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Showing results for tags 'Medical device'.
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News Article
NHS in England to offer artificial pancreas to help manage type 1 diabetes
Patient-Safety-Learning posted a news article in News
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 -
News Article
Midlands hospital investigating forceps left inside patient after surgery
Patient Safety Learning posted a news article in News
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 -
News Article
Life Sciences Council Joint Statement on Medical Devices Regulatory Reform
Patient Safety Learning posted a news article in News
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 -
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 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 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 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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News Article
More than 10,000 patients given faulty knee replacements
Patient Safety Learning posted a news article in News
More than 10,000 patients have been given a faulty knee replacement which doubles the risk of joint failure, The Telegraph has disclosed. The implant, which has been in use since 2003, was withdrawn from the market by its manufacturer in October. The Telegraph has learnt that UK health regulator the Medicines and Healthcare products Regulatory Agency (MHRA) is now preparing to issue a field safety notice, prohibiting its use. Available across multiple NHS trusts, the implant, manufactured by Zimmer Biomet, a US firm, has been shown to fail in up to 7% of patients after ten years - twice the accepted failure rate of 3.5% set by the National Joint Registry. One study found the failure rate to be much higher at 17.6% - more than five times as high as the accepted level. This can have catastrophic consequences for patients, many of whom are elderly, as undergoing a second knee replacement operation poses a much greater risk. The knee replacement, called the Nexgen, is part of a family of Zimmer Biomet implant devices with 88 possible variants. In total, these have been given to over 183,000 people in England, Wales and Northern Ireland, and more than five million worldwide. Of these variants, three combinations have been proven to place patients at a dangerously high risk of joint failure. Read full story (paywalled) Source: The Telegraph, 5 December 2022 -
News ArticleIn September, Shine Lawyers won a $300 million settlement in two class actions over the failed mesh products by Johnson & Johnson Medical and Ethicon. However, the law firm is proposing to take up to $99.5 million from the payout in costs, just under a third of the total sum. Of 11,000 women involved in the class action, Janelle Gale is one of 200 who is not happy with Shine Lawyers' compensation proposal. Representatives of the group said there was mass confusion over what compensation they might be eligible for and how many hoops they would have to jump through to receive a payment. Despite having barely any leakage before her 2014 surgery, afterwards Janelle became heavily incontinent. She was a drag-racing champion, but that came to a halt. She said it destroyed her marriage, she couldn't have sex and she still can't work. Read more Source: ABC News, 3 December 2022
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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 ArticleAfter the US Food and Drug Administration (FDA) first warned in 2008 of serious complications associated with transvaginal mesh, thousands of lawsuits have been filed, most of which were compiled into seven federal multidistrict litigation cases against the major manufacturers. This blog by Meghann Cuniff for Forbes Advisor provides an update on the progress of these law suits. It also advises on how to file a vaginal mesh lawsuit and joining a class action lawsuit.
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Content ArticleThe APPG held their annual general meeting in Parliament. Baroness Cumberlege was re-elected as Co-Chair of the group and in light of Jeremy Hunt’s recent appointment as Chancellor of the Exchequer, Sharon Hodgson MP was elected as Co-Chair, having previously supported the Group as Vice-Chair over the last calendar year. Sharon is is an Officer of the APPG for Valproate and other Anti-Epileptic Drugs in Pregnancy and Vice-Chair of the All-Party Parliamentary Group on Surgical Mesh. The current serving Vice-Chairs were re-elected, with the addition of Baroness Ritchie also joining as Vice-Chair. The Group looked back on a year of significant activity and progress, including the appointment of Dr Henrietta Hughes as the first Patient Safety Commissioner in England, and agreed that a renewed focus on seeking the implementation of redress schemes should be a priority for the Group over the next year.
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Content ArticleAn HSIB guest blog post from Henrietta Hughes introducing her vision for her new role as Patient Safety Commissioner.
