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Showing results for tags 'Medical device'.
Found 333 results
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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.
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Content ArticleRecording of the Health and Social Care Committee meeting held on Tuesday 13 December 2022. Meeting started at 10.03am, ended 11.45am.
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Content ArticleThe aim of this study was to investigate the potential role of transvaginal mesh bacterial colonisation in the development of mesh-related complication (MRCs). An observational and exploratory study from Diedrich et al. was performed including 49 patients indicated for mesh removal and 20 women of whom vaginal tissue was retrieved during prolapse surgery as a reference cohort. The authors observed distinct differences in bacterial numbers and species between patients suffering from MRCs compared to a reference cohort. Bacteria were observed at the mesh-tissue interface in a biofilm. These results strongly support the potential role of bacterial mesh colonization in the development of MRCs.
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Content ArticleThis policy paper, published by the Department of Health and Social Care, provides an update on the UK Government’s progress in implementing the recommendations of the Independent Medicines and Medical Devices Safety (IMMDS) Review, sometimes referred to as the Cumberlege Review.
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Content ArticleThis short report from the National Vascular Registry (NVR) provides information on medical devices implanted during primary and revision abdominal aortic aneurysm (AAA) repair procedures during the past three years. In response to the Cumberlege review in 2020, the NVR has enabled information on implantable devices used in aortic aneurysm repairs to be entered in its datasets from July 2020. This was accompanied by the launch of the revision aortic datasets, which capture revision procedures both after open repair and endovascular stent grafting for abdominal aortic aneurysm (AAA). In total, there were 10,678 AAA procedures in the NVR performed from 1st January 2020 to 31st July 2022 and 5,383 (50%) contained information on implanted devices. This report also contains information on the: patterns for elective and non-elective procedures. type of repair for elective and non-elective surgery, for example, open procedures. type of device and components used during the procedures.
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Content ArticleVision-based patient monitoring systems (VBPMS) are assistive tools that enable staff to enhance and support patient safety in inpatient services by delivering non-contact measurement of physiological parameters such as pulse and breathing rate, some estimate of patient location, activity or behaviour data and some form of contextual video information (which may be blurred) either in real-time or through subsequent reviews. In some cases, a VBPMS can be classified as a medical device regulated by the Medicines and Healthcare products Regulatory Agency and have specific indications for use. Providers adopting the technology need to ensure users are appropriately trained.
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Content ArticleThis case study describes the project that won the 'Future-proofing Healthcare 2022' category in the Healthcare Quality Improvement Partnership's (HQIP's) Clinical Audit Heroes Awards. The Sustainable Respiratory Care Audit team at Newcastle Hospitals NHS Foundation Trust was recognised for its work improving care for individual patients while also reducing the environmental impacts of healthcare. Their nomination detailed how the project provided a structure for the audit of patients’ techniques, preferences and knowledge about inhalers, and the need for a clinical review—interventions that can reduce the carbon footprint of healthcare while improving the quality of care.
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Content ArticleThis paper in the Journal of Patient Safety and Risk Management addresses the issue of untested products being used on the basis of 'equivalent' products having undergone regulatory testing. Manufacturers of competing products often use each other’s evidence, arguing that the published evidence is generally applicable even if the original tests and trials were performed on only one specific product. In this study, the authors looked at prophylactic dressings for pressure injury prevention to demonstrate how patient safety may be compromised if study conclusions are projected onto unstudied products.
