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Findings While national guidance says that a patient’s risk of harm should not be stratified into categories such as high, medium or low, such stratification remains common in many trusts. This is because other methods of assessing and documenting risk are not available, and because staff fear being blamed if a patient comes to harm without a risk assessment, including risk stratification, having been completed. Current research only demonstrates a link between menopause and low mood, and not between menopause and more severe mental health symptoms. Women are frequently prescribed antidepressant medication when hormone replacement therapy may be a more appropriate treatment for their symptoms. Menopause is not routinely considered as a contributing factor in women with low mood who are assessed by mental health services, and staff do not receive training in this area as standard. While there is a significant amount of national guidance relating to family engagement when treating patients with mental health conditions, mental health practitioners often find it difficult to know how and when to engage with families with complicated relationships or when the patient withdraws their consent for information sharing. There is a lack of training in this area to support staff with decision making. National guidance raised the upper age limit for referral to the Early Intervention in Psychosis pathway in 2016. Some trusts continue to prioritise younger patients for a variety of reasons – including funding, capacity and misconceptions about whether an older person can actually be experiencing a true first episode of psychosis in later life. Safety recommendations HSIB has made four safety recommendations as a result of this investigation. NHS England: HSIB recommends that NHS England works with appropriate stakeholders, including experts with appropriate experience, to create guidance on culture change. A quality improvement programme should also be developed to support practitioners in undertaking psychosocial assessments that are in line with guidance from the National Institute for Health and Care Excellence. Person-centred safety planning should be embedded within the process. Care Quality Commission (CQC): HSIB recommends that the Care Quality Commission evaluates the way in which it reviews how community mental health services assess risk of harm, to ensure its inspections are in line with the latest national guidance. National Institute for Health and Care Excellence (NICE): HSIB recommends that the National Institute for Health and Care Excellence evaluates the available research relating to the risks associated with menopause on mental health and if appropriate, updates existing guidance. Royal College of Psychiatrists (RCPsych): HSIB recommends that the Royal College of Psychiatrists forms a working group with relevant stakeholders to identify ways in which menopause can be considered during mental health assessments. Safety observations HSIB has made the following safety observations: It may be beneficial for mental health organisations to have a dedicated liaison officer who acts as a point of contact for both families and clinicians when navigating involvement in a patient’s care and decision making. It may be beneficial for organisations to involve families in care planning and assessments, and that practitioners are appropriately trained in working with families. It may be beneficial for education bodies to develop training programmes in safety planning and psychosocial assessments, once NHS England has provided guidance on how such assessments should be conducted. It may be beneficial for mental health organisations to ensure their Early Intervention in Psychosis referral process is in line with the national guidance, and that staff are clear about the upper age limit of patients accepted onto the pathway. Safety actions HSIB has noted the following safety action: NHS England has written to all mental health trusts in England to highlight the importance of taking a person-centred approach to psychosocial assessments and safety planning. The communication asks trusts to move away from risk assessment tools that stratify an individual’s risk of suicide or self-harm.

Statement "I wish to inform the House of the Government’s initial response to the report of the independent review into the maternity and neonatal services at East Kent University NHS Foundation Trust that was published on the 19 October 2022. NHS England commissioned Dr Bill Kirkup CBE to undertake this review following concerns about the quality and outcomes of care. I would like to place on the record my gratitude to the families who came forward to contribute to this review, and to express my deepest sympathies for the loss and harm that Dr Kirkup discovered in the maternity and neonatal services at East Kent. I am also grateful for Dr Kirkup and his review team for his report. Taking each of the recommendations in turn: 1) The Government already has work underway to establish a Task Force with appropriate membership to drive the introduction of valid maternity and neonatal outcome measures capable of differentiating signals among noise to display significant trends and outliers, for mandatory national use. 2i) Those responsible for undergraduate, postgraduate and continuing clinical education will be commissioned to report on how compassionate care can best be embedded into practice and sustained through lifelong learning. 2ii) Relevant bodies, including Royal Colleges, professional regulators and employers, will be commissioned to report on how the oversight and direction of clinicians can be improved, with nationally agreed standards of professional behaviour and appropriate sanctions for non-compliance. 3i) Relevant bodies, including the Royal College of Obstetricians and Gynaecologists, the Royal College of Midwives and the Royal College of Paediatrics and Child Health, will be charged with reporting on how teamworking in maternity and neonatal care can be improved, with particular reference to establishing common purpose, objectives and training from the outset. 3ii) Relevant bodies, including Health Education England, Royal Colleges and employers, will be commissioned to report on the employment and training of junior doctors to improve support, teamworking and development. 4i) The Government will consider in parallel with other relevant inquiries the duties placed on public bodies to share information with families. 4ii) Trusts will be required to review their approach to reputation management and to ensuring there is proper representation of maternity care on their boards. 4iii) The Government will continue to work with NHSE on its approach to poorly performing trusts and their leadership. 5) The Trust has already made a statement accepting the reality of these findings; acknowledging in full the unnecessary harm that has been caused; and embarking on a restorative process addressing the problems identified, in partnership with families, publicly and with external input." We continue to work with NHS England and the Care Quality Commission regarding patient safety concerns at the Trust. Further information on how the recommendations are being implemented will be outlined in Spring 2023. The Department of Health and Social Care will also closely monitor progress on these recommendations alongside the recommendations of other maternity and neonatal service inquiries to improve standards of care for mothers and babies.

