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In this blog, Steve Turner reflects on why genuine patient safety whistleblowers are so frequently ignored, side-lined or victimised. Why staff don't speak out, why measures to change this have not worked and, in some cases, have exacerbated the problems. Steve concludes with optimism that new legislation going through Parliament offers a way forward from which everyone will benefit. The scale of the problem The hidden costs of stigmatisation of healthcare whistleblowers are immense. System-wide problems in this area of healthcare are reinforced by a lack of transparency and the failure of accountability. The consequences of this failure have been investigated many times over the years. A seminal case was that of the Bristol heart surgery scandal in the 1990s. This was brought to light by the anaesthetist Steve Bolsin and led to the implementation of a system of clinical governance.[1] This advance in measures to deliver quality, consistent and safe care remains as relevant today as it ever was. More recently, the investigation into the failings at mid Staffordshire[2] highlighted how a ‘good news’ only culture, where reputation management was placed above patient safety, is failing patients. Critically for me the shocking fact is that where staff who blow the whistle can't, or don't, speak out, are ignored or silenced, the onus to expose wrongdoing falls on patients and their relatives. This involves great personal cost. The onus to expose wrongdoing falls on patients and their relatives. This involves great personal cost. This shameful thread of patient-led whistleblowing goes back a long way and has not stopped. Examples where patients, carers or relatives have had to take the lead and blow the whistle include the death of Robbie Powell,[3] Elizabeth Dixon,[4] Oliver McGowan,[5] Claire Roberts and those who died in the Belfast Hyponatraemia scandal,[6] the Gosport War Memorial Hospital scandal,[7] and the investigation into maternity services in East Kent.[8] These patient safety scandals show no sign of abating despite the report on the failings at mid Staffordshire[2] and Sir Robert Francis’ major review into whistleblowing in the NHS.[9] This is reinforced by the 2023 Bewick Review,[10] which is the first of three planned reviews into University Hospitals Birmingham NHS Foundation Trust. This review was commissioned following repeated serious concerns relating to patient safety, leadership, culture and governance, which were initially downplayed or ignored. The full story behind these failings and their significance has yet to fully come to light. Patients have to blow the whistle on unsafe care A stream of healthcare scandals (too many to mention all of them here) have been exposed by members of the public. Key examples include the case of Robbie Powell who died of untreated Addison's disease in 1990.[3] Thanks to the tenacity of Robbie’s father (Will Powell) this led to the clarification of the absence of an individual legal Duty of Candour for healthcare professionals.[11] Despite numerous reports and failed investigations, including one of which put forward 35 suggested criminal charges, the Robbie Powell case remains open with the Crown Prosecution Service (CPS). In addition, the former Welsh Ombudsman and the English Ombudsman are both calling for a public inquiry into the case.[12] Another case concerns those who died at Gosport War Memorial Hospital in the 1990s who were prescribed opioid medicines that were not indicated for their condition. This led to an Independent Review Panel,[7] which took four years and cost £14 million. The Panel found that 456 deaths in the 1990s had "followed inappropriate administration of opioid drugs". In 2019, Assistant Chief Constable Nick Downing, head of the Serious Crime Directorate for Kent and Essex Police, announced that a new criminal investigation into the deaths was to take place and the campaign for justice continues. Other serious issues include premature deaths of people with learning disabilities and autism,[13] which led to the implementation of the learning from deaths programme. On average, the life expectancy of women with a learning disability is 18 years shorter than for women in the general population. The life expectancy of men with a learning disability is 14 years shorter than for men in the general population.[14] There are numerous individual cases that support this finding, many of which were first highlighted by parents, informal carers or relatives. In 2014, the Department of Health and Social Care published a report that found that almost two-fifths of people with learning disabilities died from causes "amenable to good quality healthcare."[15] In 2022, a report by Dr Bill Kirkup into deaths in East Kent NHS maternity services[8] confirmed that the "onus was on patients to raise concerns" because the culture of fear prevented whistleblowers from speaking out. “In every case staff were aware of serious mistakes or wrongdoing but they were unaware of how to raise concerns because those who tried were subjected to peer pressure to be silent and everyone was afraid of the [personal] consequences.” These consequences were exemplified by the experience of the nursing director who was told that speaking up would harm her career. Another significant report is that into the life and death of Elizabeth Dixon,[4] which contains recommendations that apply across the board: "…6. Clinical error, openly disclosed, investigated and learned from, must not be subject to blame. Conversely, there should be zero tolerance of cover up, deception and fabrication in any health care setting, not least in the aftermath of error. (NHSE, GMC, NMC, MoJ) 7. There should be a clear mechanism to hold individuals to account for giving false information or concealing information relating to public services, and for failing to assist investigations. The Public Authority (Accountability) Bill drawn up in the aftermath of the Hillsborough Independent Panel and Inquests sets out a commendable framework to put this in legislation… It should be re-examined. (MoJ) 8. The existing haphazard system of generating clinical expert witnesses is not fit for purpose. It should be reviewed, taking onto account the clear need for transparent, formalised systems and clinical governance. (DHSC, MoJ)…" The amount of evidence and the number of reports that were initiated thanks to the tenacity and courage of patients, relatives, carers and parents, is truly shocking. How can we change this? How many more reports do we need? The only thing we can say with confidence is that lessons have not been learned. Why don’t staff speak out? I was recently asked ‘why don't staff speak out?’ There's very little rigorous research on whistleblowing in health and social care, so I can only offer my personal views on this apparent absence of ethical behaviour. I believe this quote from Margaret Heffernan (Professor of Practice at the University of Bath School of Management) goes some way to explaining this: “I have never encountered an organisation as vicious in its treatment of whistleblowers as the NHS".[16] If anyone has any doubts there are a string of high-profile cases to support it, including the cases of Steve Bolsin, Raj Mattu, Kim Holt, Peter Duffy and Chris Day. When I was asked why staff stay silent my first thought was to say that those who would speak out have all left. Of course, this can't be the full story. So, what are the other reasons? One possible reason is that people who are promoted to highly paid jobs attain these positions because they ‘toe the line’. Organisational psychologists talk about the role of enablers and ‘flying monkeys’ in maintaining this culture. A flying monkey is a psychology term that refers to an enabler of a narcissistic person, a henchman so to speak. Many staff keep their heads down and don't look too hard at what's going on around them. Some commentators see this as a behaviour that is supported by the promotion of toxic positivity. What I mean by this is a culture of talking-up successes, however small, completely ignoring failure, and therefore missing the learning that comes from failure. The widely used phrase ‘rock the boat but stay in it'[17] springs to mind here, especially the empty references to ‘radicals’ and ‘change agents’. This forms part of learning materials that are often accompanied by reams of management jargon and pseudo-science. This leads to a morally bankrupt approach where ‘all is well’ (‘nothing to see here’) and toxic positivity prevails. The belief that no matter how bad a situation is, people should maintain a positive mindset, move on and not mention it, is a way of working that is directly contradicted in these wise words by the late Professor Aidan Halligan: "Run toward problems, especially on a bad day." My views may sound very harsh, especially coming from someone like me who left direct employment with the NHS in 2008. It's important to point out that I believe the vast majority of NHS staff, at all levels from clerical staff and porters to senior managers and chief executives, do their best to work around the bullying and toxicity to deliver safe care for patients. Doing their best despite the prevailing culture rather than being supported by it. Sometimes biding their time and subtly subverting directives that are not in patients’ best interests. For clinicians, the threat of being referred inappropriately to a professional body is ever present,[18] and an environment where the pressure of work is extreme, exhausting and unstainable are also major factors. For many, the prevailing culture also means that the careers of highly skilled accountable, ethical and caring staff are held back through denial of learning opportunities and promotion, and informal blacklisting which is commonplace. There's an army of people ready for change, a huge informal network of highly motivated caring people, which is why I'm optimistic about the future. Why have ‘speaking up’ reforms failed? These are my personal views based on my experience and that of my colleagues. Since Sir Robert Francis’ whistleblowing report[9] there have been several changes designed to improve the situation. These include Freedom to Speak up Guardians (FTSU), the introduction of an institutional Duty of Candour, the ‘Fit and Proper Persons Test'[14] for Board members and the NHS Whistleblower Support Scheme. In addition, the Health and Safety Investigation Branch (HSIB) was set up in 2017 and a National Patient Safety Commissioner was appointed in 2022. Given all the above, why has there not been a reduction in high-profile healthcare failings? In my view there are several reasons. Many believe, as I do, that the approach of the Care Quality Commission (CQC) to whistleblowing is part of the problem. We often learn from investigation reports that the CQC (and other regulators) had been listing problems in their reports for years and yet no meaningful action has been taken. ‘Regulatory capture’ is a serious problem, which is when regulators are adversely influenced by the people they are inspecting. This is often linked to the revolving door of staff who move from health and care employment to the regulators, and informal links which amount to cronyism. This behaviour is something that commentators have noted and which I have experienced myself.[20]. Patients suffer as a result. The introduction of the National Guardian Office and Freedom to Speak Up Guardians in each NHS trust is also problematic. This initiative has an inbuilt conflict of interest, as the Guardians are employed by the trusts themselves. The All-Party Parliamentary Group on Whistleblowing (APPG) has heard from whistleblowers who have been failed by local Guardians, sharing their experiences that have included the disclosure of their identity to hospital management and boards, which resulted in retaliation. The APPG has also heard from local Guardians who were not supported and themselves the target of retaliation after supporting whistleblowers.[21] In addition, something which I find shocking is that the National Guardian Office appears to studiously avoid the word ‘whistleblowing’ in its material and outputs wherever possible. This adds to the stigma around healthcare whistleblowers and is inexcusable. Another lesser-known initiative is the NHS Speaking Up Support Scheme[22] (originally titled the Whistleblower Support Scheme). There is not much information available on this scheme in the public domain. I became aware of the scheme when I was asked if I wanted to apply. Later I signposted several people to the scheme. I learned that although the scheme has benefited some people, for others it appears to have made their situation worse. Through a freedom of information request, and thanks to the intervention of my MP, I have managed to obtain a redacted copy of the evaluation of the pilot scheme which supports the view of mixed results.