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Found 447 results
  1. News Article
    Thousands of people across the UK could face complex surgery to remove a spinal implant now linked to significant bone loss. This alarming development follows the device's global withdrawal from sale and an urgent recall for patients to undergo X-rays. The M6-C artificial disc implant was designed to replace damaged neck discs, offering an alternative to spinal fusion surgery, involving metal rods. However, the implant has been associated with osteolysis – a progressive condition where bone tissue is destroyed and reabsorbed by the body. Read full article. Source: The Independent, 19 June 2026
  2. News Article
    NHS England has warned that it may be unable to lawfully deploy AI features on the NHS App from next year, due to incoming medical device regulation changes. A new entry on NHSE’s operational risk register, published last week, flags the risk of an “innovation freeze” in which the organisation cannot place new and updated software and AI medical devices into clinical use in a lawful manner from spring 2027. The freeze could delay key commitments in the 10-Year Health Plan, including plans for AI-led triage on the NHS App – central to the government’s ambition to give every patient a “doctor in your pocket”. It comes as draft amendments to UK Medical Device Regulations are due to be laid before Parliament, before being implemented in 2027. NHSE said that, as a developer of its own digital tools, it must meet the new conformity assessment and classification requirements as they come into force. It confirmed that services currently in use, including in the NHS App, remain compliant under current legislation. Read full story (paywalled) Source: HSJ, 10 June 2026
  3. Content Article
    At Patient Safety Learning we believe that sharing insights and learning is vital to improving outcomes and reducing harm. That's why we created the hub; to provide a space for people to come together and share their experiences, resources and good practice examples. Diabetes is a condition that causes the amount of glucose in a person's blood to be too high. When you have type 1 diabetes, your body can’t make any insulin at all, whereas with type 2, you either can’t make enough insulin, or it can’t work properly. There are also other types of diabetes including gestational diabetes, which some women develop during pregnancy, maturity onset diabetes of the young (MODY) and latent autoimmune diabetes in adults (LADA). It is important that people with diabetes are supported to maintain good blood glucose control through diet, insulin and other diabetes medications, to prevent both acute and long-term complications. We’ve selected our top picks of useful resources about diabetes. Self-management is perhaps the most important aspect of treating diabetes effectively, so we've included some resources aimed at helping patients manage their diabetes too. 1 HSSIB reports The Health Services Safety Investigation Body (HSSIB) has published a series of reports considering the self-administration of insulin by people with diabetes mellitus. Each report focuses on specific groups of people who, due to their circumstances, may be at increased risk of harm because of the way they self-administer insulin. Insulin: supporting safe self-administration for patients in the community with a mental health problem Insulin: supporting safe self-administration for patients in the community with a disability Insulin: supporting patients to safe administration in inpatient settings 2 Decoding diabetes research – an innovative approach that makes scientific knowledge accessible to everyone In this blog, Jazz Sethi, Founder and Director of the Diabesties Foundation and part of the global team that developed D-Coded, discusses the need for the resource and outlines how it will help people living with diabetes to better understand and manage their condition. 3 Leading for patient safety: a conversation with Partha Kar Partha Kar, National Specialty Advisor for NHS England, has led work that has had an enormous impact for patients and for patient safety. In this video podcast, Steph O'Donohue from Patient Safety Learning talks to Partha about his leadership style and how it has helped him drive forward significant change in an often challenging context. 4 Decision support tool: making a decision about managing type 1 diabetes This leaflet from NHS England aims to help people with type 1 diabetes decide between the different technologies available to manage diabetes. It contains summaries of devices available and infographics outlining eligibility criteria for continuous glucose monitors (CGM), insulin pumps and hybrid-closed loop systems. 5 10 Year Vision: For diabetes prevention, care and treatment This report from Diabetes UK sets out a clear plan for the UK government about how it can improve health outcomes and tackle inequality for people living with diabetes by 2035. 