Test kits

Derek Reid made this Rhyddid Gwybodaeth request to Tayside NHS Board

Automatic anti-spam measures are in place for this older request. Please let us know if a further response is expected or if you are having trouble responding.

Tayside NHS Board Nid oedd gan y wybodaeth y gofynnwyd amdani.

Dear Tayside NHS Board,

Do the contents of the new Orient Gene LFD testing kits comply with ISO 10993 generally and ISO 10993-7:2008(en) specifically annex G H and I in relation the ethylene oxide sterilisation and limitation on residual concentrations for use in tests that involve patient contact, in this case multiple repeated patient contact.

Yours faithfully,

Derek Reid

TAY foisa, Tayside NHS Board

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TAY foisa, Tayside NHS Board

1 Atodiad

Applicant: Derek Reid
Reference: IGTFOISA9998

Please find attached response to your request under the Freedom of Information (Scotland) Act 2002.

The response is in pdf format. If this format is unsuitable, please contact us to arrange an alternative.

Regards

Lynda

NHS Tayside Information Governance Team (FOISA) Maryfield House
30 Mains Loan
Dundee
DD4 7BT

dangos adrannau a ddyfynnir

Dear TAY foisa,

"Lateral flow device (LFD) tests have been rigorously tested and are safe to use on a regular basis."

Given that workers, citizens, children and NHS staff are using these tests multiple times per week. The MHRA EUA states the following in terms of standards -Risks have been managed according to ISO14791, no mention of EO residue permitted within nasal swabs.

1-
Can you produce the laboratory test results, name and accreditation of the laboratory undertaking the tests (equipment calibration certification) and / or other material documentation, such as a health and safety risk assessment, around the safety in humans for multiple internal (in vivo) and other skin contact usage, forming the scientific basis of the response provided?

2- if you do not hold that information, please provide details of who would, so they may be requested to provide an evidence based response?

3- within Scottish government which department is responsible for specifying the tests and applicable standards and ensuring they're safe for use?

4- which department signed off on the procurement of the tests?

5- which department or government agency approved their use?

Yours sincerely,

Derek Reid

TAY foisa, Tayside NHS Board

OFFICIAL

Dear Derek
Before we can take this forward I need to clarify with you if you are
asking for an internal review of your previous request as this is in the
subject of your email, but I cannot see you asking for this in the body of
your email.
Therefore can you please confirm if you are seeking an internal review of
your previous request or if the questions you have set our below form a
brand new FOISA request for NHS Tayside. I look forward to hearing from
you.
Kind regards
Lynda
NHS Tayside Information Governance Team (FOISA)
Maryfield House
30 Mains Loan
Dundee
DD4 7BT
 
Tel Number 01382 740074
Ext 54480/70413

--------------------------------------------------------------------------

From: Derek Reid <[FOI #809675 email]>
Sent: 06 December 2021 19:28
To: TAY foisa <[NHS Tayside request email]>
Subject: Internal review of Freedom of Information request - Test kits
 
Dear TAY foisa,

"Lateral flow device (LFD) tests have been rigorously tested and are safe
to use on a regular basis."

Given that workers, citizens, children and NHS staff are using these tests
multiple times per week. The MHRA EUA states the following in terms of
standards -Risks have been managed according to ISO14791, no mention of EO
residue permitted within nasal swabs.

1-
Can you produce the laboratory test results, name and accreditation of the
laboratory undertaking the tests (equipment calibration certification) and
/ or other material documentation, such as a health and safety risk
assessment, around the safety in humans for multiple internal (in vivo)
and other skin contact usage, forming the scientific basis of the response
provided?

2- if you do not hold that information, please provide details of who
would, so they may be requested to provide an evidence based response?

3-  within Scottish government which department is responsible for
specifying the tests and applicable standards and ensuring they're safe
for use?

4- which department signed off on the procurement of the tests?

5- which department or government agency approved their use?

Yours sincerely,

Derek Reid

dangos adrannau a ddyfynnir

Dear TAY foisa,

I am asking for an internal review with the Added questions from my second response.

Yours sincerely,

Derek Reid

TAY foisa, Tayside NHS Board

OFFICIAL

Dear Derek
We can only consider previous questions as part of an internal review,
therefore we will undertake an internal review of your previous request
and will log your new questions as a new request and will be in touch once
we have a response for you.
Regards
Lynda
NHS Tayside Information Governance Team (FOISA)
Maryfield House
30 Mains Loan
Dundee
DD4 7BT
 
Tel Number 01382 740074
Ext 54480/70413

--------------------------------------------------------------------------

From: Derek Reid <[FOI #809675 email]>
Sent: 07 December 2021 23:35
To: TAY foisa <[NHS Tayside request email]>
Subject: Re: Internal review of Freedom of Information request - Test kits
 
Dear TAY foisa,

I am asking for an internal review with the Added questions from my second
response.

Yours sincerely,

Derek Reid

dangos adrannau a ddyfynnir

TAY foisa, Tayside NHS Board

2 Atodiad

Dear Derek

 

Please find attached a response to your recent request for an internal
review of IGTFOISA9998 and your new request of IGTFOISA 10086.

 

Kind regards

 

 

Lynda

 

Information Governance and Cyber Assurance Team

NHS Tayside

Maryfield House (South), 30 Mains Loan, Dundee, DD4 7BT

Tel: 01382 740074

 

 

 

From: TAY foisa
Sent: 08 December 2021 08:59
To: Derek Reid <[FOI #809675 email]>
Subject: Re: Internal review of Freedom of Information request - Test kits

 

Dear Derek

 

We can only consider previous questions as part of an internal review,
therefore we will undertake an internal review of your previous request
and will log your new questions as a new request and will be in touch once
we have a response for you.

 

 

Regards

 

Lynda

 

 

NHS Tayside Information Governance Team (FOISA)

Maryfield House

30 Mains Loan

Dundee

DD4 7BT

 

Tel Number 01382 740074

Ext 54480/70413

 

------------------------------------------------------------------------

From: Derek Reid <[1][FOI #809675 email]>
Sent: 07 December 2021 23:35
To: TAY foisa <[2][NHS Tayside request email]>
Subject: Re: Internal review of Freedom of Information request - Test kits

 

Dear TAY foisa,

I am asking for an internal review with the Added questions from my second
response.

Yours sincerely,

Derek Reid

dangos adrannau a ddyfynnir