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Showing results for tags 'Medical device / equipment'.
Found 146 results
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News Article
UK to strengthen regulation of medical devices to protect patients
Patient Safety Learning posted a news article in News
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 -
News Article
Trust was sent ‘unfit’ ventilators at height of pandemic
Patient Safety Learning posted a news article in News
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. -
Content ArticleThe 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
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News Article
Bionic eyes: Obsolete tech leaves patients in the dark
Patient Safety Learning posted a news article in News
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 -
News ArticleThe 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.
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Content ArticleFindings 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
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News ArticleThe 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
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EventWebinar 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
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Delivering Net Zero targets through environmentally conscious wound care
Patient-Safety-Learning posted a calendar event in Community Calendar
untilThis 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 -
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Wound care webinars - Stop, Think and Behave Differently
Patient-Safety-Learning posted a calendar event in Community Calendar
untilChoose 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 -
EventuntilThis 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
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Innovative Licensing and Access Pathway (ILAP) information and update
Patient Safety Learning posted a calendar event in Community Calendar
untilThe 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 -
Content ArticleThe 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
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News Article
Johnson & Johnson ordered to pay $302M in pelvic mesh case
Patient Safety Learning posted a news article in News
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 -
News Article
The US is trying to fix medical devices’ big cybersecurity problem
Patient Safety Learning posted a news article in News
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 -
News ArticleTwo 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
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Content ArticleAll 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
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News ArticleA 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
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News ArticleThe 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,