6 D1abasics: Equipping staff to care safely for inpatients with diabetes The inpatient diabetes team at University Hospital Southampton NHS Foundation Trust recently launched D1abasics, an initiative that aims to improve inpatient care for people with diabetes. In this blog, Diabetes Consultant Mayank Patel and Inpatient Diabetes Specialist Nurse Paula Johnston outline the approach and explain how it will equip staff across all specialties with the basic knowledge to care safely for people with diabetes in hospital. 7 Improving diabetes care in inpatient mental health settings Despite the prevalence of diabetes amongst individuals with Serious Mental Illness (SMI), diabetes care is not currently audited within mental health inpatient settings as it audited in physical health settings. This project piloted an audit to assess the diabetes care within London NHS Mental Health Trusts. 8 Diabetes tech: Do national aspirations and local practice align? In this 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. 9 NHS England - Language Matters: language and diabetes The language that healthcare professionals use to talk about diabetes can have a profound impact on how people living with diabetes, and those who care for them, experience their condition and feel about living with it. This guidance by NHS England sets out practical examples of language that will encourage positive interactions with people living with diabetes. When people with diabetes feel encouraged and empowered to manage their condition, it has been shown to make a difference to their health outcomes. The examples in ‘Language Matters’ are based on research and supported by a simple set of principles. 10 Key things to remember if you use injectable medication to treat your diabetes This checklist by TREND Diabetes outlines the steps patients should take to ensure they inject their insulin or other diabetes medication correctly. It explains the importance of taking steps such as moving injection sites and changing needles, and outlines how failing to do this can affect blood glucose control. 11 Improving safety for diabetic inpatients: 4 key steps In this video, Partha Kar, National Specialty Advisor for Diabetes, shares four steps to improve safety for inpatients with diabetes, based on information from the National Diabetes Inpatient Audit. He also highlights key resources to help staff improve their knowledge of diabetes and understand how to offer the safest care to people with diabetes when they are staying in hospital. 12 Diabetes technology is life-changing, but we need to be prepared when it fails In this blog, Andrew Stroud talks about his family's experiences supporting their daughter, Bia, to manage her type 1 diabetes. He describes the huge value of technology in improving diabetes management and reducing the mental burden of the condition on people with diabetes and their parents and carers. However, like all technology, medical devices for diabetes can fail, and Andrew highlights the need to be prepared for this situation to ensure the person with diabetes is safe while they cannot use the devices they rely on every day. 13 How safe are closed loop artificial pancreas systems? Closed-loop artificial pancreas systems are self-regulating systems for administering insulin to patients with type 1 diabetes. They allow for tighter blood glucose control and reduce the decision-making burden for people with diabetes. In this blog, Lotty Tizzard, Patient Safety Learning's Content and Engagement Manager, takes a look at the benefits and potential patient safety risks associated with closed-loop artificial pancreas systems (APS). People with diabetes have developed the algorithm that runs these systems and made it freely available to anyone wanting to build their own DIY artificial pancreas. This has spurred the medical tech industry to develop commercial systems, which will make the technology more widely available. But there are challenges in ensuring accessibility to all people with type 1 diabetes who would benefit from the technology, and there are questions about regulation and liability. 14 A systematic approach to insulin safety (video series by Communications PharmSocNI) This video series looks at systematic approaches to insulin safety, including: Human Factors - A Journey of Discovery; SEIPS – The Swiss Army Knife Approach; and Summary & Applying the Learning. 15 System-wide strategies for better diabetes care chapter 1: Evidence approved medicines and chapter 2: Ensuring equitable access to glucose sensing technology for type 2 insulin users Two reports from Public Policy Projects (PPP). Chapter 1 calls for changes in the use of approved medicines to improve diabetes care in the UK and chapter 2 highlights the opportunities and challenges brought by CGM technology to type 2 insulin users and other patient groups. 16 National Diabetes Foot Care Audit 2018 to 2023 Ulceration of the foot in people living with diabetes presents significant challenges, including emotional, physical and financial costs, and is associated with increased risk of both amputation and death. It affects between 1 and 2% of all people with diabetes each year and its management accounts for approximately 1% of the total NHS budget. The aim of the National Diabetes Foot Care Audit is to measure factors associated with increased risk of ulcer onset and adverse ulcer outcomes, and to share information relating to best clinical practice. 