Abstract
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.
Highlights
As of early April 2020, the world is stricken by the recent pandemic outbreak [1] of a new strain of Coronavirus, previouslyThis article is part of the COVID-19 Health Technology: Design, Regulation, Management, AssessmentHealth Technol. (2020) 10:1375–1383 lacks the ability to fight against the pathogen [7], which can have dangerous effects on subjects with already weak immune systems, or immunosuppressed or elderly subjects with existing preconditions
The supply chain of personal protective equipment (PPE), medical devices (MDs), consumables and spare parts revealed its frailty in its dependence on China’s capability to produce them, severally hindered by the lockdown since January 2020. This world pandemic has been causing an unprecedented demand of hospitalizations, especially in intensive care units (ICUs), since its early stages. This set off a chain reaction affecting a number of other routine hospitalizations, which were postponed giving priority to ICU beds in terms of resources healthcare staff is highly exposed to the risk of catching COVID-19 themselves, due to the inner nature of their daily routine, which exposes them to physical contact with patients
The COVID19 outbreak has shown clearly the unsuitability of PPEs’ regulatory framework, body of norms, and international standards to extreme conditions. This was evident to the professionals working in low-resource settings, such as low- and middle-income countries and it emerged powerfully for high-income countries during the COVID-19 pandemic
Summary
As of early April 2020, the world is stricken by the recent pandemic outbreak [1] of a new strain of Coronavirus, previously. The supply chain of personal protective equipment (PPE), medical devices (MDs), consumables and spare parts revealed its frailty in its dependence on China’s capability to produce them, severally hindered by the lockdown since January 2020 This world pandemic has been causing an unprecedented demand of hospitalizations, especially in intensive care units (ICUs), since its early stages. This set off a chain reaction affecting a number of other routine hospitalizations (e.g., elective surgeries), which were postponed giving priority to ICU beds in terms of resources (spaces, personnel, equipment) healthcare staff is highly exposed to the risk of catching COVID-19 themselves, due to the inner nature of their daily routine, which exposes them to physical contact with patients. This discussion should be continued, once this crisis will be over, especially with regard to lower-income countries, where the inadequacy of international norms is clear in everyday conditions
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