[23] Having read this report, it is unclear to me why it hasn’t been published and why it was redacted. Particularly as I think (I can’t be sure of course) that one of the redactions is a comment I made. A comment I wanted to be shared. As for the other post-Francis review initiatives, the Kark Review in 2018 on the Fit and Proper Person Test (FPPT) is unequivocal in its findings: "Essentially it [FPPT] does not ensure directors are fit and proper for the post they hold, and it does not stop the unfit or misbehaved from moving around the system."[24] In addition, the statutory current Duty of Candour[25] seems, at times, to be little more than a tick box, with the responsibility for talking to patients often left to the most junior staff. A Duty of Candour is about simply telling the truth and is everyone’s responsibility, not a task to be delegated. The need for a legal duty of candour on individuals has been highlighted by Robbie Powell’s father Will Powell and links to proposals for a Hillsborough Law. The HSIB and the National Patient Safety Commissioner initiatives have some built in limitations to what can be achieved. The HSIB’s remit does not include investigation of systemic problems. This limits the areas that they can cover. As for the National Patient Safety Commissioner, this is a new role which is very promising. Unfortunately, the scope of this role is limited, with the remit covering only medicines and medical devices. This means that these two initiatives are not able to tackle the systemic organisational cultural issues that are at the root of major patient safety failings. One thing that stands out here is that none of the above measures specifically tackle the stigma around whistleblowing in healthcare. In fact, some reinforce the stigma. A way forward Much has been written about healthcare whistleblowing and measures that have been implemented to promote positive change. Despite these, the victimisation of healthcare whistleblowers and the stigmatisation around whistleblowing in health and in social care has not abated. The measures introduced have so far achieved very little. In some instances, I believe, they have made the problem worse. The Protection for Whistleblowing Bill,[26] which passed its second reading in December 2022, proposes the repeal of the current Public Interest Disclosure Act,[27] replacing it with an Office of the Whistleblower. This would prevent concerns of genuine healthcare whistleblowers becoming buried under an employment issue, and their original patient safety concerns being side-lined. The Public Interest Disclosure Act is expensive, limited in scope and beyond the reach of most whistleblowers. It is also overly complex, with cases currently waiting for over 2 years to be heard. Employers game the system to run whistleblowers out of funds. Fewer than 12% of cases that go to the Employment Tribunal win. It does not protect patients and is not accessible to members of the public who blow the whistle. Currently there is no statutory provision to investigate or address the wrongdoing highlighted by whistleblowers. Many whistleblowers have been denied any protection because they are not workers. An Office of the Whistleblower would change this and help us identify the root causes of systemic patient safety failings.[26] I urge everyone with an interest in this subject to read the bill and watch the video of Baroness Kramer introducing the second reading of the Bill.[28] For the first time in years, I am optimistic. References Department of Health. The report of the public inquiry into children's heart surgery at the Bristol Royal Infirmary 1984-1995: learning from Bristol (Cm5207(II)); 2001. Department of Health. Report of the Mid Staffordshire NHS Foundation Trust Public Inquiry; 2013. Hartles S. Robbie Powell: Time for Truth, Justice and Accountability. Open University Harm & Evidence Research Collaborative; 2021. Kirkup B. Independent report. The life and death of Elizabeth Dixon: a catalyst for change; 2020. Ritchie F. Independent Review into Thomas Oliver McGowan’s LeDeR Process Phase two; 2020. Department of Health, Northern Ireland. Report of the inquiry into hyponatraemia related deaths; 2018. Gosport Independent Review Panel Report. The Panel Report - 20th June 2018. Dr Kirkup B. Reading the signals: maternity and neonatal services in East Kent – the report of the independent investigation; 2022. Francis R. Report on the Freedom to Speak Up review; 2015. Bewick M, et al. University Hospitals Birmingham NHS FT (UHB) Phase 1 Review by I4QU. Clinical Safety. iQ4U Consultants; 2023. Action against Medical Accidents. Robbie’s Law. The European Court Ruling in full: https://hudoc.echr.coe.int/fre#{%22itemid%22:[%22002-6998%22]}. Parliamentary and Health Service Ombudsman. Radio Ombudsman: Will Powell’s 32-year quest for justice for son Robbie; 2022. NHS England. About LeDeR; 2023. NHS Digital. Health and Care of People with Learning Disabilities, Experimental Statistics: 2018 to 2019 [PAS]; 2020. Department of Health and Social care. Premature Deaths of People with Learning Disabilities: Progress Update; 2014. Heffernan M. I have never encountered an organisation as vicious in its treatment of whistleblowers as the NHS. BMJ Talk Medicine Podcast; 2020. Bevan H. Rocking the boat and staying in it: how to be a great change agent. Slide set; 2016. Grossman D, Clare S. Birmingham hospital culture worrying - health secretary. BBC Newsnight; 2023. Care Quality Commission. Fit and proper persons: directors; 2022.   Clegg A. How cronyism corrodes workplace relations and trust. Financial Times; 2022. WhistleblowersUK, Meeting with Dr Bill Kirkup CBE and the APPG for Whistleblowing: blog; 2022. NHS England. Speaking up support scheme; 2022. Greenop D. NHSI Whistleblowers Support Scheme pilot. Final Evaluation (redacted); 2019. Obtained in 2022 following a Freedom of Information Request. Kark K, Russel J. A review of the Fit and Proper Person Test. Commissioned by the Minister of State for Health; 2018. Care Quality Commission. Regulation 20. Duty of Candour; 2023. UK Parliament. Protection for Whistleblowing Bill [HL]; 2023. UK Government. The Public Interest Disclosure Act 1998 [PIDA]. Baroness Kramer. Protection for Whistleblowing Bill, 2nd Reading, Baroness Kramer 2022. Video recording of the House of Lords introduction.