Background The introduction of ‘Freedom to Speak Up Guardians’ into every NHS trust in England was intended to support workers and trusts to better raise, respond to and learn from speaking-up concerns. However, only broad guidance was provided on how to implement the role. As a result, there is the potential for important local differences to emerge as the role is implemented across England. The overall aim of this study was to better understand the implementation of Guardians in acute trusts and mental health trusts. Results Wide variability was identified in how the Guardian role had been implemented, resourced and deployed by NHS trusts. ‘Freedom to Speak Up Guardian’ is best considered an umbrella term, and multiple versions of the role exist simultaneously across England. Any comparisons of Guardians’ effectiveness are likely to be possible or meaningful only when this variability is properly accounted for. Many Freedom to Speak Up Guardians identified how a lack of available resources, especially time scarcity, negatively and significantly affected their ability to effectively respond to concerns; their opportunities to collect, analyse and learn from speaking-up data; and, more generally, the extent to which they developed their role and speak-up culture. Conclusions Optimal implementation of the Guardian role has five components: establishing an early, collaborative and coherent strategy congruent with the values of Freedom to Speak Up fosters the implementation of policies and robust, yet supportive, practices informed by frequent and reflexive monitoring of Freedom to Speak Up implementation that is underpinned by sufficient time and resource allocation that leads to a positive implementation climate that is congruent with Freedom to Speak Up values and is well placed to engender positive and sustainable Freedom to Speak Up culture and the well-being of a Guardian.

