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In 2015, few people had even heard of pelvic mesh implants, let alone the devastating complications they could cause. Women were told their pain was “normal,” their concerns dismissed, their injuries hidden behind a wall of medical gaslighting. But what began as a small group of women raising their voices against an invisible epidemic turned into one of the UK’s most powerful grassroots campaigns for patient safety and medical justice. As Sling The Mesh marks its 10th anniversary, it celebrates a decade of courage, compassion, and relentless campaigning that has changed lives – and policy – forever. Over the next decade, Sling The Mesh will: Demand proper aftercare and support for all mesh-injured patients. Push for accountability from manufacturers and regulators. Campaign for awareness around hernia and other less-recognised mesh complications. Advocate for safer alternatives and patient-centred decision-making. Empower the next generation of campaigners to keep raising their voices. Push for tougher regulations and oversight of medical devices. Lobby for Sunshine legislation for transparency around funding from industry to the healthcare sector which can bias prescribing and affect research integrity.

Patients with vision or hearing loss frequently encounter difficulties accessing vital health information, medication instructions, and effectively using medical devices. This report for the Patient Safety Commissioner for England, commissioned from Professor Margaret Watson, highlights serious gaps and deficiencies in the way that people with visual and/or hearing impairment or loss (referred to as sensory impairment) are able to access and use medicines and medical devices safely. This report presents the results of a short-term study to explore the challenges experienced by patients with sensory impairment in relation to their safe and effective access to and use of medicines and medical devices. This study was conducted from September to December 2024. The primary data that were generated were derived from three sources: Focus groups involving individuals with visual impairment or loss, including people with diabetes. Key Informant responses to an electronic survey. Medicines and Healthcare products Regulatory Agency (MHRA) Yellow Card reports. Patients reported distressing experiences due to inaccessible packaging, unreadable patient information, inadequate communication about medication changes and a lack of suitable reporting mechanisms for issues. The report makes the following recommendations: The MHRA needs to review – working alongside patients – whether their current guidance and regulations for the licencing and packaging of medicines goes as far as is possible to enable their safe use by those with sensory impairment. The Association of the British Pharmaceutical Industry (ABPI), MHRA and Department of Health and Social Care (DHSC) should work together to restart work – alongside published milestones – to digitise paper-based patient information leaflets via the existing UK Electronic Patient Information Task Force (ePIL). As part of this restart, ePIL – working with patients – should examine how to maximise the benefits of this work for patients with sensory impairment. NHS England’s Diabetes Programme Team should launch a patient reference group to assess, understand and mitigate the barriers and enablers to the safe and effective roll-out of medical devices and other education programmes for the management of diabetes (such as DAFNE) for those with sensory impairments. DHSC and NHS England need to ensure the work announced to improve and expand the NHS App in ‘Reforming elective care for patients’ includes an assessment – conducted with the input of patients – to determine whether further accessibility improvements are required, especially for people with visual impairment. In a number of other areas, the report states that the Patient Safety Commissioner wants to make observations to a number of bodies – highlighting the outcome without specifying the solutions, in keeping with the ethos of the recent Health Services Safety Investigations Body (HSSIB) report ‘Recommendations but no action: improving the effectiveness of quality and safety recommendations in healthcare.’ The report makes the following observations: A patient’s medical record needs to include a prominent flag of accessibility needs and detailed information about these needs to ensure that the healthcare professional can provide any required reasonable adjustments. All relevant healthcare professionals – including community pharmacists – must have sufficient access to these patient records and flags. Healthcare professionals, particularly community pharmacy personnel and others involved in the direct supply of medicines and medical devices, must have sufficient funding to support the additional time and resources required by to undertake assessments of patient needs and provide the required ‘reasonable adjustments’ for medicines and medical devices. With the anticipated increase in prevalence of sensory impairment amongst the general population, further guidance is required to promote evidence-based practice by health and social care professionals in terms of the medicine journey of people with sensory impairment. It is also crucial that there is provision of training to healthcare professionals (ideally within the undergraduate curricula) regarding the needs of people with sensory impairment. People with experience of sensory impairment should be included in the design of medical devices, as well as user information and instructions to accompany their supply and use. Manufacturers need to provide more resources to facilitate the demonstration of the effective use of medical devices, especially for people with visual impairment.