In this anonymous blog, a person with type 1 diabetes describes their recent experience upgrading their insulin pump, a medical device used to continuously deliver insulin instead of taking multiple daily injections. They describe how communication issues and gaps in staff knowledge led to a significant delay in accessing the pump, which caused them significant stress. They also ask whether recent announcements about increased access to diabetes technology over the next few years will match up to the reality experienced by people with diabetes accessing care at local healthcare organisations. In December 2023, NICE approved the roll out of hybrid closed loop systems to all patients with type 1 diabetes, which will make a big difference to both life-impact and clinical outcomes for thousands of adults and children in England. The announcement was a big deal, making mainstream news and lighting up social media. Looking behind the headlines, it will take up to five years to see technology reach everyone who is eligible, as NICE has stated. However, I’m dubious as to whether that target is achievable, because with all the will—and even all the funding—in the world, we need to have enough staff with the right training to make it happen. Diabetes teams need clinical training related to each system, but they also need to know how to run the process of getting this tech from factory to patient, with all the right forms signed and permissions given. They will be dealing with much larger volumes of requests, authorisations and administrative tasks on a daily basis. I recently had a brush with the administrative burden of upgrading my tech, and it somewhat highlighted this gap between the promise and the reality. I’ve been fortunate enough to be on an insulin pump for over a decade. Last December, with my current pump coming to the end of its life, I had the opportunity to choose a new one that I could use alongside my current continuous glucose monitor (CGM) to make a hybrid closed loop system. It felt like a weight had been lifted—in a few weeks, I would have access to a system that promised to make life a bit easier. Fast forward six months, and there’s a different story to tell. I was finally trained and ‘plugged in’ to my new pump last week. Unfortunately, I found myself in a marathon effort to try and access the new device. There were extended delays in getting approval, ordering the pump and booking a training session. My old pump crept out of warranty and became increasingly unreliable, and my stress levels crept up as I tried to figure out why things weren’t progressing. I left so many voice messages and emails to try and establish what was going on, but I often received no reply or call back. I’m still not fully clear on why it all took so long, but I have picked up that the delay was due to a combination of staffing issues, missed emails and lack of familiarity with the tech company's systems. At the beginning of the process, I had been told it would take a few weeks. I don’t want to lay all the blame on the team that runs the service, where I know there are capacity issues. But the experience revealed holes in the system that prevent patients accessing support and treatment that has been agreed. I was bolshy and desperate enough to push things through, and ended up contacting the company directly to see if they could help, which they did. It was me, as the patient, who pieced together where communication had gone wrong and highlighted what needed to happen. I know the health system pretty well and will keep asking until I find the person who can answer my question. My fear is that many people don’t know where to start, or where to go next when they meet a wall of silence. Friends sometimes forward me articles about how people with diabetes will soon all have access to the latest tech, but the headlines usually fail to convey the reality. ‘Soon’ and ‘all’ are subjective terms, depending on the systems that exist within your local organisation. While I believe the national team is putting significant effort into addressing access inequalities and postcode lotteries, there is still so much to do to ensure that patients receive the care they are entitled to and maintain their trust in their healthcare team. I hope that the promise will become a reality sooner rather than later, and that people with diabetes don’t face an uphill struggle to access the help they have been told to expect. The commitment from NHS England to the goal of universal access to closed-loop technology should rightly be celebrated. But the missing link between national policy, local practice and, vitally, how these are communicated to patients, needs some attention. As it stands, it is a recipe for frustration and anxiety.