17 Diabulimia: what is it and why have so few people heard of it? Type 1 diabetes with disordered eating (T1DE), or diabulimia as some experts call it, is a serious eating disorder that people with type 1 diabetes can develop where the person reduces or stops taking their insulin as a way of managing their weight. The condition can be life-threatening. Although studies are limited, it’s estimated that eating disorders affect more than a third of patients with type 1 diabetes. This episode of the Healthcare Improvement podcast looks at diabulimia and a new toolkit published by SIGN, part of Healthcare Improvement Scotland, which sets out recommendations to raise awareness and provide guidance on how best to support people living with the diabulimia. 18 NHS England: Children and young people diabetes toolkit This toolkit is designed to support integrated care systems (ICSs) to design, plan, and deliver high-quality treatment and care for children and young adults aged 0-25 years with all types of diabetes. 19 Insulin therapy in primary care The management of insulin therapy requires knowledge of the type of diabetes it is being used for and appropriate dosing, as well as correct injection technique, to prevent complications and medication errors. Diabetes nursing specialist Debbie Hicks shares key points on the management of insulin therapy for nurses in primary care. 20 Handbook: Diabetes footcare in dark skin tones Covering essential topics such as physiology, history-taking, assessment techniques, and investigative methods, this handbook has been designed to provide essential information as well as quick tips to healthcare professionals to improve foot care for people with dark skin living with diabetes. Featuring clinical assessments and visual/audio guides, this handbook is the product of a unique collaboration across healthcare professional specialities, and with input from people living with diabetes. 21 Addressing racial inequalities in paediatric diabetes Dita Aswani and Fulya Mehta are both consultant paediatricians and NHS England national advisors for Children and Young adults’ (CYA) diabetes. In this blog, they outline racial inequalities that persist in paediatric diabetes and present five key areas for change. In summary they talk about what healthcare professionals can do to reduce inequalities through their own practice. Do you have a resource or story about diabetes to share? We’d love to hear about it - leave a comment below or join the hub to share your own post.
  4. Content Article
    The Medicines and Healthcare products Regulatory Agency (MHRA) regulates medicines, medical devices and blood components for transfusion in the UK. This roundup provides a summary of their latest safety advice for medicines and medical device users. It includes details of medicine recalls, medical device field safety notices and details of how to report drug reactions and device incidents. This month's Safety Roundup includes: Drug Safety Update on Nasal decongestant sprays and drops containing xylometazoline hydrochloride / oxymetazoline hydrochloride: increased risk of rebound congestion, rhinitis medicamentosa, and tachyphylaxis with overuse. Drug Safety Update on Finasteride and Dutasteride – updated safety warnings for psychiatric side effects and sexual dysfunction. Device safety Information on Kimal Procedure Packs containing recalled components: Namic Angiographic Syringe with the risk of syringe disconnection; Namic Manifolds with the risk of foreign particulates. Important guidance for use in urgent procedures where there are no alternatives. Device safety Information on Risk of severe harm from use of incorrect giving (administration) set for blood transfusion. Device safety Information on Allurion Gastric Balloon: Updated safety information due to the risks of gastric outlet obstruction, small bowel obstruction and gastric perforation. Letters, medicines recalls and device notifications sent to healthcare professionals in May 2026. News and guidance on: Dostarlimab (Jemperli) and immune-related skin adverse reactions: updates to the product information. BNF and BNFC updated guidance on medicines that cause drowsiness to help prevent co-sleeping deaths.
  5. Content Article
    A new study reveals how the immune system behaves in people who have had complications from surgical mesh implants. Result? There is evidence of ongoing, abnormal immune activation throughout the body, not just at the implant site. Most research on mesh complications looks at local problems such as damage or inflammation where the mesh is placed. However, this paper asks a bigger question. Do these patients also have a whole‑body (systemic) immune response, not just a local one? The answer appears to be YES. The study was conducted by a team at the NHS Newcastle Mesh Complication Centre who say the mechanisms underpinning mesh complications remain largely unknown. Also, there are no reports characterising systemic immune dysregulation – in other words, the immune system not working as it should. The paper shows that people with mesh complications have measurable changes in their immune system throughout the body, suggesting complications may be partly driven by systemic inflammation not just local damage.
