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Found 335 results
  1. News Article
    Ministers are considering putting a cancer warning on all breast implants a decade after women had ‘a cocktail of chemicals intended for mattresses’ put into their bodies. Experts and MPs are calling for tighter regulation and better support after the PIP faulty breast implant scandal left women – including breast cancer survivors – ‘suffering and dying in silence’. Health minister Maria Caulfield pledged on Monday to consider a so-called ‘black-box’ warning on breast implant packaging like in the US. It came during a debate on the faulty breast implant scandal which saw 47,000 British women given ‘ticking time bomb’ implants made by Poly Implant Prothese (PIP). PIP implants were outlawed in 2010 when they were revealed to be made with substandard silicone and up to six times more likely to rupture. Victims of the scandal have reported a wide range of serious side-effects as experts say they are linked to a raft of health problems including the new form of cancer. Anyone with a PIP implant can officially apply to have it removed by the NHS, but Labour MP Fleur Anderson said: ‘Many applications have been turned down, leaving women with a ticking time bomb in their body. ‘They are unable to afford to get their implants removed privately, are worried that they will rupture further, and are experiencing clear side-effects.’ The MHRA acknowledged the risk of cancer for all breast implants but said PIP implants are not at greater risk than any other. Read full story Source Mail Online, 31 January 2023
  2. News Article
    Artificial hip and knee joints that have to be removed after failing early are to be examined routinely to save the NHS £200million a year – and reduce unnecessary pain for patients in future. Less than 1 in 100 removed implants are examined to see why they failed, so surgeons don’t learn what went wrong or pick up on potential scandals. Consultant orthopaedic surgeon Raghavendra Sidaginamale, of North Tees and Hartlepool NHS Trust, said: "Most removed implants are put in the bin. A wealth of information goes down the drain." Now the NHS is setting up an Implants Analysis Service, enabling hospitals to send them off to be analysed for signs of unusual wear or chemical degradation. Each year, 15,000 hip and knee replacements are replaced. If this happens within ten years, they are deemed to have failed early. Jason Wilson, of the IAS, said they are ‘like a black box flight recorder in a plane’, adding: "They hold a wealth of information we can learn from." Read full story Source: Daily Mail, 29 January 2023
  3. News Article
    More than 100,000 people with type 1 diabetes in England are to be offered an artificial pancreas, which experts believe could become the “holy grail” for managing the disease. The groundbreaking device uses an algorithm to determine the amount of insulin that should be administered and reads blood sugar levels to keep them steady. A world-first trial on the NHS found it was more effective at managing diabetes than current devices and required far less input from patients. The device is now set to be rolled out across the NHS in England after it won approval from the National Institute for Health and Care Excellence (NICE). Prof Partha Kar, national specialty adviser for diabetes at NHS England, said: “This technology has been proven to give the best control for managing type 1 diabetes and should make things like amputations, blindness, and kidney problems possibly a thing of the past.” Read full story Source: The Guardian, 10 January 2023
  4. News Article
    A hospital is investigating how a pair of metal surgical forceps were left inside a patient after they had been stitched up after abdominal surgery. Worcestershire Acute Hospitals NHS trust has apologised unreservedly and said the incident at Redditch’s Alexandra hospital was “exceptionally rare”. The medical blunder only became apparent after a seven-hour abdominal procedure last month, according to BBC Midlands, when the forceps were reported to be missing. The worst fears of medics were confirmed when the missing 15cm arterial clamp was found by an X-ray while the patient was still under anaesthetic. The surgical instrument could not be immediately removed and the patient was moved to intensive care overnight before another operation was performed the next day to retrieve the clamp. It is understood the trust’s investigation will look at whether the required double-checking of all instruments was conducted before the patient was stitched up after surgery. It will also examine the end of operation signing-out process, which is supposed to ensure such errors do not happen. Read full story Source: The Guardian, 23 December 2022
  5. News Article
    The reform of the UK’s Medical Device regulation offers a golden opportunity to drive innovation and growth in the UK’s Life Science sector while ensuring patient safety remains at the heart of the regulatory approach. But there is an urgent need for action to ensure we do not lose this opportunity. Senior members of the Life Sciences Council, Will Quince MP, Minister of State at the Department of Health and Social Care, Dr June Raine, CEO, Medicines and Healthcare products Regulatory Agency (MHRA) and Peter Ellingworth, CEO, Association of British HealthTech Industries (ABHI) have today announced a new agreement to accelerate the delivery of the future UK HealthTech regulatory system. Acknowledging the Chancellor’s priorities of stability and growth supported by regulatory reforms, and the importance of the success of the system to UK patients and the Life Science sector, they have formed an advisory group on behalf of the Life Sciences Council to drive the delivery of the ambition of the Life Sciences Vision to have a best in class regulatory system. The advisory group has agreed that aligned proposals will be published on three priority areas: international recognition routes for innovation system capacity. Read full press release Source; Gov.UK, 16 December 2022
