Asked by: Baroness Ritchie of Downpatrick (Labour - Life peer)
Question to the Department of Health and Social Care:
To ask His Majesty's Government when they intend to implement all of the recommendations contained in the Independent Medicines and Medical Devices Safety Review report First Do No Harm, published on 8 July 2020.
Answered by Lord Markham - Parliamentary Under-Secretary (Department of Health and Social Care)
The Independent Medicines and Medical Devices Safety (IMMDS) Review was clear in its finding that the healthcare system failed to listen to patients’ concerns on the issues covered by the review. The Government’s 2021 response to the review set out which of the review’s recommendations the Government had accepted. We also published an update in an online-only format in December 2022 setting out progress made against those recommendations, which includes appointing the first ever Patient Safety Commissioner in England to champion patients’ voices in relation to the safety of medicines and medical devices. In April 2023, the Government also responded to the recommendations made by the Health and Social Care Committee in its report ‘Follow-up on the IMMDS report and the Government’s response’, published in January 2023. A copy of the follow-up report is attached.
Asked by: Baroness Ritchie of Downpatrick (Labour - Life peer)
Question to the Department of Health and Social Care:
To ask His Majesty's Government what assessment they have made of the Independent Medicines and Medical Devices Safety Review report First Do No Harm, published on 8 July 2020.
Answered by Lord Markham - Parliamentary Under-Secretary (Department of Health and Social Care)
The Independent Medicines and Medical Devices Safety (IMMDS) Review was clear in its finding that the healthcare system failed to listen to patients’ concerns on the issues covered by the review. The Government’s 2021 response to the review set out which of the review’s recommendations the Government had accepted. We also published an update in an online-only format in December 2022 setting out progress made against those recommendations, which includes appointing the first ever Patient Safety Commissioner in England to champion patients’ voices in relation to the safety of medicines and medical devices. In April 2023, the Government also responded to the recommendations made by the Health and Social Care Committee in its report ‘Follow-up on the IMMDS report and the Government’s response’, published in January 2023. A copy of the follow-up report is attached.
Asked by: Baroness Ritchie of Downpatrick (Labour - Life peer)
Question to the Department of Health and Social Care:
To ask His Majesty's Government what recent assessment they have made of the recommendation for an Independent Redress Agency in the Independent Medicines and Medical Devices Safety Review report First Do No Harm, published on 8 July 2020.
Answered by Lord Markham - Parliamentary Under-Secretary (Department of Health and Social Care)
The Government has asked the Patient Safety Commissioner, Dr Henrietta Hughes, to undertake work looking at redress for people harmed by pelvic mesh and sodium valproate. The work is intended to focus on the views of those affected, improving the understanding of how many people have been affected and how, the case for redress and what form it could take.
The Patient Safety Commissioner office has stated that the report setting out the findings from this work is expected to be published on 7 February this year. The Government will consider the report’s findings before deciding how to proceed on this matter.
The Government published its response to the Independent Medicines and Medical Devices Safety review in July 2021, which did not accept the recommendation to establish a redress agency, this position remains unchanged.
Asked by: Mundell, Oliver (Scottish Conservative and Unionist Party - Dumfriesshire)
Question
To ask the Scottish Government, in light of it approaching four years since the report of the Independent Medicines and Medical Devices Safety Review, First Do No Harm, was published, and that three years have nearly passed since the Scottish Government published its plan for delivering on its commitment to implement, in full, the recommendations of the review, whether it will (a) provide an update on its delivery plan and (b) confirm when it expects to implement the remaining recommendations of the review to improve the lives of those impacted by sodium valproate, Primados and mesh implants.
Answered by Minto, Jenni - Minister for Public Health and Women's Health
There has been progress in implementing the Scottish Government’s delivery plan:
The Scottish Government considers, further to the undertaking offered in 2021, that it is taking appropriate action to pursue the outcomes sought by all of the recommendations of the 2020 report insofar as they relate to devolved matters.
