COVID-19: Urgent KN95 Face Mask Warning
The Health & Safety Executive (HSE) have put out an urgent safety alert warning people of the potential danger of using face masks claiming to be KN95 approved.
Due to the current demand for respiratory protective equipment (RPE) and personal protective equipment (PPE) caused by the COVID-19 coronavirus pandemic, a substantial number of fraudulent and/or unregulated masks have entered the UK market.
In the UK, Filtering Face Pieces (disposable respirator masks) require CE marking and certification in accordance with meeting the European standard BS EN149:2001+A1:2009. Without a CE mark, it is illegal for PPE to be sold or supplied in the UK and EU markets. *
KN95 is a self-assessed performance rating under the Chinese standard GB2626:2006, undertaken by the manufacturer. While broadly similar to the European standard for FFP2 face masks, there is no independent assessment or certification required for the rating to be used, and therefore does not say anything as to the quality of the materials or effectiveness of the mask.
According to a recent HSE press release, as many as 90% of PPE concerns received by the HSE are in relation to KN95 masks, which are often accompanied by fake or fraudulent paperwork. To date, the HSE has quarantined around 1.5 million KN95 masks, and prevented a further 25 million items falsely claiming to be FFP3 respirators.
A spokesperson for the HSE said: “Respirators that are not CE marked, and cannot be shown to be compliant, must be removed from supply immediately.
“If these masks have not been through the necessary safety assessments, their effectiveness in controlling risks to health cannot be assured for anyone buying or using them. They are unlikely to provide the protection expected or required.”
*Due to demand, there is a temporary exception to CE marking on PPE allowing the NHS and other healthcare services to use non-CE marked N95 respirator masks, which are manufactured and tested in accordance with US standards. This is a temporary measure for healthcare services and is under strict assessment by the UK government and HSE.
Rick Brunt, director of operational strategy for the HSE, said: “The KN95 facemask should not be purchased or used.
“KN95 has not been a principal source of PPE for the NHS, who has already made the decision not to supply this respirator to frontline clinicians fighting the coronavirus pandemic.
“We have found that the lack of independent testing has contributed to there being a substantial quantity of inadequate and poor-quality masks on the market, claiming to comply with the KN95 standard.
“We understand a lot of people, mainly in sectors outside of healthcare, have bought these facemasks without realising they are non-compliant. We are concerned that people wearing them are not being protected from breathing in harmful substances in the way they expect. Protective equipment must protect.”