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Showing results for tags 'Medical device'.
Found 335 results
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News Article
Misplaced tube contributed to first UK child Covid death, coroner rules
Patient Safety Learning posted a news article in News
A misplaced medical tube contributed to the death of the first child in the UK to die after contracting Covid, a coroner has found. Ismail Mohamed Abdulwahab, 13, of Brixton, south London, died of acute respiratory distress syndrome, caused by Covid-19 pneumonia, on 30 March 2020, three days after testing positive for coronavirus. He had a cardiac arrest before he died. Ismail’s death prompted widespread alarm about the potentially lethal impact of Covid on children. Hours before Ismail died, an endotracheal tube (ET) used to help patients breathe was found to be in the wrong position. A consultant in paediatric intensive care decided to leave it and monitor him. Giving his judgment on Thursday, senior coroner Andrew Harris said: “I am satisfied that he [Ismail] would not have died when he did were it not for the tube misplacement.” On Wednesday, the inquest at London Inner South London coroner’s court heard evidence from Dr Tushar Vince, a consultant in paediatric intensive care at King’s College hospital who treated Ismail on 29 March after he had been intubated. Asked by Harris if it would be reasonable to put the positioning of the ET on the death certificate as one of the causes, Dr Vince said: “I think it would be reasonable to consider it, yes.” She said: “I was so focused on the lungs I just didn’t see how high this tube was and I’m so sorry that I didn’t see it.” Read full story Source: The Guardian, 2 March 2023 -
News Article
The mesh in my body is a 'ticking time bomb'
Patient Safety Learning posted a news article in News
Sam Hindle has 23cm of polypropylene mesh in her body and lives in constant fear that it will become unstable and cause irreversible damage. "You are in your own Battle Royale, strapped to a time bomb, and thinking when is it going to go off," she told the BBC. Sam, 46, is one of hundreds of women in Scotland who have suffered life-changing symptoms since they had a transvaginal mesh implant. After years of campaigning by the women, the Scottish government has promised it will cover the costs of mesh removal at private clinics in the UK and US. But Sam has been waiting more than two years just for a referral to the Complex Mesh Surgical Service in Glasgow to start the process. The Scottish government announced last year that it had signed a contract to allow NHS patients to visit a US expert for mesh removal surgery The contract with Gynaecologic and Reconstructive Surgery of Missouri, where Dr Dionysios Veronikis operates, follows a similar contract agreed with Spire Healthcare in Bristol. The cost of each removal procedure is estimated to be £16,000 to £23,000. But in order to access such treatment, women have to be assessed by the national service in Glasgow. Women like Sam say there are waiting years to just get referred for assessment. With further delays for appointments and then waits for surgery. Read full story Source: BBC News, 2 March 2023 -
News Article
Woman died after breathing tube put in food pipe
Patient Safety Learning posted a news article in News
A mother-of-one died after a breathing tube was put into her food pipe, despite staff raising concerns it was inserted incorrectly, an inquest heard. Emma Currell, 32, had just received dialysis and was heading home to Hatfield, Hertfordshire, in an ambulance when she had a seizure. An anaesthetic team was called to sedate her as her tongue had swelled and she was bleeding from the mouth. Dr Sabu Syed, who was a trainee anaesthetist, told the hearing: "I used suction to remove blood and I was able to push the tongue to the side and got a partial view." She said she believed she inserted the tube into the trachea - the windpipe - and had asked her senior colleague Dr Prasun Mukherjee to check the position of the tube. "Dr Mukherjee was busy doing other tasks," she added. Technician Nicholas Healey said he flagged his concerns when there was no carbon dioxide reading on the ventilator, which was not faulty. He said that both he and Dr Syed had raised concerns about the tube being in the wrong place. The court heard the hospital had drawn up a guideline checklist for trachea procedures since Ms Currell's death and staff were due to have "no trace = wrong place" training on the warning signs of incorrect insertion. Read full story Source: BBC News, 27 February 2023 -
Content ArticleHospitals and other medical organisations are being hit by a rising number of cyberattacks; ransomware strikes on healthcare doubled annually between 2016 and 2021, according to a study published in December in the Journal of the American Medical Association. After a cyberattack, hospitals are forced to cancel procedures, reroute patients to other facilities and resort to pen-and-paper record-keeping. In this article, Wall Street Journal reporter James Rundle looks at how cyberattacks and a regulatory push are increasing the pressure on medical device manufacturers to improve the security of their products.
