Background: I refer to this document dated 27 April 2021 : FAQs on using single use FFP3 RPE for hospital staff” issued by your Healthcare Associated Infection & Antimicrobial Resistance programme (HARP):
At section 2.2 you comment on the fact that Healthcare Workers were provided with Respiratory Protective Equipment (RPE) which “appear to have out-of-date ‘use by/expiration dates’ or have re-labelled dates". By way of comment, I don’t know why you say “appear to be out of date” – they WERE out of date (actually many years out of date).
My FoI enquiry relates to the assurance that you gave “Please be assured that products … have passed stringent tests that demonstrate they are safe.”
There are 3 main elements to my FoI request:
1) Please would you provide the documents which PHW relied upon to form the conclusion that they were safe. These should confirm:
a) whether the laboratory/laboratories which conducted the tests were UKAS-accredited for this type of testing;
b) how many respirators were issued to staff in Wales which were beyond their expiry date (as originally marked on the packaging, not the ‘re-label’);
c) the actual number of respirators tested BY PUBLIC HEALTH WALES (or laboratories it used) and how PHW ensured that the sample was statistically representative of the total number of masks issued i.e. (b) above;
d) that the test methods set out in EN 149:2001+A1:2009 were used or, if not, precisely what test methodology was used.
e) If Public Health Wales did not carry out any testing itself but relied upon testing carried out by other UK authorities (e.g. Public Health England) then please provide the laboratory reports that they provided you with. If this is the case then please indicate whether it was
(i) that other UK authority which assured you that the tests showed that the respirators were safe for use; or
(ii) or whether it was Public Health Wales’ own interpretation of the laboratory reports that the respirators were safe for use.
2) Please would you also confirm the full range of manufacturers involved (e.g. 3M, others?) and provide me with copies of any correspondence that you had with those manufacturers (as the experts in their products) about the continuation of use beyond the expiry date.
3) Please would you provide copies of any correspondence that you had with the HSE concerning the continuation of use beyond the expiry date.
Thank you for your request dated 22nd October 2023.
Welsh Government countermeasures/Personal Protective Equipment (PPE) and NHS Wales Shared Services Partnership (NWSSP) procurement are responsible for issuing PPE from the pandemic Influenza stock. They advised Public Health Wales (PHW) and NHS Wales the stock was relabelled after advice from Public Health England (PHE) that the masks could be issued with new expiry dates following testing. PHE, Department of Health and Social Care (DHSC) procurement organised testing of the Pandemic Influenza Preparedness (PIP) stock on behalf of the UK nations and liaised with Health and Safety Executive (HSE) to assure safety. They were not deemed out of date after the expiry date had been extended. It is our understanding that the 3M masks were over-labelled twice, tested before they were issued during COVID and issued with a letter to the service.
There are 3 main elements to my FoI request:
1) Please would you provide the documents which PHW relied upon to form the conclusion that they were safe. These should confirm:
a) whether the laboratory/laboratories which conducted the tests were UKAS-accredited for this type of testing;
Public Health Wales does not hold the documented information that were used to form the conclusion of safe usage. It is our understanding that PHE, DHSC procurement organised testing of the 3m Pandemic Influenza Preparedness (PIP) stock on behalf of the UK nations and communicated directly with HSE and so any requests for further information on accreditation would need to be directed to PHE. PHW does not test or procure PPE and is only responsible for issuing it to its own staff. The Infection Prevention Control (IPC) leads of the Healthcare Associated Infection & Antimicrobial Resistance Programme
(HARP) team at PHW advises on precautions and type of PPE, how it should be to be worn etc. to prevent transmission of infection. Any testing would have been scrutinised by NHS Wales Shared Services Partnership (NWSSP) procurement, Surgical Materials Testing Laboratory (SMTL) and signed off for use by Welsh government countermeasures lead and not PHW.
b) how many respirators were issued to staff in Wales which were beyond their expiry date (as originally marked on the packaging, not the ‘re-label’);
PHW purchased PPE from NWSSP to provide to its own staff in clinical practice but do not issue PPE to staff in other NHS Wales organisations. For details on PPE issued by NHS Organisations in Wales to their staff you would need to contact the Health Boards directly.