  6. News Article
    Women who underwent mesh surgery were not given accurate information before the life-altering procedure, a case review has found. The study also said poor communication between patients and doctors led, in some cases, to mistrust. Medical notes were often misleading or did not detail the surgery that had occurred or its outcomes. The review spent two years looking at the cases of 18 women who received transvaginal mesh implants. It has now called for a comprehensive register to be set up to keep track of women who have had operations to remove mesh in Scotland, abroad and privately. The Transvaginal Mesh Case Record Review by Glasgow Caledonian University makes a series of other recommendations, including: Better aftercare following surgery Clear language so patients understand exactly what surgery is going to achieve. Read full story Source: BBC News, 21 June 2023
  7. News Article
    A soft robotic device that moves through the body like a worm could make bowel cancer screening much more comfortable by reducing pain and and discomfort, according to the scientists developing it. Researchers at Imperial College London said they have created a new type endoscope that is soft, flexible, and capable of extending and curling on its own inside the body. Around 900,000 colonoscopies – which involves an endoscope being passed through the bottom – are performed every year in the UK, the majority of which are for screenings for bowel cancer. The procedure is invasive and more than 75% of patients develop significant pain, according to Nisha Patel, a consultant gastroenterologist at Imperial College Healthcare NHS Trust in London, who is running clinical trials with the device. She said: “We know patients experience either discomfort or pain during the procedure and this affects uptake of further procedures and patient experience. The experts are also hoping that compared to current endoscopes, which requires specialist skills, their self-propelling robotic version will be easier to use and could, in future, be deployed in GP surgeries or outpatient clinics. Read full story Source: The Independent, 18 June 2023
  8. News Article
    AN Ayrshire MSP has called for an end to surgical mesh being implanted in hernia patients in Scotland. A Freedom of Information request by Labour's Katy Clark has revealed that one in 12 of all hernia patients in NHS Ayrshire and Arran who have been implanted with surgical mesh since 2015 have been readmitted to hospital due to complications. And the West of Scotland MSP has backed a petition by constituents calling for the suspension of the use of surgical mesh until an independent review has been carried out. It follows the recent public health scandal over the pain and suffering endured by many women across Scotland implanted with transvaginal mesh. It took years of tireless campaigning by affected women before the Scottish Government took action, last year creating a mesh removal reimbursement scheme. Read full story Source: Irvine Times, 9 June 2023
  9. News Article
    A ground-breaking, mandatory national medical device outcome registry has been launched to collate detailed information on all procedures involving high-risk (Class III/IIb) devices, including pacemakers, hip joint replacements and breast implants. Led by NHS England’s Outcomes and Registries programme, and developed in partnership with NEC Software Solutions (NEC), the Medical Device Outcome Registry platform (MDOR) will capture data on over two million medical device procedures and more than 10 million unique devices used on patients each year across the NHS and independent healthcare sector, addressing recommendations from the Cumberlege review and Patterson inquiry. Collecting key details of the procedure, the clinicians involved and devices used, the registry will include clinical observational and patient outcome data, providing a single, comprehensive repository to improve patient safety and outcomes. Scott Pryde, delivery director for the Outcomes and Registries Programme, NHS England, said: “Millions of people receive high-risk medical devices and implants every year. Whereas most procedures are a complete success, when things go wrong it can result in serious harm for the patients affected. The Medical Device Outcome Registry will be responsive to concerns about the safety and outcomes of patients who receive high-risk medical devices, such as implants, and will use the data to actively detect, predict and prevent patient harm, and improve outcomes for patients". “The result will be in a step change in improving patient safety in these procedures, providing clinicians and healthcare teams with secure access to critical information they can use to inform clinical decisions and improve the experience of patients before, during and after their procedures.” Read full story Source: Clinical Services Journal, 31 May 2023
  10. News Article
