Investigation of the Biocompatibility of Surgical Masks

Author:

Sipahl Hande1,Bayram Filiz Esra Onen2,Palabiyik Saziye Sezin3,Bayram Dilara4,Aydin Ahmet2

Affiliation:

1. Yeditepe University Faculty of Pharmacy, Department of Pharmaceutical Toxicology, 34755/ İstanbul , Turkey

2. Yeditepe University , Istanbul , Turkey

3. Atatürk University , Erzurum , Turcia

4. Marmara University , Istanbul , Turcia

Abstract

Abstract According to the ISO10993-1 standard medical devices should be evaluated before marketing. Although there are studies that monitor the toxicity of several marketed medical devices, none of them describe the toxicity of masks that are widely used to avoid occupational exposure to biological hazard or toxic chemicals. The aim of this study was to evaluate the biocompatibility of eight purchased surgical masks of different brands, investigating their cytotoxicity and inflammation inducing capacity. Cytotoxicity was assessed via the MTT cell viability assay and inflammation was monitored by measuring nitrite, kynurenine and tryptophan levels. A preliminary study revealed that four samples were capable of killing L929 cells. Therefore the materials composing these masks were also evaluated separately. While the exposure to non-woven materials did not involve any changes in cell survival, exposing cells to elastic and sponge materials led to death in significant levels. Also, significant increases in nitrite levels with a decrease in tryptophan and kynurenine levels were obtained with cells treated with these materials, suggesting an inflammatory response that could be related to the observed cytotoxicity. Our studies revealed that the half of the randomly collected masks did not suit the biocompatibility criteria established by the ISO10993-1 standard, which is a quite unexpected result.

Publisher

Walter de Gruyter GmbH

Subject

Clinical Biochemistry,Molecular Medicine,Biochemistry

Reference30 articles.

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3. 3. Turkish Medicines and Medical Devices Agency (TMMDA). Medical Devices Directive at http://mevzuat.basbakanlik.gov.tr/Metin.Aspx?MevzuatKod=7.5.15023&MevzuatIliski=0&sourceXmlSearch=t%C4%B1bbi%20cihaz%20y%C3%B6netmeli%C4%9F

4. 4. CEN-European Committee for Standardization. Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process. 2009a:Standart No. EN ISO 10993-1.

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