Jump to content

Search the hub

Showing results for tags 'Medical device'.

More search options

  • Search By Tags

    Start to type the tag you want to use, then select from the list.

  • Search By Author

Content Type


Forums

  • All
    • Commissioning, service provision and innovation in health and care
    • Coronavirus (COVID-19)
    • Culture
    • Improving patient safety
    • Investigations, risk management and legal issues
    • Leadership for patient safety
    • Organisations linked to patient safety (UK and beyond)
    • Patient engagement
    • Patient safety in health and care
    • Patient Safety Learning
    • Professionalising patient safety
    • Research, data and insight
    • Miscellaneous

Categories

  • Commissioning, service provision and innovation in health and care
    • Commissioning and funding patient safety
    • Digital health and care service provision
    • Health records and plans
    • Innovation programmes in health and care
    • Climate change/sustainability
  • Coronavirus (COVID-19)
    • Blogs
    • Data, research and statistics
    • Frontline insights during the pandemic
    • Good practice and useful resources
    • Guidance
    • Mental health
    • Exit strategies
    • Patient recovery
    • Questions around Government governance
  • Culture
    • Bullying and fear
    • Good practice
    • Occupational health and safety
    • Safety culture programmes
    • Second victim
    • Speak Up Guardians
    • Staff safety
    • Whistle blowing
  • Improving patient safety
    • Clinical governance and audits
    • Design for safety
    • Disasters averted/near misses
    • Equipment and facilities
    • Error traps
    • Health inequalities
    • Human factors (improving human performance in care delivery)
    • Improving systems of care
    • Implementation of improvements
    • International development and humanitarian
    • Safety stories
    • Stories from the front line
    • Workforce and resources
  • Investigations, risk management and legal issues
    • Investigations and complaints
    • Risk management and legal issues
  • Leadership for patient safety
    • Business case for patient safety
    • Boards
    • Clinical leadership
    • Exec teams
    • Inquiries
    • International reports
    • National/Governmental
    • Patient Safety Commissioner
    • Quality and safety reports
    • Techniques
    • Other
  • Organisations linked to patient safety (UK and beyond)
    • Government and ALB direction and guidance
    • International patient safety
    • Regulators and their regulations
  • Patient engagement
    • Consent and privacy
    • Harmed care patient pathways/post-incident pathways
    • How to engage for patient safety
    • Keeping patients safe
    • Patient-centred care
    • Patient Safety Partners
    • Patient stories
  • Patient safety in health and care
    • Care settings
    • Conditions
    • Diagnosis
    • High risk areas
    • Learning disabilities
    • Medication
    • Mental health
    • Men's health
    • Patient management
    • Social care
    • Transitions of care
    • Women's health
  • Patient Safety Learning
    • Patient Safety Learning campaigns
    • Patient Safety Learning documents
    • Patient Safety Standards
    • 2-minute Tuesdays
    • Patient Safety Learning Annual Conference 2019
    • Patient Safety Learning Annual Conference 2018
    • Patient Safety Learning Awards 2019
    • Patient Safety Learning Interviews
    • Patient Safety Learning webinars
  • Professionalising patient safety
    • Accreditation for patient safety
    • Competency framework
    • Medical students
    • Patient safety standards
    • Training & education
  • Research, data and insight
    • Data and insight
    • Research
  • Miscellaneous

News

  • News

Find results in...

Find results that contain...


Date Created

  • Start
    End

Last updated

  • Start
    End

Filter by number of...

