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Found 146 results
  1. News Article
    New plans to strengthen the regulation of medical devices to improve patient safety and encourage innovation have been published. Following the UK’s exit from the European Union (EU), the Medicines and Healthcare products Regulatory Agency (MHRA) has a unique opportunity to improve how medical devices and in vitro diagnostic medical devices (IVDs) are regulated in the UK. The package of reforms will apply to medical devices such as hearing aids, x-ray machines and insulin pumps; new technologies such as smartphone apps and Artificial Intelligence (AI); as well as certain cosmetic pro
  2. News Article
    A trust was supplied with ventilators that were not ‘fit for NHS purposes’ by two suppliers at the height of the first Covid wave, HSJ has revealed. Guy’s and St Thomas’ Foundation Trust has now received a refund for both contracts, which were signed in March 2020 just as the pandemic began to hit the NHS. The service rushed to secure the equipment in response to fears that existing ventilator capacity would be inadequate to deal with the rising number of seriously ill Covid patients. At the time, the use of ventilators was the only effective therapy for the sickest Covid patients.
  3. Content Article
    The authors identified a range of internal and external barriers to UDI implementation in health systems, including: lack of organizational support information technology gaps clinical resistance information technology vendor resistance limitations in manufacturer support gaps in reference data lack of an overall UDI system). They also identified strategies for overcoming these barriers, including: relationship building education engagement communication. They concluded that next steps to advance UDI adoption nee
  4. News Article
    Hundreds of people who had retinal implants to improve their sight face an uncertain future as the technology they rely on is now obsolete. Second Sight stopped making its Argus II bionic eyes several years ago to focus on a brain implant instead. According to IEEE Spectrum it is now hoping to merge with a biopharmaceutical firm which does not make eye implants. IEEE Spectrum reports that Second Sight actually discontinued its retinal implants - which effectively take the place of photoreceptors in the eye to create a form of artificial vision - in 2019. Patients contacted by IE
  5. News Article
    The Medicines and Healthcare products Regulatory Agency (MHRA) has issued a national patient safety alert for the NovoRapid PumpCart prefilled insulin cartridge and the Roche Accu-Chek Insight Insulin pump system following concerns raised about cracked cartridges and insulin leaks. Patients are being asked to check the pre-filled glass insulin cartridge for cracks prior to use. The cartridge should not be used if it has been dropped even if no cracks are visible. Closely follow the updated handling instructions in the pump user manual when changing pre-filled glass insulin cartridges.
  6. Content Article
    Findings There is no requirement to report issues nationally relating to incorrectly decontaminated surgical instruments. This means that the size of the issue is unknown and that the healthcare system does not fully understand the risks and issues it is holding. Risks and issues are held within individual SSDs and are not integrated within wider trust management systems. Trusts frequently focus on clinical risks and not on the risks that arise from non-clinical supporting departments but which present a patient safety risk. There is no national requirement for NHS tru
  7. News Article
    The NHS has become 'dangerously over-reliant' on China for vital medicines and supplies, a report has warned. One in six medical items used in UK hospitals — including needles, bandages and oxygen — are shipped from the communist state. Thinktank Civitas found that overall NHS dependency on Chinese supply chains has trebled since 2019, with the UK now sending £6.2billion a year to Beijing for medical gear. Security experts are now calling for an 'NHS Security Act' to wean Britain off Chinese medical items and start manufacturing more domestically. Civitas looked at 228 medi
  8. Event
    Webinar to report on progress with updating the ISO 23908 standard on safety mechanisms in the design and manufacture of devices and the prevention of sharps injuries. See the agenda below. Agenda for webinar on 22.06.22 at 09.00 updating the ISO 23908 standard on safety mechanisms and the prevention of sharps injuries.docx Click here to join the meeting
  9. Event
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    This free webinar will cover: Understanding the Government’s Net Zero Strategy Its impact on Health Care Professionals and Clinical Procurement teams Sharing practical initiatives in wound care Speakers: Professor Matthew Cripps, Director, Behaviour Change Team, NHS England and NHS Improvement Paddy Markey, Marketing Manager Wound Care, Coloplast Sian Fumarola, Head of Clinical Procurement, Integrated Supplies and Procurement Department Register for the webinar
  10. Event
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    Choose the right dressing for the right wound: reduce waste, save time, save money, enhance lives In this webinar the following topics will be discussed: FarlaCare and their simple colour coding wound assistive solutions Demistifying wound care and helping you to do your job with ease Pick the right dressing every time, less waste, less time and less consumption. Speakers: Roy Lilley, health policy analyst, writer, broadcaster and commentator on the National Health Service and social issues Dr Leanne Atkin, PhD MHSc RGN is a Lecturer Practitioner at
