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A nurse puts on personal protective equipment before caring for a Covid-19 patient.
Thomas Lohnes / Getty Images
- The protective face masks used by many doctors are not safe.
- A study carried out on 12 brands of KN95 masks by the University of Cape Town revealed that none of them met the stipulated safety requirements.
- It found that they did not provide adequate protection against dangerous respiratory pathogens, including Mycobacterium tuberculosis and SARS-CoV-2 that causes Covid-19.
The protective face masks used by many healthcare professionals are not safe.
A study conducted on 36 masks, from 12 KN95 brands, by a team of medical experts from the University of Cape Town, found that none of them met the stipulated safety requirements.
Eight of the brands had identifiable manufacturer details, only one was on the National Institute for Occupational Safety and Health (NIOSH) approved list, and the mask type and manufacturing details were printed on only two of the 12 brands based on the NIOSH and EU regulatory requirements.
The number of layers of individual masks from 12 different brands varied between three and only one of the 36 KN95 masks passed the seal test, even after modifying the ear loop tension using different methods.
Fifteen masks, which passed the sealing test, failed the qualitative fit test and of the eight masks tested, only four passed the filtration efficiency test.
In a report published by the researchers, they claimed that the masks do not provide adequate protection against dangerous respiratory pathogens, including Mycobacterium tuberculosis and SARS-CoV-2 that cause Covid-19.
READ | In Depth: South Africa’s Tangle of Medical Device Regulation
“Our findings will have relevance even after the Covid-19 epidemic has passed because existing KN95 stocks can be delivered to healthcare workers to prevent M. Tuberculosis infection. We recommend not this practice, given that these masks they do not meet the stipulated security requirements “, reads the report prepared by Keertan Dheda.
Key strengths of the research included a test protocol that incorporates sealing, fit testing, and measurement of the filtration integrity of the masks.
“To our knowledge, this is the only published study that has evaluated all of these parameters and dimensions across a range of different KN95 brands and that involves 36 different KN95 masks. However, the study has several limitations.
“We tested only a limited number of masks, and only those that we had access to. However, some masks that were sent to us came from outside the Western Cape area, although most were already being used in hospitals in the Western Cape or elsewhere. regions. of SA.
“Second, we only ran tests on a limited number of participants. However, we ran several different types of tests and included modifications to try to improve the facial seal, and a further increase in the sample size of the participants is unlikely. participants changed our results, “Dheda said.
The researchers did not measure or categorize facial dimensions.
“Finally, although we do test the integrity of the filter of the masks, this may not equate to the type of testing that uses commercially standardized equipment that certified bodies like NIOSH can perform.
“However, we used similar flow rates, a commercially available particle counter, a surgical mask as a negative control, and certified KN95 masks as positive controls to validate our findings. We are in the process of validating our low-cost test platform against a commercially available standardized system as the TSI 8130A Automated Filter Tester (TSI, USA), “added Dheda.
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