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Content ArticleInhalers are a key treatment for respiratory conditions, with approximately 60 million dispensed in England every year. However, inhalers are not always used in an optimal way, which can lead to poor disease control and avoidable deaths. Inhaler emissions account for approximately 3% of the NHS carbon footprint. The propellant used in metered dose inhalers is responsible for most of these emissions. Alternative options with a significantly lower carbon footprint exist, such as dry powder inhalers. The UK has a higher metered dose inhalers prescribing rate compared with other European countries. These countries have demonstrated that safe and effective care can still be delivered using other inhaler devices. Wyre Forest Health Partnership (WFHP) was formed from a merger of five GP practices and now comprises of six sites across Worcestershire with over 50 doctors, 200+ staff, and more than 73,000 patients. WFHP identified that, in line with the UK, they too had high prescribing rates for metered dose inhalers, and decided to act – to improve the health of their respiratory patients, while reducing their environmental impact. This case study shows what they did.
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Content Article
In this blog, Kath Sansom, founder of the Sling the Mesh campaign, unpacks the findings of a medical device performance study into polypropylene mesh published by the Emergency Care Research Institute (ECRI) in the US. The document highlights significant gaps in evidence about the risk of complications associated with polypropylene (PP) surgical mesh. -
Content ArticleWe need a public register to show if healthcare professionals are in the pay of industry – or more patients will suffer, writes Margaret McCartney following the publication of the Independent Medicines and Medical Devices Safety Review. Hospitals in England are meant to publish registers of interest of staff – but a 2016 study shows that only a minority give the details they should. A publicly accessible digital register, updated at least annually and compelled by the regulator, would create transparency and get rid of the huge amount of work that campaigners have had to do to untangle where conflicts lie. Declarations alone can’t sort the problems of conflicted medicine. But a public register would allow us to know whose advice isn’t independent. We will still need to be alert to the unintended consequences of a register, and research will be needed. The UK is lagging behind. Kath Sansom, a journalist who founded the Sling the Mesh campaign, told Margaret: “I had no idea that I couldn’t trust my doctor or surgeon to give the best advice. It is essential that medics declare industry funding.”
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Content ArticleThis report by the US non-profit organisation the Emergency Care Research Institute (ECRI) was commissioned by the US Food and Drug Administration (FDA) to determine the safety profile of polypropylene (PP) mesh used in a variety of surgical procedures. ECRI performed a comprehensive literature search and systematic review to identify the current state of knowledge about how patients' bodies respond to PP mesh.
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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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Content ArticleIn this blog, Luke Yamaguchi describes his experience of hernia mesh surgery and the impact the procedure had on his health. He tells his story of having laparoscopic hernia repair using polypropylene (PP) mesh, which left him with severe chronic pain. After nine years, he underwent mesh removal surgery. Alongside his story, he describes the risks associated with surgical mesh and the use of PP as a material, highlights the lack of research about its side-effects and draws attention to the role of industry in promoting the use of mesh.
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Content ArticleThis article outlines how the first trials relating to harm caused by the LifeCell Strattice biologic patch will proceed. The Strattice patch is a form of surgical mesh used to treat hernias, but unlike other polypropylene mesh devices, it is composed of pig skin preserved in a solution that chemically links together proteins in the tissue. Patients involved in the US litigation complain that they suffered painful injuries from the Strattice patch. They claim that the manufacturer knew it had problems following multiple reports from patients, but failed to act to stop its use. The US Food and Drug Administration (FDA) received at least 450 adverse event reports on Strattice from September 1990 until September 2020. Among those reports were six patient deaths and 340 patient injuries, and many patients have had to undergo mesh removal.
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Content ArticleVaginal mesh implants were introduced in the late 1990s as a routine treatment for stress urinary incontinence and pelvic organ prolapse, common complications following childbirth. However, these flexible plastic scaffolds have led to life-altering complications for many women including nerve damage, chronic pain, and several reported deaths. This blog outlines the story of vaginal mesh, from the 1990s to the present day.
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Content ArticleThe Medicines and Healthcare products Regulatory Agency (MHRA) is reviewing its approach to engagement with healthcare professionals to improve the safety of medicines and medical devices. It wants to ensure that healthcare professionals are receiving actionable information and guidance on safe use of medicines and medical devices that they can take into their working practice, providing timely advice to patients. The MHRA wants to hear from you to enable them to transform how they communicate with you and how they work together with you for the common goal of greater patient safety. The consultation closes 18 January 2023.
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Content ArticleThis article* is an update from Dr Henrietta Hughes, Patient Safety Commissioner for England.
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Content ArticleSpecialist centres for those affected by mesh implants, as recommended by the Independent Medicines and Medical Devices Safety Review, became operational formally in April 2021. HSJ analyses how they performed in their first year.