This is a joint blog by Patient Safety Learning and Sling the Mesh, highlighting key areas of concern included in their recent response to the Royal College of Obstetricians and Gynaecologists consultation on a new Mesh Complications Management Training Pathway. One of the three areas of patient harm investigated by the Independent Medicines and Medical Devices Safety (IMMDS) Review (also known as the Cumberlege Review) related to implanted pelvic mesh. Complications with mesh implants can have a life-changing impact, resulting in severe and chronic pain, infections, reduced mobility, sexual difficulties, autoimmune issues and psychological strain. The Review made a number of recommendations in regard to the shocking scale of avoidable harm experienced by mesh-injured patients, including the establishment of a network of specialist centres that could provide treatment, care and advice for mesh-injured patients. It also recommended that: “Professional bodies should lead on ensuring surgeons only operate within their capabilities. They must provide guidance for their members and ensure that surgeons are appropriately trained, and this should be assured through the appraisal process.”[1] Mesh Complications Training Pathway In the context of this, at the start of this year the Royal College of Obstetricians and Gynaecologists (RCOG) published a consultation on a new Mesh Complications Training Pathway. It states that this has been: “… developed to equip doctors in commissioned regional specialised centres with the clinical skills needed to manage patients presenting with a wide range of mesh implant complications originally inserted for urinary incontinence (UI), pelvic organ prolapse (POP) and rectal prolapse”.[2] This Training Pathway is a much-needed piece of work and should be an important tool in providing patients with confidence in the training and standard of care offered by specialists dealing with mesh complications. However, we have identified a number of key patient safety concerns that we believe need addressing. In this blog, Patient Safety Learning and Sling the Mesh highlight some of the key issues included in our joint response to this consultation. You can find a link to our full consultation response at the end of this blog. Importance of patient engagement One key area of concern was the approach taken to the consultation process. This was held over a fairly short period (initially 3 weeks, subsequently extended to 4) and in our view not publicised enough with mesh-injured patients and groups. While the development of the Training Pathway did involve a focus group comprised of six women with mesh related issues, we believe that RCOG have missed an opportunity to engage much more widely. Patient engagement is key to improving patient safety, even more so when there has been a significant loss of trust for patients in healthcare professionals, such as in the case of surgical mesh. We believe it is vital that RCOG, further to its focus group, should be engaging directly with patient groups to hear their concerns and experiences and to genuinely co-produce this type of guidance. Patient groups with large membership bases are often well placed to provide insights, evidence, and expertise on specific areas of care. For example, in the case of this consultation, Sling the Mesh were able to highlight specific issues relating to the removal of rectopexy and sacrocolpopexy patients, which may not have been captured by a more limited focus group approach to engagement. If effectively engaged with, patient groups can provide a vast repository of patient experience to draw on in improving patient safety and services. Absence of Patient Reported Outcome Measures (PROMs) To fully understand the effectiveness of mesh removal procedures, and identify any emerging patient safety concerns, it is essential that they are accompanied by universal outcome measures for capturing and monitoring patient outcomes. We are concerned that the Training Pathway currently makes no reference to this. In our view it is vital that such information is gathered and that those working in Mesh Centres are proficient at using databases to capture this evidence. This can be used to compare outcomes from procedures at different sites and subsequently feed into requirements which can inform the development of this Training Pathway. Requirements for Mesh Centres In our consultation response we highlighted that the specific training requirements for Specialist Mesh Centres were not included in the Training Pathway. We expressed concerns that in the absence of this, there is a risk that service provision may be variable and that, without appropriate oversight, women may be at risk of inadequate services provision and an increase in avoidable harm. We also highlighted the specific points concerning Mesh Centres: It is important that for a Mesh Centre to be accredited or credentialed it must demonstrate the surgical competency to perform total/complete/entire removal of the mesh device. Significant concerns among patients that some mesh removal centres are run by surgeons who have previously implanted mesh and told the women involved that mesh is not a concern for them. In some cases, women are having to return to the surgeon who initially implanted their mesh, which they are describing as extremely traumatising. Many members of Sling the Mesh have found that they have to first go through a range of other treatments, such as psychiatric treatment and pain management, before they are subsequently given the opportunity to discuss mesh removal with a consultant. Concerns raised by patients that currently some Mesh Centres do not have the skills and experience required for the removal of rectopexy mesh, which requires skilled colorectal and urogynaecology teams working in unison. The need to ensure aftercare is in place, particularly in cases of rectopexy mesh, with patients who have had this major surgery raising concerns with Sling the Mesh about the lack of support for patients in this respect. This procedure can often result ongoing health issues and in some cases require additional surgery. We have heard concerning accounts where patients have needed to attend Accident and Emergency after having been previously discharged following this procedure. Surgical procedural requirements The Training Pathway lists a number of surgical procedural requirements for healthcare professionals working in Mesh Centres. A specific area of concern relates to several procedures listed