This is a brief summary of a Westminster Hall debate in the House of Commons on the 27 March 2025 concerning the first anniversary of The Hughes Report on valproate and pelvic mesh. What is a Westminster Hall Debate Westminster Hall debates give Members of Parliament (MPs) an opportunity to raise local or national issues and receive a response from a government minister. Any MP can take part in a Westminster Hall debate. The Hughes Report The Independent Medicines and Medical Devices Safety Review, published in July 2020, highlighted the scale of avoidable harm related to three medical interventions: hormone pregnancy tests, sodium valproate and pelvic mesh implants. One of the Review’s key recommendations was that separate redress schemes should be established for patients adversely affected by these interventions. Published on the 7 February 2024, the Patient Safety Commissioner for England set out options for redress for two of these interventions, pelvic mesh and sodium valproate in The Hughes Report. It recommends the government creates a two-stage financial redress scheme – an interim scheme to enable the identification of all those harmed ensuring patients receive financial redress quickly – and a main scheme. You can find Patient Safety Learning’s reflections on the first anniversary of this report’s publication here. House of Commons debate In the discussion MPs highlighted individual cases from their constituents relating to pelvic mesh and sodium valproate and also discussed: The need to confirm a timeline for the Government's response to The Hughes Report. Considering whether there is scope to implement a sunshine-style piece of legislation to ensure the transparency of payments made by industry to the healthcare sector. The difficulties of getting financial redress outside of a Government scheme. On mesh, it was noted that of the 1,252 legal cases initiated between 2014 and 2024, only 356 were settled in or out of court with damages, but 678 were concluded without any such damages being awarded. Concerns about specialist mesh removal centres being run by clinicians who have inserted mesh. Considering whether the initial interim payment of £25,000, proposed by the report, could be prioritised ahead of finalising arrangements for the main payment. Responding on behalf of the Government to this debate was Ashley Dalton MP, Parliamentary Under-Secretary of State for Public Health and Prevention. She noted that: The previous Government had held a consultation on the principle of mandatory reporting for industry payments made to the health sector. The Department of Health and Social Care was now considering options regarding payment reporting, with an aim to publish a response later this year. The Government is still considering all the options and the associated costs before responding to The Hughes Report’s recommendations. She stated that she would write to Baroness Marron to clarify timescales around this.

This blog from Pentland Medical and Dawn Stott Associates highlights the findings from their report ‘Surgical airway securement: A report analysing responses to a survey, focus groups and freedom of information requests’.[2] The aim of the work is to look at patient harm from surgical airway securement in critical care environments and, ultimately, to underscore the importance of continuous learning, a culture of transparency and collaboration across disciplines to sustain improvements in patient safety. Background Securing an airway device is a critical component of patient safety, particularly in situations where airway management is essential to life support, such as during surgery, emergency care or critical illness. The airway device, typically an endotracheal tube or laryngeal mask airway, ensures that a patient’s airway remains open for adequate oxygenation and ventilation. The WHO Guidelines for Safe Surgery states that “Securing the airway of a patient undergoing general anaesthesia is the single most critical event during induction.”[1] As all healthcare professionals working in the anaesthetic environment will know, properly securing the device is paramount as any displacement or dislodgement can lead to life-threatening complications like hypoxia, aspiration or airway obstruction. Ensuring that the airway stays in place for the time needed is an equally important part of this process. Currently, this is often done with the use of off-label materials, such as tape and ties, which can cause facial damage ranging from minor redness to severe tissue damage. This tape can also pose an infection risk, but, perhaps more pertinently, any off-label methods are not fit for purpose. Although they are embedded in healthcare practice and are used world over, tape and ties were never designed to perform airway securement. Consultation on airway device securement Following an inaugural round table discussion meeting led by Dawn Stott Associates, a ‘cross sector’ Short Life Working Group (SLWG) was formed to consult on the way an airway device is currently secured when a patient is undergoing a surgical intervention. The group’s goals were to identify systemic barriers to the standardisation of airway management and to develop guidance to support a more robust and consistent way of securing the airway device. The group’s mission was to: review current policy, guidance and legislation to help interpret and apply them to daily