The Health and Social Care Select Committee have published a new report reviewing the progress that the UK Government has made in implementing the recommendations of the Independent Medicines and Medical Devices Safety Review, sometimes referred to as the Cumberlege Review. This blog sets out Patient Safety Learning’s reflections on this report.
The Independent Medicines and Medical Devices Safety (IMMDS) Review examined the response of the healthcare system in England to the harmful side effects of three medical interventions: hormone pregnancy tests, sodium valproate and pelvic mesh implants. These interventions have resulted in a truly shocking degree of avoidable harm to patients over a period of decades, with the Review describing the healthcare system’s response to this as “disjointed, siloed, unresponsive and defensive."
Over two years on from the publication of the IMMDS Review’s report, First Do No Harm, the Health and Social Care Select Committee has today published a new report reviewing the implementation of its recommendations to date. The Review made nine overarching safety recommendations, of which the Government accepted four in full, two in part, one in principle and rejected two.
Following an evidence session held on 13 December 2022, the Health and Social Care Select Committee’s report focuses specifically on two of the three medical interventions considered by the IMMDS Review, sodium valproate and pelvic mesh implants, and makes recommendations for Government action on these issues.
The Committee’s report highlights the need to ensure that the below recommendations of the IMMDS Review, which the Government accepted, are fully implemented:
- That the Medicines and Healthcare products Regulatory Agency (MHRA) substantially revises its approach, particularly in relation to adverse event reporting and medical device regulation and ensures that it engages more with patients and their outcomes.
- A central patient-identifiable database should be created by collecting key details of the implantation of all devices at the time of the operation.
- That it sets up a register of clinicians’ interests and ensures this includes financial and non-pecuniary interests for all doctors.
- That it establishes a register of industry payments to clinicians.
Ensuring that the MHRA is responsive to patients and their outcomes is a long-term piece of work. The MHRA has come forward with numerous activities aimed at improving its approach in this respect, including the introduction of a new Patient Involvement Strategy. While the jury is still out on what the impact of this will be, Patient Safety Learning believes that to meet the Review’s recommendation will require more than just increased patient involvement; it will mean meeting patients’ expectations that healthcare products are safe and that patients are free from avoidable harm.
Turning to the creation of a central patient-identifiable database and a register of industry payments, there has been a lack of significant progress on these recommendations to date. However, pilot work on the register of clinicians’ interest has taken place and it has been stated by the Minister Maria Caulfield MP that implementation of this will begin in 2023. On each of these recommendations, we support the Committee’s calls for increased urgency by the Government in regards to their implementation. We also believe that there should be openly published timetables setting out plans for this.
You can read more about the importance of registering of clinicians interests, industry payments to clinicians and the need for greater transparency and reporting around financial conflicts of interest in healthcare in a blog on the hub by Sling the Mesh founder Kath Sansom.
A central focus of the report is the need for greater support for the women and children affected by the medical interventions covered by the IMMDS Review. Related to this, one of the key recommendations of the Review was to establish a new independent Redress Agency for those harmed by medicines and medical devices. It was envisioned that:
“The Redress Agency will administer decisions using a non-adversarial process with determinations based on avoidable harm looking at systemic failings, rather than blaming individuals.”
However, the Government rejected this recommendation, along with a recommendation to establish separate redress schemes for patients adversely affected by hormone pregnancy tests, sodium valproate and pelvic mesh. Instead they pointed towards patients having the right to take healthcare providers to court through clinical negligence, or manufacturers through product liability.
Patient Safety Learning believes, like many individual patients and patient groups, that this response was wholly unsatisfactory. A new blog published on the hub this week highlights how for many harmed patients affected by the interventions considered in the report the clinical negligence route simply is not viable. In the absence of any system of redress, this leaves them with no assistance to help meet the cost of any additional care and support they may need.
