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Found 45 results
  1. Content Article
    Actions General practices: Practices using EMIS: If you have received a ‘task’ from EMIS identifying specific patients who have a record of a mechanical heart valve and are receiving a DOAC, and you have not already actioned this request, urgently review these patients to ensure they are on the most appropriate anticoagulation therapy and monitoring. Practices using TPP: If you have received a ‘task’ from TPP identifying specific patients who have a record of a mechanical heart valve and are receiving a DOAC, and you have not already actioned this request, urgently review these patients to ensure they are on the most appropriate anticoagulation therapy and monitoring. Practices using other GP system software: If your practice does not use EMIS or TPP software, urgently review all patients with a mechanical heart valve to ensure they are on the appropriate anticoagulant therapy and monitoring. Providers of anticoagulation services: Urgently check patient records from January 2020 to identify any patient with a mechanical heart valve who has been switched from a VKA to an alternative anticoagulant. For identified patients you should either: (i) Urgently review these patients if still under the care of the service to ensure they are on the appropriate anticoagulant therapy and monitoring or (ii) Work with the patient’s GP to ensure the patient receives an urgent review.
  2. Content Article
    I love and support the NHS. But when things go wrong for patients and service users, the system is often too slow to change or respond effectively. I have been through complaints, the Ombudsman and Inquest processes around the poor end of life care of my late mother. Those processes took years and were almost as stressful as those last few days of my mother’s life. I would not do it again. At the time, I reported the incident in detail to the CQC (inspectors), to the CCG (commissioners), to Healthwatch (local and national), but I noted no evidence of change. In fact, the CQC continued for years to report similar failings at the same hospital. Too many other patients and service users say the same thing. I met many of these patients/users when I was part of the user/patient led group PHSOthefacts. Then, my elderly friend and neighbour asked me to be their advocate around their wishes for end of life care and unfortunately things were not perfect at all. I was able, through connections I had made from the previous experiences I mention above, to get a meeting with senior managers involved with her care. However, sadly I do not think much came of that either. I believe others could go through the same suffering my friend experienced. There are immense pressures on the NHS. Hospitals have budgets to operate within, reputations to manage and targets to meet, as well as keeping patients and staff safe. While the system is under huge pressure, and many of the known ‘complaint’ processes are not designed to improve patient safety, the good news is there is a growing awareness of the need to listen and learn from patients and service users, drawing on the best safety science and using independent experts. Safety improvement rather than simply complaining (often seen as an administrative process) is what so many patients and families most want to see so others do not suffer the same way as their loved one. Fortunately, via a convoluted route, I did discover the Patient Safety team of NHS England who was able to take one of my concerns about care very seriously. I also learned about the development of the Healthcare Safety Investigation Branch (HSIB). So the good news is that as well as traditional routes like Complaints, the Ombudsman (PHSO) and reporting to formal bodies (perceived as inadequate by too many patients/users who have been through this process), there are four developments to note of NHS dealing with events when patients suffer harm or potential harm: 1. New guidance is being developed by NHS England to help hospitals and health services address safety concerns and involve patients in this. 2. HSIB, who carry out up to 30 independent investigations a year, is developing an exemplar model of involving the patient and family perspective in these investigations. It offers an exciting, new, more change-focused, learning-focused and system-focused way of understanding and addressing many of the harmful incidents patients' experience, aligned with service users and families who wish to embark on a journey resulting in learning. Watch this HSIB video 'Why it's important that we learn from incidents'. 3. There is increasing recognition of the role of patients in all health decision-making, which is well covered in the Patients Associations' 'Shared decision making: a reality for everyone'. In fact, I recently wrote a blog for the hub on a particular patient harm issue: 'Please don't undermine my pain relief! A call for learning and respect for patients with long tern needs', which I then shared via ENGLAND.shareddecisionmaking@nhs.net and I was put in contact with a relevant Clinical Improvement Team in NHSE/I who were interested to learn more. 4. Finally, patients, service users and families can log issues on the NHS England NRLS reporting tool – although no one will get back to you personally, the information you share could be used to improve safety for future patients. However currently it is vastly under used (50 patient/family reports a year) compared to the general NHS complaints system (over 100,000 a year). In contrast, the system also logs and analyses nearly 2 million NHS staff-reported harm or potential harm incidents a year, examined by a team of NHS-employed independent patient safety experts. It may contribute to vital learning in the future and it is currently reviewed and upgraded, but to my mind the process is going too slow with regard to patient and family reporting. I think the patient, service user and family voice should be heard loud and strong. There should be a reporting option for where patients and users can go if they do not want to go through complaints, Ombudsmen, Inquest, legal or other processes (e.g. to CQC or CCG), or indeed want to do something alongside these processes and want to ensure independent health safety experts are made aware of concerning incidents. Please let me know if you are interested about developments in this latter area as there will be working groups wanting to hear the patient, service user and family experience, and I will be involved and want to ensure other harmed patient voices and their advocates are heard. The patient, service user, family and carer voice must be heard and acted on to improve patient safety at these difficult times.