anaesthetic practice to support healthcare facilities and personnel with materials and resources on airway device securement and management to help ensure compliance with policy to establish an environment where standardisation of approach is accepted to make guidance available to support healthcare professionals ensure that the patient is safe. The group also reviewed the broader issues around patient safety and the cultural challenges around change management in securing an airway device with tapes. Current guidance What has been astonishing for the SLWG is that no guidance exists from any recognised bodies in the UK on securing an airway device. The Difficult Airway Society (DAS) is generally regarded as the leading authority on anything airway related, not just in the UK but also internationally. However, while the DAS guidance states that healthcare professionals should secure the airway device, it does not go beyond this to advise on best techniques or materials that should be used. This absence of national guidance has resulted in an inconsistent approach to securing an airway device within UK hospitals, and with it the risk of facial harm, infections and more serious incidents that are entirely preventable. Until now there has not been any solution designed and risk-assessed to secure an airway device in the theatre environment, leaving a vacuum where healthcare professionals worldwide are forced to improvise by developing their own techniques and by using off-label generic materials such as tape and ties. There are also a huge number of varying circumstances encountered involving the use of different airway products and surgical positions that further complicates matters when it comes to a standardised approach to airway device securement. It is the opinion of the SLWG that the report we have produced provides compelling evidence for an urgent review of the existing practices for airway securement and for guidelines to be established, which include the requirement for dedicated medical devices to perform airway device securement. The study We used three approaches to gather information: A survey for healthcare practitioners was developed to explore whether there is a standardised approach to securing an airway device in their hospital. The intention was to use the findings to support ongoing work around safer patient care and better clinical outcomes. Focus groups were held to provide insight into how things are currently being done. Freedom of Information (FOI) requests were sent to NHS Foundation Trusts. The information requested was for the period between the 1 January 2020 to 31 December 2023. The FOI requests were designed to define how patient safety is delineated around securing an airway device and how standardisation can be improved to ensure the reduction of current incidents of failure and infection to patients. What we found The responses from the FOI requests show that a substantial number of trusts have experienced inadequate patient outcomes because of poor airway management (see the tables below). It also highlighted that many trusts do not report these patient safety incidents. This is sometimes due to the normalisation of the process and that the incidents are so ‘small’ it is not felt necessary to report them. Feedback from one Trust suggested that many professionals involved in the management of airway did not want to change their practices. Several Trusts stated that they did not routinely record this type of information and would therefore only be able to fulfil the FOI request if they were paid to do so under Section 12 of the FOI Act, underlining the lack of normal visibility of this data. Total responses to the FOI questions Five hospitals were unable to provide the information in the format requested but responded as follows: Key findings from the survey 23% of the people surveyed were aware of incidents of poor patient care resulting from their airway securement techniques. How people currently secured an airway: - 57% used tapes and ties - 20.16 % used elastoplast or similar - 4.3% used a fit for purpose device (not specified) - 8.7% used a mixture of methods depending on procedure - 9.4% didn’t respond. 56.5% of the respondents were aware of the infection risks associated with using tapes. However, they continued to use this as a method of securing the airway device even though it is an unlicenced and unhygienic way of managing the securement. 95.7% of the respondents were aware that the airway may migrate during the intervention and could cause serious harm to the patient but continued to use the same methods of securement. During the focus groups we asked about communication. The responses below showed that there wasn’t always an open and honest culture within the operating department. Infection Prevention and Control guidance The National Infection Prevention and Control Manual, Chapter one, Standard Infection Control Precautions (SICPs) states that care equipment can be easily contaminated with blood and other bodily fluids and infectious agents.