HSE safety alert issued against KN95 face masks

12 June 2020
2 min read

A safety alert has been issued, urging all employers and suppliers not to purchase or use KN95 face masks as PPE.

KN95 is a performance rating that is broadly equivalent to the EU standard for FFP2 face masks. Products manufactured to KN95 requirements rely on a self-declaration of compliance by the manufacturer. There is no independent certification or assurance of their quality.

This respirator has been identified as suspect by HSE experts and locally arranged testing has confirmed they would not meet requirements, including to protect against the ongoing coronavirus pandemic. About 90% of the PPE concerns and queries currently being received by HSE involve KN95 masks which are often accompanied by fake or fraudulent paperwork.

HSE has quarantined around 1.5 million KN95 masks, prevented 25 million items claiming to be FFP3 respirators entering the supply chain and prevented a further four lines consisting of many millions of items entering the supply chain.

Rick Brunt, HSE’s director of operational strategy said: 'The KN95 face mask 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.'

Domestic, European and international organisations continue to raise concerns regarding KN95 masks, including details of counterfeit and illegal products. HSE is working to remove them from the supply chain with colleagues in the Office for Product Safety and Standards (OPSS), Border Force, the Medicines and Healthcare products Regulatory Agency (MHRA) and Trading Standards to identify manufacturers and suppliers of these masks and prevent them entering the UK.

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.

A copy of the alert can be found here.

Also this week, there has been updated guidance from NHS England stating that from next Monday, June 15, dental practices are required to ensure that staff wear a surgical mask when not in PPE to reduce transmission risks.

It also states that if a staff member has been in contact with someone confirmed as a COVID-19 case, whether a co-worker or a patient, and contact with this person occurred while not wearing PPE, they should self-isolate for 14 days following Test and Trace requirements. Practices are also advised to make business continuity arrangements for staff absence due to self-isolation.