  6. Content Article
    Sling the Mesh in collaboration with researchers at the RCSI University of Medicine and Health Science are conducting a survey of people with pelvic complications. Participation involves an online survey that will take approximately 30 minutes. You are eligible to participate if you were implanted with any type of pelvic mesh (incontinence, bladder leaks, rectopexy) in a UK facility after 1 January 1998 and have experienced any pelvic mesh related complication. Find out more from the link below.
  7. Content Article
    Surgical implants, such as joint replacements, are used for many serious conditions. Innovation continues to supply new implants, including outputs of the soft robotics revolution. However, they carry risk of complications with potentially devastating consequences. This opinion paper provides the reflections of two surgical technologists on present challenges to safety, efficacy and broad implementation of medical implants. They highlight lack of familiarity with implant surgery in healthcare services, with concomitant risk. First-in-human application of new implants is not sufficiently standardised and regulated. IDEAL-D is a structured framework for medical devices (Idea, Development, Exploration, Assessment, Long-term study). Once CE-marked and approved for mainstream use, there are problems with the implementation. ‘Early adopter’ surgeons and centres face cultural inertia, lack of funding support and issues around training, especially learning curves. Patient selection may not be well-defined, and complications inaccurately reported, affecting implant dissemination detrimentally. The Cumberlege report showed how harmful this can be. There is need to standardise early clinical studies. Implementation of implantable devices requires changes to whole-team training, funding and post-implementation reporting. The IDEAL-D framework represents an important step, but other system-wide changes are required if implants are to achieve their intended clinical impact.
  8. Content Article
    Sling the Mesh welcomes the speech in Parliament on the 16 April that recognised the mesh‑injured community in the new refreshed Women’s Health Strategy, thanks to Health Minister Karin Smyth who explicitly acknowledged how our pain was ignored for years. That recognition did not happen by accident, it happened because we made a fuss, typing emails furiously – refusing to let the mesh‑injured community be forgotten, downplayed or erased. Listen to it at 12:41. The new Strategy was launched and is a powerful document which recognises that women’s voices are often ignored and downplayed across the health sector. The Strategy outlines 117 calls to action to improve women’s health across their lifetime. Karen Smyth Health Minister, said: “For too long, women have been left to navigate a confusing system, fighting to get the basic care they deserve, and under-represented in health research. Above all, women’s voices and choices have been dismissed, and it is truly shocking how often women have been ignored when telling medical professionals about their pain. From pelvic mesh to endometriosis, we are expected to put up with pain as our lot in life, as if it were normal. But it is not normal, and since coming into office this Government have taken a number of measures to improve women’s health.” Shadow Health Minister Dr Caroline Johnson said: “I find it remarkable that the Minister has the audacity to talk about women harmed by pelvic mesh when, after almost two years in office, the Government have still not responded to the Hughes report. When do they intend to do so?” MP Oliver Ryan said: “I am quite ashamed to say that before being elected to this place, I did not know enough about women’s health issues, and in particular the issues with pelvic and vaginal mesh—the wait for treatment and the struggle to be heard—and endometriosis; people with that condition face a wait for diagnosis and a struggle for recognition. Since I was elected, I have been contacted by tens of women across Burnley, Padiham and Brierfield, who are fighting the fight for recognition of these topics on behalf of women across the country. It is because of that that I am educated enough to stand here today. Those women feel ignored and abandoned by a health service that does not care enough about women’s health issues. Will the Minister give a commitment to campaigners such as the women in Burnley, Padiham and Brierfield who have approached me that because of this strategy, they will now be heard? MP Chris Vince said: “I was shocked by the number of women from my constituency of Harlow who came forward to tell me about their terrible experiences of being gaslit, ignored and disrespected, particularly when it came to endometriosis and the pelvic mesh scandal.”