The review found that while in many cases care and treatment were appropriate, there were a number of cases that raised specific patient safety concerns. Below is a summary of key themes from this report: Out of area placements An out of area placement occurs when a person with acute mental health needs who requires inpatient care is admitted to a unit that does not form part of the usual local network of services. This review found that there was significant variation for people who are autistic and/or have a learning disability in this regard. This was most striking in the South West of England and Midlands regions, where 73% and 68% of all placements, respectively, were out of area compared to the national average of 57%. The report notes this can have significant impacts on the person affected by this, making it more difficult for them to maintain links with family, local services, communities and clinical/social work professionals. Hospital rather than community care It found that a significant number of patients covered by SWRs did not need to be in a hospital setting to receive the right care and treatment. The national average was 41%, while in the South West of England 53% of individuals did not need to be in hospital settings. The report linked this figure to delays in discharge processes, with patients staying in hospital settings for longer than needed as a result. Concerns about the involvement of family members and carers Concerningly, the report notes that examples of poor communication with family members and carers ‘far outweighed’ examples of effective communication, including: Being excluded from planning and decisions about their loved ones. Not being provided with basic information such as how to contact family members and visiting times. Not being listened to in relation to the care and treatment of their family member, or decisions about their care and wellbeing. There was regional variation in these figures, with one particularly striking case being an Integrated Care System stating that in 39% of their safe and wellbeing reviews, family representatives either could not be contacted for the purposes of the review, they did not want to be contacted or the individual did not want them to be contacted. Advocacy Another area of concern cited was the availability and quality of advocacy for people in hospital, which the report describes as generally inconsistent. Concerns included: Family members having to step into the role of advocates in place of professional advocacy, though they are generally not trained to do so, may not know all the options available and cannot be fully independent. Some provides being resistance to creating a “culture of importance” around advocacy. Poor advocacy awareness in places, which extended to limited attempts by providers to contact advocates and proactively involve them in processes and decisions relating to individuals. Safeguarding In the 3% of cases where safeguarding concerns were raised (50 out of 1,770), serious concerns noted by the report included: Inconsistent and/or high levels of restraint, seclusion and segregation. Patients not being assessed appropriately under the Mental Capacity Act or assessments not being completed in a timely way Harms associated with weight gain during admission (increasing the likelihood of health problems and premature mortality) and long lengths of stay. Issues associated with individuals being placed in inappropriate settings (for example, mixed-gender wards), the absence of CCTV in inpatient settings, issues with staff attitudes and relationships. Low quality and inconsistent of incident reporting. Inappropriate and inconsistent use of medication. The review also said that one region noted that safeguarding referrals were not always made appropriately, and plans were not always implemented to prevent the incidents from happening again. Physical health The report notes that it found multiple references to individuals with a high body mass index and significant weight gain following people being admitted to hospital, including instances where this led to people developing diabetes. This was a key area of concern also raised in the Cawston Park safeguarding adults review. Individual wellbeing and positive mental health The report noted that in many mental health inpatient settings there were not enough activities for people to do and not enough done to help maintain social connections. It noted that meaningful activities were not consistently available and, where they were, were not always age-appropriate, co-planned and person-centred. Workforce The report noted a number of workforce issues, including: Families and advocates raised concerns about whether wards were unsafe when there were significant staff shortages on them. Staff burnout. Heavy reliance on agency and/or temporary staff which can have negative impacts on patients being able to access regular activities and on patient-staff relationships. Reports of staff not having the appropriate training or skillset to effectively meet the needs of individuals. Conclusions and next steps Throughout the report there are a number of sections detailing ‘key considerations’ for providers and Integrated Care Systems, though no specific actions. It notes towards the end of the report that following on from this, NHS England, on a national and regional footprint, working with people with lived experience, family carers, integrated care boards, providers and commissioners, will bring partners together to look at specific actions that will address the challenges and themes highlighted through this thematic review over the next 12 months.

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."[1] 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.[2] The Review made nine overarching safety recommendations, of which the Government accepted four in full, two in part, one in principle and rejected two.[3] 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. Implementing recommendations 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.[4] 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.[5] Redress 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.”[1] 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.[6] 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”.[2] 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.”[2] 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.”[1] 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.[7] 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.”[2] 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.[8] References 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.

This report follows on from an evidence session held by the Select Committee on the 13 December 2022 to assess the Government’s progress against recommendations made in the Independent Medicines and Medical Devices Safety (IMMDS) report, First Do No Harm. This featured contributions from the Government Minister Maria Caulfield MP, patients and patient groups, and representatives from NHS England and the Medicines and Healthcare products Regulatory Agency (MHRA). Summary of the reports recommendations The Government should: Urgently ensure that the accepted recommendations 6 and 7 of the IMMDS review are fully implemented. Consider an alternative strategy for how to pro-actively contact pelvic mesh patients who have had the procedure about their post-operative experiences and possible side effects. Make the arrangements necessary to ensure the register of clinicians’ interests can be set up swiftly, subject to the pilot phase concluding, to prevent further delay. Move at pace to bring in the necessary secondary legislation to set this up a register of industry payments to clinicians. Ensure that the Patient Safety Commissioner for England’s ability to carry out her important role, as her duties and responsibilities is more clearly defined, is not impeded by a lack of resource for and within her office. The Department of Health and Social Care should: Respond to concerns raised about interactions and consultations with stakeholders around care schemes stemming from the review, reflecting on this experience and considering how to improve engagement with them in the future. The Secretary of State for Health and Social Care should: Make a statement detailing the Patient Safety Commissioner’s review of redress schemes for the medical interventions dealt with by the IMMDS review, and what additional resources will be made available to her to undertake it. The Minister for Mental Health and Women’s Strategy should: Make a statement 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.

