Employers should not purchase ‘KN95’ face masks as personal protective equipment because they are unlikely to protect wearers against contracting Covid-19, the Health and Safety Executive (HSE) has warned.
The regulator said products manufactured to KN95 requirements rely on the manufacturer self-declaring that they are compliant with the standard, with no independent certification or assurance of their quality. This had led to many counterfeit products entering the supply chain, with some masks claiming to be KN95 compliant arriving with fraudulent paperwork.
HSE experts identified the KN95 masks they came across as “suspect” and tests found they would not sufficiently protect employees against contracting coronavirus.
Some 90% of the PPE queries received by the HSE concerned KN95 face masks.
“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,” Rick Brunt, HSE director of operational strategy, said.
“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.”
The HSE said it was attempting to remote counterfeit KN95 and FFP3 masks from the supply chain with colleagues in the Office for Product Safety and Standards, Border Force, the Medicines and Healthcare products Regulatory Agency (MHRA) and Trading Standards. So far they have “quarantined” some 1.5 million KN95 masks to prevent them from entering the supply chain.
The safety alert does not relate to N95 masks which are manufactured to a US standard and have been given permission for use specifically in UK healthcare settings.
5 comments
When will Americans be able to trust ANYTHING related to which masks are safe for wearing NOT IN THE OPERATING ROOMS OR ICU???????
While it’s best that front liners don’t take the risk, let’s not forget than most people don’t have access to N95, therefore KN95 is their best option, especially if you suffer HIV or are a cancer survivor.
Most people do not get masks because the dealers have made the price too high, a few dollars a piece. For a long time, ordinary people can’t support this cost.
Since most people don’t have access to N95, KN95 is indeed their best option if they are seeking a respirator that offers some degree of protection from the wearer readily inhaling the virus. Surgical masks and homemade masks offer little to no protection for the wearer, but are mainly concerned with source containment.
However, not all KN95 respirators are created equal. If you are going to purchase KN95 masks, make absolutely positive you are purchasing FDA-authorized KN95 masks from a legitimate distributor. Be careful, there are MANY counterfeit KN95 masks on the market! Check the FDA website at this link for information as to which KN95s are authorized, and which are not: https://www.fda.gov/medical-devices/coronavirus-disease-2019-covid-19-emergency-use-authorizations-medical-devices/personal-protective-equipment-euas#appendixa
Most people do not get masks because the dealers have made the price too high, a few dollars a piece. For a long time, ordinary people can’t support this cost. Now, N95 masks only cost a few tenths of a dollar.