Internal Reference Number: FOI_6460
Date Request Received: 03/02/2022 00:00:00
Date Request Replied To: 09/03/2022 00:00:00
This response was sent via: By Email
Request Summary: New Medical Devices
Request Category: Private Individuals
| Question Number 1: Could you please provide a copy of the Trusts/entity鈥淣ew Medical Device policy?鈥� | |
| Answer To Question 1: We do not have a New Medical Device policy. However the acquisition of new products is covered under various policies; Procurement Policy Medical Devices Management Policy Suppliers and Representative Code of Conduct Policy To accompany this answer to question 1 please also see the documents listed below:  Procurement Policy SFT October 21 v8 - final (3).pdf Medical Devices Management Policy V5.0 final.pdf Suppliers and Representatives Code of Conduct Policy -v7.pdf | |
| Question Number 2: Could you please provide a copy of the Trusts/entity鈥淢edical Devices and Procurement Review Group policy?鈥� | |
| Answer To Question 2: We do not have a Medical Devices and Procurement Review Group policy | |
| Question Number 3: Could you please provide a copy of the Trusts/entity鈥淏usiness case template for new medical devices or technology鈥� for new medical/diagnostic device approval? | |
| Answer To Question 3: Please see attached Capital Medical Equipment 22-23 bid form To accompany this answer to question 3 please also see the documents listed below:  Capital Medical Equipment 22-23 Bid form.docx | |
| Question Number 4: Could you please provide a list of all approved medical devices in your Trusts/entity? Excel format, word or PDF is fine. | |
| Answer To Question 4: Please see attached SFT medical devices To accompany this answer to question 4 please also see the documents listed below:  SFT medical devices.xlsx | |
| Question Number 5: Could you please provide a copy of the policy which supports 鈥渕edical devices on trial requirements鈥�. | |
| Answer To Question 5: Various policies support "Medical Devices on Trial Requirements" Procurement Policy Medical Devices Management Policy Suppliers and Representative Code of Conduct Policy To accompany this answer to question 5 please also see the documents listed below: Procurement Policy SFT October 21 v8 - final (3).pdf Medical Devices Management Policy V5.0 final.pdf Suppliers and Representatives Code of Conduct Policy -v7.pdf | |
| Question Number 6: Could you please provide the policy for including a new pathology test within the Trusts/entity? | |
| Answer To Question 6: There is no specific policy for New Pathology Tests. However a process is followed by which an impact assessment is completed this will confirm costs and resources required including benefits to the Trust and service improvement. Approval is then sought at Divisional Management level or if significant resource is required a business case presented to the relevant committee or board will be submitted and any new equipment requirements will be trialled/purchased in line with Procurement Policy and Medical Devices Management Policy. | |
| Question Number 7: Could you please provide the policy for the 鈥淣ew medical Product Selection Group鈥� | |
| Answer To Question 7: The Trust has 6 Technology Working Groups (TWG) have been established as sub-groups of the Medical Devices Committee | |
| Question Number 8: Could you please confirm how often new medical device review meetings take place? | |
| Answer To Question 8: Medical Devices Committee - Meets 3 times a Year | |
| Question Number 9: Could you please provide me the name of the staff member responsible for finances of new medical devices and their email address. | |
| Answer To Question 9: Lisa Thomas - Chief Finance Officer lisathomas2@nhs.net | |
| Question Number 10: Could you please provide me the name of the staff member responsible for procurement of new medical devices and their email address. | |
| Answer To Question 10: sft.procurement@nhs.net | |
| Question Number 11: Lastly, could you please supply a copy of the last 3 鈥楴ew Medical Device meeting鈥� minutes and also the location of where they are published on your website? | |
| Answer To Question 11: Part of the minutes of the Medical Devices Committee are considered commercially sensitive, therefore see redacted minutes attached. See Refusal Notice under sect 36 attached To accompany this answer to question 11 please also see the documents listed below: MDC Minutes final 28.09.20.pdf MDC Minutes final 04.10.21.pdf MDC Minutes Final 28.06.21.pdf | |
| Please see Attachments: | |
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