Summary recommendations The National Screening Committee should reconsider the case for a targeted national screening programme to detect high fracture risk in 2023. The Government should instigate a public health campaign to address the lack of awareness and complacency in the public about bone health. Osteoporosis must be given parity with other long-term conditions, and defined as such within the NHS, to allow enhanced and equitable care and management. NHS England must outline plans to expand DXA services to deliver and exceed their recommended 4% increase in capacity in order to tackle the current backlog and future-proof services, and improve access by including DXA in minimum specifications for Community Diagnostic Centres. Every individual who requires ongoing management or surveillance to reduce their fracture risk should have a personalised ‘bone health management plan’ with a specified timescale for reviews. ICSs should utilise the breadth of skills and expertise within the multi-disciplinary team to optimise and streamline local management pathways for people at high risk of fragility fracture. Establish a new National Specialty Adviser for Fracture prevention and Osteoporosis within the NHS England and NHS Improvement clinical advisory structure, and equivalent in Scotland, Wales and Northern Ireland. The APPG recommends proportionate recognition of the importance of osteoporosis throughout healthcare education, with increased prominence in undergraduate and post-graduate healthcare professional training. Specialist services must support primary care colleagues to provide the best care to patients. All relevant national guidelines should be reviewed to better support imaging of the spine where there is a suspicion of vertebral fracture, particularly in patients with risk factors for osteoporosis. NHS England must provide sufficient funding for ICSs to deliver against national quality standards and NICE clinical guidance.

10:03:23 Witness(es): Emma Murphy, Founder, Independent Foetal Anti-Convulsant Trust (In-FACT); Janet Williams, Founder, Independent Foetal Anti-Convulsant Trust (In-FACT); Kath Sansom, Campaigner, Sling the Mesh Campaign. 10:36:55 Witness(es): Professor Sir Cyril Chantler, Deputy Chair, Independent Medicines and Medical Devices Safety Review; Simon Whale, Review Member and Communications Lead, Independent Medicines and Medical Devices Safety Review; Baroness Julia Cumberlege, Chair, Independent Medicines and Medical Devices Safety Review. 11:03:10 Witness(es): Maria Caulfield MP, Parliamentary Under-Secretary of State (Minister for Mental Health and Women's Strategy), Department of Health and Social Care; Dr Aidan Fowler, National Director of Patient Safety in England, Department of Health and Social Care; William Vineall, Director of NHS Quality, Safety and Investigations, Department of Health and Social Care; Celia Ingham-Clark, Medical Director for Professional Leadership and Medical Workforce, Department of Health and Social Care; Dame June Raine, Chief Executive, Medicines and Healthcare products Regulatory Agency (MHRA).

