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Found 337 results
  1. Content Article
    This Healthcare Safety Investigation Branch (HSIB) report charts the emerging patient safety risks that can come with the introduction of ‘smart’ infusion pump technology into hospitals. Smart infusion pumps are the latest generation of programmable devices that administer medication. They are seen as a way of improving safety as the smart functionality aims to prevent underdoses or overdoses – they are equipped with features such as alerts or alarms to help detect problems. The investigation was launched after one NHS Trust recorded three incidents where a smart infusion pump delivered an overdose of fentanyl, a powerful pain medication. The patients weren’t harmed as it was swiftly picked up, however it emphasised the new risks that come with introducing new technology and the potential for serious medication errors. The investigation focused on the barriers to implementing the technology effectively across the NHS, rather than on the technology itself.
  2. Content Article
    Laura Anne Jones MS (Member of the Senedd) tabled a formal written question concerning the implementation of the findings of the Cumberlege Review in Wales. This is the formal response from the Minister for Health and Social Services, Vaughan Gething MS.
  3. Content Article
    Across the world, people are suffering from life-altering and serious chronic pain conditions caused by surgical mesh complications.Mesh Down Under are a New Zealand based campaign group whose mission is to:raise awareness amongst New Zealanders about the complications that are not rare with the use of surgical mesh. provide information to enable anyone considering having surgical mesh surgery, particularly women having pelvic floor or bladder sling repairs, to be fully informed before consenting to this surgery.shout out to our health professionals and government bodies so that patient stories are no longer 'news to them' but an acknowledged public health issue that needs to be addressed.highlight the importance of reporting adverse events associated with medical devices.Follow the link below to find out more.
  4. Content Article
    This blog sets out a timeline of the major landmarks for transvaginal surgical mesh since its first approval in 1996.
  5. News Article
    As part of wide-reaching work being carried out to review the methods and processes the National Institute for Health and Care Excellence (NICE) uses to develop guidance, the organisation has launched a public consultation on proposals for changing how it selects the topics it will develop guidance on. Covering guidance on medicines, medical devices and diagnostics, the proposals clarify the criteria which would see a device or diagnostic selected for NICE guidance development. In particular, these include where costs and impacts are expected to be significantly cost-incurring or cost-saving – or there is uncertainty around the likely cost or the impact it would have on the healthcare system. With regard to medicines, the new proposals would confirm the commitment made in the 2019 Voluntary Scheme for Branded Medicines Pricing and Access that pledged NICE would appraise all new active substances and significant licence extensions for existing medicines, except where there was a clear rationale not to do so. Similarly, all new or significantly modified interventional procedures that would protect patient safety will be selected if they are available to the NHS or independent sector, or set to be used outside of formal research. This proposed approach would move away from the 15 criteria currently used to select topics for evaluation by NICE’s Centre for Health Technology Evaluation and provide a clearer and simpler process. Helen Knight, Programme Director for Technology Appraisals and Highly Specialised Technologies at NICE, said: “Topic selection plays an important role in the development of NICE guidance and is designed to ensure that the guidance we produce is on topics that support healthcare professionals and others to provide care of the best possible quality. “These proposals will ensure we can continue to meet these ambitions at a time of unprecedented change in the healthcare system.” The consultation on the proposals runs until 19 November. This will be followed by a separate public consultation on the case for change to its processes in February and March 2021. Read full story Source: NHE, 12 October 2020
  6. Content Article
    Advances in 3D printing, also called additive manufacturing, are capturing attention in the healthcare field because of their potential to improve treatment for certain medical conditions. A radiologist, for instance, might create an exact replica of a patient’s spine to help plan a surgery; a dentist could scan a broken tooth to make a crown that fits precisely into the patient’s mouth. In both instances, the doctors can use 3D printing to make products that specifically match a patient’s anatomy. The technology is not limited to planning surgeries or producing customised dental restorations such as crowns; 3D printing has enabled the production of customized prosthetic limbs, cranial implants, or orthopedic implants such as hips and knees. At the same time, its potential to change the manufacturing of medical products—particularly high-risk devices such as implants—could affect patient safety, creating new challenges for Food and Drug Administration (FDA) oversight. When 3D printing is used to manufacture a medical product at the point of care, oversight responsibility can become less clear. It is not yet apparent how the agency should adapt its regulatory requirements to ensure that these 3D-printed products are safe and effective for their intended use. The FDA does not directly regulate the practice of medicine, which is overseen primarily by state medical boards. Rather, the agency’s jurisdiction covers medical products. In some clinical scenarios where 3D printing might be used, such as the printing of an anatomical model that is used to plan surgery, or perhaps one day the printing of human tissue for transplantation, the distinction between product and practice is not always easy to discern. This issue brief explains how medical 3D printing is used in health care, how FDA regulates the products that are made, and what regulatory questions the agency faces.