Joined

  • Start

    End

Group

First name

Last name

Country

Join a private group (if appropriate)

About me

Organisation

Role

Found 335 results
  1. News Article
    Trusts must start submitting full data on surgeries which include a high-risk medical device into a new national registry by December as part of a national push to increase accountability and safety around surgery. NHS England is launching the new mandatory medical device outcome registry this month. The new registry was created in response to Baroness Cumberlege’s “First Do No Harm” review and initial data submissions about surgeries that include a high-risk medical device will begin in June. Details of the launch arrangements have been set out in a draft letter which HSJ has seen and understands is set to be sent to medical directors and other system leaders imminently. Relevant procedures include those, for example, involving either a Class III device, like an implant, or a Class IIb therapeutic device, such as drug-eluting balloon catheter. Read full story (paywalled) Source: HSJ, 16 May 2023
  2. Content Article
    Pharmaswiss Česka republika s.r.o. and distributor Bausch & Lomb UK Limited is recalling all unexpired batches of Emerade 500 micrograms and Emerade 300 micrograms adrenaline auto-injectors (also referred to as pens) from patients. This is due to an issue identified during an ISO 11608 Design Assessment study where some auto-injectors failed to deliver the product or activated prematurely. Specifically, the 1-metre free-fall (vertical orientation) pre-conditioning resulted in damage to internal components of the auto-injector, leading either to failure to deliver the product or premature activation. This damage was not visibly apparent following the pre-conditioning but was evident only on subsequent functional testing. It is unclear what impact this has on auto-injectors in clinical use, however as a precautionary measure and owing to the inability to identify this issue before the auto-injectors are used, the auto-injectors are being recalled. Healthcare professionals should inform patients, or carers of patients, who carry Emerade 300 or 500 microgram auto-injector pens to obtain a prescription for and be supplied with an alternative brand. They should then be informed to return their Emerade 300 or 500 microgram pens to their local pharmacy.
  3. News Article
    Hundreds of children who manage their type 2 diabetes by regularly pricking their finger can now monitor their glucose levels using automated sensors, the government’s expert health advisers have announced. Doctors and nurses in England, Wales and Northern Ireland have been advised they can now give glucose monitoring devices to children with type 2 diabetes who currently use the more intrusive finger-prick testing methods, the National Institute for Health and Care Excellence (NICE) said on Thursday. The health minister Helen Whately said that offering children the devices would relieve a burden and “empower them to manage their condition more easily”. She said: “Type 2 diabetes is increasingly being diagnosed in children, many of whom face the constant stress of needing to monitor their blood glucose levels by finger-prick testing – often multiple times a day – just to stay healthy and avoid complications.” The NICE committee that reached the decision heard that children found finger pricking to check their glucose levels several times a day “burdensome”, “tiring” and “stressful”. The devices, which give a continuous stream of real-time information on a smartphone, have already been recommended for children with type 1 diabetes, a less aggressive form of the disease. Read full story Source: The Guardian, 11 May 2023
  4. Content Article
    Should new draft legislation around the use of mesh in women regarding incontinence or prolapse and a new guidance on a national registry meaning every woman choosing mesh in the future must be logged on a database be extended? Haydn Wheeler argues that a broader database is in need.
  5. News Article
    Patients, or carers of patients, who carry Emerade 300 or 500 microgram adrenaline auto-injector pens should immediately contact their GP to obtain a prescription for, and be supplied with two auto-injectors of a different brand. Pharmacists and pharmacy teams can also help with obtaining new prescriptions and dispensing of new pens. Patients or carers should then return all Emerade 300 and 500 micrograms auto-injectors to their local pharmacy. Patients should only return their Emerade pens when they have received a replacement from their pharmacy which will be an alternative brand - either EpiPen or Jext. They should ensure they know how to use the replacement pen, as each brand of pen works differently. Patients should ask their doctor, pharmacist, or nurse for help with this. Instructions are included inside the pack, along with details of the manufacturer’s website that also provides information, including videos, on how to use a new EpiPen or Jext adrenaline pen. This precautionary recall is because some 300 microgram and 500 microgram Emerade auto-injector pens may rarely fail to activate if they are dropped, meaning a dose of adrenaline would not be delivered. Premature activation has also been detected in some of the 300 microgram and 500 microgram pens after they have been dropped, meaning that a dose of adrenaline is delivered too early. The activation failure and premature activation was detected during a design assessment conducted by the manufacturer and therefore means there is a potential for some 300 microgram and 500 microgram Emerade pens to fail during use after having been dropped. Read MHRA Press Release. 9 May 2023