c) the actual number of respirators tested BY PUBLIC HEALTH WALES (or laboratories it used) and how PHW ensured that the sample was statistically representative of the total number of masks issued i.e. (b) above;
PHW do not test or organise the testing of PPE and so does not hold this information. The PIP stock testing of FFP3 was organised by PHE on behalf of UK nations. Welsh Government may be able to provide the information requested.
d) that the test methods set out in EN 149:2001+A1:2009 were used or, if not, precisely what test methodology was used.
Please refer to the response to c above.
e) If Public Health Wales did not carry out any testing itself but relied upon testing carried out by other UK authorities (e.g. Public Health England) then please provide the laboratory reports that they provided you with. If this is the case then please indicate whether it was
(i) that other UK authority which assured you that the tests showed that the respirators were safe for use; or
Public Health wales did not receive any laboratory reports and so does not hold this information.
(ii) or whether it was Public Health Wales’ own interpretation of the laboratory reports that the respirators were safe for use.
PHW does not interpret laboratory reports on PPE testing and so does not hold this information. Expertise in Wales is within SMTL. Welsh Government would have to assure themselves of the methodology used and issue assurance information to NHS Wales that the stock was safe to use. Neither the HARP team or wider PHW have expertise in PPE or FFP3 testing. The HARP team provides infection prevention and control expertise.
2) Please would you also confirm the full range of manufacturers involved (e.g. 3M, others?) and provide me with copies of any correspondence that you had with those manufacturers (as the experts in their products) about the continuation of use beyond the expiry date.
Public Health Wales does not hold this information and would need to be obtained from NWSSP on makes and models. I have provided contact details below.
3) Please would you provide copies of any correspondence that you had with the HSE concerning the continuation of use beyond the expiry date.
PHW did not have any direct correspondence with HSE and so does not hold this information. The information requested may be held by Welsh Government and/or NWSSP or SMTL
Please see below contact details to obtain this information:
All the Health Boards in Wales:
Aneurin Bevan University Health Board
http://www.wales.nhs.uk/sitesplus/866/page/39187
Betsi Cadwaladr University Health Board
http://www.wales.nhs.uk/sitesplus/861/page/39134
Cardiff and Vale University Health Board
http://www.cardiffandvaleuhb.wales.nhs.uk/freedom-of-information-new
Cwm Taf Morgannwg University Health Board
https://cwmtafmorgannwg.wales/foi/
Swansea Bay University Health Board
https://sbuhb.nhs.wales/about-us1/foia/
Hywel Dda University Health Board
http://www.wales.nhs.uk/sitesplus/862/page/52085
Powys Teaching Health Board
http://www.powysthb.wales.nhs.uk/freedom-of-information
Welsh Government
Requesting information from the Welsh Government (FOI requests) | GOV.WALES
Digital Health and Care Wales
Freedom of information - Digital Health and Care Wales (nhs.wales)
NHS Shared Services Partnership
Making a Freedom of Information Request - NHS Wales Shared Services Partnership
Department of Health and Social Care (For PHE requests)
Department of Health and Social Care - GOV.UK (www.gov.uk)
The Surgical Materials Testing Laboratory (SMTL)
Contact Us - The Surgical Materials Testing Laboratory (SMTL)
If you are unhappy with the service you have received in relation to your request and wish to make a complaint or request a review of the decision, you should write to the Corporate Complaints Manager, Public Health Wales NHS Trust, 3, Number 2, Capital Quarter, Tyndall Street, Cardiff, CF10 4BZ.
If you are not content with the outcome of your complaint or review, you may apply directly to the Information Commissioner for a decision. Generally, the ICO cannot make a decision unless you have exhausted the complaints procedure provided by the Trust. The Information Commissioner can be contacted at:
Information Commissioner for Wales
2nd Floor
Churchill House
Churchill Way
Cardiff
CF10 2HH
Telephone: 029 2067 8400
Email: wales@ico.org.uk