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.

The aim of this paper is to present and validate a framework for assessing healthcare facilities in low-resource settings to collect evidence and inform policies on the harmonisation, regulation and contextualised design of medical devices. Methods A literature review and focus groups with several experts of medical device design, clinical engineering, health technology assessment and management, allowed the creation of a protocol, comprising two parts: a semi-structured interview and electrical safety measures. Results Three hospitals were assessed in Benin and three in Uganda. All the health centres resulted to be facing typical challenges for low-resource settings, including the lack of funding, expertise, a well-established maintenance program, spare parts and consumables, and unreliable power supplies. Conclusion As there is a paucity of information regarding low-resource settings, the proposed framework can be used by clinical or biomedical engineers to assess and thereby propose actions for improving the conditions of healthcare 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.

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