    A brand-new genetic research resource, known as a ‘biobank’, will be piloted by the Medicines and Healthcare products Regulatory Agency (MHRA) in a joint venture with Genomics England to better understand how a patient’s genetic makeup can impact the safety of their medicines. The Yellow Card biobank, which will contain genetic data and patient samples, will operate alongside the MHRA’s Yellow Card reporting site for suspected side effects and adverse incidents involving medicines and medical devices. It forms part of a long-term vision for more personalised medicine approaches, as scientists will use the repository of genetic information in the biobank to determine whether a side effect from a medicine was caused by a specific genetic trait. This will in turn enable doctors to target prescriptions using rapid screening tests, so patients across the UK will receive the safest medication for them, based on their genetic makeup. Adverse Drug Reactions (ADRs), or side effects, continue to be a significant burden on the NHS and account for one in 16 hospital admissions. Understanding the underlying mechanism of an adverse reaction would support the development of pharmacogenetic testing strategies, such as the screening tests enabled through the information provided by the Yellow Card biobank. These strategies would in turn provide the opportunity to prevent rather than react to adverse drug reactions. The biobank pilot will officially begin on 1 June 2023 with participant recruitment commencing later this year, on 1 September. Read full story Source: MHRA, 25 May 2023
  11. News Article
    Trusts must start submitting full data on surgeries which include a high-risk medical device into a new national registry by December as part of a national push to increase accountability and safety around surgery. NHS England is launching the new mandatory medical device outcome registry this month. The new registry was created in response to Baroness Cumberlege’s “First Do No Harm” review and initial data submissions about surgeries that include a high-risk medical device will begin in June. Details of the launch arrangements have been set out in a draft letter which HSJ has seen and understands is set to be sent to medical directors and other system leaders imminently. Relevant procedures include those, for example, involving either a Class III device, like an implant, or a Class IIb therapeutic device, such as drug-eluting balloon catheter. Read full story (paywalled) Source: HSJ, 16 May 2023
  12. News Article
    Hundreds of children who manage their type 2 diabetes by regularly pricking their finger can now monitor their glucose levels using automated sensors, the government’s expert health advisers have announced. Doctors and nurses in England, Wales and Northern Ireland have been advised they can now give glucose monitoring devices to children with type 2 diabetes who currently use the more intrusive finger-prick testing methods, the National Institute for Health and Care Excellence (NICE) said on Thursday. The health minister Helen Whately said that offering children the devices would relieve a burden and “empower them to manage their condition more easily”. She said: “Type 2 diabetes is increasingly being diagnosed in children, many of whom face the constant stress of needing to monitor their blood glucose levels by finger-prick testing – often multiple times a day – just to stay healthy and avoid complications.” The NICE committee that reached the decision heard that children found finger pricking to check their glucose levels several times a day “burdensome”, “tiring” and “stressful”. The devices, which give a continuous stream of real-time information on a smartphone, have already been recommended for children with type 1 diabetes, a less aggressive form of the disease. Read full story Source: The Guardian, 11 May 2023
  13. News Article
    Patients, or carers of patients, who carry Emerade 300 or 500 microgram adrenaline auto-injector pens should immediately contact their GP to obtain a prescription for, and be supplied with two auto-injectors of a different brand. Pharmacists and pharmacy teams can also help with obtaining new prescriptions and dispensing of new pens. Patients or carers should then return all Emerade 300 and 500 micrograms auto-injectors to their local pharmacy. Patients should only return their Emerade pens when they have received a replacement from their pharmacy which will be an alternative brand - either EpiPen or Jext. They should ensure they know how to use the replacement pen, as each brand of pen works differently. Patients should ask their doctor, pharmacist, or nurse for help with this. Instructions are included inside the pack, along with details of the manufacturer’s website that also provides information, including videos, on how to use a new EpiPen or Jext adrenaline pen. This precautionary recall is because some 300 microgram and 500 microgram Emerade auto-injector pens may rarely fail to activate if they are dropped, meaning a dose of adrenaline would not be delivered. Premature activation has also been detected in some of the 300 microgram and 500 microgram pens after they have been dropped, meaning that a dose of adrenaline is delivered too early. The activation failure and premature activation was detected during a design assessment conducted by the manufacturer and therefore means there is a potential for some 300 microgram and 500 microgram Emerade pens to fail during use after having been dropped. Read MHRA Press Release. 9 May 2023
  14. News Article