as ‘Mandatory’ requirements in the Pathway which involve a partial removal of vaginal prolapse mesh, taking out the vaginal section only and leaving in the arms embedded deep in the pelvis. Sling the Mesh have members who have undergone this procedure in the UK and subsequently experienced significant disability and pain resulting from a partial removal of this type. We expressed concerns in our response about the potential for the guidance as written resulting in this becoming the default treatment option for women with vaginal prolapse mesh. We also highlighted a specific concern relating to two procedures listed in the Training Pathway as ‘Optional’ that involve the full removal of vaginal prolapse mesh. These involve the removal the implant in its totality, including the arms embedded in the tissue of the pelvis. We set out concerns that this was misleading as in practice the UK does not currently have any surgeons who are able to perform this type of total removals of vaginal prolapse mesh, and as such is not in practice a viable option for patients. Misleading language Another area of concern highlighted in our consultation response related to the language used in parts of the Training Pathway. Certain procedures that relate to partial removals of mesh are described as removing ‘the entirety of the mesh’. However, in these cases by ‘entirety’ they refer to all the mesh only in relation to a specific part of the body. We are concerned this could easily misunderstood as a full mesh removal when this is not what the procedure entails. Considering cases where complications may arise following surgery, where women may experience pain or disability, it would be concerning if their formal medical records referred to mesh removal in ‘entirety’ when in practice implanted mesh remains. To ensure clarity for patients and surgeons, we have suggested that the terms such as ‘total’ or ‘complete’ should be reserved to describe only the surgical procedures where the mesh device is removed in its entirety. Any other type of removal surgery should include the word ‘partial’. Further engagement needed In establishing and providing the care, treatment, and advice for mesh-injured patients, we believe it is vital that a patient-centred approach is taken. When it comes to mesh removal surgery, patients also need confidence that their experiences and concerns are being listened to and acted upon. We believe that RCOG has a key part to play in this and await to see how they will respond to the issues we have highlighted. References The IMMDS Review, First Do No Harm, 8 July 2020. RCOG, Mesh Complications Management Training Pathway, Last Accessed 9 February 2022. Related reading First Do No Harm APPG public meeting on redress: Speech from Kath Sansom (26 January 2022). Kath Sansom, ‘Mesh removal surgery is a postcode lottery’ – patients harmed by surgical mesh need accessible, consistent treatment (2 December 2021). McFadden et al, The long-term impact of vaginal surgical mesh devices in UK primary care: a cohort study in the CPRD (4 August 2021). Sharon Hartles, Mesh: Denial, half-truths and the harms (23 March 2021). Patient Safety Learning, A year on from the Cumberlege Review: Initial reflections on the Government’s response (23 July 2021).

In this blog, Lotty Tizzard, Patient Safety Learning’s Content and Engagement Manager, looks at the difficulties people experience in disposing of needles and injection devices safely at home. Variation in services across the UK can lead individuals to dispose of sharps incorrectly, posing a risk to refuse workers and the wider public. Sharps injuries pose a significant global risk to staff and patient safety, and many of these injuries are caused by incorrect disposal. The Royal College of Nursing (RCN) estimates that there are 100,000 sharps injuries in healthcare in the UK every year,[1] and research by both the RCN and The European Biosafety Network highlights that the situation has worsened under the pressure of the Covid-19 pandemic.[2][3] There is also evidence that sharps injuries are underreported, meaning the number of incidents could be much higher.[2] The Safer Healthcare and Biosafety Network recently launched a working group on standardising injection technique in diabetes care to reduce the risk of needlestick injuries, which will include research to better understand the incidence and causes. But a related area that has received little attention is the disposal of sharps at home, where a healthcare worker is not involved. There are many people who self-administer injectable medication and need to dispose of sharps at home, either on a long- or short-term basis. People with diabetes make up a large proportion of this group, but there are many others, including those self-administering warfarin, biologic drugs for autoimmune conditions, IVF and cancer treatments. And although “all HCPs, downstream workers and members of the public are at risk of sharps/needlestick injury,”[4] regulatory guidance outside of healthcare settings is minimal. It makes sense that “safe disposal requires that… safe sharps disposal systems and processes be present and known to all persons at risk for sharps contact.”[5] But anecdotal evidence and lack of national policy on the issue suggest that this is not always the case for people in the UK who inject at home. Although legislation requiring the safe disposal of sharps in healthcare and occupational settings was passed in 2013,[6] it does not cover sharps waste generated by individuals at home. Indeed, there is lack of clarity about who is responsible for making sure these sharps are disposed of safely. The NHS website states that, “If you have a medical condition… and use needles at home, your local council may be responsible for collecting your full sharps bin.” This statement demonstrates this lack of clarity for people who self-inject—that the local council ‘may’ help doesn’t speak of a clear, accessible safety process. Improper sharps disposal is a global public health risk This is a problem, because when needles and other sharps are not disposed of safely, they pose a considerable health risk to refuse workers, other household members and the general public. The TREND Diabetes ‘Correct Injection Technique in Diabetes Care Best Practice Guideline’, widely used by healthcare workers in the UK, states that “sharp medical devices present a potential risk for both injury and transmission of disease [such as] hepatitis and HIV.”