneity among the trials with no significant benefit shown. This systematic review replicates the same research methods and meta-analysis while expanding it to include papers between 2014 and 2018. One of the trials included in the previous review published results in the interim. Additionally, 2 ongoing trials identified in the 2014 review are yet to publish any result. Meta-analysis of the reports showed no heterogeneity between trials and no significant improvement shown by balloon angioplasty, with or without stenting, versus medical therapy. Further studies are recommended in order to assess the benefits of balloon angioplasty for patients with more severe renal artery stenosis.

Is Shouldice the best NON-MESH inguinal hernia repair technique? A systematic review and network metanalysis of randomized controlled trials comparing Shouldice and Desarda.

BACKGROUND: Current guidelines state that the Shouldice technique has lower recurrence rates than other suture repairs and therefore is strongly recommended in non-mesh inguinal hernia repair. Recently a new tissue repair technique has been proposed by Desarda and studied in trials against Lichtenstein technique. METHODS: The present study was performed according to the PRISMA Statement for Network Meta-analysis and the AMSTAR 2 checklist. The method of network meta-analysis was chosen to evaluate randomized controlled trial published on tissue repair and comparing Lichtenstein respectively with Desarda and Shouldice techniques. The following parameters: operative time, recurrence, complications (general, intraoperative, Surgical Surgical Site Occurrences), VAS score on postoperative day 1, numbness, chronic pain and return to daily activities. RESULTS: Fourteen RCTs, involving 2791 patients, fulfilled the inclusion criteria and were selected for final analysis. The anchored indirect treatment comparison showed that Desarda's technique requires a significantly shorter operative time (MD: -12.9 min; 95% CI: -20.6 to -5.2) and has a quicker recovery (MD: -6.6 days; 95% CI: -11.7 to -1.4). Outcomes concerning intraoperative complications, early postoperative pain, seroma/hematoma, hydrocele and infection rates, recurrence, numbness and chronic pain were similar among the two techniques. CONCLUSIONS: Desarda's hernia repair can be a valuable alternative to Shouldice technique for the treatment of primary inguinal hernia repair if a non-mesh technique is chosen, because of its reproducibility and quicker postoperative recovery. We recommend performing well designed prospective studies comparing both techniques directly.