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Showing results for tags 'Medical device'.
Found 333 results
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Content ArticleContinuous glucose monitors (CGM) are devices that offer an alternative to finger stick blood glucose testing in adults and children with any type of diabetes. This practice guide in the BMJ offers guidance on CGM for primary care providers and aims to reduce uncertainty and improve prescribing rates of CGM.
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Content Article
In this opinion piece, Kath Sansom, founder of Sling the Mesh, looks at why an audit of pelvic mesh outcomes due to be published in April 2023 has again failed to capture the true extent of the harm caused by the procedure. She outlines why the approach taken by the Government and NHS Digital was flawed and why it is so important to understand both the proportion of women who have experienced harm as a result of the procedure, and the nature of their injuries and side effects.- Posted
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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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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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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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News Article
The FDA is still letting doctors implant untested devices into our bodies
Patient Safety Learning posted a news article in News
When Kathleen Yaremchuk, Chair of the department of otorhinolaryngology (ear, nose and throat) at Henry Ford Hospital in Detroit, began getting calls about mysterious cases of respiratory distress, she launched a study to figure out what was going on. All these patients, it turned out, had a small device implanted in the top of their spines to relieve pain. The object, used to hold a protein that stimulates bone growth, was cleared for sale by the Food and Drug Administration in 2003 without clinical testing in humans. When Yaremchuk and her colleagues reviewed the records of all 260 patients implanted with the device at Henry Ford Hospital between 2004 and 2009, they found that a significant number developed airway obstruction, trouble swallowing and respiratory failure, in some cases leading to death. The neck implant is just one of the products associated over the past decade with 1.7 million injuries and more than 80,000 deaths. A searing global investigation last year by the International Consortium of Investigative Journalists places much of the blame on significant failings in the FDA’s oversight. The agency’s laissez faire attitude has resulted in artificial hips that cause cobalt poisoning (which can damage the heart and brain); surgical mesh that cuts through flesh and organs, causing infections and haemorrhage; and defibrillators that repeatedly shock patients beyond human endurance. Safety problems have led to recalls of devices implanted in hundreds of thousands of people. And the devices can be difficult or impossible to remove if they go bad No wonder many patient advocates cheered when the FDA announced in November that it planned to make “transformative” changes in the way more than 80% of medical devices are cleared for sale in the United States. But the promised transformation is mere window dressing. Two key loopholes still exist, allowing most products to be approved for sale without clinical trials in humans. Read full story (paywalled) Source: The Washington Post, 4 January 2019 -
News Article
Improving patient safety in the NHS with point-of-care scanning
Clive Flashman posted a news article in News
A new report has highlighted how point-of-care scanning in the NHS can help to improve patient safety, saving the NHS millions of pounds. Six NHS hospital trusts which implemented regular point-of-care scanning have ensured complete traceability of healthcare items to help improve patient safety while securing millions of pounds of savings and releasing thousands of hours of clinical time, a new report reveals. ‘A scan of the benefits: the Scan4Safety evidence report’ details the results at hospital trusts that took part in a national two-year programme, known as Scan4Safety, to investigate the benefits of point-of-care barcode scanning in the NHS. Full article here We wonder if @Richard Price might like to post more about what the impact of Scan4safety has been at University Hospitals Plymouth. Perhaps here: https://www.pslhub.org/learn/commissioning-service-provision-and-innovation-in-health-and-care/digital-health-and-care-service-provision/other-health-and-care-software/ -
News Article
Machine 'could quadruple' heart and lung transplants
Patient Safety Learning posted a news article in News
The number of heart and lung transplants could quadruple thanks to a "reanimation" machine used in a pioneering operation, a hospital says. The device, developed at Royal Papworth Hospital in Cambridge, managed to pump oxygenated blood into both organs in a world-first procedure. The machine can revitalise deteriorating organs allowing "donation after circulatory death" (DCD). Hospital surgeon Pedro Catarino said it was like "recharging the batteries". "It is reanimation and then it replenishes the energy stores of the heart, what we call reconditioning, which allows it be transplanted," he said. "We think it could at least double and perhaps quadruple the number of [heart and lungs] available for transplant." He said it was desperately needed, adding: "Patients die on the waiting list every day." Read full story Source: BBC News, 23 March 2020 -
Content Article
“There’s no problem with the mesh”: A personal account of the struggle to get vaginal mesh removal surgery
Anonymous posted an article in Women's health
In this blog, a woman who has suffered from severe pain and complications for 17 years due to transvaginal mesh shares her experience. She talks about how the device has changed her life, how her symptoms have been repeatedly dismissed by surgeons, and the variation she has witnessed between different specialist mesh centres.- Posted
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Content ArticlePatient safety alerts are issued to providers of NHS care to support them to take specific actions to keep patients safe. Although some content of past alerts is outdated, some of the actions from previously issued alerts continue to be relevant and remain valid beyond the timescales of the original alert. Over 140 alerts issued up to November 2019 (including ‘notices’ or ‘rapid response reports’) were recently clinically reviewed to identify which actions within those alerts remain valid and should be considered as ‘enduring standards’. The review covered alerts issued by the NHS England and NHS Improvement National Patient Safety Team and its predecessor organisation, the National Patient Safety Agency (NPSA). The review also summarised other content from the alerts identified as general principles that can be applied more widely to inform wider ongoing safety improvement. The key elements from the review are highlighted. The pages do not set out any new actions for organisations to implement, but act as an aid to support providers to confirm that ‘enduring standards’ from previously completed alerts have been embedded locally, and that the general principles are considered within ongoing patient safety improvement.
