Assessing Biocompatibility of Face Mask Materials during COVID-19 Pandemic by a Rapid Multi-Assays Strategy.

Tiziana Petrachi,Alberto Ferrari,Aldo Tomasi,Luca Accorsi,Giorgio Mari,Luigi Rovati,Francesco Ganzerli,Davide Pasini,Mattia Piccini,Massimo Dominici,Francesco Burini,Aurora Cuoghi,Elena Veronesi,Valentina Bergamini,Elisa Resca,Laura Aldrovandi,Gaelle Françoise Arnaud

doi:10.3390/ijerph18105387

Abstract

During the coronavirus disease 2019 (COVID-19) pandemic, scientific authorities strongly suggested the use of face masks (FMs). FM materials (FMMs) have to satisfy the medical device biocompatibility requirements as indicated in the technical standard EN ISO 10993-1:2018. The biologic evaluation must be confirmed by in vivo tests to verify cytotoxicity, sensitisation, and skin irritation. Some of these tests require an extensive period of time for their execution, which is incompatible with an emergency situation. In this study, we propose to verify the safety of FMMs combining the assessment of 3-[4,5-dimethylthiazolyl-2]-2,5-diphenyltetrazolium bromide (MTT) with quantification of nitric oxide (NO) and interleukin-6 (IL-6), as predictive markers of skin sensitisation or irritation based on human primary fibroblasts. Two hundred and forty-two FMMs were collected and classified according to spectrometer IR in polypropylene, paper, cotton, polyester, polyethylene terephthalate, 3-dimensional printing, and viscose. Of all FMMs tested, 50.8% passed all the assays, 48% failed at least one, and only 1.2% failed all. By a low cost, rapid and highly sensitive multi assays strategy tested on human skin fibroblasts against a large variety of FMMs, we propose a strategy to promptly evaluate biocompatibility in wearable materials.

Highlights

Social contact increases infection rates due to the spread of saliva droplets in the air and on surfaces through coughing and sneezing. Various measures, such as better sanitation, social distancing, and the use of face masks (FMs), were recommended by the health authorities to reduce the spread of the infection [1]
A total of 242 FM materials (FMMs) were collected and classified according to the type of material used for the internal layer in contact with the skin
When FMs were composed of more than one layer, the internal portion in contact with the skin of the face was used for grouping purposes

Summary

Introduction

Social contact increases infection rates due to the spread of saliva droplets in the air and on surfaces through coughing and sneezing. Various measures, such as better sanitation, social distancing, and the use of face masks (FMs), were recommended by the health authorities to reduce the spread of the infection [1]. The massive general use of FMs resulted in a global supply shortage of these devices, in particular in health care settings. The difficulties of FM supply and distribution prompted several companies to convert their manufacturing to FM production.

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