  3. Content Article
    PP mesh has been widely used in surgery for stress urinary incontinence (SUI) and transvaginal or transabdominal prolapse since the 1990s,[1] and hernia repair since the 1950s.[2] In spite of this long history, there is a surprising lack of research into the link between surgical mesh and autoimmune conditions. Among the many complications reported by women who have had vaginal mesh surgery, autoimmune symptoms feature high on the list. One member of the Sling the Mesh Facebook group was recently looking for answers about her own autoimmune symptoms when she came across a Medical device material performance study polypropylene safety profile put together by the ECRI. This blog will look at the key issues that it highlights concerning surgical mesh research. What did the ECRI report aim to find out? Produced by US non-profit organisation the ECRI, on behalf of the FDA Center for Devices and Radiological Health (CDRH), the report looks at existing research literature about PP mesh degradation and physiological responses to PP mesh. The authors of the report conducted a systematic review of 158 articles that were selected for inclusion, to answer five questions posed by the FDA[3]: What is the typical/expected local host response to polypropylene? Does the material elicit a persistent or exaggerated response that may lead to systemic signs or symptoms, beyond known direct toxicity problems? Are there any patient-related factors that may predict, increase, or decrease the likelihood and/or severity of an exaggerated, sustained immunological/systemic response? Are there any material-related factors that may predict, increase, or decrease the likelihood and/or severity of an exaggerated, sustained immunological/systemic response? What critical information gaps exist and what research is needed to better understand this issue? Key findings Surgical mesh results in high infection and hospitalisation rates The report states that “data pointed to infection in 40% of event reports associated with PP mesh. There were five deaths, and when patient harm was reported, 44% required intervention or hospitalisation.”[3] This is a very high incidence of infection that warrants further research. There is low quality of evidence around pain, mesh migration and hernia mesh The report found moderate to low quality of evidence about inflammation, mesh migration and pain related to general surgical mesh and transvaginal prolapse mesh. They found no evidence at all relating local responses for diaphragmatic hernia meshes and male SUI mesh. The report calls for higher quality of evidence on local responses to PP mesh. There are big research gaps around systemic responses Worryingly, questions 3 and 4 posed by the FDA—which consider factors that contribute to a immunological or systemic response—could not be answered. The ECRI concluded that “none of the studies provided useful information regarding material-related factors that may affect a sustained immunological/systemic response.”[3] This is because there were few studies that reported any data related to systemic reactions, and where they did, the quality of evidence was low. The report calls for “higher quality of evidence around systemic responses to PP mesh as there is currently very low to low quality of evidence.”[3] This applies to both PP as a material and specific PP mesh devices. Some mesh causes more complications than others The report states that “evidence suggested that lightweight PP mesh was less likely than heavier weight PP mesh to cause pain or foreign body sensation.”[3] Mesh-specific research is needed to identify which patients are most at risk of complications from individual mesh products. Although mesh is no longer being used in the UK to treat female SUI and prolapse, it is still being used in a wide range of other surgical procedures in the UK, and there are no restrictions on its use in many countries. The report highlights that, “there were no studies on diaphragmatic hernia mesh and male SUI mesh that met the inclusion criteria, either in terms of local or systemic responses,” and calls for specific studies on these procedures and devices. What’s next for surgical mesh research? The huge gaps in research evidence about PP mesh that the report highlights have serious implications. As there is little ‘evidence’ of harm, it allows the healthcare system to ignore the concerns of patients suffering with debilitating complications. This is particularly the case with systemic reactions to mesh—until we have some clear, peer-reviewed evidence around the link between autoimmune conditions, the