  7. Community Post
    We should all strive to keep antibiotics working for our NHS surgeons and future generations, by decreasing antibiotic use in medicine. It is mums themselves who could dramatically decrease antibiotic use, in the only medical specialty where this is possible - in obstetrics - by keeping skin intact; by being informed of the 10cm diameter that 'Aniball' and 'Epi-no Delphine Plus' birth facilitating devices, the mechanical version of Antenatal Perineal Massage, achieve by skin expansion (much like by 'earlobe skin expanders') prior to birth, for back of baby's head. This enables a normal birth for many more babies by shortening birth, with no cutting (episiotomies) or tearing, and much fewer Caesarean sections, as each Caesarean section requires antibiotics to be injected into mum, to kill any bacteria, which might have invaded a skin cell, from being implanted with that skin cell, deep into the wall of the uterus, by the surgeon's knife. There are around 750,000 births in the UK alone and three-quarters of mums are damaged during birth and at risk of developing infection; so a dramatic decrease in antibiotic use is possible. Empowering mums with knowledge; that both the skin and the coats of the pelvic floor muscles, which form the floor of the lower tummy, can be stretched painlessly, in preparation of birth, from the 26th week of pregnancy, so a gentler, kinder birth for both baby and mum becomes possible by decreasing risky obstetric interventions. Muscle can be stretched to 3 times its original length, if stretched painlessly over 6 or more occasions, and still retains its ability to recoil back, contracting to its original length. So there is no damage to mum. Baby's delicate head is not used to achieve this 'birth canal widening', because Antenatal Perineal Massage or Aniball or Epi-no Delphine Plus have already achieved this prior to the start of birth. In birth this stretching is rushed within the last 2 hours of birth, with risk of avulsion of pelvic floor muscle fibres from the pubic bone and risk of skin tearing or the need for episiotomy. The overlying skin will likewise stretch without tearing if done over 6 or more occasions. The maximal opening in the outlet or lower part of the pelvis is 10cm diameter, so 10cm diameter is the goal of the birth aiding devices and 'Antenatal Perineal Massage' or 'Birth Canal Widening' - opening doors for baby maximally. The mother reviews on 'Aniball' and 'Epi-no Delphine Plus' are impressive: Wanda Klaman, a first time mum, gives birth at nearly 42 weeks to a 4.4kg baby, with no need for episiotomy or forceps; Sophie of London, avoids episiotomy, when forceps are used to aid delivery for her baby who lays across her tummy - transverse lay, because the skin at this opening is so stretchy thanks to the birth facilitating devices. Cochrane Collaborate Report on Antenatal Massage https://pubmed.ncbi.nlm.nih.gov/23633325/ https://www.dailymail.co.uk/news/article-7450045/Fears-infections-pandemic-grow-NINETEEN-new-superbugs-discovered-UK.html https://www.mirror.co.uk/news/uk-news/mistakes-maternity-wards-setting-nhs-22702909
  8. Content Article
    Insight into medical device and system failure and the teachings of Henry Petroski, a professor of civil engineering at Duke University, who wrote about failure analysis and design theory.
