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Showing results for tags 'Medical device / equipment'.
Found 217 results
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News Article
Australian women win landmark vaginal mesh class action against Johnson & Johnson
Patient Safety Learning posted a news article in News
Hundreds of women left in debilitating pain by faulty transvaginal mesh devices have won a landmark case against multinational giant Johnson & Johnson. The Australian class action against companies owned by Johnson & Johnson was won on behalf of 1,350 women who had mesh and tape products implanted to treat pelvic prolapse or stress urinary incontinence, both common complications of childbirth. The devices all but ruined the lives of many. Women have been left in severe, debilitating and chronic pain, and often unable to have intercourse. The vast majority also suffered a significant psychological toll. The mesh eroded internally in many cases, has caused infections, multiple complications, and is near impossible to completely remove, Australia’s federal court has heard. The devices were not properly tested for safety before being allowed on to the Australian market, though Johnson & Johnson and the associated companies clearly knew the potential for serious complications. The companies were accused of launching a “tidal wave” of aggressive promotion at doctors, marketing the devices as cheap, simple to insert, and a relatively risk-free way to boost profits. All the while, their potential dangers were minimised, downplayed or ignored, both in communications to doctors and patients, the plaintiffs alleged. When patients complained of pain, they were frequently disbelieved. Read full story Source: The Guardian, 21 November 2019 -
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 Although some content of past alerts is outdated, some of the actions from previously issued alerts continue to be relevant and remain valid beyond the timescales of the original alert.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 ArticleV60 and V60 Plus devices are designed for in-hospital use. They can be used to provide average volume assured pressure support (AVAPS), pressure-controlled ventilation (PCV), continuous positive airway pressure (CPAP), and positive pressure ventilation (PPV) treatment to patients in critical care and high dependency unit (HDU) settings. The safety concern identified relates to a number of electrical faults in the devices, which can result in an unexpected shutdown, leading to loss of ventilation. There are two ways in which this shutdown can occur: The first will sound a warning to alert the user that the machine is shutting down. This will let the user know they need to switch to an alternative source of ventilation. There is a risk that the patient will be unventilated while this second source of ventilation is prepared. The second failure mode will cause the device to shut down with no warning alarm. If a ventilator fails in use and does not alarm, the patient will be unventilated until the clinician becomes aware and responds. If unnoticed by healthcare professionals, ventilation failure can have a severe health impact on patients. This can include hypoxia, which can result in long-term cognitive impairment to the patient. There is also a risk of death if a patient is without ventilation for a sustained period of time Philips has no permanent solution to correct this issue and as such we are issuing this alert to help hospitals manage the risk.
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Content Article
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In this blog Patient Safety Learning’s Chief Executive, Helen Hughes, discusses the connection between procurement, supply chains and patient safety, ahead of an upcoming Safety for All Campaign webinar on this topic. -
Content ArticleThis article in the Journal of Diabetes Science and Technology reviews the literature from various geopolitical regions and describes how a substantial number of patients with diabetes improperly discard their sharps. Data support the need to develop multifaceted and innovative approaches to reduce the risks associated with improper disposal of medical sharps into local communities.
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Content Article
Prevention of Future Deaths report – Van Tuyen (22 February 2022)
Mark Hughes posted an article in Coroner reports
Van Thai Tuyen was admitted to the Royal London Hospital on 1 August 2021 for treatment of a stroke. A nasogastric tube was inserted to administer medication and food, due to Mr Tuyen being assessed as having an unsafe swallow. Despite an x-ray showing that the nasogastric tube had been misplaced into his right lung the tube was used to administer approximately 300ml of liquid feed. This caused the cavitating necrotising pneumonia from which he died.- Posted
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Content ArticleWhere a new or under-recognised risk identified through the NHS England's review of patient safety events doesn’t meet the criteria for a National Patient Safety Alert, NHS England look to work with partner organisations, who may be better placed to take action to address the issue. To highlight this work and show the importance of recording patient safety events, they publish regular case studies. These case studies show the direct action taken in response to patient safety events recorded by organisations, staff and the public, and how their actions support the NHS to protect patients from harm.
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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 ArticleIn 2002 the UK Department of Health and the Design Council jointly commissioned a scoping study to deliver ideas and practical recommendations for a design approach to reduce the risk of medical error and improve patient safety across the National Health Service (NHS). The research was undertaken by the Engineering Design Centre at the University of Cambridge, the Robens Institute for Health Ergonomics at the University of Surrey and the Helen Hamlyn Research Centre at the Royal College of Art. The research team employed diverse methods to gather evidence from literature, key stakeholders, and experts from within healthcare and other safety-critical industries in order to ascertain how the design of systems—equipment and other physical artefacts, working practices and information—could contribute to patient safety. Despite the multiplicity of activities and methodologies employed, what emerged from the research was a very consistent picture. This convergence pointed to the need to better understand the healthcare system, including the users of that system, as the context into which specific design solutions must be delivered. Without that broader understanding there can be no certainty that any single design will contribute to reducing medical error and the consequential cost thereof.
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Content ArticleThe need for radical investment and reform of diagnostic services was recognised at the time the NHS Long Term Plan was published in 2019. This report, commissioned by NHS England at that time, alongside a review of adult screening services, was nearing publication before the COVID-19 pandemic struck. However, while the recommendations made pre-pandemic still stand, additional actions will be needed to deliver safe, high quality diagnostic services in an endemic phase of the disease and to support the recovery of diagnostic services.
