Health and Safety Executive
10 August 2021
Sarah Albon
Redgrave Court
Merton Road
Bootle
Merseyside L20 7HS [email protected] http://www.hse.gov.uk/
Dear Lord Alton,
Thank you for your letter of 30th July 2021 in respect of your concerns regarding the distribution of the Fangtian FT 045A respirator to healthcare workers in the NHS.
This is a significant incident and we are currently investigating.
As with any HSE
investigation, we are looking to establish what happened and why. HSE will take enforcement action, should this be appropriate, in accordance with the principles laid out in our Enforcement Policy Statement.
As this incident is the subject of an on-going investigation, I hope you will understand that I cannot comment on how the product came to be supplied.
I can, however, confirm that HSE did not agree or approve the release of the Fangtian FT 045A respirator for use in the NHS or elsewhere. HSE does not need to give permission for PPE products to be released on to the market; importers and distributors have the legal responsibility to supply safe and compliant personal protective equipment (PPE).
When concerns about the respirator were raised with DHSC, timely action was taken to remove it from use and recall it, using their rapid action taskforce (RAT) approach. HSE were content with DHSC’s proposals and as a result we did not have to use our enforcement powers to require a recall.
Yours sincerely,
Sarah Albon
Chief Executive
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Text of Letter sent to the Health and Safety Executive
Sarah Newton, Chair HSE Board
Sarah Albon, Chief Executive
July 30th 2021.
I am writing in connection with a BBC report into face masks: https://www.bbc.co.uk/news/uk-57999162
The BBC reported that tests revealed that a million masks supplied to the NHS as high grade did not meet the correct level of protection.
The masks, assumed to be the FFP3 type, also had invalid CE safety marking and the British Medical Association rightly said it was “scandalous” that staff working in the pandemic had been put at risk.
The Department of Health and Social Care said a strategy was in place to provide alternatives.
Tests carried out in February showed that masks branded “Fang Tian” and marked as FT-045A distributed for use in the NHS in England failed FFP3 requirements.
The report issued by the British Standards Institution in June also stated the personal protective equipment carried a “false” CE mark.
The report said the masks bore the discontinued identifying number for BSI Assurance UK Limited but it said the masks had not been certified by the BSI..
The Department of Health and Social Care said that 1.12 million of the masks were either in use in the NHS or in stores when they were withdrawn earlier this year.
In February the Department said it had commissioned “independent testing” of the masks and that they would communicate the outcome “shortly”. The results were finally shared with NHS staff earlier this month.
In the letter seen by the BBC, the DHSC said it was important to “reassure” users that the masks “should have afforded protection equivalent to the level that the World Health Organisation recommends” for performing aerosol-generating procedures.
Test results showed the masks would have passed this lower FFP2 standard. But it is the higher FFP3 standard that is recommended in the UK.
You will see the concerns raised about this by the BMA’s Dr Vishal Sharma in the BBC report. Dr.Sharma rightly says that “there are serious questions that need answering: how did they end up within the supply chain, let alone being distributed to hospitals? Why were problems not identified earlier? How many were used by healthcare workers before the recall, and did any staff become sick, or worse, after wearing them?” Unison said that “Wherever (staff) were put at risk by sub-standard PPE, their employer has to investigate fully and report any incidents to the Health and Safety Executive (HSE).”.
You were quoted as saying that you are continuing your inquiries.
I assume that you will address Dr.Sharma’s question about how these masks got into the supply chain – and identify the subcontractor in China which made the masks.
I am deeply concerned that the product ordered by NHS SCCL was the FT045 mask (for which paperwork was correct) but the product which was actually delivered was the FT045A mask which had never been manufactured or tested before – a fake product – made in China by what an only charitably be described as a dodgy sub contractor.
The consequence has been that medical staff have been exposed to a lethal virus along with patients. Every time a clinician has been passed a packaged mask they will now inevitably ask whether they can be confident that they are using a mask that will block the virus.
I would particularly like to know whether the NHS SCCL (Supply Chain Coordination Limited) undertook safety checks and, if not, what enforcement action you are intending to take.
As it would also appear that there has been considerable material loss to the UK taxpayer I am also writing to the Auditor General and to the Chair of the Public Accounts Committee to ask what action is being taken to seek restitution of the public money used in the purchase of these masks.
Yours sincerely,
David Alton
Professor the Lord Alton of Liverpool,
Independent Crossbench Member of the House of Lords.
https://twitter.com/DavidAltonHL/status/1422203607211024390?s=20