pattern of patients having their symptoms dismissed will continue. We need health services and funders to take this knowledge gap seriously and invest in understanding the true extent of harm caused by surgical mesh. Related reading Regulatory flaws: Women were catastrophically failed in the mesh, Primodos and Sodium Valproate tragedies (April 2021) Ineffective medical device recalls are a patient safety scandal (October 2021) Mesh News Desk - Strattice hernia mesh trial preparation underway (17 October 2022) References 1 Kent C. Transvaginal mesh timeline: the gynaecological scandal that rocked the world. Medical Device Network, 9 January 2020 2 Baylón K, Rodríguez-Camarillo P, Elías-Zúñiga A et al. Past, Present and Future of Surgical Meshes: A Review. Membranes. 7 September 2017 3 Lucas S. Medical Device Material Performance Study: Polypropylene Safety Profile. Emergency Care Research Institute, 2020
  4. Content Article
    Key findings Local host responses to polypropylene (PP) used in surgical mesh included pain, foreign body sensation, seroma and haematoma. When PP mesh was used in other surgeries (female stress urinary incontinence mesh or mini-sling, transvaginal or transabdominal prolapse mesh), the primary local responses were erosion/exposure followed by dyspareunia and pain. Studies reported these complications from immediately post surgery to five years post surgery. Evidence suggested that lightweight PP mesh was less likely than heavier weight PP mesh to cause pain or foreign body sensation. There were no studies elucidating patient– or material-related factors contributing to systemic responses. ECRI’s data pointed to infection in 40% of event reports associated with PP mesh. There were five deaths, and when patient harm was reported, 44% required intervention or hospitalisation. Evidence gaps The report identifies the following evidence gaps: Studies of local and systemic host response to PP as a material. Studies examining local or systemic host response to diaphragmatic hernia mesh. Better quality evidence regarding local responses such as inflammation, mesh migration, and pain and regarding systemic responses to mesh such as allergy, autoantibody development and systemic inflammation.
  5. Content Article
    Organisers of the HSJ Patient Safety Congress are pleased to confirm that three of the UK’s most influential figures in the field will be speaking at the event – which is taking place on 15-16 September in Manchester Central. The Congress is the only event of its kind which brings together stakeholders from across the health and care spectrum to debate the most critical patient safety issues, sharing practical solutions to enable progress, in line with the national Patient Safety Strategy. The 2-day annual meeting provides a welcome opportunity to demonstrate best practice, innovation and renewed efforts to drive forward the nationwide commitment of putting safety and quality at the heart of patient care. Around 1,000 delegates from across the sector are expected to attend. The Congress also coincides with the much-anticipated appointment of the first Patient Safety Commissioner for England (September 2022), as well as over 700 new Patient Safety Specialist roles across the country. As part of the line-up of key speakers, Commons Health & Social Care committee Chair Jeremy Hunt, former Secretary of State turned patient safety campaigner, will share his views on how reducing avoidable deaths can be done while saving money, reducing backlogs and improving working conditions. National Director of Patient Safety Dr Aidan Fowler will provide a long-awaited update on the NHS Patient Safety Strategy three years after its launch, looking at progress and new priorities through the pandemic period. And, Dr Henrietta Hughes OBE, newly appointed as the first Patient Safety Commissioner will reveal her immediate priorities for the new role. Speaking to the HSJ earlier this month, Dr Hughes, commented; “I was really keen….to see what we could do to actually put the patient voice at the absolute heart of how we make decisions in healthcare, how we design healthcare, but also how we listen to people when things go wrong”. Others due to speak include former Chief Inspector of Hospitals, Ted Baker; NHSE Deputy Chief Nursing Officer for Improvement, Professor Charlotte McArdle; and Health Foundation Chief Executive, Jennifer Dixon. The programme includes: pioneering case studies; platforms to exchange ideas with peers to find ways to best support staff welfare, including the implications and impact of long-covid on patient safety; exploring the opportunities