[4] Sharps injuries can also have a significant psychological impact on individuals who experience them. A 2021 study into unsafe sharps disposal around the world found that “a substantial number of patients with diabetes mellitus improperly discard their sharps” and described the situation as an “emerging global crisis and significant public health risk”.[7] There have been a number of other studies in the last five years into the situation with household disposal in multiple countries around the world including the US,[8] Ghana,[9][10] India [11] and Sri Lanka,[12] but no study of this kind has been conducted in the UK in the last decade. The most recent study that examined the UK situation was a global survey of people with type 1 diabetes carried out in 2009, which found that 21% of people with diabetes in the UK and Ireland were disposing of sharps directly into their household rubbish,[13] but we do not have a clear picture of the current extent of this problem. The impact of improper sharps disposal is also difficult to assess. Like in the healthcare sector, there are very specific criteria for reporting needlestick injuries (NSIs) within waste disposal services. This means that the true number of sharps injuries as a result of improperly discarded domestic sharps in the UK is nearly impossible to quantify. However, we can look at the picture in the US, where recent research by The Environmental Research & Education Foundation into NSIs at municipal recycling facilities estimated that between 781 and 1,484 NSIs occur each year at recycling facilities.[14] Home sharps disposal - the UK picture Services and advice about safe sharps disposal vary geographically, and uncertainty about the process contributes to some people throwing their medical sharps in the general household waste, sometimes with no protective container at all. To get an idea of experiences in different areas, I asked social media contacts with type 1 diabetes in the UK about how they dispose of their sharps and the response was, as expected, mixed.[15] The NHS website points to local councils as having responsibility, but a quick look at the provision offered by different local authorities in London demonstrates a varied picture. Some councils provide free pick up services, while Hackney council charges residents for the service. Some councils require a referral from a healthcare professional and some require individuals to drop sharps off at a designated location themselves. Looking across the UK, evidence from patients suggests even wider variations in provision. Some areas of Scotland have no provision for sharps disposal at all, and one Twitter user in Scotland reported being asked by their diabetes specialist nurse to put their sharps in an empty detergent bottle before putting them in the normal household waste.[15] In the absence of a local clinical waste disposal service, this approach does offer some protection from injury, but it is clearly far from ideal. The TREND Guideline advises that, “Under no circumstance should sharps material be disposed of into the public refuse or rubbish system,”[4] indicating a mismatch between best practice recommendations and local policy. There are also stark differences in how local councils present information. Some provide clear and thorough guidance on the process and how to access the service. For example, the Enfield Council website includes details of areas served and waste items covered, and an online form. But this is not the same everywhere, and one Twitter user described the information on their council website as “a horror show.” Healthcare workers can also be unclear about home sharps disposal, particularly when someone is using them for short-term treatments. One patient told me, “I used needles at home for a short time whilst having my treatment and was given a bin to dispose of them in, but the nurses seemed unclear what I should do with it when full. They didn't give me any information on what to do with it, where to take it, or the dangers of just chucking it away.” This lack of knowledge demonstrates a process and knowledge gap that runs right the way through the healthcare system. Tackling the problem of improper sharps disposal So what needs to be done to improve the situation and reduce the safety risks associated with home use of needles and other sharps? Building an evidence base We need up-to-date research about the scale of improper home sharps disposal in the UK, and the prevalence and impact of injuries that occur as a result. National policy In response to this evidence, access to sharps disposal needs to be made consistent across the country, and national policy is needed to clarify the responsibility of local councils and NHS services. This would lead to greater clarity and easier access. Clear information on disposal processes If they are to fulfil their role in ensuring safe disposal, people who use sharps at home need clear, easy-to understand information. A national policy needs to be accompanied by clear information on who is providing the clinical waste services and where. Ongoing education on sharps disposal The TREND Guideline states that “safe disposal of sharps should be taught to people with diabetes who inject… from the beginning of the injection therapy initiation and reinforced thereafter.”[4] However, a 2018 US study found that people who had diabetes for more than 30 years had the lowest rate of correct sharps disposal,[16] suggesting that continued education is important. Related reading Injection technique and dual safety in diabetes care - a new SHBN working group to tackle safety risks Needlestick injuries – making the point for safety Sharps injuries and Covid (research by Ipsos MORI on behalf of European Biosafety Network) References 1 Safer sharps. NHS Supply Chain. Accessed 5 January 2022 2 Pressures of pandemic and lack of training see 50% rise in sharps injuries. Royal College of Nursing, 21 May 2021 3 Sharps injuries and Covid. European Biosafety Network and Ipsos Mori, 24 July 2021 4 Hicks D, James J, Smith M. Correct injection technique in diabetes care: Best practice guideline, 2nd edition. Trend Diabetes. March 2021 5 Frid A, Kreugel G, Grassi G et al. New Insulin Delivery Recommendations. Mayo Clinic Proceedings. 1 September 2016 6 Health and Safety (Sharp Instruments in Healthcare) Regulations 2013: Guidance for employers and employees. Health and Safety Executive. March 2013 7 Thompson B, Cook C. Unsafe Sharps Disposal Among Insulin-Using Patients With Diabetes Mellitus: An Emerging Global Crisis. Journal of Diabetes Science and Technology. 