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News Article
Wearable fitness trackers could interfere with cardiac devices, study finds
Patient Safety Learning posted a news article in News
Wearable fitness and wellness trackers could interfere with some implanted cardiac devices such as pacemakers, according to a study. Devices such as smartwatches, smart rings and smart scales used to monitor fitness-related activities could interfere with the functioning of cardiac implantable electronic devices (CIEDs) such as pacemakers, implantable cardioverter defibrillators (ICDs), and cardiac resynchronisation therapy (CRT) devices, the study published in the Heart Rhythm journal found. Researchers found that the electrical current used in wearable smart gadgets during “bioimpedance sensing” interfered with proper functioning of some implanted cardiac devices from three leading manufacturers. Lead researcher, Dr Benjamin Sanchez Terrones, of the University of Utah. said the results did not convey any immediate or clear risks to patients who wear the trackers. However, the different levels of electrical current emitted by the wearable devices could result in pacing interruptions or unnecessary shocks to the heart. Further research was needed to determine the actual level of risk". “Our research is the first to study devices that employ bioimpedance-sensing technology as well as discover potential interference problems with CIEDs such as CRT devices. We need to test across a broader cohort of devices and in patients with these devices. Collaborative investigation between researchers and industry would be helpful for keeping patients safe,” Sanchez said. Read full story Source: The Guardian, 22 February 2023 -
Content ArticleFor 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.
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Content ArticleThe 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.
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Content ArticleMesh 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.
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Content ArticleThis 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.
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Content ArticleThe 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.
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News Article
Scientists identify a molecular culprit behind medical implant rejections
Patient Safety Learning posted a news article in News
Every year, millions of people live fuller lives because of a medical device implanted somewhere in their body - from hip joints, to teeth, to heart valves. Known as Foreign Body Response (FBR), inflammation and scarring around an implant is natural, but in some cases, it can severely damage healthy tissue and can even lead to death if the implant is not removed. FBR-related implant failure rates range widely among different medical devices, but reducing those rates has been difficult because scientists still don’t understand the underlying biology that causes FBR. Now, researchers from the University of Maryland have discovered the molecular basis for FBR, identifying a key biological pathway that future drug therapies could target to reduce the risk of implant rejection. Shaik O. Rahaman, an associate professor in the Department of Nutrition and Food Science in the College of Agriculture and Natural Resources at UMD, and his colleagues identified a specific cellular signaling system that kicks in when the body recognises the inherent difference in stiffness between an implant and the surrounding tissue. This system detects the mismatch and triggers inflammation and scarring, which is part of the body’s normal defense system. But in FBR, the signaling system can set up a cycle of chronic inflammation and continual scar-tissue build-up that leads to implant rejection. “This is a huge leap forward in this field,” Rahaman said. “So far, the medical industry has been making biomedical implants randomly, out of materials they think might work without knowing the molecular basis of the foreign body response that leads to rejection. We don’t know why it happens, and until we do, we can’t effectively develop strategies to prevent it.” Read full story Source: College of Agriculture and Nature Resources, 19 January 2023 -
