Recommendations & Conclusions
9 items
1
Recommendation
Sixth Report - Follow-up on the IMMDS r…
Accepted
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 recommendations 6 and 7 of the IMMDS review are fully …
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 …
Department of Health and Social Care
2
Conclusion
Sixth Report - Follow-up on the IMMDS r…
Accepted
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. We therefore recommend that the Government consider an alternative strategy …
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 …
Department of Health and Social Care
3
Recommendation
Sixth Report - Follow-up on the IMMDS r…
Accepted
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 make the arrangements necessary to ensure the register can be …
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 …
Department of Health and Social Care
4
Recommendation
Sixth Report - Follow-up on the IMMDS r…
Accepted
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 when the register would be active. A register would provide …
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
5
Conclusion
Sixth Report - Follow-up on the IMMDS r…
Acknowledged
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 pre- appointment hearing with Dr Hughes, metrics for success and …
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 …
Department of Health and Social Care
6
Conclusion
Sixth Report - Follow-up on the IMMDS r…
Accepted
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 up care schemes such as this one. We therefore urge …
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
7
Conclusion
Sixth Report - Follow-up on the IMMDS r…
Accepted
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 represent a substantial change or benefit to stakeholders who have …
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 …
Department of Health and Social Care
8
Recommendation
Sixth Report - Follow-up on the IMMDS r…
Accepted
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 and her office has access to proper independent expert advice …
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 …
Department of Health and Social Care
9
Conclusion
Sixth Report - Follow-up on the IMMDS r…
Accepted
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 the IMMDS report and the Government’s response 21
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 …
Department of Health and Social Care