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The definition of ‘success’ for incontinence mesh surgery was based on The British Society of Urogynaecology (BSUG) ‘pad test question’, which looked at whether a woman was using fewer incontinence pads after surgery. Like most women who had a mesh sling for incontinence implanted, I passed this test with flying colours. But the complications I experienced as a result of the surgery were painful, debilitating and life-changing, an experience shared by thousands of women who have had a pelvic mesh implant. For both incontinence and prolapse mesh, outcome logging merely looked at whether the prolapse had been fixed and did not query the onset of new pain or complications. Lack of follow-up, data collection and recognition of mesh as the cause of women's symptoms when they present with complications has led to a gross underestimation of the scale of pelvic mesh-related harm. So the prospect of an audit that would look to remedy this was a positive one. In 2020, the final report of the Independent Medicines and Medical Devices Safety (IMMDS) Review, ‘First Do No Harm’, called for “a retrospective audit and follow-up of women who had pelvic mesh surgery in 2010,” to be conducted by NHS Digital. The report highlighted that this should provide “far greater detail on mesh complications in the decade after surgery,” and that NHS Digital should make “every effort” to obtain sufficient data.[1] On 5 December 2022, the Minister for Women, Maria Caulfield MP, confirmed in the Commons that an audit had been completed following the acceptance of the IMMDS Review’s recommendation and would be published in 2023.[2] However, the record later had to be corrected, as it became clear in a further parliamentary question that, contrary to the stated intention of NHS Digital who conducted the audit, “...only Hospital Episode Statistic data was used in the audit and no other data was employed. Patients were not contacted as part of this audit.”[3] History repeats itself - the NHS audits the same data I was horrified to find out that instead of making “every effort” to get accurate information, NHS Digital have simply repeated the same exercise they carried out in 2018 in their retrospective audit of annual Hospital Episode Statistics (HES) data on mesh implant procedures. For the 2023 audit, they used the same approach taken in the 2018 audit and exclusively used HES data. This approach was highlighted in ‘First Do No Harm’ as being “widely criticised for its omissions, [for example] lack of any private sector data and for its implied underestimate of long-term complications.”[1] I wrote to the Health and Social Care Select Committee on behalf of Sling the Mesh in December 2022 to highlight the shortcomings of using HES data in isolation.[4] The Committee shared our concerns, highlighting that: “Without records of which patient has undergone which procedure, or been prescribed which drug, the health system will continue to, in the words of the IMMDS review team, “fly blind”... Although the retrospective audit of mesh implants is an encouraging first step, it will be unlikely to reflect and take into account all of the adverse effects women have experienced due to the nature of data used in the audit. We therefore recommend that the Government consider an alternative strategy for how to proactively contact those who have had the procedure about their postoperative experiences and possible side effects.”[2] NHS Digital’s approach does not paint a true picture of the extent of the harm caused by pelvic mesh. There are many issues with using purely HES data for a mesh audit, namely that: HES data does not capture complications, as women have not been followed up and therefore the spectrum of suffering has not been logged. it does not take into account any data from GPs or primary care, where potentially thousands of women have sought help for their mesh complications. Most of these women will not yet have set foot in a hospital for consultation or treatment. it does not take into account data from private hospitals, which may be recorded differently or not have been logged at all. there are discrepancies in how pelvic mesh insertion and removal is logged by different trusts and healthcare professionals. HES data sometimes lacks necessary detail on the nature of treatment. For example, until recently, there was no specific HES code for rectopexy mesh insertion or removal, which means the specific issues associated with this surgery are difficult to identify through data. How should the Government conduct an audit of mesh patients? If the Government is serious about understanding the true extent of harm caused by pelvic mesh, it needs to contact all women who have had mesh surgery within a specific time period to establish whether they have had complications or injuries over the following years. Mesh has a ticking time bomb nature, in that it can be fine for many months or even years before causing problems like erosion, so this long term follow-up is crucial to gauge the extent of harm. Instead of using unreliable and incomplete data, an audit needs to take the approach of the Paterson Inquiry and recall all affected patients.