News ArticleMesh campaigners claim Scotland's Health Secretary Humza Yousaf refused to meet them to hear their concerns. Patients blame surgical mesh products for leaving them disabled and in chronic pain and want the Scottish Government to hold an independent review into the use of the products. However, followihttps://www.dailyrecord.co.uk/news/mesh-campaigners-claim-humza-yousaf-29075491ng a debate in the Scottish Parliament earlier this month, the Health Secretary denied their request. Campaigner Roseanna Clarkin, of the Scottish Global Mesh Alliance, said Yousaf has refused several requests for meetings with campaigners spanning nearly two years. Roseanna, who has been left with crippling pain after mesh was used on her umbilical hernia in 2015, has blasted him for “ignoring” those affected by mesh procedures. From the late 90s until 2018, women in Scotland were treated with polypropylene mesh implants for stress urinary incontinence and pelvic organ prolapse. In some, it caused severe pain and life-changing side effects. While the Independent Medicines and Medical Devices Safety Review called for a pause in use of vaginal mesh, the products are not banned for all procedures. The Scottish Global Mesh Alliance were behind the petition calling for an independent review which was debated at Holyrood. They want to suspend the use of all surgical mesh and fixation devices while a review is carried out. Roseanna said: “Why do they assume mesh in another part of the body would respond differently and not cause extreme pain and serious infections?” Read full story Source: Daily Record, 29 January 2023
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News Article
New strategy to boost NHS access to innovative medical technology
Patient Safety Learning posted a news article in News
Patients across the UK are set to benefit from access to safe, effective and innovative equipment and medical devices as part of the first ever medical technology (medtech) strategy published today. The blueprint for boosting NHS medtech will focus on accelerating access to innovative technologies, such as the latest generation of home dialysis machines that enable patients to manage their own health at home and in their day to day lives. It also sets out steps which need to be taken to ensure patients can access safe, effective and innovative technology through the NHS, which can help diagnose, treat and deliver care more quickly, freeing up clinician time. The NHS spends £10 billion a year on medtech including syringes, wheelchairs, Minister of State for Health Will Quince said: "The UK’s innovative spirit delivered revolutionary technology during the pandemic - from COVID tests and ventilators - and we want to harness this in promoting cutting-edge medical advancements to improve patient care. The NHS spends around £10 billion a year on medical technology and I’m looking forward to working with industry to use this as we focus on reducing hospital stays, enhancing diagnosis, preventing illness and freeing up staff time. This new medtech strategy will help build a sustainable NHS with patients at the centre so people can continue to access the right care at the right time." The key aims of the strategy are to: boost the supply of the best equipment to deliver greater resilience to health care challenges, such as pandemics, and enhance NHS performance through modernised technology which will enable faster diagnosis, treatment and ultimately discharge to free up hospital beds. encourage ambitious, innovative research to secure the UK’s position as a global science superpower and attract vital investment for the UK economy and create jobs across the country. In 2021, there were already around 60 different research programmes supporting innovative technologies, representing over £1 billion of funding. increase understanding and awareness of medtech by clinicians which will lead to more informed purchasing on new products and deliver better value for taxpayer money and better services for patients. build on the Life Sciences Vision to improve collaboration between the NHS, the National Institute for Health and Care Excellence (NICE) and the Medicines and Healthcare products Regulatory Agency (MHRA) as an innovation partner to ensure patients can access the right products safely. Read full story Source: DHSC, 3 February 2023 -
Content ArticleMedical 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.
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News ArticleMinisters 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
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Content Article
Patient Safety Commissioner: 100 Days Report (2 February 2023)
Patient Safety Learning posted an article in England
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. -
News ArticleArtificial 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
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Content ArticleThis report was produced by NHS Digital to investigate activity in the NHS in England surrounding patients who have had a procedure for the treatment of urogynaecological prolapse or stress urinary incontinence, including those where mesh, tape or their equivalents have been used. The report uses Hospital Episode Statistics (HES) data and was undertaken to help the NHS and others establish a clearer national picture of patients who have had these procedures. NHS Digital notes that these statistics are classified as experimental and should be used with caution. Experimental statistics are new official statistics undergoing evaluation.
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Content ArticleThis 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.