    The rising prevalence of hernia disorders, technological advancements in hernia repair devices, growing adoption of mesh in hernia repair surgeries, rising geriatric population and high adoption of hernia repair surgical procedures are some of the key factors driving the global hernia repair devices market, reports Yahoo News. Leading players operating in the global hernia repair devices market are adopting both organic and inorganic growth strategies such as collaborations, acquisitions, and new product launches to garner a higher market share. For instance: In February 2023, TELA Bio, Inc announced the launch of two additional configurations of its OviTex LPR device. The new configurations are 15 x 20 cm and 15 x 25 cm ellipses designed for ventral and incisional hernias. In December 2022, Deep Blue Medical Advances announced that they have received an additional 510(k) clearance from the US FDA for its T-Line Hernia Mesh for the subway technique in open hernia surgery. However, in a recent Tweet, campaign group Sling the Mesh voice their concerns:
  15. News Article
    Patients who have had older types of hip replacement may be at greater risk of heart damage than previously thought, researchers have said, because of cobalt leaching out of so-called metal-on-metal implants. Tens of thousands of UK patients were fitted with these devices during the 2000s, when they were marketed as a solution for young, active patients who needed a hip replacement that would last a lifetime. The issue is that tiny metal ions made up of cobalt and chromium are thought to break off from the implants and leak into the blood, and there are fears this could cause muscle, bone and organ damage. Surgeons began to voice concerns about the implants in 2008, and in 2012 the Medicines and Healthcare products Regulatory Agency (MHRA) issued guidance recommending annual blood or MRI checks for patients who had received them. Since then, mounting evidence has suggested that such individuals may be at greater risk of heart disease. Read full story Source: The Guardian, 26 April 2023
  16. News Article
    A woman whose daughter took her own life after being left in chronic pain caused by giving birth has spoken of her family's heartbreak. Sara Baines, 34, from Flintshire, died in September last year leaving her family devastated. This week an inquest heard Sara suffered from chronic pain due to complications resulting from surgical mesh that was implanted after she gave birth in 2011. Her mother, Alison Sharrock, says Sara was failed by the health system on multiple occasions. Sara bled heavily whilst giving birth and suffered a second-degree tear. She had to have two surgeries to repair the tear, neither of which was completely successful. Sara found herself completely incontinent, at the age of 24. In 2015, Sara was advised to have mesh fitted. Alison said: "We were told the mesh was a 'quick-fix'. It felt like the answer to all her problems and she was thrilled. She had surgery but afterwards, though the incontinence improved, she had terrible abdominal pain." The pain became so severe that Sara was offered a hysterectomy, aged 28. Afterwards, the pain only intensified, and her general health deteriorated. She suffered water infections, skin rashes, gum disease and unexplained pain. Unable to eat or sleep, she became depressed and anxious. "She felt nobody was really listening to her. She felt she was gaslighted and fobbed off," said Alison. Kath Sansom, founder of Sling The Mesh which has almost 10,000 members suffering irreversible pan and complications from surgical mesh implants, said: "Our hearts go out to Sara's family. Nine out of 10 people in our support group were not told any risks of having a plastic mesh permanently implanted." Read full story Source: Mail Online, 24 March 2023 Further reading on the hub: Doctors’ shocking comments reveal institutional misogyny towards women harmed by pelvic mesh “There’s no problem with the mesh”: A personal account of the struggle to get vaginal mesh removal surgery ‘Mesh removal surgery is a postcode lottery’ - patients harmed by surgical mesh need accessible, consistent treatment
  17. Content Article
    For years, it has been known that pulse oximeters may present racial biases, with studies dating back as far as the late 1980s suggesting a flaw in how the device measures oxygen in people with darker skin tones. This article looks at how the Covid-19 pandemic finally brought the problem to the forefront of medicine. Ashraf Fawzy, Assistant Professor of Medicine at the Johns Hopkins University School of Medicine, talks about how he and other doctors noticed a trend in pulse oximeter readings not matching up to patient symptoms, and how they went on to research the issue, publishing their results in a study in May 2022. Their study found that Black and Hispanic patients were 29% and 23% less likely than white patients, respectively, to have pulse oximeters recognise their eligibility for more aggressive Covid-19 treatment. The resulting delay in care for patients with darker skin tones is likely to have a significant impact on patient outcomes.
  18. Content Article
    The MHRA is aware of cases of increased intraocular pressure in patients recently implanted with EyeCee One preloaded and EyeCee One Crystal preloaded intraocular lenses (IOLs), which are manufactured by NIDEK and distributed by Bausch + Lomb. The root cause has not been identified and further investigations are ongoing with the manufacturer.  Due to the potential risks for patient safety, you should stop using these IOLs and quarantine remaining stock immediately pending the results of further investigations. Additional communications will be issued shortly advising clinicians and affected patients on the next steps.