[5] If the cost of such an exercise would be prohibitively high, they could take a sample of women from across the country and use their findings to estimate the extent and nature of harm caused by pelvic mesh. Why is a reliable pelvic mesh audit important? Being able to quantify the extent of the harm is important so that we can establish an accurate figure of risk; what percentage of women suffer harm due to pelvic mesh, and what is the likelihood of more of them developing complications in years to come? Until we have this knowledge, the Government and regulatory system can’t learn the necessary lessons from the mesh scandal to ensure other devices don’t cause this degree of harm. Health services will also continue failing women when they seek help for injuries and complications that are likely to have been caused by mesh. So many women have also been subject to the secondary harm of gaslighting and not having their symptoms taken seriously by healthcare professionals. Having accurate data on harm caused by mesh would help put an end to the healthcare system seeing women’s concerns as ‘hysterical hearsay’. It would also help women understand that their complications must be taken seriously and that their symptoms are not ‘all in their heads’. Why is the Government not pushing for an accurate audit? When compared to the Government response to Paterson, the retrospective mesh audit seems like a token effort. Why is the Government less willing to understand and tackle the issues associated with mesh complications? Perhaps because, rather than being the responsibility of “one bad apple”, the harm caused by pelvic mesh is the responsibility of a system that failed to research, regulate and monitor the effects of medical devices designed to be implanted inside people’s bodies. There is also the fact that knowing the true extent of the harm caused by pelvic mesh has the potential to create a huge financial burden, if the Government ever agrees to fulfil its responsibility to set up a Redress Agency for women harmed by pelvic mesh surgery. Related reading The difficulty of medical negligence cases and why financial redress from the Government is so important for mesh victims (17 January 2023) Doctors’ shocking comments reveal institutional misogyny towards women harmed by pelvic mesh - a Patient Safety Learning blog (19 July 2022) “There’s no problem with the mesh”: A personal account of the struggle to get vaginal mesh removal surgery (1 May 2022) References 1 First Do No Harm. The report of the Independent Medicines and Medical Devices Safety Review, 8 July 2020 2 Health and Social Care Select Committee: Follow-up on the IMMDS report and the Government’s response Sixth report of session, 20 January 2023 3 Question on surgical mesh implants. Parallel Parliament, 14 December 2022 4 Letter to Health Select Committee December 2022. Sling the Mesh, December 2022 5 Government response to the independent inquiry report into the issues raised by former surgeon Ian Paterson. Department of Health and Social Care, 16 December 2021

The National Comparative Audit of Blood Transfusion is the largest programme of clinical audits of blood transfusion in the world and is funded by NHS Blood and Transplant. It began in 2002 and audits the administration of blood and blood components as well as assessing appropriate use of blood in various clinical settings. It is concluding its work on three National Comparative Audits: 2018 audit of the use of fresh frozen plasma, cryoprecipitate and transfusions for bleeding in neonates and other children 2019 Re-audit of the medical use of red cells 2021 audit of NICE Quality Standard 138 This webinar includes a 40 minute presentation by experts from NCA and SHOT teams. Register

This one day masterclass, Mr Perbinder Grewal, General & Vascular Surgeon and Human Factors Trainer, will focus on teams working effectively and productively through improving the culture within healthcare organisations. There will be a focus on how safety and culture is perceived by healthcare staff and how culture relates to QI and audit. The outcome of the day is to not only improve safety culture and patient safety but also staff experience and staff engagement. Key learning objectives: Define culture within healthcare. Understand safety culture. Explore culture of quality improvement and audits. Improve civility within teams. Learn how to lead cultural change. All Medical and Non-medical Staff should attend. This masterclass is aimed at Clinical Staff, Team Managers, Senior Management. Register hub members receive 20% discount. Email: info@pslhub.org for discount code.