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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 ArticleTCC-CASEMIX has created a unique infrastructure to provide total traceability of medical device performance. This infrastructure is supported by The Association of British HealthTech Industries [ABHI]. We refer to it as an 'Open Registry Infrastructure' for medical devices. It is 'open', because unlike existing clinically focused registries, which are 'closed', we enable wide searches across the registries connected into it. It is 'open' because registries will 'declare the content' (I don't know what I don't know, so how can I search for what I don't know?) Access to this infrastructure is through a Data Access Portal which is being configured for the specific needs of each stakeholder group. We are seeking interest from patient groups who would like to join an Advisory Board to help specify how data should be presented to patients in a way that is relevant and meaningful. Our vision is to link this portal into an enhanced pre-operative assessment process, and to transform patient informed consent.
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Content Article
WireSafe® is an innovative solution designed to prevent retained guidewires during central venous catheter (CVC) insertion. Retained guidewires are never events that require urgent removal if accidentally left in. They occur in about 1 in 300,000 procedures. We interviewed Maryanne, who developed the WireSafe®, on the innovation, the human factor considerations in designing it and the difficulties she faced getting a new product into the NHS. -
Content Article
Prevention of Future Deaths report – Mary Land
Mark Hughes posted an article in Coroner reports
Mary Land was a patient on an Acute Respiratory care unit 'surge' ward at Pinderfield Hospital, being treated for COVID pneumonia against a backdrop of comorbidities. On 5 February 2021 she was discovered in an unresponsive condition, with the tube connecting her facemask to a BIPAP ventilator detached at the connection point to the mask. In his report, the Coroner raised patient safety concerns relating to how the tubes of her Philips Respironics AF 541 mask became detached from the ventilator. -
Content ArticleTwo new factsheets from the Centers for Disease Control and Prevention (CDC) are intended to help healthcare workers, managers and purchase agents ensure the safe handling and disposal of sharps during the US's COVID-19 mass vaccination effort.
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Content ArticleSince Claire Griffiths underwent a rectopexy operation she has suffered almost constant, debilitating pain. In this article, published by Yahoo Style, she describes her experience and the devastating impact on her life. Also quoted in the article is Sling the Mesh’s founder Kath Samson, who says:"Nobody really knows how many are suffering because the NHS and the regulatory body the MHRA has not kept a database of how many women have had the operation and how many are suffering."
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Content Article
Kath Sansom, is a journalist and campaigner who, following a pelvic mesh implant, was left in intense pain and subsequently founded the Sling the Mesh campaign. In this powerful opinion piece, Kath highlights the lack of transparency and reporting around financial conflicts of interest in UK healthcare, and why this poses a serious threat to patient safety. Drawing on legislation that was introduced in the US and recommendations from the Cumberlege Review, Kath calls for urgent action to be taken to prevent patients from suffering harm in the future. -
Content Article
Prevention of Future Deaths report – Ann Geraghty
Patient Safety Learning posted an article in Coroner reports
Ann Geraghty was being treated for heart failure at Good Hope Hospital and subsequently died following a cardiac arrest. In their report, the Coroner raised patient safety concerns relating to two periods of ventricular standstill (this is a rare issue when the heart stops beating and stands perfectly still), which were missed due to a combination of policy, staffing, workplace and equipment issues. -
Content ArticleIn this article, published by the Harm & Evidence Research Collaborative, Sharon Hartles examines the UK Government’s response in relation to the implementation of the recommendations set out in the Independent Medicines and Medical Devices Safety Review, First Do No Harm report. She explores how the Government’s response has impacted on those harmed by the side effects of Primodos, Mesh and Sodium Valproate.
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Content ArticleKishorkumar Patel and Kofi Aning were both treated at the Nightingale Hospital in London in April 2021. In both cases there was a serious incident in which the wrong filter was found to have been used within the breathing systems of their intensive care ventilator.
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Content ArticleThe Government has recently published it's response to the recommendations set out in the First Do No Harm report of the Independent Medicines and Medical Devices Safety Review, chaired by Julia Cumberlege. One of the recommendations was for manufacturers to publish details of payments they make to teaching hospitals, research institutions, and individual clinicians, similar to the American Physician Sunshine Payment Act. The Government has said it is “exploring options to expand and reinforce current industry schemes, including making reporting mandatory through legislation.” In this editorial, Sonia McLeod looks at the gaps that exist in the UK's current system for disclosure and highlights some important considerations when setting up a new system or process if it is to be effective. Read the full article Related reading: A year on from the Cumberlege Review: Initial reflections on the Government’s response (Patient Safety Learning, 23 July 2021) Independent Report of the Patient Reference Group – response to the report of the Independent Medicines and Medical Devices Safety Review (21 July 2021) No such thing as a free lunch – why recording conflicts of interests must be mandatory
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Content Article
Jacqui Shaw, 54, underwent surgery for pelvic organ prolapse during which surgical mesh was inserted. She assumed the operation would improve her quality of life. Instead, her days are now blighted by agonising pain and despair. In this video, published on the Mail+, Jacqui bravely shares her story, and her uncertainty for the future. She describes how she found the support group Sling the Mesh, and subsequently many others who were also experiencing devastating consequences of surgical mesh. -
Content ArticleHealthcare Safety Investigation Branch (HSIB) looked into the suitability of equipment and technology used within maternity departments to conduct continuous fetal heart rate monitoring during labour and birth. Although there are multiple methods used to monitor fetal heart rate, the main equipment used is a continuous fetal heart rate monitoring is the cardiotocograph (CTG) machine. There has been some common safety issues identified with availability of equipment and functionality, staff understanding of the equipment and its purpose and an inability to understand and interpret the fetal heart rate. HSIB conducted an investigation into how cardiograph machines are used, any problems staff experienced while using them and problems that staff using them and how the equipment was purchased experienced, and how staff are trained and assessed as being competent to use them.
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Content Article
Needlestick injuries – making the point for safety
Becky T posted an article in Staff safety
An article outlining the significance of needlestick injuries - their risks to healthcare workers, their cost, and the importance of prevention.
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