  9. News Article
    A disgraced surgeon whose artificial bowel mesh procedures injured more than 450 patients has cost the NHS more £20m in compensation payments, the BBC has been told. Bristol surgeon Tony Dixon was removed from the medical register last year for serious misconduct, including performing unnecessary surgeries, using surgical mesh to treat bowl complaints without patient's informed consent, and fabricating patient records. NHS Resolution confirmed it has paid out £19.12m so far to 245 claimants - and there are hundreds more unsettled claims to be dealt with. Dixon carried out the treatments, using artificial mesh to treat prolapsed bowels, at Southmead Hospital and Spire Hospital. The BBC first revealed allegations made against Dixon in 2017, when many women complained of severe pain following their operations. Kath Sansom, founder of the patient-led campaign group Sling the Mesh, previously said that women had suffered "horrific complications" such as pain, nerve damage, and mesh erosion - where the mesh slices into nearby organs and tissues. Dixon used a technique known as mesh rectopexy to treat bowel problems and has promoted it through a series of studies. Some of his studies have been flagged with formal editorial warnings due to the concerns about the validity of the data. Read full story Source: BBC News, 20 April 2026
  10. Content Article
    French actor / theatre director and hernia mesh advocate Arnaud Dennis is in an assisted dying clinic in Belgium. In this powerful interview the 42 year old speaks about how he is awaiting approval for euthanasia after devastating complications from a hernia mesh that destroyed his life. In this final public appeal, he denounces the major health scandal of mesh, giving his last thoughts to the hundreds of implant victims he has represented in France and warns of systemic medical and institutional failures – as well as the conflicts of interests /payments from industry to surgeons, which continue to help fuel the lucrative mesh machine.
  11. Content Article
    The Medicines and Healthcare products Regulatory Agency (MHRA) regulates medicines, medical devices and blood components for transfusion in the UK. This roundup provides a summary of their latest safety advice for medicines and medical device users. It includes details of medicine recalls, medical device field safety notices and details of how to report drug reactions and device incidents. This month's Safety Roundup includes: Letters, medicines recalls and device notifications sent to healthcare professionals in March 2026. News and guidance on: Publication of meningitis factsheet . Patients to get new medicines up to six months sooner under new joint MHRA-NICE approval process.
  12. Content Article
    Most health systems and hospitals have older medical devices that they have used for years, and some of those devices can pose risks to their cybersecurity. Dr. Marcus Schabacker, president and CEO of ECRI, talked with Chief Healthcare Executive about the problems arising from legacy medical devices.
  13. News Article
    Diabetes patients and their families in the United States are raising concerns, and in some cases filing lawsuits, after Abbott Diabetes Care recalled glucose monitors linked to seven deaths. In December, Abbott recalled certain sensors used in its FreeStyle Libre 3 and FreeStyle Libre 3 Plus systems, warning they could produce falsely low glucose readings. The company reported 736 serious adverse events potentially tied to the issue, including 57 in the United States, along with seven deaths worldwide. One person in the US whose death has been linked to the equipment by their family is Michael Ford of Oakland, California, who had Type 2 diabetes. On a November morning, the 68-year-old’s FreeStyle Libre 3 Plus sensor reportedly issued a low-blood-sugar alert, prompting his son and full-time caregiver, Davonte Ford, to respond. Trusting the device and following medical guidance, he told NBC News, Davonte Ford gave his father fast-acting carbohydrates to raise his blood sugar – unaware that just eight days later Abbott would issue an urgent warning that about 3 million sensors could produce inaccurate readings. Michael Ford’s death is not included in Abbott’s official count of deaths potentially linked to the equipment, although his sensor came from one of the recalled production lots. Abbott did not list the specific serial number of his device in the recall, leaving families and legal experts concerned that the recall may have overlooked affected devices. According to a lawsuit Davonte Ford filed last month, the reading displayed on his father’s device that morning was “catastrophically inaccurate.” For patients, discovering flaws in devices they rely on can be frightening. Angela Ivery, 71, of Spruce Pine, North Carolina, said she repeatedly went to the emergency room after her Libre 3 sensor falsely indicated low blood sugar, only to find her levels were normal with a traditional finger-stick test, all before receiving a recall notice. Read full story Source: The Guardian, 11 March 2026
  14. Content Article
    Sling the Mesh are taking their fight to 10 Downing Street, urging the Prime Minister to commit to a long‑overdue compensation scheme for women harmed by pelvic mesh – and set out a clear timeframe and firm dates for action. The letter they are handing in to Sir Kier Starmer is published below. Sling the Mesh are calling on English Parliament to take the lead by setting out a robust financial redress framework that the devolved nations can follow.