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News ArticleA hernia mesh lawsuit recently filed by a Washington woman alleges that a Strattice “pig skin” mesh product used during her hernia repair was defective and failed, resulting in the need for two additional revision surgeries. The Strattice Reconstructive Tissue Matrix is a hernia repair mesh introduced in 2008, which is constructed from porcine, or pig skin. The mesh is then preserved in a phosphate buffered aqueous solution. It is marketed as a cross-linked graft device, which is intended to chemically link the proteins in the tissue together. However, a growing number of lawsuits allege that the design actually increases the risk of foreign body responses, infections and other complications. Hundreds of injuries and several deaths have been linked to the Strattice hernia mesh made from pig skin, according to the lawsuit. Read full story Source: About Lawsuits.com, 20 January 2023
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Content ArticleThis 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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Content ArticleThis multinational research study in the journal Diabetes Research and Clinical Practice aimed to investigate perceived to people with diabetes adopting and maintaining open-source automated insulin delivery (AID) systems. 129 participants with type 1 diabetes from 31 countries were recruited online to elicit their perceived barriers towards the building and maintaining of an open-source AID system. The study identified a range of structural and individual-level barriers to the uptake of open-source AID, including: sourcing the necessary components lack of confidence in one's own technology knowledge and skills perceived time and energy required to build a system fear of losing healthcare provider support Some of these individual-level barriers may be overcome over time through the peer-support of the DIY online community as well as greater acceptance of open-source innovation among healthcare professionals. The findings have important implications for understanding the possible wider use of open-source diabetes technology solutions in the future. Further reading How safe are closed loop artificial pancreas systems?
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Content ArticleThis webinar was organised by the Chartered Institute of Ergonomics & Human Factors (CIEHF) in partnership with the Israel Human Factors and Ergonomics Association (IHFEA). It looks at the impact of human factors in the design and use of a range of medical devices. Experts from Israel, the Netherlands and the UK share their insights about the challenges involved and how they were overcome. In her talk, Avital Zik shares examples from her experience in leading the human factors work of the Medtronic Lung Navigation system. Lung cancer care is currently invasive, ineffective, inefficient, difficult for users and often comes too late. Avital's team is on a mission is to transform the future of lung care.
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Content Article
In this opinion piece, Kath Sansom, founder of campaign group Sling the Mesh, looks at flaws in the Government’s approach to women harmed by pelvic mesh surgery receiving financial redress. She highlights the unsuccessful case of Sarah*, who attempted to bring a clinical negligence case after suffering multiple complications as a result of pelvic mesh, to demonstrate that the national Redress Agency recommended by the Cumberlege Review is still very necessary. -
Content ArticleThis paper in the journal RSC Advances aimed to track changes in chemical bonding taking place in PP meshes on the nanoscale via mechano–chemical processes. The authors used the novel and advanced spectroscopic characterisation technique secondary electron hyperspectral imaging (SEHI) to build high resolution chemical maps. Polypropylene (PP) surgical mesh is associated with serious clinical complications when used in the pelvic floor for repair of stress urinary incontinence or support of pelvic organ prolapse. While manufacturers claim that the material is inert and non-degradable, there is a growing body of evidence that asserts PP fibres are subject to oxidative damage. Material surgically removed from patients suffering with clinical complications has shown some evidence of fibre cracking and oxidation. It has been proposed that a pathological cellular response to the surgical mesh contributes to medical complications, but the mechanisms that trigger the specific host response against the material are not well understood. The study presented key insights into the mechano–chemistry reaction of PP which can cause polymer oxidation, changes in molecular structure, crack/craze formation and the release of etched oxidised insoluble particles. SEHI, provided a new route to link the effect of localised stresses to reactions of mechano–chemistry within PP. The method of mechanical distension testing during hydrogen peroxide exposure followed SEHI image analysis could form the basis of an “early warning” system which has the ability to identify materials which are not appropriate for use as medical implants.