  6. Content Article
    This blog on the Sling the Mesh website provides an overview of research by Professor Carl Heneghan, Director of the Centre for Evidence-Based Medicine at Oxford University, into regulatory issues relating to pelvic mesh. It outlines issues uncovered by Professor Heneghan and his colleagues, including the fact that clinical trial data was not required in the regulation of mesh and that early evidence of complications was ignored in the approval of subsequent devices.
  7. News Article
    The rising prevalence of hernia disorders, technological advancements in hernia repair devices, growing adoption of mesh in hernia repair surgeries, rising geriatric population and high adoption of hernia repair surgical procedures are some of the key factors driving the global hernia repair devices market, reports Yahoo News. Leading players operating in the global hernia repair devices market are adopting both organic and inorganic growth strategies such as collaborations, acquisitions, and new product launches to garner a higher market share. For instance: In February 2023, TELA Bio, Inc announced the launch of two additional configurations of its OviTex LPR device. The new configurations are 15 x 20 cm and 15 x 25 cm ellipses designed for ventral and incisional hernias. In December 2022, Deep Blue Medical Advances announced that they have received an additional 510(k) clearance from the US FDA for its T-Line Hernia Mesh for the subway technique in open hernia surgery. However, in a recent Tweet, campaign group Sling the Mesh voice their concerns:
  8. Content Article
    Central line–associated bloodstream infections (CLABSI) account for many harms suffered in healthcare and are associated with increased costs and disease burden. Central line rounds, like medical rounds, are a multidisciplinary bedside assessment strategy for all active central lines on a unit. The project team designed a HIPAA-protected, text-based process for assessing central lines for risk factors contributing to infection. Staff initiated a consultation via a virtual platform with an interdisciplinary team composed of oncology and infectious disease experts. The virtual discussion included recommendations for a line-related plan of care.
  9. Content Article
    In this blog, Patient Safety Learning considers key patient safety issues relating to complications from surgical mesh implants, highlighting further sources of opinion and research on the hub.
  10. News Article
    Patients who have had older types of hip replacement may be at greater risk of heart damage than previously thought, researchers have said, because of cobalt leaching out of so-called metal-on-metal implants. Tens of thousands of UK patients were fitted with these devices during the 2000s, when they were marketed as a solution for young, active patients who needed a hip replacement that would last a lifetime. The issue is that tiny metal ions made up of cobalt and chromium are thought to break off from the implants and leak into the blood, and there are fears this could cause muscle, bone and organ damage. Surgeons began to voice concerns about the implants in 2008, and in 2012 the Medicines and Healthcare products Regulatory Agency (MHRA) issued guidance recommending annual blood or MRI checks for patients who had received them. Since then, mounting evidence has suggested that such individuals may be at greater risk of heart disease. Read full story Source: The Guardian, 26 April 2023
  11. Content Article
    On 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)
  12. Content Article
    In 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.
  13. Content Article
    We 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.
  14. Content Article
    NHS Resolution received 2,600 claims for needlestick injuries for incidents occurring between 2012 – 2022. Needlestick injuries can be costly to investigate and increase the risk blood-borne infections. Fortunately, the harm and cost of most needlestick injuries are largely avoidable. NHS Resolution has created two new resources to share the learning from these claims and help organisations identify how to prevent future injuries.
  15. Content Article
    Research paper by Toye et al. published in the Lancet on the experience of women reporting damage from vaginal mesh.
  16. Content Article
    New 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.
  17. Content Article
    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.
  18. Content Article
    This 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.
  19. News Article