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News ArticleRussell-Cooke personal injury and clinical negligence partner Grant Incles recently represented Mrs Karen Preater in a clinical negligence case over vaginal mesh surgery performed on her at a hospital in north Wales in 2014. Wrexham County Court found in favour of Mrs Preater, and roundly dismissed allegations made by the defendant in this case, the Betsi Cadwaladr University Health Board, that the claimant had lied in the presentation of her case, as part of a Fundamental Dishonesty defence. Mrs Preater underwent vaginal mesh surgery in January 2014 - to which she had not been properly consented. The surgery itself was performed negligently and as a result she suffered a life-changing chronic pain condition. In late 2020, the defendant carried out intrusive video surveillance of Mrs Preater and trawled through her life on social media, proceeding to launch a defence of Fundamental Dishonesty pursuant to S.57 of the Criminal Justice and Courts Act 2015. The defendant alleged that the claimant was seeking to lie to the Court about her ability to work and need for care and assistance which, if found to be correct by the Court, would have meant that Mrs Preater would have lost all of her claimed compensation, and which may well have led to an application by the defendant to have her committed to prison for her alleged dishonesty. The case was fought to trial over seven days in July 2022. HHJ Howells found that Mrs Preater had not sought to deceive any party at any time and should be fully compensated for her grave suffering since being injured over eight years ago. Read full story Source: Russell-Cooke, 4 August 2022 Court judgement: 22081101.Preater v BCUHB approved judgment dated 4 August 2022.pdf
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News ArticleRegina Stepherson needed surgery for rectocele, a prolapse of the wall between the rectum and the vagina. Her surgeons said that her bladder also needed to be lifted and did so with vaginal mesh, a surgical mesh used to reinforce the bladder. Following the surgery in 2010, Stepherson, then 48. said she suffered debilitating symptoms for two years. An active woman who rode horses, Stepherson said she had constant pain, trouble walking, fevers off and on, weight loss, nausea and lethargy after the surgery. She spent days sitting on the couch, she said. In August 2012, Stepherson and her daughter saw an ad relating to vaginal mesh that mentioned 10 symptoms and said that if you had them, to call a lawyer. Vaginal mesh, used to repair and improve weakened pelvic tissues, is implanted in the vaginal wall. It was initially — in 1998 — thought to be a safe and easy solution for women suffering from stress urinary incontinence. But over time, complications were reported, including chronic inflammation, and mesh that shrinks and becomes encased in scar tissue causing pain, infection and protrusion through the vaginal wall. More than 100,000 lawsuits have been filed against makers of mesh, according to ConsumerSafety.org, making it “one of the largest mass torts in history.” Read full story Source: Washington Post, 20 January 2019
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News Article
Rollout of omicron vaccine threatened by ‘flimsy needles’
Patient Safety Learning posted a news article in News
NHS staff have warned that needles supplied with a Covid vaccine which targets the omicron strain are “not fit for purpose” and could place vaccinators and members of the public at risk. Dozens of messages shared on an NHS staff forum reveal widespread concerns about the needles supplied with the Moderna SpikeVax vaccine, which are said to bend when vaccinators pierce the top of the vial containing the Covid-19 vaccine doses. The SpikeVax bivalent vaccine was the first to target both the original and the omicron strain of the virus. It is due to play a key role in the NHS’s autumn Covid vaccination booster programme. One pharmacist said: “They [the needles] just are not fit for purpose and as such we are not using them and are using the original needles until a solution is found”. A UK Health Security Agency spokesperson confirmed the problem, stating: “We are aware that some NHSE sites are experiencing some problems with the use of the new needle and syringe being supplied for administrating the Moderna bivalent vaccine. We are in touch with the supplier about these concerns, including the facilitation of additional training support, but if necessary will also offer an alternative suitable product to avoid any disruption to the vaccination programme.” Read full story (paywalled) Source: HSJ, 15 September 2022 -
Content ArticleOn the 20 January 2023 the Health and Social Care Select Committee published a reported with reviewed 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. This paper sets out the UK Government’s response to the recommendations set out in this report. Related reading: Health and Social Care Select Committee: Follow-up on the IMMDS report and the Government’s response (20 January 2023) Patient Safety Learning: Response to the Select Committee report on the Independent Medicines and Medical Devices Safety Review (20 January 2023)
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Content ArticleIn this blog, Carl Heneghan, Professor of Evidence-based Medicine at the University of Oxford and Clinical Epidemiologist Tom Jefferson look at the long-term consequences of inadequate regulation and approval of pelvic mesh devices. They argue that regulators and health systems around the world failed to heed the early warnings, which lead to thousands of women being irreversibly harmed. They highlight that as early as 1999, a study of 34 women who had ProteGen mesh implants showed that 50% of mesh devices had eroded through the vaginal wall. Boston Scientific voluntarily recalled 20,000 devices as a result. In spite of this, the FDA continued to approve vaginal mesh devices, citing ProteGen as their predicate device.
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Content ArticleWe often hear the mesh scandal blamed on poor surgeon skill. We also hear the argument that high use mesh implanting surgeons are likely to have fewer patients suffering mesh complications, than a less experienced surgeon. However, this study published in JAMA in October 2018, based on NHS data, shows that high mesh implanting surgeons produce the same or even more mesh complications compared to low volume implanters.
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Content ArticleNew study from Farr et al. into the effect of implanting polypropylene (PP) surgical mesh into patients. More evidence is needed to show the harmful effect to patients by implanting a foreign body into them, especially into the pelvic floor.
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Content ArticleResearch paper by Toye et al. published in the Lancet on the experience of women reporting damage from vaginal mesh.