of Integrated Care Systems (ICSs); updates and insights from the Patient Safety Commissioner as well as first-hand reflections from Patient Safety Specialists. And, new for 2022, delegates will also be able to join sessions looking at specific safety concerns in high priority service areas such as women’s healthcare, digital health and care & safety in non-acute settings – as well as ‘hands on’ demonstrations such as CPR training in the exhibition hall. Shaun Lintern, Sunday Times Health Editor, who will once again be chairing the event comments; “We have to be realistic that the NHS has faced some huge challenges over the last two years and, therefore, a real aim of the Congress is to present a programme which brings together speakers and experts from right across the health system – as well external contributors – who will look at some of the ‘big issues’, engaging with our audience and suggesting positive ways forward. “Everybody has a role in patient safety - whatever their position or level within their organisation - and this Congress really is for everybody.”
  6. Content Article
    This review was carried out in response to the very low numbers of investigations or reviews of deaths at Southern Health NHS Foundation Trust. Over a four-year period, fewer than 1% of deaths in Southern Health’s learning disability services and 0.3% of deaths in their mental health services for older people were investigated as a serious incident requiring investigation. Throughout this review, families and carers have told the CQC that they often have a poor experience of investigations and are not always treated with kindness, respect and honesty. This was particularly the case for families and carers of people with a mental health problem or learning disability. However, there is currently no single framework for NHS trusts that sets out what they need to do to maximise the learning from deaths that may be the result of problems in care. This means that there are a range of systems and processes in place, and that practice varies widely across providers. As a result, learning from deaths is not being given enough consideration in the NHS and opportunities to improve care for future patients are being missed. This reports sets out the next steps.
  7. Content Article
    The new research maps the provision of safer custody telephone lines across the prison estate - dedicated phone lines which enable family members and others to pass on urgent information when they have concerns. It finds that provision is patchy, under-resourced and even non-existent in some prisons, leaving families struggling to share their concerns with prison staff. The report reveals that: Almost two in five (37%) prisons in England and Wales appeared to have no functioning dedicated safer custody telephone lines for families to get in touch. Of these, nearly one in five prisons (18%) had no publicly advertised number for a dedicated safer custody telephone line. A further 18% of prisons advertised a dedicated line, but when called the number either wasn’t operational, was not answered, or went through to a general prison switchboard. Of the 75 dedicated safer custody telephone lines that went through to safer custody departments, only 13 (17%) were answered by a member of staff. Over 80% of dedicated safer custody lines that went through to safer custody departments (62 prisons in total) put the caller straight through to an answer machine.
  8. Content Article
    Key findings: The majority of studies typically classify patient harm as preventable if it occurs as a result of an identifiable modifiable cause and its future recurrence can be avoided by reasonable adaptation to a process or adherence to guidelines. At least 6% of patients experienced preventable harm across the healthcare service. 13% of the identified preventable harm causes prolonged or permanent disability or leads to death. The main types of patient safety incidents which contribute to preventable harm are medication incidents, diagnostic incidents and incidents occurring following the receipt of suboptimal clinical management/therapies. Despite the large number of studies included in this review, the quality and depth of data presented on preventable patient harm is very low. Preventability was reported as a secondary outcome across the vast majority of the studies – ie broadly, most of the studies were not focused on preventability. Research to identify the major preventable sources of severe patient harm as well as the stages, the systems and the practitioners involved in the occurrence of preventable harmful incidents is needed.