  9. Content Article
    This was a debate from the Scottish Parliament on the 8 September 2020 concerning the recommendations in the recently published First Do No Harm report by the Independent Medicines and Medical Devices Safety Review, chaired by Baroness Cumberlege (also known as the Cumberlege Review). The debate centred on a motion put forward by Jeane Freeman MSP, Cabinet Secretary for Health and Sport, which read as follows: That the Parliament welcomes the recommendations made by Baroness Cumberlege in her report on the independent medicines and medical devices safety review; acknowledges the Scottish Government's apology to women and families affected by Primodos, sodium valproate and transvaginal mesh; welcomes the Scottish Government’s commitment to establish a Patient Safety Commissioner, and notes the actions taken by the Scottish Government to offer improved services for women who have suffered complications as a result of transvaginal mesh.
  10. Content Article
    To get the safest—and not just the cheapest—devices, the NHS needs to start taking ergonomics seriously, experts say. In March 2020, the UK government commissioned non-medical manufacturers, including Dyson and Renault, to produce ventilators for the excess number of patients expected to have respiratory failure as a result of COVID-19. Because the machines would be used by non-specialist clinicians during the pandemic, NHS England commissioned guidance1 on ergonomic (also known as human factors) design of the ventilators, aimed at achieving “optimum human safety and performance.” However, the commissioning of the ventilator guidance remains an exception rather than the rule. There are, however, signs that the NHS is starting to take human factors seriously—and COVID-19 is a driver.
  11. News Article
    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/
  12. Content Article
    On Wednesday 8 July 2020 the Independent Medicines and Medical Devices Safety Review published its report First Do No Harm, examining how the healthcare system in England responds to reports about the harmful side effects from medicines and medical devices. Chaired by Baroness Julia Cumberlege, the review focused on looking at what happened in relation to three medical interventions: hormone pregnancy tests, sodium valproate and pelvic mesh implants. In this blog Patient Safety Learning consider the reports findings in more detail, highlighting the key patient safety themes running through this, which are also found in many other patient safety scandals in the last twenty years. It also looks at what needs to change to prevent these issues recurring and asks whether NHS leaders stick with the current ways of working, make a few improvements, or take this opportunity for transformational change.
  13. Content Article
    The government-commissioned review, First Do No Harm, into why mesh implants and other treatments were allowed to harm hundreds of women said the failings were “caused and compounded by failings in the health system itself”. HSJ's Health Check podcast considers why it is being buried by government. 
  14. News Article
    The NHS have duped thousands of women into believing the most common incontinence mesh operation is safe, by not adding loss of sex life into its risk figures, campaigners say. The move keeps figures low so surgeons can reassure women that it is a safe day case operation. The discovery is buried in a report from five years ago, and when questioned on it, the MHRA, tasked with making sure implants are safe for patients, passed the buck and blamed the report authors. The revelation comes after a debate in Westminster, where health minister Jackie Doyle Price said there was not enough evidence to suspend the plastic implants and quoted a risk of 1-3%. However, those figures were blown out of the water just weeks before the debate in a landmark study using the NHS’s own hospital re-admission figures which show TVT mesh tape risk is at least 10%. Campaigners say even that is not a reflection of the true scale of the mesh disaster because it does not take into account women going to doctors for pain medication or those suffering in silence. Read full story Source: Cambs Times, 31 October 201t
  15. Content Article
    Out-patient Parenteral Antibiotic Therapy (OPAT) is now a routine part of care in the UK following demonstration that it is safe and effective for patients and OPAT is now being actively promoted as part of the UK government’s stewardship initiatives. NHS North Tees and Hartlepool share their experience of redesigning their OPAT services. See the attachment below for details on the project. 
  16. Content Article
    This Review was announced in the House of Commons on 21 February 2018 by Jeremy Hunt, the then Secretary of State for Health and Social Care. Its purpose is to examine how the healthcare system in England responds to reports about harmful side effects from medicines and medical devices and to consider how to respond to them more quickly and effectively in the future. The Review was asked to investigate what had happened in respect of two medications and one medical device: hormone pregnancy tests (HPTs) – tests, such as Primodos, which were withdrawn from the market in the late 1970s and which are thought to be associated with birth defects and miscarriages; sodium valproate – an effective anti-epileptic drug which causes physical malformations, autism and developmental delay in many children when it is taken by their mothers during pregnancy; and pelvic mesh implants – used in the surgical repair of pelvic organ prolapse and to manage stress urinary incontinence. Its use has been linked to crippling, life- changing, complications; and to make recommendations for the future. The Review was prompted by patient-led campaigns that have run for years and, in the cases of valproate and Primodos over decades, drawing active support from their respective All-Party Parliamentary Groups and the media. 
