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

New intelligent network approach for monitoring physiological parameters : the case of Benin

Benin health system is facing many challenges as: (i) affordable high-quality health care to a growing population providing need, (ii) patients’ hospitalization time reduction, (iii) and presence time of the nursing staff optimization. Such challenges can be solved by remote monitoring of patients. To achieve this, five steps were followed. 1) Identification of the Wireless Body Area Network (WBAN) systems’ characteristics and the patient physiological parameters’ monitoring. 2) The national Integrated Patient Monitoring Network (RIMP) architecture modeling in a cloud of Technocenters. 3) Cross-analysis between the characteristics and the functional requirements identified. 4) Each Technocenter’s functionality simulation through: a) the design approach choice inspired by the life cycle of V systems; b) functional modeling through SysML Language; c) the communication technology and different architectures of sensor networks choice studying. 5) An estimate of the material resources of the national RIMP according to physiological parameters. A National Integrated Network for Patient Monitoring (RNIMP) remotely, ambulatory or not, was designed for Beninese health system. The implementation of the RNIMP will contribute to improve patients’ care in Benin. The proposed network is supported by a repository that can be used for its implementation, monitoring and evaluation. It is a table of 36 characteristic elements each of which must satisfy 5 requirements relating to: medical application, design factors, safety, performance indicators and materiovigilance

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, trafc 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 Unifed Modelling Language (UML) schemes, and was informed by a risk analysis, that highlighted some of its essential requirements and specifcations. Consequently, the chosen constructive solution of the robotic system, i.e., a robotic-arm structure, was designed and manufactured using computeraided design and 3D printing. Result The fnal 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 diferent physical keypads and touch screens. Better performance of the system can be foreseen by introducing improvements in the industrial production phase. Conclusion This frst prototype paves the way for further research in this area, allowing for better management and preparedness of next pandemic emergencies. © 2023, The Author(s)

Altered modulation of lamin A/C-HDAC2 interaction and p21 expression during oxidative stress response in HGPS

Defects in stress response are main determinants of cellular senescence and organism aging. In fibroblasts from patients affected by Hutchinson-Gilford progeria, a severe LMNA-linked syndrome associated with bone resorption, cardiovascular disorders, and premature aging, we found altered modulation of CDKN1A, encoding p21, upon oxidative stress induction, and accumulation of senescence markers during stress recovery. In this context, we unraveled a dynamic interaction of lamin A/C with HDAC2, an histone deacetylase that regulates CDKN1A expression. In control skin fibroblasts, lamin A/C is part of a protein complex including HDAC2 and its histone substrates; protein interaction is reduced at the onset of DNA damage response and recovered after completion of DNA repair. This interplay parallels modulation of p21 expression and global histone acetylation, and it is disrupted by LMNAmutations leading to progeroid phenotypes. In fact, HGPS cells show impaired lamin A/C-HDAC2 interplay and accumulation of p21 upon stress recovery. Collectively, these results link altered physical interaction between lamin A/C and HDAC2 to cellular and organism aging. The lamin A/C-HDAC2 complex may be a novel therapeutic target to slow down progression of progeria symptoms

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 informationThe online version contains supplementary material available at 10.1007/s12553-021-00570-6

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