[3] They classify care equipment as either: Single use – equipment which is used once on a single patient then discarded. Must never be reused even on the same patient. Single patient use – equipment which can be reused on the same patient. Reusable invasive equipment – used once then decontaminated e.g. surgical instruments. Reusable non-invasive equipment (often referred to as communal equipment) – reused on more than one patient following decontamination e.g. commode, patient transfer trolley. Multi-patient rolls of tape are, by definition, classified as ‘non-invasive re-usable equipment’, which by reason of the SICPs above, must be decontaminated to adhere to the National Infection Control Standards. As findings from our surveys/focus groups made clear, this is not happening because rolls of tape by their structure cannot be decontaminated. Education Ongoing education is one of the most crucial elements of managing the securement of the patient airway. Many organisations have integrated crisis management training, including human factors education into their anaesthesia and airway management programmes.[4] Simulated learning offers a dynamic and risk-free environment where learners can apply theoretical knowledge to practical scenarios, enhancing understanding and retention. By mimicking real-world situations, it allows individuals to develop critical skills, problem-solving abilities and confidence without the consequences of real-life errors. Encouraging innovation and change There is a continuing desire to make airway management safer. Innovations and new equipment continue to be developed to support safer anaesthetic practices; however, if healthcare professionals were to put forward the suggestions of tapes and ties to the regulatory bodies that manage new innovations, they would not pass the scrutiny and rigor and endure the processes in place to get the product to market. This speaks volumes about the archaic way of securing an airway device – but how do we encourage change within an environment that is entrenched in history and a ‘this is the way we have always done it’ mentality? New regulatory systems and sometimes political unawareness can cause pressures on the industry due to their often single-minded need to cut headline costs. Only recently, the Association for British Healthcare Industries announced that £50k worth of registration projects have been withdrawn due to the costs associated with compliance. This will have a catastrophic impact on much needed healthcare innovation and products that are designed to support patient safety.[5] How collaboration can make things happen This project has highlighted the importance of a team approach when trying to develop a standardised approach to different parts of the critical care environment. Another issue the project group discussed was how standardisation of certain practices made things much easier. However, it was thought that all approaches for standardisation should be backed up by rationale and be evidence based. Those involved in the discussions felt that training of new members of the team would be much easier if certain ways of working were standardised. Conclusion Effective airway device securement is a critical component of patient safety in clinical settings. Proper securement techniques reduce the risk of unplanned extubation, displacement, infection risks, facial tissue harm and compromising the airway, which can lead to life-threatening complications. Healthcare providers must be well-trained in securing airway devices and remain vigilant in monitoring their stability throughout patient care. Standardised protocols, high-quality materials and evidence-based practices are essential for ensuring the reliability of airway device securement. Regular assessments, interdisciplinary collaboration and the use of checklists further enhance safety by promoting consistency and reducing errors. In their WHA 72.6 Resolution (2019), WHO Health Ministers mandated for the global patient safety action plan 2021-2030 to be implemented.[6] Within the resolution at 5.3 they suggest they will make available guidance on how to create cultures that operate transparently and encourage speaking up.[7] Unfortunately, through the research we have undertaken and discussions we have had with individuals throughout this project, we have witnessed a damaging culture that exists within the healthcare environment. We believe that this is leading to a nation of healthcare professions who feel let down, devalued and unable to speak up and speak out to support better patient results. We did meet and talk to some professionals who worked in an environment of support and nurture, but sadly the majority of individuals felt unheard in a massive environment of ‘noise’. It has become evident that trusts generally only change their practices following an incident which is costing them more than it would have done to use a product that is designed for purpose. Failure to see the impact of such obstinacy on the patient and their wellbeing is a very blinkered approach to improvement and innovation. By prioritising proper securement practices, healthcare teams can improve patient outcomes, prevent adverse events and reinforce a culture of safety in airway management. Ongoing research and innovation in device design and securement techniques will continue to advance this critical aspect of patient care. Despite its contributions, this study is not without limitations and future research is needed with larger and more diverse samples, refining methodology and exploring additional variables. However, the outputs do highlight the issue that the project is championing for change. We are pleased to report that our work has garnered international