A year ago, you implemented a new approach to auditing at Barnsley. Can you tell us what prompted it? In healthcare, we tend to measure safety by looking at negatives. The number of falls, the number of category 2 pressure ulcers, the number of adverse events etc. Our whole system is built on it, from local auditing and Datix reporting, to CQC inspections. But counting the number of pressure ulcers for example, doesn’t really tell you about the standards of pressure ulcer care. I wanted to look at things differently; to focus more on the interventions and good practice that helps keep patients safe. Where did you start? We started with pressure ulcer reduction. Our Tissue Viability team and I looked at the learning from Root Cause Analyses and worked together to create a list of all of the things we can do to help prevent pressure ulcers. Skin assessments, pillow positioning, moving patients etc. If we ticked every box for every patient, would we prevent pressure ulcers altogether (unless the patient doesn’t follow the advice)? I took this list and worked with the digital app company, Perfect Ward to build a simple-to-use auditing tool. It allows us to measure safety by our standards of care and interventions rather than counting negative outputs. If our standards of care are high and a lot of people are still getting pressure ulcers, we have assurance on the standard of care being delivered. How did you implement the pressure ulcers audit? Once we had created the list of standards and preventative measures, we used the app to do an audit of around 35% of patients on each ward. At the start of the project, we found that teams were on average hitting 64% of the standards. The digital app provides a performance rating system, with red with red (less than 70%), amber (greater than 70% but less than 90%) and green (90% or more). The performance of the team against these ratings dictate how we would support each team moving forward. For example, if an audit showed a team to be performing at the lowest level (red), we made a commitment to support them on a weekly basis until they were performing at the highest level (green). How have staff responded? Staff have responded really well. This system provides recognition, and credit where credit is due. It can help staff to feel confident when they are providing high standards of care and to know that they are doing the right thing for the patients. Where there is room for improvement, the Perfect Ward app makes it is easy to see where the gaps in the delivery of interventions exist so they can be tackled. The tissue viability nurses are there to support, coach and to help problem solve. There may be certain interventions that are consistently missed which can sometimes be a sign that the wider organisation needs to help solve the issue. Safety is a shared responsibility, and we need to make sure we have the systems in place to support success. What support have you needed along the way? It’s really important to have passionate people who understand and believe in this approach to auditing. You need to have an Executive Team who are prepared to look at measuring outcomes differently. I’m lucky, our Director and Deputy Director of nursing are very supportive. It’s also important to acknowledge that it is not a silver bullet; change takes time. That can be frustrating for some people who want to see results quickly. It’s taken a year but teams are now hitting on average 94% of the standards set out by the auditing tool, and we are starting to see decreases in category 2 pressure ulcers (per 1000 bed days) since June 2020. What have you learnt? It has been really important to constantly engage staff and build good relationships, to make sure we understand everyone’s competing priorities. The approach has been a great enabler for quality improvement methodology, empowering teams to find their own solutions and really own the results. What’s next? This approach to auditing is not rocket science. It can be used to raise standards of care in most circumstances within health and social care – without focusing on the negatives. We have successfully applied it to both pressure ulcer and falls prevention at Barnsley and just started on nutrition and hydration. In the future I’d like to see it used in other areas, to identify what excellent dementia care in hospitals looks like for example. It could also be used to ensure that staff have a good understanding of the Mental Capacity Act and safeguarding processes. Or to make sure patients are being well-fed. It really is just a blueprint that can be used to raise standards of care, and safety in any circumstance. Final thoughts? I personally don’t like to look at my work as reducing harm. I prefer to look at it in terms of improving the standards of care we give our patients. The difference is important. Photograph of the Tissue Viability Team. Above is an example of a checklist used for pressure sores. The graph above shows the trust average on delivery of the pressure ulcer prevention interventions across adult inpatient wards over a 12 month period. The 'distribution of score' graph above shows the percentages scored across the adult inpatient wards for each month over a 12 month period. This graph shows more areas achieving 90% (or more) and fewer scoring 70% or less as time has progressed.