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Content ArticleIn this article, the first in a series of two on pelvic mesh and its medicolegal challenges, Dr Ivan Ramos-Galvez, Consultant in Pain Medicine and expert witness, explores the uses of pelvic mesh and the complications that can arise. The second in the series focuses on the physical and psychological effects pelvic mesh implants can have on claimants.
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Content ArticleThis briefing examines the results of a US study which showed that 80% of patients that have an infection from a cardiac implant are not treated according to clinical practice guidelines, increasing their chances of death from infection. When patients with implantable cardiac devices have an infection, current guidelines state that these devices should be removed, however, this did not happen for the majority of the 1,065,549 Medicare patients included in the study that had a cardiac implant infection between 2006 and 2019.
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Content ArticleThe efficacy of injection therapy in diabetes depends on correct injection technique. The aim of the Insulin Injection Technique Questionnaire was to understand how people with diabetes inject, so that guidance can be tailored towards improving injection technique. This article in the Journal of Diabetes analyses the results of the 2008-2009 survey and identifies areas where improvements have been made since the last survey, and areas where there is still progress to be made.
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Content ArticleIn this episode of the Institute of Economic Affairs (IEA) Podcast, IEA Head of Political Economy Dr Kristian Niemietz discusses the findings of the Independent Medicines and Medical Devices Safety Review, and how the healthcare system in England responds to reports about harmful side effects from medicines and medical devices. Kristian speaks with Simon Whale, panel member and communications lead for the Independent Medicines and Medical Devices Safety Review and Dr Sonia Macleod, lead researcher, Independent Medicines and Medical Devices Safety Review. They discuss how the NHS, and other health bodies, could improve their services to address poor care and prevent harm.
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Content ArticleMany devices in current use were marketed before the US Food and Drug Administration (FDA) began regulating devices in 1976. Thus, manufacturers of these devices were not required to demonstrate safety and effectiveness, which presents both clinical and ethical problem for patients, especially for women, as some of the most dangerous devices—such as implanted contraceptive devices— are used only in women. This article from Madris Kinard and Rita F. Redberg investigates whether and to what extent devices for women receive less rigorous scrutiny than devices for men. This article also suggests how the FDA Center for Devices and Radiological Health could more effectively ensure safety and effectiveness of devices that were marketed prior to 1976.
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Content ArticleThis blog on the tech website Mashable outlines the key points of a recent international consensus statement on open-source automated insulin delivery. It discusses the need for a consensus statement, the impact of this technology on the lives of people with diabetes and the importance of the statement in paving the way for further user-driven technologies and innovations in healthcare.
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Content ArticleThe Medicines and Healthcare products Regulatory Agency (MHRA) share their Board meetings and public sessions. Follow the link to see previous Board agenda and Board papers and recordings of the sessions.
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Content ArticleThis best practice guideline for healthcare professionals covers optimum injection technique for people with diabetes taking injectable medications. It is an update to the original Injection Technique Matters guideline published in 2009.
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Content ArticleThis guide for people who inject insulin or GLP-1 to treat diabetes includes information on: how to correctly inject insulin where to inject to ensure insulin and GLP-1 medication enter the body correctly how to avoid ‘Lipos’ how to store medication correctly how to dispose of needles safely.
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Content ArticleThis checklist is for people who inject insulin or GLP-1 medication to treat their diabetes. It details the steps patients should take to ensure they inject their medication correctly and explains the impact of failing to take certain steps - such as moving injection sites and changing needles - on blood glucose control.
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Content Article
For World Diabetes Day, Lotty Tizzard, Patient Safety Learning's Content and Engagement Manager, takes a look at the benefits of closed-loop insulin delivery, how patients have literally led on its development, and patient safety issues associated with artificial pancreas systems. -
Content ArticleIn this article, Dr Ivan Ramos-Galvez, Consultant in Pain Medicine at the Royal Berkshire Hospital, discusses the physical and psychological issues that can arise following surgery for pelvic mesh implants. Dr Ramoz-Galvez highlights that around a third of reported complications are systemic symptoms such as runny nose, muscle pain, brain fog and lethargy, which may be the result of a chronic inflammatory state within the body. Their link to pelvic mesh implants is suggested by the fact that many women report that these symptoms resolve after their implant is removed. He also discusses the wide-ranging impact of pelvic mesh side effects for women who experience them, highlighting that the consequences are not only physical, but also psychological, social and financial. He calls for the medical profession to recognise this and develop treatments that cover all aspects of pelvic mesh complications.
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Content ArticleColette Longstaffe, a registered nurse working in NHS Supply Chain in the Clinical and Product Assurance Team (CaPA), discusses how medical device design can impact on usability and patient safety, and the importance of embedding human factor principles into product specifications for the NHS procurement frameworks.
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Content ArticleThis is an Early Day Motion tabled in the House of Commons on the 21st October 2021, which notes disappointment with the UK Government’s response to the Independent Medicines and Medical Devices Safety Review. The motion calls on the Government to reconsider its response and to implement all nine recommendations in their entirety, and to ensure patient safety remains paramount in any changes to regulatory approval frameworks.
