The Inadequacy of Regulatory Frameworks in Time of Crisis and in Low-Resource Settings: Personal Protective Equipment an
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ORIGINAL PAPER
The Inadequacy of Regulatory Frameworks in Time of Crisis and in Low-Resource Settings: Personal Protective Equipment and COVID-19 Leandro Pecchia 1,2
&
Davide Piaggio 1
&
Alessia Maccaro 1 & Claudio Formisano 3 & Ernesto Iadanza 2,4
Received: 16 April 2020 / Accepted: 22 April 2020 # The Author(s) 2020
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-ItYourself (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. Keywords COVID-19 . International standards . Personal protective equipment . Masks . Visors . Face-shields . CE marking
1 Introduction As of early April 2020, the world is stricken by the recent pandemic outbreak [1] of a new strain of Coronavirus, previously unknown to mankind, denominated Severe Acute Respiratory Syndrome CoronaVirus 2 (SARS-CoV-2). This
* Leandro Pecchia [email protected] 1
Applied Biomedical Signal Processing and Intelligent eHealth Lab, School of Engineering, University of Warwick, Coventry, UK
2
Health Technology Assessment Division, International Federation for Medical and Biological Engineering, Florence, Italy
3
Andrea Grimaldi” Medical Care, San Giorgio a Cremano, Naples, Italy
4
Department of Information Engineering, University of Florence, Florence, Italy
virus is part of the family of the coronaviruses, which are viruses commonly affecting mammals and birds. Although the respiratory tract infections on humans caused by
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