The Committee’s report notes that the Minister Maria Caulfield MP has indicated that she is willing to look at the idea of a Redress Agency, as well as separate redress schemes. We would welcome this and support the Committee’s call for a formal statement on this with “more details on what such a review would include and seek to achieve, and timeline for completion”.
Audit of mesh patients
Another recommendation of the IMMDS Review was for a retrospective audit of women who had pelvic mesh surgery, to help gain a fuller understanding of the nature and extent of mesh associated complications, with this data informing decisions over future pelvic mesh surgery.
The Committee’s report notes that while this audit is underway, there are significant concerns that it is failing to adequately capture mesh related complications due to the data it draws on. The report therefore recommends that the Government “consider an alternative strategy for how to pro-actively contact those who have had the procedure about their post-operative experiences and possible side effects.”
Patient Safety Learning supports this recommendation, which echoes the IMMDS Review’s intentions that as part of this audit:
“Every effort should be made to obtain sufficient data, and the audit results (assuming it is feasible) should be used to inform decisions over the future of pelvic mesh surgery.”
Patient Safety Commissioner
The Committee’s report also stresses its support for the work of the new Patient Safety Commissioner for England, Dr Henrietta Hughes, urging the Secretary of State to ensure her duties and responsibilities are not impeded by a lack of resource for and within her office. It suggests that any additional work she may be tasked with relating to reviewing redress arrangements should be accompanied by additional resources.
Patient Safety Learning supports this recommendation. The Patient Safety Commissioner can play an important role in helping to tackle unsafe care and empowering patients; however, her office must have the necessary resources and support to achieve this as indicated by the Select Committee.
Engaging with patients
At Patient Safety Learning, we believe that patient engagement is key to improving patient safety and identify this as one of the six foundations of safer care in our report, A Blueprint for Action. Patients should be engaged for safety at the point of care, if things go wrong, in improving services, advocating for changes and in holding the system to account.
We concur therefore with the Committee’s calls for the Department of Health and Social Care to improve its approach to this, following concerns raised by patients and patient groups:
“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 the Department to reflect on the experience of some of the stakeholders with lived experience in this instance, and to consider how to improve engagement with them in the future.”
Hormone pregnancy tests
One area of disappointment though that we would note with the Select Committee’s report is that it does not consider any of these issues in relation to patients and family members affected by hormone pregnancy tests, one of the three interventions covered by the IMMDS Review. They state that they were unable to do so due to ‘ongoing litigation’.
Patient Safety Learning does not believe this is acceptable. Many of the issues covered by this review, such as reforms to the MHRA, a register of clinicians’ interests and industry payments and potentially revisiting proposals for an independent Redress Agency, equally concern those affected by hormone pregnancy tests. While this may be complicated in some areas by ongoing legal proceedings, the exclusion of this group of patients is in our view impossible to justify.
You can read more about this issue, and the work being done by patients and groups to fight for justice and improve patient safety, in an interview on the hub with the Chair of the Association for Children Damaged by Hormone Pregnancy Tests, Marie Lyon.
- The IMMDS Review, First Do No Harm: The report of the Independent Medicines and Medical Devices Safety Review, 8 July 2020.
- Health and Social Care Select Committee, Follow-up on the IMMDS report and the Government’s response: Sixth Report of Session 2022-23, 20 January 2023.
- Patient Safety Learning, A year on from the Cumberlege Review: Initial reflections on the Government’s response, 23 July 2021.
- MHRA, Patient Involvement Strategy 2021-25, 1 October 2021.
- Kath Sansom, No such thing as a free lunch – why recording conflicts of interests must be mandatory, 9 April 2021.
- Kath Sansom, The difficult of medical negligence cases and why financial redress from the Government is so important for mesh victims, 17 January 2023.
- Patient Safety Learning, The Patient-Safe Future: A Blueprint for Action, 2019.
- Patient Safety Learning, Patient Safety Spotlight interview with Marie Lyon, chair of the Association for Children Damaged by Hormone Pregnancy Tests, 22 February 2022.