1 December 2021 8 Montoya J, Thompson B, Boyle M et al. Patterns of Sharps Handling and Disposal Among Insulin-Using Patients With Diabetes Mellitus. Journal of Diabetes Science and Technology. 22 October 2019 9 Udofia E, Gulis G, Fobil J. Solid medical waste: a cross sectional study of household disposal practices and reported harm in Southern Ghana. BMC Public Health. 18 May 2017 10 Egbenyah F, Udofia E, Ayivor J et al. Disposal habits and microbial load of solid medical waste in sub-district healthcare facilities and households in Yilo-Krobo municipality, Ghana. Plos One. 10 December 2021. 11 Moray K, Manjunath K, Shalini A et al. The insulin sharps disposal study: Evaluation of a structured patient education initiative in an urban community health centre in India. Journal of Family Medicine and Primary Care. 31 December 2020 12 Atukorala K, Wickramasinghe S, Sumanasekera R et al. Practices related to sharps disposal among diabetic patients in Sri Lanka. Asia Pacific Family Medicine. 7 December 2018 13 De Coninck C, Frid A, Gaspar R et al. Results and analysis of the 2008–2009 Insulin Injection Technique Questionnaire survey. Journal of Diabetes. 16 August 2010 14 Kantner D. Study Quantifies Needlestick Injury Rates for Materials Recovery Facility Workers. Waste 360. 10 September 2018 15 Twitter thread @LottyTizzard, 13 December 2021 16 Huang L, Katsnelson S, Yand J et al. Factors Contributing to Appropriate Sharps Disposal in the Community Among Patients With Diabetes. Diabetes Spectr. 2018:31:155-158

In this opinion piece, Kath Sansom, founder of the Sling the Mesh campaign, highlights the many issues that women face when trying to get pelvic mesh slings surgically removed. She calls for the NHS to give patients a voice and to develop a robust and consistent plan to tackle the issues faced by patients harmed by surgical mesh. In Spring 2021, I was due to meet a senior NHS official, along with a group of pelvic mesh campaigners, to ask for consistent training of all surgeons performing mesh removal procedures. That meeting was cancelled, and I’m calling for it to be reinstated, and fast. We desperately need action to sort out the inadequate, piecemeal approach the NHS has taken to redress the harm caused by surgical mesh. I manage a Facebook support group of over 9,200 women, most of whom are still living with debilitating pain and side effects caused by pelvic mesh. Each experience tells of harm added to harm - of mesh removal surgery being hard to access and inconsistent, and of hopelessly long waiting lists. Mesh specialist centres - inconsistent and inaccessible There are seven mesh complication centres in the UK[1] - six in England, one in Scotland and none in Wales or Northern Ireland - but assessment and surgical procedures vary hugely between these centres: There is no consistent training for surgeons undertaking mesh removal, with each centre taking its own approach. This needs to be addressed urgently with centralised training and standards to ensure that the most effective, evidence-based approach is taken for each and every woman. Some surgeons seem reluctant to undertake mesh removal and many women are sent away with no treatment other than to ‘keep taking painkillers’. It shouldn’t be that the care a patient is offered depends on a surgeon’s preference. There are only seven mesh specialist centres, meaning some women have to travel hundreds of miles for every appointment. Many have to undergo surgery without a family member or friend with them because of travel costs. In addition, there is only one centre in the country, in London, that will consider removing rectopexy mesh. This mesh may have been implanted in a smaller number of patients, but the incidence and severity of harm seems to be even greater than for women with transvaginal mesh. When patients are offered mesh removal surgery, waiting times are often in excess of two years. As with many other areas of the healthcare system, the problem has been worsened by the Covid-19 pandemic. Emerging victims of the surgical mesh scandal The Cumberlege Review began to shed some light on the harm caused to women who had pelvic mesh implanted. But the story is so much bigger than pelvic mesh - new patients who have had mesh implanted in other areas of the body are increasingly approaching Sling the Mesh, reporting pain and other side effects. There has been no review in England into the use of mesh to treat hernias[2], and we are seeing an increasing number of women reporting complications after mesh has been inserted into the abdomen following TRAM flap surgery[3], a procedure where abdominal tissue is used in breast reconstruction. Many of these people report being told by their surgeons that their pain is caused by ‘anxiety’; much the same story women with transvaginal mesh complications were given six years ago before the media started covering this issue extensively. This amounts to medical gaslighting and adds to the harm caused by the initial insertion of mesh devices. The NHS needs to learn from the hard lessons of the pelvic mesh scandal and take a joined-up and patient-centred approach to dealing with these emerging issues. The NHS needs to listen and take action Baroness Cumberlege’s review should have marked a sea change in the treatment of women who have suffered harm as a result of transvaginal mesh. But the NHS response has lacked will and focus, leaving thousands of patients still living with pain and distress as a result of surgical harm. Those individuals and agencies with the power to bring consistency and compassion to mesh removal surgery need to listen to the patients who have suffered life-changing injury. And taking the time to meet with us would be a good first step. Suggested reading Regulatory flaws: Women were catastrophically failed in the mesh, Primodos and Sodium Valproate tragedies - a blog by Kath Sansom Ineffective medical device recalls are a patient safety scandal - a blog by Kath Sansom A year on from the Cumberlege Review: Initial reflections on the Government’s response (Patient Safety Learning, 23 July 2021) Transvaginal Mesh Timeline (7 December 2017) References 1. 'England Mesh Complication Centres Announced'. British Society of Urogynaecology website, 5 February 2021 2. 'Hernia mesh complications "affect more than 100,000"'. BBC website, accessed 22 November 2021 3. 'Breast reconstruction using tissue from your tummy'. Macmillan Cancer Support website, accessed 22 November 2021