Covid: Warnings of 'counterfeit' NHS face masks were dismissed
- Published
An FFP3 mask, not the brand being withdrawn by the Department of Health
One million face masks, described by a confidential government report as counterfeit, were sent out for use in NHS hospitals despite warnings about their authenticity.
According to the report, health officials dismissed concerns, instead focusing on getting the masks out rather than considering "red flags".
The masks were sent for use by NHS staff during the Covid-19 pandemic.
The Department of Health said immediate action was taken when the issue arose.
"We have strengthened our assurance processes and introduced robust safeguards to prevent this in future," a spokesman added.
'Pressure' applied
BBC News first reported last February that more than a million high-grade masks in use in the NHS in England had been withdrawn over safety concerns. The FFP3 face coverings, worn by medics working in intensive care, were branded Fang Tian and marked as "FT-045A".
Now a report has revealed that issues with them were dismissed for months. It was only after a nurse contacted the Chinese manufacturer directly and was told they were "fake goods" that officials took action.
After the Department of Health and Social Care (DHSC) made its own direct enquiries, the manufacturer told them: "The masks you got do not have certificate. I am sorry that you got the faked goods from bad guys."
A catalogue of errors is laid bare in a highly-critical internal government report, disclosed to BBC News under the Freedom of Information Act.
The report says before the masks were released into the NHS in September 2020, a Health and Safety Executive (HSE) representative queried why the FT-045A model number did not appear to be covered by the safety certificate provided for the masks.
Yet health officials applied "pressure" to clear the face coverings for use, saying they had been given assurances they were authentic and fit for purpose.
"The certificate clearly states FT-045A as a model number and the packaging and picture of the masks states this too," wrote one official from the NHS's supply chain body. "I do not understand why this now cannot be released."
The HSE representative then authorised their use, the report said, but it added that because the mask "appeared" to be CE safety marked, it did not need to provide sign-off.
The HSE told the BBC no authorisation was given for the product.
However, that model of mask had not been certified and they were later shown to fail tests to the required standard. They did meet a lower World Health Organisation FFP2 standard.
Officials then began to receive reports from hospitals using the masks that they were not fit for purpose.
BBC News has been investigating the government's handling of PPE contracts during the pandemic:
Fifty million face masks could not be used in the NHS because they did not meet its specifications.
Safety watchdog felt political pressure to approve the use of PPE suits.
The use of 10 million surgical gowns was suspended for frontline NHS staff because of packaging.
Millions of medical gowns were never used, having been bought for £122m.
Firm investigated by the UK medical regulator after it was awarded a £30m contract.
In November 2020, Mid and South Essex University Hospitals Group complained the masks were failing tests to make sure they fit securely. They reported the FT-045As only passed 40% of the time.
One of the group's hospitals also found filters had fallen out and in some instances seams in the masks had split. A DHSC official replied that this was an "isolated incident" and distribution of the masks continued.
That same month an "anonymous report" reached the DHSC claiming the Chinese manufacturer Fangtian was not aware it had sold any FFP3 masks to the NHS, and a police investigation into fraud or counterfeiting was ongoing in the country.
Although the UK supplier was asked to investigate, this warning was also ultimately dismissed.
Back in 2020 these masks were being used almost exclusively in the highest risk procedures where the risk for the wearer was the greatest
More complaints from hospitals followed in December 2020, including one from Medway NHS Foundation Trust, which said a member of staff had displayed "Covid-like symptoms" after a faulty mask they were wearing in an infected area failed.
The investigation says it has not been able to confirm if the individual went on to test positive for Covid-19.
It was not until February 2021, after a nurse in the Midlands contacted the Chinese manufacturer directly, that the concerns were properly investigated.
"Back in 2020 these masks were being used almost exclusively in the highest risk procedures where the risk for the wearer was the greatest," said Vishal Sharma, chair of the consultants committee at the doctors' union the BMA.
"That's why it's really worrying to find that actually these masks were not protecting people as they should have done."
'Red flags' missed
The immense pressure to source personal protective equipment during the pandemic "undoubtedly" led to some people taking advantage of weaker procurement systems, the report concludes. But it finds no evidence of any criminal activity by individuals in the UK.
The report says the NHS supplier, Polyco Healthline Ltd, believed the masks it bought from China were being made under licence. It say they were supplied by a reputable producer of PPE that provided evidence of licencing arrangements.
However, Fangtian, the Chinese firm that developed the masks, told the investigation it gave no such authorisation to any other manufacturer.
It is understood Polyco Healthline has serious misgivings about this claim.
The report says without being able to send an investigator to China, it is unlikely the full facts around the production of the masks will ever be ascertained.
A spokesperson for DHSC said it was "wrong to suggest the department ignored complaints". "As soon as we became aware of the issue with the products, we took immediate action to recall the affected products and commissioned an investigation."