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Actions for ophthalmology, ophthalmic theatres, and Medical Devices Safety Officers. To be completed 26 January 2023 Please take the following actions immediately: Nominate a lead person to take responsibility for completing these actions. Note – we recommend including colleagues in purchasing, supplies, and the Medical Device Safety Officer (MDSO). Identify if your organisation uses these IOLs Stop using these impacted products immediately Quarantine these impacted IOLs until further notice. Consider using a suitable alternative product if available following local risk assessment Immediately notify any other departments who need to be aware of this notice.

Vision for medtech The vision focusses on 3 central objectives: right product right price right place. These concepts centre on delivering the highest quality of care for patients and interact with and balance against each other - often, as focus on one component increases, focus on the others can decrease. Striking the best possible balance between these objectives is difficult, but the aim is to reach an optimal point where all 3 elements are weighted appropriately so the UK medtech sector best supports the UK health and care system in delivering improved health outcomes for patients. Four priority areas Having considered the broader landscape and current activity, the strategy has identified four priority areas: Priority 1: resilience and continuity of supply. Priority 2: innovative and dynamic markets. Priority 3: enabling infrastructure. Priority 4: specific market focusses.

The Patient Safety Commissioner outlines the range of different stakeholders she has met within her first 100 days in office, including patients, healthcare staff, patient safety specialists and healthcare providers. She also details the number of different areas of concern that have been raised with her in this period, including: pelvic mesh complications isotretinoin side effects painful gynaecological investigations Covid vaccination concerns mental health difficulties fluoroquinolone side effects Yellow Card scheme reporting concerns about electroconvulsive therapy. The report then sets out in more detail her reflections on patient safety concerns relating to the three medical interventions covered by the Independent Medicines and Medical Devices Safety Review: pelvic mesh, Sodium valproate and Primodos. She also highlights some positive areas of patient safety work she has encountered in her first 100 days in office, including the Scan 4 Safety initiative, NHS Resolution’s work on consent resources and how the new Patient Safety Incident Response Framework (PSIRF) is seeking to ensure that patients’ voices are included in incident investigations. The report concludes by setting out her top three priorities: 1. Culture Change The Patient Safety Commissioner plans to: hold a public consultation on the Principles of Better Patient Safety for the Patient Safety Commissioner work with healthcare leaders to put patient voice at the core of their activity and reporting amplify patients’ voices in all parts of the health system to ensure they are heard identify and highlight where patient voice is neglected challenge organisations to identify a named patient voice on all Boards and to place patient stories at the top of their meeting agendas campaign to improve the use of Yellow Card reporting campaign to see the NHS number used as the default and unique identifier ·work to ensure patients are engaged in the development of all national specifications develop the Patient Safety Commissioner website as a hub of best practice in championing patient voice. 2. Pelvic mesh The Patient Safety Commissioner plans to: co-produce resources for patients and GPs about side effects from pelvic mesh surgery work with NHS England to provide patients choice of access to specialist mesh centres work with the health system to ensure that information is available to all patients on national registries. 3. Sodium valproate The Patient Safety Commissioner plans to: support the health system to include the views of all stakeholders including patients to reduce harm from sodium valproate to the lowest possible level work with health leaders to ensure that all relevant patients are on a Pregnancy Prevention Plan (PPP) and given the necessary information collaborate with partners to ensure annual reviews are carried out by specialist prescribers work with partners across health to eliminate dispensing of sodium valproate in unlabelled white boxes work with professional regulators to streamline the advice to their registrants on sodium valproate and contraception raise patient awareness through charity collaboration.

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.

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.