interest, prompting efforts to replicate the exercise in both the USA and Europe. This global recognition underscores the significance of our findings and highlights the potential for broader applications in enhancing safety standards worldwide. These strategies, combined with continuous education and integration of innovative technologies, demonstrate the potential for significant improvement in patient safety related to airway device management. References World Health Organization. Guidelines for Safe Surgery 2009. Safe Surgery Saves Lives, 2009. Pentland Medical and Dawn Stott Associates. Surgical airway securement: A report analysing responses to a survey, focus groups and freedom of information requests, November 2024. NIPCM. National Infection Prevention and Control Manual, Chapter one; Standard Infection Control Precautions (SICPs). Tankard K, Sharifpour M, Chang MG, Bittner EA. Design and Implementation of Airway Response Teams to Improve Patient Safety. J Clin Med 2022; 11(21): 6336. https://doi.org/10.3390/jcm11216336. Fick M. Insight: Medical device makers drop products as EU law sows chaos. Reuters, 19 December 2022. World Health Organization. WHO Global Patient Safety Action Plan 2021 – 2030. Towards eliminating available harm in healthcare, 3 August 2021. World Health Organization. Consensus statement: Role of policy-makers and health care leaders in implementation of the Global Patient Safety Action Plan 2021–2030, 13 July 2022. You can read the full report of this study here or by scanning the QR code below:

A year ago today the Patient Safety Commissioner for England published The Hughes Report, which set out options for redress for those who have been harmed by valproate and pelvic mesh. In this blog, Patient Safety Learning reflects on the failure to act on its recommendations 12 months on. The Independent Medicines and Medical Devices Safety (IMMDS) Review published its report, First Do No Harm, on 8 July 2020. It examined how the healthcare system in England responds to reports about harmful side effects from medicines and medical devices, focusing on three medical interventions: hormone pregnancy tests (HPTs) sodium valproate pelvic mesh. The report outlined how these interventions had resulted in a truly shocking degree of avoidable harm to patients over a period of decades. It made nine recommendations as part of this, two of which specifically concerned redress options for patients: “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. 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. Recommendation 4: Separate schemes should be set up for each intervention—HPTs, 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.”[1] Though the Government initially rejected both these recommendations, patients and family members harmed by these medical interventions continued to tirelessly campaign for appropriate redress.[2] Responding to this, in early 2023 the then Minister for Mental Health and the Women’s Health Strategy, Maria Caulfield MP, signalled that the Government would be willing to look again at the issue of redress. She commissioned the Patient Safety Commissioner for England to explore redress options for those who have been harmed by two of the interventions covered by the IMMDS Review: sodium valproate and pelvic mesh. The Hughes Report Published on the 7 February 2024, the Patient Safety Commissioner set out options for redress for those harmed by pelvic mesh and sodium valproate in The Hughes Report.[3] At the core of its recommendations is a proposal to create a two-stage financial redress scheme. Responding at the time, we set out our support for these recommendations.[4] Patient Safety Learning believes, like many individual patients and patient groups, that there must be redress options for patients harmed by the interventions covered by the IMMDS Review. There is considerable evidence that for many patients the clinical negligence route is simply not viable and, 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. We also believe that this should extend to those affected by hormone pregnancy tests, who fell outside of the scope of The Hughes Report’s recommendations. Excluding patients and family members affected by hormone pregnancy tests from redress is not acceptable or in keeping with the spirit of the IMMDS Review’s recommendations. Commenting on this, our Chief Executive Helen Hughes said: “It is now over four and a half years on from the redress schemes first being recommended by the IMMDS Review. We think that it is unacceptable that there has been no response to The Hughes Report, over a year after its publication. Patients and their families are suffering unacceptably without redress schemes. The Government must respond to this report promptly and take steps to deliver redress for all those affected by pelvic mesh, sodium valproate and hormone pregnancy tests as a matter of urgency.” References The IMMDS Review. First Do No Harm, 8 July 2020. Department of Health and Social Care. Government response to the report of the Independent Medicines and Medical Devices Safety Review, 21 July 2021. Patient Safety Commissioner for England. The Hughes Report: options for redress for those harmed by valproate and pelvic mesh, 7 February 2024. Patient Safety Learning. Reflections on The Hughes Report: Pelvic mesh, sodium valproate, hormone pregnancy tests and options for redress, 20 February 2024.