Policy information request

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Dear East Suffolk and North Essex NHS Foundation Trust,

I would like to request the following information under the Freedom of Information Act in relation to the research I am completing.

Having reviewed your website and policies, I am unable to obtain the relevant documents, which is why I have made this request. I would like to know which documents are used for the review and approval of new medical devices within your NHS Trust/entity.

The exact naming of the documents may differ, but the context is the same, so we ask for judgement to be used, and please let us know if you require further clarification.

1. Could you please provide a copy of the Trusts/entity“New Medical Device policy?”
2. Could you please provide a copy of the Trusts/entity“Medical Devices and Procurement Review Group policy?”
3. Could you please provide a copy of the Trusts/entity“Business case template for new medical devices or technology” for new medical/diagnostic device approval?
4. Could you please provide a list of all approved medical devices in your Trusts/entity? Excel format, word or PDF is fine.
5. Could you please provide a copy of the policy which supports “medical devices on trial requirements”.
6. Could you please provide the policy for including a new pathology test within the Trusts/entity?
7. Could you please provide the policy for the “New medical Product Selection Group”
8. Could you please confirm how often new medical device review meetings take place?
9. Could you please provide me the name of the staff member responsible for finances of new medical devices and their email address.
10. Could you please provide me the name of the staff member responsible for procurement of new medical devices and their email address.
11. Lastly, could you please supply a copy of the last 3 ‘New Medical Device meeting’ minutes and also the location of where they are published on your website?

All documents can be provide in word, PDF or a readable format.

Thank you for your help on this matter and look forward to hearing from you. Any questions please do let me know.

Yours faithfully,

Carolyn Tuson

FOI Requests, East Suffolk and North Essex NHS Foundation Trust

Please be advised that we have received your request for information.

From 1st July 2018, Ipswich and Colchester Hospitals merged to become East Suffolk and North Essex NHS Foundation Trust. Therefore, unless otherwise specified, responses are on behalf of East Suffolk and North Essex NHS Foundation Trust.

Your reference number is 7592

We shall deal with your request in accordance with the Trust's Freedom of Information Act 2000 procedures.

In the meantime, if you have any queries, please do not hesitate to contact us. Please direct any responses to the address supplied or email [East Suffolk and North Essex NHS Foundation Trust request email]

Should our response to your request breach the statutory timeframe and you remain unhappy with our response you have the right to complain to the Information Commissioners Office and you can contact them at

The Information Commissioner's Office
Wycliffe House
Water Lane
Wilmslow
Cheshire
SK9 5AF

Tel: 0303 123 1113
Website: www.ico.org.uk

There is no charge for making an appeal.

Amy Witham
Freedom of Information Team
East Suffolk and North Essex NHS Foundation Trust
Email: [East Suffolk and North Essex NHS Foundation Trust request email]

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FOI Requests, East Suffolk and North Essex NHS Foundation Trust

6 Attachments

From 1^st July 2018, Ipswich and Colchester Hospitals merged to become
East Suffolk and North Essex NHS Foundation Trust. Therefore, unless
otherwise specified, responses are on behalf of East Suffolk and North
Essex NHS Foundation Trust.

 

Thank you for your recent enquiry regarding information held by the East
Suffolk and North Essex NHS Foundation Trust:

 

1.       Could you please provide a copy of the Trusts New Medical Device
policy?”

2.       Could you please provide a copy of the Trusts “Medical Devices
and Procurement Review Group policy?”

3.       Could you please provide a copy of the Trusts “Business case
template for new medical devices or technology” for new medical/diagnostic
device approval?

4.       Could you please provide a list of all approved medical devices
in your Trusts? Excel format, word or PDF is fine.

5.       Could you please provide a copy of the policy which supports
“medical devices on trial requirements”.

6.       Could you please provide the policy for including a new pathology
test within the Trusts/entity?

7.       Could you please provide the policy for the “New medical Product
Selection Group”

8.       Could you please confirm how often new medical device review
meetings take place?

9.       Could you please provide me the name of the staff member
responsible for finances of new medical devices and their email address.

10.   Could you please provide me the name of the staff member responsible
for procurement of new medical devices and their email address.

11.   Lastly, could you please supply a copy of the last 3 ‘New Medical
Device meeting’ minutes and also the location of where they are published
on your website?

 

Your enquiry has been dealt with in accordance with the Trust’s Freedom of
Information Act 2000 Policy and Procedures. We are pleased to enclose the
information you requested:

 

1.       Could you please provide a copy of the Trusts New Medical Device
policy?” See attached (medical device management policy)

2.       Could you please provide a copy of the Trusts “Medical Devices
and Procurement Review Group policy?” See attached (introduction of
clinical products and therapeutic to the trust for lease trial or
purchase)

3.       Could you please provide a copy of the Trusts “Business case
template for new medical devices or technology” for new medical/diagnostic
device approval? See attached  (Business case framework)

4.       Could you please provide a list of all approved medical devices
in your Trusts? Excel format, word or PDF is fine. There is no list as of
yet but one is being made

5.       Could you please provide a copy of the policy which supports
“medical devices on trial requirements”. See attached (medical device
management policy)

6.       Could you please provide the policy for including a new pathology
test within the Trusts/entity? N/A

7.       Could you please provide the policy for the “New medical Product
Selection Group” See attached (introduction of clinical products and
therapeutic to the trust for lease trial or purchase)

8.       Could you please confirm how often new medical device review
meetings take place? Monthly

9.       Could you please provide me the name of the staff member
responsible for finances of new medical devices and their email address.
EBME that would Phil Harman Or Tom Westhead

10.   Could you please provide me the name of the staff member responsible
for procurement of new medical devices and their email address. Tom
Westhead plus Clinical procurement

11.   Lastly, could you please supply a copy of the last 3 ‘New Medical
Device meeting’ minutes and also the location of where they are published
on your website? See attached

 

If you have any queries about the enclosed information please contact us

 

The Public Sector Information Regulations provide a framework for public
sector organisations to licence the re-use of their information.  Please
request a re-use licence in order to re-use the information. Without the
necessary permission, you can breach our copyright.

 

Brief extracts of any material may be reproduced without our permission,
under the “fair dealing” provisions of the Copyright, Designs and Patents
Act 1988 for the purposes of research for non-commercial purposes; private
study; criticism; review and news reporting. All are subject to an
acknowledgement of ourselves as the copyright owner.  For guidance notes
on a range of copyright issues, see the Office of Public Sector
Information web site.

 

If you are unhappy with the service you have received in relation to your
request you should write to us. Please also contact us if you require a
copy of our Freedom of Information Act 2000 Complaints Procedure.  Any
complaints you wish to make in relation to Environmental Information
Regulations (EIR) requests, must be sent to us within 40 working days of
receipt of this letter.

 

If you remain dissatisfied with the handling of your request or complaint,
you have a right to appeal to the Information Commissioner at:

 

The Information Commissioner's Office

Wycliffe House

Water Lane

Wilmslow

Cheshire

SK9 5AF

Telephone: 08456 30 60 60 or 01625 54 57 45

Website: [1]www.ico.org.uk

 

There is no charge for making an appeal.

 

We hope that we have been able to answer your query to your satisfaction
and that you find the information provided useful.

 

 

Matthew Negus

Freedom of Information Team

East Suffolk and North Essex NHS Foundation Trust

[East Suffolk and North Essex NHS Foundation Trust request email]

 

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and North Essex NHS Foundation Trust, Turner Road, Essex, CO4 5JL

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Dear FOI Team,
Thank you very much for such a comprehensive response to our request. This is very helpful and we will review and revert if needed.

Yours sincerely,

Carolyn Tuson