The 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 had 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’. In this report, the Government provides a progress update on the implementation of the Review’s recommendations, which is summarised below: Recommendation 1 - The government should immediately issue a fulsome apology on behalf of the healthcare system to the families affected by primodos, sodium valproate and pelvic mesh. Progress update - Complete. On 9 July 2020, the day after publication of the review, the Government issued an unreserved apology on behalf of the healthcare system to the women affected, as well as their children and their families, for the time the system took to listen and respond. Recommendation 2 - The appointment of a Patient Safety Commissioner who would be an independent public leader with a statutory responsibility. Progress update - Complete. The Government appointed Dr Henrietta Hughes as the Patient Safety Commissioner for England on 12 July 2022. Recommendation 3 - A new independent Redress Agency for those harmed by medicines and medical devices should be created based on models operating effectively in other countries. Progress update - The Government did not accept recommendation 3. Recommendation 4 - Separate schemes should be set up for each intervention – HPTs (hormone pregnancy tests), valproate and pelvic mesh – to meet the cost of providing additional care and support to those who have experienced avoidable harm and are eligible to claim. Progress update - The Government did not accept recommendation 4. In this report they point to NHS Resolution having now launched two claims gateways on their website to provide further support to patients who may wish to bring a clinical negligence claim in relation to pelvic mesh and sodium valproate. Recommendation 5 - Networks of specialist centres should be set up to provide comprehensive treatment, care and advice for those affected by implanted mesh; and separately for those adversely affected by medications taken during pregnancy. Progress update - Complete for specialist mesh centres. There are now nine specialist centres in operation in England. They state that this ensures that women in every region have access to these services and note that each mesh centre is led by a multidisciplinary team to ensure patients get access to the specialist care and treatment that they need, including pain management and psychological support. Ongoing for medicines in pregnancy. They state that their view was that a network of new specialist centres is not the most effective way forward to help those adversely affected by medicines taken during pregnancy. The report notes that NHS England has instead taken forward work to improve care pathways for children and families adversely affected by medicines in pregnancy. Ongoing for sodium valproate. The report states that the MHRA is introducing stronger regulatory measures to continue to reduce the number of pregnancies exposed to sodium valproate, including new patients under 55 years of age needing two specialists to document that no other medicine is effective or tolerated. It notes that work continues to improve compliance with regulatory measures, with the MHRA and NHS Digital establishing the Medicines and Pregnancy Registry to track NHS prescriptions of valproate in girls and women of childbearing age in England. In 2022 to 2023, an audit will be carried out by pharmacies to measure adherence to MHRA regulations. Recommendation 6 - The MHRA needs substantial revision, particularly in relation to adverse event reporting and medical device regulation. Progress update - Ongoing. They state that the MHRA has embarked upon an ambitious organisation-wide transformation to ensure it becomes a progressive and responsive patient-focused regulator of medical products. It notes that the Agency has been establishing a new organisational structure that improves how it listens and responds to patients and the public, developing a more responsive system for reporting adverse incidents, and strengthening the evidence to support timely and robust decisions that protect patient safety. Recommendation 7 - A central patient-identifiable database should be created by collecting key details of the implantation of all devices at the time of the operation. This can be linked to specifically created registers to research and audit the outcomes both in terms of the device safety and patient-reported outcomes measures. Progress update - Ongoing. In 2021 to 2022, a scoping exercise was undertaken to determine how best to deliver this recommendation. This provided a significant amount of learning. They state that they concluded that, for England, expanding the coverage and breadth of existing registries will best deliver harmonised data collections that contain patient, device and outcome-level data. They have an target to increase registry coverage from 15% to 80% over the next 3 years. In parallel, the report notes that the Government are working with devolved governments to develop a UK-wide approach that will enable secure data sharing, system interoperability and UK-wide coverage, where appropriate to do so. Recommendation 8 - Transparency of payments made to clinicians needs to improve. The register of the General Medical Council (GMC) should be expanded to include a list of financial and non-pecuniary interests for all doctors, as well as doctors’ particular clinical interests, and their recognised and accredited specialisms. In addition, there should be mandatory reporting for the pharmaceutical and medical device industries of payments made to teaching hospitals, research institutions and individual clinicians. Progress update - Ongoing. The report states that they are currently piloting systems for doctors to declare their interests in NHS and independent settings across the UK. Full implementation will begin in 2023, subject to a successful review of the pilot systems. Once this system is in place for doctors, they note that they will then consider systems for other healthcare professionals. The report also notes that the Government has legislated through the Health and Care Act 2022 to enable the Secretary of State for Health and Social Care to make regulations requiring companies to publish or report information about their payments to the healthcare sector. The Government is reviewing the information gathered from stakeholders to develop plans on how best to deliver on the objectives of this recommendation. Recommendation 9 - The government should immediately set up a taskforce to implement this review’s recommendations. Its first task should be to set out a timeline for their implementation. Progress update - Not accepted. The Government did not accept recommendation 9. In this report they point to having instead established a Patient Reference Group to inform work to develop the 2021 government response. The Patient Reference Group published an independent report on their work in July 2021. Related reading Independent Medicines and Medical Devices Safety Review: A joint letter from the Association for Children Damaged by Hormone Pregnancy Tests, Sling The Mesh and In-Fact, 17 February 2022. Kath Sansom, 10 problems with NHS England’s specialist mesh centres, 3 October 2022. Patient Safety Spotlight interview with Marie Lyon, chair of the Association for Children Damaged by Hormone Pregnancy Tests, 22 February 2022. Patient Safety Learning, A year on from the Cumberlege Review: Initial reflections on the Government’s response, 26 July 2021.

Addressing these safety challenges must be a key priority for the new Prime Minister and Health Secretary. This report makes five recommendations, highlighting the vital role that the intelligent collection and monitoring of patient safety data, and the rapid response to any concerns they raise, can play in the continuous improvement of patient safety. Underpinning all of these recommendations is the principle that, first and foremost, patient safety needs to be seen and truly understood from the patient’s perspective. Recommendations: The breadth of patient safety data needs to increase. The accuracy of key patient safety measures needs to improve. A workforce plan for the NHS and social care system is urgently needed. Integrated Care Systems need to play a central role in monitoring patient safety. Progress in the safety of maternity services needs to accelerate.