  17. Content Article
    Michael Seres was a husband, a father, a successful entrepreneur and many more things. Most importantly in some ways, he was a lifelong Chrohn's patient who finally succumbed to an associated cancer last weekend. His loss has hit hard those who knew and admired him and the tributes have been numerous and from both clinicians and other patients. His death is a real loss for anyone interested in promoting patient engagement, and the involvement of patients in safer medical practise.
  18. Content Article
    The Medical Device Safety Officer role was created on 20 March 2014 following the publication of an NHS England Patient Safety Alert that aimed to help healthcare providers increase the quality and frequency of incident reporting for medication errors and medical devices problems. The alert called on large healthcare provider organisations across both public and independent  sectors, along with healthcare commissioners, to identify named responsible persons in both medication and medical device safety roles. A new National Network was set up to support Medical Device Safety Officers through improved communication and feedback on reported safety issues, monthly webinars, online forums, conferences and workshops. An editorial board was established to provide expert and strategic clinical support for the Medical Device Safety Officers and the National Network. This handbook provides practical information and resources to support those who have been designated the Medical Device Safety Officer in their organisation. It is particularly relevant to people new in post or as a quick reference for established staff.
  19. Content Article
    Unknown to its hypertension specialists, a major teaching hospital changed the cuffs on its sphygmomanometers from manufacturer-validated to a uniform washable alternative, in line with ‘Health and Safety’ concerns surrounding potential cross-contamination between patients. When clinic doctors suspected serious under-reading with the new cuffs, a systematic comparison was undertaken in 54 patients using two UM-101 sphygmomanometers: one using the original, manufacturer-supplied cuff and the other with the washable replacement. The study confirmed an average under-reading of 8±10/5±5 mm Hg using the washable cuff, and a third of patients with poorly controlled hypertension were considered normotensive, after using this cuff. The UM-101 sphygmomanometers have now been re-fitted with the original cuffs. Sphygmomanometer cuffs are not interchangeable between devices and a modicum of common sense should be shown to prevent changes made in the name of Health and Safety from having the opposite effect to that intended.
  20. Content Article
    Blood pressure (BP) has been measured with a cuff for over a 100 years. Recently, ‘tricorders’ and smartwatches that measure BP without a cuff using pulse transit time (PTT) have become available. These BP measurements are based on the inverse relationship between BP and PTT. PTT can be measured as the timing delay in a QRS complex on an EKG and the onset of a photoplethysmography wave, for example measured from a finger. Since these measurements are relatively more user‐friendly than conventional cuff‐based measurements they may aid in more frequent BP monitoring. Using a guidelines‐based protocol, Bard et al. investigated the accuracy and precision of two popular PTT‐based BP measuring devices: the Everlast TR10 fitness watch (Everlast, New York City, NY) and the BodiMetrics tricorder (BodiMetrics, Manhattan Beach, CA).
  21. News Article
    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
  22. Content Article
    All 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.
  23. Content Article
    Maybe your blood pressure has been creeping up over time, or you’re starting treatment for hypertension. So your doctor suggests you buy a home blood pressure monitor to help keep track between office visits. Simple enough, right? But a quick check online reveals hundreds of different models — and even a bunch of apps for your smartphone. How do you even start to sort through all that without, well, spiking your blood pressure? This article highlights six things you need to know.
  24. Content Article
    The Central Alerting System (CAS) is a web-based cascading system for issuing patient safety alerts, important public health messages and other safety critical information and guidance to the NHS and others, including independent providers of health and social care. Alerts available on the CAS website include National Patient Safety Alerts (from MHRA, NHS England and NHS Improvement and the UK Health Security Agency (UKHSA)), NHS England and NHS Improvement Estates Alerts, Chief Medical Officer (CMO) Alerts, and Department of Health & Social Care Supply Disruption alerts.
  25. News Article
    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
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