IMMDS Review follow up one-off session

Health and Social Care Committee Closed Inquiry
Opened: 1 Sep 2022 Closed: 6 Feb 2023 Parliament page
MPs will examine government progress on recommendations made by the Independent Medicines and Medical Devices Safety (IMMDS) Review in a report, ‘First Do No Harm’, published in 2020. An update by Ministers on progress to implement the government’s response was due this summer. A Minister from the Department of Health … Read more
4 Recommendations
5 Conclusions
1 Report
2 Oral sessions
5 Letters
2 Events
Activity timeline 11 events
24 Apr
2023
Report published
20 Jan
2023
Report published
11 Jan
2023
Correspondence
20 Dec
2022
Correspondence
20 Dec
2022
Correspondence
20 Dec
2022
Correspondence
20 Dec
2022
Correspondence
13 Dec
2022
Oral evidence
13 Dec
2022
Formal meeting (oral evidence session) · Room 6, Palace of Westminster
13 Sep
2022
Oral evidence
13 Sep
2022
Formal meeting (oral evidence session) · Room 16, Palace of Westminster
Oral evidence sessions 2 sessions
13 Dec 2022
View on parliament.uk
Baroness Julia Cumberlege · Independent Medicines and Medical Devices Safety Review Celia Ingham-Clark · Department of Health and Social Care Dame June Raine · Medicines and Healthcare products Regulatory Agency (MHRA) Dr Aidan Fowler · Department of Health and Social Care Emma Murphy · Independent Foetal Anti-Convulsant Trust (In-FACT) Janet Williams · Independent Foetal Anti-Convulsant Trust (In-FACT) Kath Sansom · Sling the Mesh Campaign Maria Caulfield · Department of Health and Social Care Professor Sir Cyril Chantler · Independent Medicines and Medical Devices Safety Review Simon Whale · Independent Medicines and Medical Devices Safety Review William Vineall · Department of Health and Social Care
13 Sep 2022
View on parliament.uk
Baroness Julia Cumberlege · Independent Medicines and Medical Devices Safety Review Celia Ingham-Clark · Department of Health and Social Care Dame June Raine · Medicines and Healthcare products Regulatory Agency (MHRA) Dr Aidan Fowler · Department of Health and Social Care Emma Murphy · Independent Foetal Anti-Convulsant Trust (In-FACT) Janet Williams · Independent Foetal Anti-Convulsant Trust (In-FACT) Kath Sansom · Sling the Mesh Campaign Marie Lyon · Association for Children Damaged by Hormone Pregnancy Tests Professor Sir Cyril Chantler · Independent Medicines and Medical Devices Safety Review Simon Whale · Independent Medicines and Medical Devices Safety Review William Vineall · Department of Health and Social Care
Title HC No. Published Items Response
Sixth Report - Follow-up on the IMMDS report and the Government’… HC 689 20 Jan 2023 9 Responded
Recommendations & Conclusions
9 results
1 Recommendation Accepted
Sixth Report - Follow-up on the IM…
Ensure urgent and full implementation of IMMDS review recommendations 6 and 7 on patient records
Without records of which patient has undergone which procedure, or been prescribed which drug, the health system will continue to, in the words of the IMMDS review team, “fly blind”. We recommend that the Government urgently ensures that the accepted … Read more
Government Response
The government confirmed full implementation of IMMDS recommendations 6 and 7, detailing MHRA's transformation, new adverse incident reporting systems, and patient involvement strategy, alongside the development of a new medical device-level registry platform architecture (MDOR) with a target launch in April 2023 and an improved pelvic floor registry due in May 2023.
Department of Health and Social Care
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2 Conclusion Accepted
Sixth Report - Follow-up on the IM…
Retrospective mesh implant audit insufficient for capturing all adverse patient experiences
Although the retrospective audit of mesh implants is an encouraging first step, it will be unlikely to reflect and take into account all of the adverse effects women have experienced due to the nature of data used in the audit. … Read more
Government Response
The government committed to proactive measures beyond the retrospective audit, including designing a patient questionnaire (PROMs/PREMs) to be completed by April 2023 and integrated into the Pelvic Floor Registry by May 2023, and commissioning the development of a validated PROM for pelvic floor disorders by NIHR starting May 2023.
Department of Health and Social Care
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3 Recommendation Accepted
Sixth Report - Follow-up on the IM…
Set up register of clinicians' interests swiftly after pilot conclusion to prevent delay
We were encouraged to hear that the Government is going ahead with pilots of a register of clinicians’ interests, but we are disappointed by the speed at which the Government is acting on this recommendation. We urge the Government to … Read more
Government Response
The government committed to beginning the implementation phase for a register of doctors' interests in England in April 2023, with CQC monitoring publications after an 18-month lead-in period. They also plan to progress at different paces with devolved governments and consider systems for other healthcare professionals later.