  15. News Article
    "I walked into the hospital able-bodied and came out on crutches." Susan McLarnon is one of thousands of women across the UK who have experienced serious complications after being given a vaginal mesh implant to treat a prolapse and urinary incontinence She says she now lives in "constant pain" and is calling for the government to commit to a deadline for a redress scheme. McLarnon is one of several women travelling to Downing Street later to hand a letter to the prime minister asking for "urgent action" to be taken on compensation for those harmed by pelvic mesh implants. Some women were left in permanent pain, unable to walk, work or have sex, after the surgery to treat incontinence and pelvic organ prolapse. Two years ago, a major report, external called for urgent action but campaigners are still waiting. Kath Sansom, founder of Sling The Mesh, who will be handing in the letter at Downing Street with the other women, said pelvic mesh had "stolen women's health, irreversibly ruined their quality of life, their independence, and their future". They are calling for a timescale for a funded, government-backed compensation scheme for all women who have been harmed. The UK Department of Health and Social Care said it is "carefully considering" the recommendations in the report and aims to provide an update in due course. Read full story Source: BBC News, 10 March 2026
  16. Content Article
    Advances in home diabetes management technologies have transformed how millions of people manage their condition outside of traditional clinical settings. Devices such as insulin pumps, continuous glucose monitors (CGMs), and integrated systems that combine the two have enabled tighter glucose control, fewer manual interventions, and greater independence for patients. Closed-loop systems, in particular, represent a major step forward—automating insulin delivery based on real-time glucose data and significantly improving quality of life. Yet as these technologies become more sophisticated and widely adopted, they also introduce new safety risks—especially when critical recall information, software updates, or safety warnings fail to reach patients and caregivers in a timely or understandable way. When recall communications break down, the consequences can be severe. This ECRI article looks at why recall communication matters more than ever, the clinical consequences of missed or misunderstood recalls and shared responsibility for improving recall communication. Further reading on the hub: Diabetes technology is life-changing, but we need to be prepared when it fails - A blog by Andrew Stroud How safe are closed loop artificial pancreas systems? Blog - When diabetes devices fail
  17. Content Article
    This case study is one in a set of patient safety ‘how we acted on patient safety issues you recorded’ case studies which show the direct action taken in response to patient safety events recorded by organisations, staff and the public, and how their actions support the NHS to protect patients from harm. The National Patient Safety Team identified an issue related to delivery of insulin via insulin pen safety engineered needle devices (SENDs). There are both active and passive SENDs available for insulin pens, which have different mechanisms of use. A recorded incident described a type 1 diabetic developing diabetic ketoacidosis (DKA) where no precipitating factors were identified other than potentially the method of insulin administration. A review of incident data revealed a theme of insulin ‘pooling’ on the skin following administration. This may occur when the needle of a passive SEND retracts during administration, due to releasing pressure too early so insulin sits on the skin. Reports describe patients developing DKA or hyperglycaemia due to delayed recognition of suboptimal insulin administration technique via some insulin pens. The insight from the review was shared with TREND for their ‘Injection Technique Matters’ resource and The Royal College of Nursing for RCN Sharp Safety Guidance. Findings were shared with the National Association of Medical Device Educators and Trainers (NAMDET) members via an article in their MDET journal to expand awareness that both passive and active insulin pen SENDs require education and training for use. The findings were also shared with clinical procurement specialists recommending that user education and training requirements are essential considerations when selecting either active or passive insulin pen SENDs, focussing on the additional needs of the temporary or transient workforce.