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Surgeon's News: Surgical safety update (March 2023)
Patient Safety Learning posted an article in Surgery
Surgeons' News is a magazine for surgical, dental and allied healthcare professionals. Published quarterly by the Royal College of Surgeons of Edinburgh, it features comment and opinion from leading professionals, plus reviews and reports on subjects relevant to all career levels. Two articles in this month's issue we want to highlight are the Surgical safety update (p.10) on cases from the Confidential Reporting System for Surgery (CORESS) and Safe passage (p.18) discussing the National Patient Safety Syllabus. -
Content ArticleThis Healthcare Safety Investigation Branch (HSIB) investigation aims to improve patient safety by supporting healthcare staff in the safe use of central venous catheters to access a patient’s blood supply. Specifically, it looks into the use of tunnelled haemodialysis central venous catheters, which are a type of central line. The reference event involved Joan, who had a cardiac arrest caused by an air embolus after her haemodialysis catheter was uncapped, unclamped, and left open to air. This took place during a procedure to take blood culture samples to test for a possible line infection (where bacteria or viruses enter the bloodstream). This investigation’s findings, safety recommendations and safety observations aim to prevent the future occurrence of an air embolus following uncapped and unclamped haemodialysis catheters, and to improve care for patients across the NHS.
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Patient Safety Commissioner for England update (22 March 2023)
Patient Safety Learning posted an article in England
This article* is an update from Dr Henrietta Hughes, Patient Safety Commissioner for England. -
Content ArticleTension pneumothorax can occur following chest trauma, respiratory disease and infection, or during resuscitation requiring invasive or non-invasive ventilation. It is a life-threatening condition resulting from a collapsed lung when air trapped in the pleural cavity compromises cardiopulmonary function. Immediate temporary decompression is required to prevent cardiac arrest. This is commonly done by inserting a needle and cannula, usually used for intravenous access, through the chest wall into the pleural cavity (needle thoracostomy). The needle is withdrawn, and the cannula left in place to allow the trapped air to flow out. New blood control (closed system) intravenous cannulas are increasingly used in the NHS; at least 130 trusts bought a total of three million of them in the last year. They look very similar to both traditional and standard safety cannula (with needle guard or shield) but have an extra integral septum which closes when the needle is withdrawn and stops free flow in or out of the cannula. Flow is only possible once an intravenous line or Luer-lock syringe is attached to the hub, which opens the septum. Blood control (closed system) cannulas help prevent blood spillage, exposure and contamination, when used for their intended intravenous purpose, but they cannot be used to decompress a pneumothorax without additional equipment. The main patient safety risks are: staff may select a blood control (closed system) cannula not realising its limitations for this procedure a blood control (closed system) cannula may wrongly be assumed to be functioning in a patient who is deteriorating rapidly a second needle might be introduced risking very significant damage to the lung as it reinflates.
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Content ArticleAir flowmeters attached to piped medical air outlets are primarily used to drive the administration of nebulised medication; typically for short periods to manage respiratory conditions. Most other uses of piped medical air do not require an air flowmeter. Due to the proximity of the piped medical air and oxygen outlets at the bedside, and the similarity in design of flowmeters, there is a significant risk when using air flowmeters that patients may be inadvertently connected to medical air instead of oxygen. A previous alert and additional communications have sought to minimise the use of air flowmeters by encouraging their replacement with compressor or ultrasonic nebulisers, alongside additional risk reduction methods if air flowmeters remained in use. However, despite the measures outlined above, 108 Never Events describing unintentional connection were reported in a recent three-year period ; over a third of incidents occurred in emergency departments. Consequences included respiratory arrest, cardiac arrest, collapse (requiring ITU admission and ventilation), and nine incidents of incorrect connection when responding to cardiac arrest, which will have impacted on the chance of successful resuscitation; six patients subsequently died.
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Content ArticleAll patients with prosthetic mechanical heart valves require life-long oral anticoagulation with a vitamin K antagonist (VKA), usually warfarin, as these valves predispose the patient to systemic embolism. Thrombosis of a prosthetic valve is potentially life-threatening as it can result in haemodynamically severe stenosis or regurgitation and acute heart failure. The risk depends on the type of valve, its position, and other factors. Since 1 March 2020, 14 incidents have been reported of patients with a mechanical heart valve being switched to a a low molecular weight heparin (LMWH) or a direct oral anticoagulant (DOAC); two patients were hospitalised due to valve thrombosis and/or required emergency surgery and one was admitted due to severe anaemia. The reports included cases where patients’ anticoagulation was switched from warfarin in primary and in secondary care.