Department of Health and Social Care
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4 Recommendation Accepted
Sixth Report - Follow-up on the IM…
Bring in secondary legislation swiftly for register of industry payments to clinicians
Although the Government has also given itself the powers to set up a register of industry payments to clinicians, no decision has been made yet about how to implement it, and officials were not able to share a plan of … Read more
Government Response
The government committed to launching a six-week UK-wide public consultation in Spring 2023 to gather public and industry views on potentially introducing regulations to mandate the reporting of industry payments and benefits to clinicians.
Department of Health and Social Care
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5 Conclusion Acknowledged
Sixth Report - Follow-up on the IM…
Patient Safety Commissioner's role impeded by lack of clear responsibilities and resources
Although the vision for what the role of Patient Safety Commissioner will achieve is publicised by the Department, no statement of specific assignments or areas of responsibility, have been published yet. As we set out in our report on the … Read more
Government Response
The government acknowledged the Patient Safety Commissioner's appointment and work, stating they are continuing to work with her on appropriate resource levels and will report back once discussions conclude. The Commissioner will publish her business plan after her website is complete.
Department of Health and Social Care
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6 Conclusion Accepted
Sixth Report - Follow-up on the IM…
Patient engagement with lived experience stakeholders remains inadequate for care schemes
We are concerned that although the letter from the Department seems to outline various interactions and consultations with stakeholders, and mentions Sling the Mesh by name, this is not the experience of some patients. Patient input is vital in setting … Read more
Government Response
The government committed to reviewing mesh centre outcomes and patient experience, and has appointed two patient advocates to the NHS England Specialised Women’s Services Clinical Reference Group. An audit of specialist mesh centres is due to take place in 2023.
Department of Health and Social Care
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7 Conclusion Accepted
Sixth Report - Follow-up on the IM…
New clinical negligence pathways offer no substantial improvement for seeking redress
It is positive that the Government has improved its communication and information online around how to bring claims of clinical negligence through the 20 Follow-up on the IMMDS report and the Government’s response new “pathways”. However, these pathways do not … Read more
Government Response
The government described the existing claims gateways, established with NHS Resolution for pelvic mesh and sodium valproate, which aim to simplify information access and the claims process. They committed to continuing to monitor the operation of these gateways and work with NHS Resolution to respond to any learning.
Department of Health and Social Care
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8 Recommendation Accepted
Sixth Report - Follow-up on the IM…
Require Secretary of State to detail resources for Patient Safety Commissioner's redress review
The focus of Patient Safety Commissioner and small team, and must remain, patient safety and harm prevention. If the additional responsibility of reviewing redress is placed on the Patient Safety Commissioner, the Secretary of State must ensure that the Commissioner … Read more
Government Response
The government confirms the Patient Safety Commissioner will undertake a four-month review of redress schemes for sodium valproate and pelvic mesh, focusing on affected individuals' views and the case for redress. They have agreed additional resources for the Commissioner to support this work and a report will be published, though the government does not believe a new redress agency is necessary.
Department of Health and Social Care
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9 Conclusion Accepted
Sixth Report - Follow-up on the IM…
Committee seeks Minister's statement on redress review and Redress Agency timeline
We would welcome a statement from the Minister on the review of redress and a possible Redress Agency, with more details on what such a review would include and seek to achieve, and timeline for completion. (Paragraph 60) Follow-up on … Read more
Government Response
The government has provided a specification for redress work to the Patient Safety Commissioner, which will focus on affected individuals' views and the case for redress, expected to take four months with a report to be published. However, the government explicitly rejected the creation of a new redress agency.
Department of Health and Social Care
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Government Response AI assessment · 9 of 4 classified
Accepted 8
Acknowledged 1
Total 4 recs + 5 conclusions
Correspondence 5 letters
11 Jan 2023 To committee Letter from Minister Maria Caulfield (IMMDS review) 19.12.22
Parliament page
20 Dec 2022 Correspondence from Celia Ingham-Clark on the IMMDS Review 16.12.22
Parliament page
20 Dec 2022 Correspondence from FDNH review team on the IMMDS Review 15.12.22
Parliament page
20 Dec 2022 Correspondence from In-FACT on the IMMDS Review 14.12.22
Parliament page
20 Dec 2022 Correspondence from Sling the Mesh on the IMMDS Review 16.12.22
Parliament page