  18. Content Article
    More than two years after the Hughes Report was published, the UK Government has yet to provide a clear timeline for implementing a compensation scheme for the thousands of patients harmed by pelvic mesh and valproate. Published in February 2024 by the Patient Safety Commissioner for England, Professor Henrietta Hughes, the report examined options for redress for patients and families affected by these interventions. In this letter to the Prime Minister Keir Starmer, Professor Hughes urges him to ensure that a clear timetable is set and that financial redress is delivered without further delay.
  19. Content Article
    The Medicines and Healthcare products Regulatory Agency (MHRA) is inviting members of the public to provide their views on proposals for the approach to recognising CE marked medical devices in Great Britain. The MHRA welcomes the views from anyone who will be impacted by the proposals, including medical device manufacturers and distributors, trade associations, regulatory experts, approved bodies, healthcare professionals including clinicians and those involved in procurement of medical devices, devolved administrations and patient representative organisations. MHRA are inviting views on the following proposals: Extending the current transitional arrangements for devices that comply with the Medical Device Directive (MDD) to align with the EU timelines for devices to transition from MDD to EU Medical Devices Regulation. Indefinitely recognising devices that comply with the EU Medical Device Regulation (EU MDR) and EU in vitro Diagnostic Medical Devices Regulation (EU IVDR). Introduction of an international reliance route for devices classified higher in Great Britain than in the EU. This consultation closes at 11:59pm on 10 April 2026.
  20. Content Article
    Although insulin is used daily by millions of people around the world, it is considered a high-alert drug that has been associated with more medication errors than any other medication type or class. One challenge in administering insulin is that it is measured in “units” rather than milliliters (mL), requiring unique insulin syringes with the appropriate markings. Using a syringe intended for other medication to administer insulin could lead to an overdose of up to 100 times the intended dose. To identify contributing factors and develop strategies to reduce the risk of wrong dose errors related to the use or selection of syringes, researchers focused on event reports submitted by Pennsylvania facilities in the USA over the last decade that involved U-100 insulin and syringe-related issues resulting in dosing errors or near misses. Some of the key takeaways of their detailed study—which encompassed 74 reports from 47 facilities—are that over a third of errors that reached the patient were serious events and among reports specifying syringe volume, 73.8% involved a 1-mL syringe. Contributing factors included using the wrong syringe due to improper syringe storage, similar cap color or packaging, and provider’s lack of experience. Variability in hospital insulin protocols and formularies was also observed. The authors encourage facilities to evaluate and standardize their existing insulin protocols and formularies, and implement the suggested safety strategies for preventing syringe-related insulin dose errors.
  21. News Article
    A mum-of-three left in "constant, disabling pain" after an operation says women like her should not suffer in silence. Kerry Watson, 40, uses a walking stick and takes more than 100 tablets a week to deal with the agony caused by having a vaginal mesh implant to treat a prolapsed bladder in 2014. She is 1 of 25 women who have received compensation following operations carried out by a single surgeon in north Wales. The Betsi Cadwaladr University Health Board has apologised, admitting Kerry was not fully informed of the risks and side effects or of the alternatives to the mesh surgery. Kerry, from Kinmel Bay in Conwy county, said she woke up from the operation in pain which never went away, and got gradually worse. "It felt like I had a needle through my back, and it was coming out my front, and I couldn't twist past it," she said. "Your mental health is affected. You get brain fog, you're tired, you're fatigued. You can't function as a woman – and that's every day for 10 years," she said. "I'm a mum to three boys, but I felt like I was failing. As they were getting older, I couldn't even stand to watch them play football. The NHS announced it would pause using vaginal mesh in 2018 following patient safety concerns. Read full story Source: BBC News, 27 February 2026
  22. Content Article