  19. Content Article
    This blog by Carl Heneghan, Professor of Evidence-based Medicine at the University of Oxford and Clinical Epidemiologist Tom Jefferson, looks at safety and regulatory issues associated with Essure, a permanent contraceptive implant. Essure anchors inside the fallopian tubes and reacts with the tissues, causing them to become inflamed and scarred. The resulting scar tissue then blocks the tubes off, intending to prevent fertilisation. The devices are about 4cm long and contain a stainless steel, nickel and titanium inner coil and an expanding outer coil containing iron, chromium and tin. Essure has been shown to cause allergic reactions, lifelong inflammatory reactions and internal injuries. The authors examine how Essure came to be approved for use in the USA, the UK and the rest of Europe, highlighting regulatory failings and conflicts of interest with the medical tech industry. They also highlight how pressure from women harmed by Essure resulted in its use being banned in several countries. The blog then describes ongoing efforts to access UK data on reports of adverse events due to Essure that are held by the Medicines and Healthcare Regulations Agency (MHRA). Freedom of Information requests for this data have been denied.
  20. Content Article
    The National Institute for Clinical Excellence (NICE) updated their guidance for continuous glucose monitoring (CGM) in 2022, recommending that CGM be available to all people living with type 1 diabetes. This review in the journal Diabetes, Obesity and Metabolism aimed to compare regulatory standards for CGM in the UK and Europe, with those applied in the USA by the Food and Drug Administration (FDA) and in Australia by the Australian Therapeutic Goods Administration (TGA). It describes the processes in place and highlights that the criteria applied in the UK for assessing accuracy do not translate into real-life performance. The authors offer a framework to evaluate CGM accuracy studies critically and conclude that FDA- and TGA-approved indications match the available clinical data, whereas CE marking indications applied in the EU can have discrepancies. They argue that the UK can bolster regulation, but that this need to be balanced to ensure that innovation and timely access to technology for people with type 1 diabetes are not hindered.
  21. Content Article
    Mesh implantation for hernia repair has become standard practice for the majority of hernia repairs. Mesh-based hernia repairs have been shown to be a durable solution, however, postoperative complications, such as chronic postoperative pain, remain a concern. To date, there have been few investigations into the inflammatory response to mesh. In this study, Fadaee et al. present their experience in diagnosing and treating a subpopulation of patients who require mesh removal due to a possible mesh implant illness. They found predisposing factors include female sex, history of autoimmune disorder, and multiple medical and environmental allergies and sensitivities. Presenting symptoms included spontaneous rashes, erythema and oedema over the area of implant, arthralgia, headaches and chronic fatigue. Long-term follow up after mesh removal confirmed resolution of symptoms after mesh removal. The authors hope this provides greater attention to patients who present with vague, non-specific but debilitating symptoms after mesh implantation.
  22. Content Article
    Medical technology, or ‘medtech’, is of vital importance to the UK health and care system. The Government's first Medical technology strategy outlines how it will ensure the health and social care system can reliably access safe, effective and innovative medical technologies that support the continued delivery of high-quality care, outstanding patient safety and excellent patient outcomes in a way that makes the best use of taxpayer money.
  23. Content Article
    In this report, Dr Henrietta Hughes, Patient Safety Commissioner for England, reflects on her first 100 days in this new role. She sets out what she has heard, what she has done and her priorities for the year ahead.
  24. Content Article
    This video shows CCTV footage of Bob being treated for a cardiac arrest on his way to watch a football match at the AMEX stadium in Brighton. The video could be used as a training tool to show how to start cardiopulmonary resuscitation (CPR) and how to use an automated external defibrillator (AED). The video highlights what the AED is analysing and then shocking, showing what happened to the electrical rhythm as it converts ventricular fibrillation (VF) to sinus rhythm. It also features the voice prompts from the cardiac arrest. Bob survived with a completely normal quality of life and was the seventh person (out of seven) at the AMEX stadium to have a cardiac arrest and survive with a normal quality of life. The video shows great team work and human factors interactions between the St John Ambulance volunteers who saved Bob's life, the stewarding team and paramedics.
  25. Content Article
    This Health and Social Care Select Committee report reviews the progress that the UK Government has made in implementing the recommendations of the Independent Medicines and Medical Devices Safety Review, sometimes referred to as the Cumberlege Review. You can read Patient Safety Learning’s reflections on this report here.
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