Asked by: Baroness Ritchie of Downpatrick (Labour - Life peer)
Question to the Department of Health and Social Care:
To ask His Majesty's Government, further to the Independent Medicines and Medical Devices Safety Review report First Do No Harm, published on 8 July 2020, what discussions they have had regarding the provision of monetary compensation for people adversely affected by clinical and surgical pelvic mesh.
Answered by Lord Markham - Parliamentary Under-Secretary (Department of Health and Social Care)
The Government has asked the Patient Safety Commissioner, Dr Henrietta Hughes, to undertake work looking at redress for people harmed by pelvic mesh and sodium valproate. The work is intended to focus on the views of those affected, improving the understanding of how many people have been affected and how, the case for redress and what form it could take.
The Patient Safety Commissioner office has stated that the report setting out the findings from this work is expected to be published on 7 February this year. The Government will consider the report’s findings before deciding how to proceed on this matter.
The Government published its response to the Independent Medicines and Medical Devices Safety review in July 2021, which did not accept the recommendation to establish a redress agency, this position remains unchanged.
Mar. 11 2024
Source Page: MHRA response to Equity in Medical Devices: Independent ReviewFound: MHRA response to Equity in Medical Devices: Independent Review
Mar. 12 2024
Source Page: Modified MAGEC X system for early onset scoliosis treatment can now be used in the UKFound: of these devices, should discuss the options available to them with their medical team.
Asked by: Gulhane, Sandesh (Scottish Conservative and Unionist Party - Glasgow)
Question
To ask the Scottish Government what cost (a) savings and (b) avoidance it has identified since the implementation of Scan4Safety in Scotland.
Answered by Gray, Neil - Cabinet Secretary for NHS Recovery, Health and Social Care
The NHSScotland Scan For Safety Programme was established to provide rapid electronic traceability for high-risk implantable medical devices; linking patients to the medical devices used in their care, thus improving patient safety and fulfilling a key theme from the Independent Medicines and Medical Devices Review and a future regulatory requirement. In addition, the improved medical device data will provide a patient implant record and with appropriate safeguards provide an opportunity to improve our knowledge of real world medical device outcomes.
Implementation of NHS Scotland Scan for Safety has now been successfully completed in four specialties within two Health Boards and the Programme Team is currently engaging with the local Board teams to measure the benefits being realised in these Health Board areas. The benefits to be realised over time will cover areas such as patient safety, operational efficiency and clinical productivity. While the level of each benefit will depend on the Health Board implementing scanning technology across all affected specialties within a Board area, the Programme Team will work closely with each Board to ensure the identified benefits are maximised as much as possible between now and programme closure in March 2026.
Since the rollout of the National Inventory Management System (IMS)(a pre-cursor in supporting rollout of the Scan for Safety Programme), across all Health Boards in March 2023, data is now available across all Health Boards which suggests savings may be made regarding stock management in each Board area. This data will be validated with each Health Board as part of the Scan for Safety Programme implementation activity, due to be completed by March 2026. The level of savings (or avoidance) will vary in each Board. These benefits will be aggregated at a national level in due course and reported through to the National Programme Board as implementation progresses. Some benefits, such as the digital tracking of medical devices in the event of a recall, can only be realised and verified if a recall notice is received and this may not happen during the lifecycle of the programme.
Asked by: Baillie, Jackie (Scottish Labour - Dumbarton)
Question
To ask the Scottish Government how many children have been affected as a consequence of their mothers being prescribed sodium valproate during pregnancy.
Answered by Minto, Jenni - Minister for Public Health and Women's Health
We do not know the numbers of children affected because the information has not been collected historically.
In response to the Independent Medicines and Medical Devices Safety Review (IMMDSR), the Scottish Government commissioned Public Health Scotland (PHS) to establish a medicines in pregnancy surveillance asset. This resource will support monitoring and reporting to progress improvements in the safe use of valproate and other teratogenic medicines in Scotland. Its first output is due to be published by PHS in April 2024 and will include prescribing data and trends for valproate and other anti-seizure medicines.
Written Evidence Jan. 24 2024
Committee: Health and Social Care Committee (Department: Department of Health and Social Care)Found: PSN0026 - Expert Panel: Evaluation of Government’s progress on meeting patient safety recommendations