  11. Event
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    This Webinar hosted by Hamilton Medical, will focus on the clinical use of intelligent ventilation software. Agenda Intro from Chair Luigi Camporata Presentation from Prof. Giorgio A. Iotti : “ The birth and growth of the visionary idea” Presentation from Laura Buiteman-Kruizinga: “Lung protective ventilation in the time of COVID-19” Followed by a Q&A Register for the webinar
  12. Event
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    The Medicines and Healthcare products Regulatory Agency (MHRA) will be holding a joint virtual Innovative Licencing and Access Pathway (ILAP) information and update session. This event will provide an opportunity for patient groups and patient experts to receive an update on the work of the ILAP, how the MHRA involve patient and public representatives, and future developments about how the MHRA are accelerating the time to market and facilitating patient access to innovative medicines. This event is open to all patient and public representatives who are involved in the work of any of the
  13. Content Article
    The six-week consultation outlines a number of key proposals that strengthen the current code of practice, to ensure that experts providing the MHRA with advice are independent and impartial, and that the processes in place to manage conflicts of interest are robust and clear to all. It also enables greater inclusion of patient experts in committee discussions so that individuals with lived and personal experiences can contribute to discussions more easily. The proposals include: A register of interests accessible to all (through GOV.UK), which will be updated to reflect any chang
  14. News Article
    A California appeals court has upheld a lower court ruling that Johnson & Johnson must pay penalties to the state for deceptively marketing pelvic mesh implants for women, but reduced the amount by $42 million to $302 million. Johnson & Johnson had appealed in 2020 after Superior Court Judge Eddie Sturgeon assessed the $344 million in penalties against Johnson & Johnson subsidiary Ethicon. Sturgeon found after a non-jury trial that the company made misleading and potentially harmful statements in hundreds of thousands of advertisements and instructional brochures for near
  15. News Article
    Medical devices are one major weak point in health care cybersecurity, and both the US Congress and the Food and Drug Administration took steps towards closing that gap this week —Congress with a proposed bill and the FDA with new draft guidelines for device makers on how they should build devices that are less likely to be hacked. Devices like infusion pumps or imaging machines that are connected to the internet can be targets for hacks. Those attacks can siphon off patient data or put their safety directly at risk. Experts consistently find that devices in use today have vulnerabilities
  16. News Article
    Two thousand ventilators being used in UK hospitals are at risk of suddenly shutting down due to electrical faults that have led to a global safety alert. Hospitals have been ordered to source replacement ventilators after Philips Respironics said its breathing support devices could suddenly stop working, in some cases without activating a warning alarm. The Medicines and Healthcare products Regulatory Agency (MHRA) said the problem related to “a number of electrical faults in the devices, which can result in an unexpected shutdown, leading to loss of ventilation”. It said there
  17. Content Article
    All actions to be completed by 31 May 2022 1. Urgently identify and locate affected devices in your organisation. 2. Identify alternative ventilators available on site. a. If no alternatives are available, use local procurement procedures to acquire suitable alternative devices. b. If no suitable alternative is available, and capacity is an issue currently (or expected imminently), additional devices are available for NHS organisations. Details for how to access these devices can be found in the ‘Additional information’ section of this alert. 3. Train all relevant staff on alter
  18. News Article
    A patient was left traumatised when his body caught on fire halfway through surgery - leaving his insides scorched. Mark, 52, went to hospital for a routine abscess removal - but woke up to the news that a freak accident in theatre had sparked an horrific blaze. A diathermy machine, used to stop bleeding, caused a swab to catch fire - before flames burnt their way through his exposed flesh, Mark explained. It took over a year for Mark - not his real name - to recover from his dreadful injuries - and the emotional scarring it caused. Between 2008 and 2018, 37 cases were ackn
  19. News Article
    The national supply chain agency will bring management of significant areas of NHS spend in-house on a permanent basis in a major overhaul of its operating model, HSJ has been told. NHS Supply Chain’s current operating model, which has existed since 2018, has outsourced day-to-day management of the procurement of most of the goods and services bought by trusts as part of the “category towers” structure. Under this structure, 11 category towers each cover a different spend area with a service provider to manage the available products and services. But, in an exclusive interview,
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