KN95 filtering facepiece respirators distributed in South Africa fail safety testing protocols
| العنوان: | KN95 filtering facepiece respirators distributed in South Africa fail safety testing protocols |
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| المؤلفون: | L Timm, Keertan Dheda, J. C. le Roux, Rubeshan Perumal, Aliasgar Esmail, S Sivarasu, L. Mottay |
| المصدر: | South African Medical Journal; Vol. 111 No. 3 (2021); 234-239 SAMJ: South African Medical Journal, Volume: 111, Issue: 3, Pages: 234-239, Published: MAR 2021 |
| بيانات النشر: | South African Medical Association NPC, 2020. |
| سنة النشر: | 2020 |
| مصطلحات موضوعية: | Safety Management, Infectious Disease Transmission, Patient-to-Professional, business.product_category, Coronavirus disease 2019 (COVID-19), N95 Respirators, Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), Fit testing, South Africa, Occupational Exposure, Materials Testing, Humans, Medicine, media_common.cataloged_instance, Respirator, European union, Safety testing, Filter material, media_common, Protocol (science), SARS-CoV-2, business.industry, COVID-19, Equipment Design, General Medicine, Reliability engineering, Equipment Failure Analysis, business |
| الوصف: | BACKGROUND: Given the global shortage of N95 filtering facepiece respirators (FFP2 in Europe) during the COVID-19 pandemic, KN95 masks (Chinese equivalent of the N95 and FFP2) were imported and distributed in South Africa (SA). However, there are hardly any published independent safety data on KN95 masks. OBJECTIVES: To evaluate the seal, fit and filtration efficiency of several brands of KN95 masks marketed for widespread use in SA healthcare facilities, using standardised testing protocols. METHODS: The verifiability of manufacturer and technical details was first ascertained, followed by evaluation of the number of layers comprising the mask material. The testing protocol involved a directly observed positive and negative pressure user seal check, which if passed was followed by qualitative fit testing (sodium saccharin) in healthy laboratory or healthcare workers. Quantitative fit testing (3M) was used to validate the qualitative fit testing method. The filtration efficacy and integrity of the mask filter material were evaluated using a particle counter-based testing rig utilising aerosolised saline (expressed as filtration efficacy of 0.3 µm particles). Halyard FLUIDSHIELD 3 N95 and 3M 1860 N95 masks were used as controls. RESULTS: Twelve KN95 mask brands (total of 36 masks) were evaluated in 7 participants. The mask type and manufacturing details were printed on only 2/12 brands (17%) as per National Institute of Occupational Safety and Health and European Union regulatory requirements. There was considerable variability in the number of KN95 mask layers (between 3 and 6 layers in the 12 brands evaluated). The seal check pass rate was significantly lower in KN95 compared with N95 masks (1/36 (3%) v. 12/12 (100%); p99% for the N95 masks at the 0.3 µm particle size). CONCLUSIONS: The KN95 masks tested failed the stipulated safety thresholds associated with protection of healthcare workers against airborne pathogens such as SARS-CoV-2. These preliminary data have implications for the regulation of masks and their distribution to healthcare workers and facilities in SA. |
| وصف الملف: | application/pdf; text/html |
| تدمد: | 2078-5135 0256-9574 |
| URL الوصول: | https://explore.openaire.eu/search/publication?articleId=doi_dedup___::3e184388d772a49fb43c1e874f0a2844 https://doi.org/10.7196/samj.2021.v111i3.15381 |
| حقوق: | OPEN |
| رقم الأكسشن: | edsair.doi.dedup.....3e184388d772a49fb43c1e874f0a2844 |
| قاعدة البيانات: | OpenAIRE |
| تدمد: | 20785135 02569574 |
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