    The Medicines and Healthcare products Regulatory Agency (MHRA) regulates medicines, medical devices and blood components for transfusion in the UK. This roundup provides a summary of their latest safety advice for medicines and medical device users. It includes details of medicine recalls, medical device field safety notices and details of how to report drug reactions and device incidents. This month's Safety Roundup includes: Drug Safety Update on Falsified Mounjaro KwikPen 15mg pre-filled pens Drug Safety Update on Semaglutide (Wegovy, Ozempic and Rybelsus): risk of Non-arteritic Anterior Ischemic Optic Neuropathy (NAION) Drug Safety Update on IXCHIQ Chikungunya vaccine: updates to restrictions of use following safety review Drug Safety Update on GLP-1 receptor agonists and dual GLP-1/GIP receptor agonists: strengthened warnings on acute pancreatitis, including necrotising and fatal cases Letters, medicines recalls and device notifications sent to healthcare professionals in February 2026  News and guidance on: UKHSA and MHRA issue reminder to healthcare professionals regarding use of non-sterile alcohol-free wipes Updates to instructions for use (IFUs) of Cardinal Health Chest Drainage Units & accessories Respiratory tube connector: risk of patient harm due to manufacturing defect Medical devices regulations: targeted consultation on the indefinite recognition of CE marked devices
  23. News Article
    UK patients could be among the first in the world to benefit from breakthrough medical devices, as clinical investigations reach their highest level on record in 2025. New figures from the Medicines and Healthcare products Regulatory Agency (MHRA) show a 17 per cent rise in approved clinical investigations compared with last year, as companies increasingly choose Great Britain to test cutting-edge health technologies. At the same time, the MHRA is rolling out new measures to back innovation and remove barriers for smaller companies, including a fee waiver pilot, early market access to promising devices, and enhanced support for high-impact technologies. AI-powered medical devices are also surging, including tools that scan medical images to spot disease earlier, guide treatment decisions and personalise care. New studies include digital tools that adjust treatment in real time, such as an app to help people with chronic obstructive pulmonary disease manage their condition, while giving clinicians better information to personalise treatment. Studies in advanced eye technologies have also risen, as companies test new ways to protect vision and restore sight. Read full article. Source: Medicines and Healthcare products Regulatory Agency, 19 February 2026
  24. News Article
    As we mark two years since the publication of the Hughes Report, a Westminster Hall debate was held that gave a stern warning to government – do not cruelly give women false compensation hope. Following the debate, Wes Streeting was interviewed by ITV, where he made a statement saying he intends to be the Health Secretary who finally delivers on the Hughes Report. For many women, this was the first time in years they felt a glimmer of real political commitment. Words alone are not enough – but they matter. They set expectations. And we will hold him to that promise. MPs from across the House once again highlighted the cost of delay and called for an urgent full, fair compensation scheme, proper psychological support for affected families and an end to the the systemic failings that allowed these women’s health scandals to unfold. The Hughes Report in 2024 followed on from the Fist Do No Harm report in 2020 – both of which called for non adversarial financial for women harmed by pelvic mesh, including rectopexy mesh, sodium valproate, and Primodos. Sadly, Primodos families have been dropped from compensation scheme talks. Read full story Source: Sling the Mesh, 12 February 2026
  25. Content Article
    This is a brief summary of a Westminster Hall debate in the House of Commons on the 11 February 2026 concerning the second 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: Two years on from its publication, the Government have still not published an official response to the Hughes report. No redress scheme has been implemented and no timeline has been announced. It was suggested that a compensation scheme as recommended by The Hughes report would save the excessive costs of litigation that the NHS would have to pay out—money that could then be used for the treatment of patients. Although the Patient Safety Commissioner’s remit extends to England only, this is a UK-wide issue. The report said that the Department of Health and Social Care should engage with the devolved governments on where and how the two-stage redress approach should apply across the UK. The Northern Ireland Department of Health has stated that its approach will be informed by the final position of the UK Government, but their final position has not been determined. Responding on behalf of the Government to this debate was Karin Smyth MP, the Minster for Secondary Care. She noted that: The Government remains committed to working alongside the Patient Safety Commissioner for England and her team to better support patients and ensure that steps are taken to prevent similar harm in the future, both in this area and across the wider patient safety landscape. The Government have to consider options for financial redress collectively, with input from a number of Departments. The Government are committed to setting out our response at the earliest credible opportunity while ensuring that it is both robust and deliverable.
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