    A woman whose daughter took her own life after being left in chronic pain caused by giving birth has spoken of her family's heartbreak. Sara Baines, 34, from Flintshire, died in September last year leaving her family devastated. This week an inquest heard Sara suffered from chronic pain due to complications resulting from surgical mesh that was implanted after she gave birth in 2011. Her mother, Alison Sharrock, says Sara was failed by the health system on multiple occasions. Sara bled heavily whilst giving birth and suffered a second-degree tear. She had to have two surgeries to repair the tear, neither of which was completely successful. Sara found herself completely incontinent, at the age of 24. In 2015, Sara was advised to have mesh fitted. Alison said: "We were told the mesh was a 'quick-fix'. It felt like the answer to all her problems and she was thrilled. She had surgery but afterwards, though the incontinence improved, she had terrible abdominal pain." The pain became so severe that Sara was offered a hysterectomy, aged 28. Afterwards, the pain only intensified, and her general health deteriorated. She suffered water infections, skin rashes, gum disease and unexplained pain. Unable to eat or sleep, she became depressed and anxious. "She felt nobody was really listening to her. She felt she was gaslighted and fobbed off," said Alison. Kath Sansom, founder of Sling The Mesh which has almost 10,000 members suffering irreversible pan and complications from surgical mesh implants, said: "Our hearts go out to Sara's family. Nine out of 10 people in our support group were not told any risks of having a plastic mesh permanently implanted." Read full story Source: Mail Online, 24 March 2023 Further reading on the hub: Doctors’ shocking comments reveal institutional misogyny towards women harmed by pelvic mesh “There’s no problem with the mesh”: A personal account of the struggle to get vaginal mesh removal surgery ‘Mesh removal surgery is a postcode lottery’ - patients harmed by surgical mesh need accessible, consistent treatment
  20. Content Article
    This article* is an update from Dr Henrietta Hughes, Patient Safety Commissioner for England.
  21. Event
    until
    The event will be hosted by Lord Bethell, Member of the House of Lords and the former Health Minister, who will provide the opening remarks. Health Tech Alliance Chair Dame Barbara Hakin will welcome attendees and chair the event. The event will consist of opening remarks, a keynote address, networking and drinks. This event series follows the successes of our previous Conferences, originating in January 2020 where the launch of the Artificial Intelligence in Health and Care Award was announced. Our previous keynote speakers include the then-Health Ministers Matt Hancock, Lord Bethell and Lord Kamall, Jeremy Hunt, and Dr Sam Roberts, Chief Executive of NICE. In 2023 we are adding this Networking Reception to address the need for dialogue between politicians, the health system, and industry in helping the NHS to fix much of its current challenges. Drinks and refreshments will be provided to the attendees. The reception is organised by the Health Tech Alliance, a coalition of HealthTech companies and bodies from across the health system working collaboratively to drive up the adoption of vital health technologies, devices and diagnostics that are proven to benefit patient outcomes and deliver cost savings to the NHS. Reserve a place
  22. News Article
    The U.S. Food and Drug Administration (FDA) is providing an update on reports of squamous cell carcinoma (SCC) in the scar tissue (capsule) that forms around breast implants. Previously, on 8 September 2022, the FDA released a safety communication informing the public of reports of cancers, including SCC and various lymphomas, in the capsule that forms around breast implants. The various lymphomas are not the same as the lymphomas described previously by the FDA as breast implant-associated anaplastic large cell lymphoma (BIA-ALCL). This update includes information from the FDA’s review of literature and medical device reports (MDRs). The FDA is aware of 19 cases of SCC in the capsule around the breast implant from published literature. There have been reports in the literature of deaths from progression of the disease. While the FDA continues to believe that occurrences of SCC in the capsule around the breast implant may be rare, the cause, incidence and risk factors remain unknown. Read full story Source: US FDA, 8 March 2023
  23. Content Article
    Continuous 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.
  24. News Article
    Elon Musk's attempt to implant microchips into human brains has been rejected by US medical regulators over concerns about the safety of the technology. Mr Musk's Neuralink business, which is hoping to insert tiny chips into people's skulls to treat conditions such as paralysis and blindness, was denied initial permission for clinical trials last year. US medical regulators were said to have "dozens" of concerns over the risks posed by the device, Reuters reported. Concerns include fears that tiny electrodes could get lodged in other parts of the brain, which could impair cognitive function or rupture blood vessels. Neuralink's chips are designed to be threaded into the brain using tiny filaments and harness artificial intelligence technology to pick up brain activity using a so-called "brain computer interface". Read full story (paywalled) Source: The Times, 3 March 2023
  25. 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.
×
×
  • Create New...