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Showing results for tags 'Medical device / equipment'.
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Content ArticleSurgeons' 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. In an article in the June issue (page 18), Maryanne Mariyaselvam describes some of the latest solutions being developed to protect patients and clinicians from potential errors.
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Content ArticleWhen something goes wrong in health and social care, the people affected and staff often say, "I don’t want this to happen to anyone else." These 'Learning from safety incidents' resources are designed to do just that. Each one briefly describes a critical issue - what happened, what the Care Quality Commission (CQC) and the provider have done about it, and the steps you can take to avoid it happening in your service.
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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. The device, which releases the insulin your body needs through the day and night, comprises a pump, tube, battery and a pre-filled glass insulin cartridge. In some of the reported leakage incidents, the cartridges were found to be cracked and provided an inadequate supply of insulin to patients. However, leakages also occurred in cases where no cracks in the cartridge were visible. In some patients there were consequences of not receiving enough insulin from their pump system, including reports of severely high blood sugar and diabetic ketoacidosis (a serious complication of diabetes when the body produces high levels of blood acids called ketones). Health care professionals are being advised to contact patients over the next six months using said device to discuss their individual needs and source an alternative pump where appropriate. Key patient recommendations are: Check the pump and cartridge regularly for damages, for example cracks or leakage. If you smell insulin (a strong antiseptic chemical smell) this could also indicate a leakage. Do not use the cartridge if cracks or leakage are seen or if the cartridge was dropped. Follow the instructions of your Accu-Chek Insight user manual for replacing a cartridge and for cleaning the cartridge compartment in the insulin pump. During the day and before going to sleep please carefully check that your insulin pump is delivering insulin and there are no leakages. Never change treatment delivery methods without first consulting a relevant healthcare professional. Failure of insulin delivery due to leakage may not result in an alert notification from the insulin pump and cracks and leakages may not always be visible. You should check blood glucose levels multiple times throughout your day whilst using pumps. Tell your healthcare professional immediately if you suspect a problem with your insulin delivery. Read full story Source: Gov.UK, 26 May 2022
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Content ArticleThe MHRA continues to receive serious reports of harm associated with insulin leakage for the NovoRapid PumpCart prefilled insulin cartridge in the Accu-Chek Insight Insulin pump. In some patients, there were serious consequences arising from inadequate supply of insulin, including diabetic ketoacidosis (DKA). Although the manufacturer Roche Diabetes Care (RDC) has implemented a number of risk minimisation strategies to reduce the incidence of these events, the impact of these is inconclusive and we are taking further action to protect patients. To protect patient safety, diabetes healthcare professionals should inform patients who use the Accu-Chek Insight of the risk of leakage. Clinical care decisions should be made to ensure patients are moved onto alternative pumps where possible.
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Content ArticleThis Healthcare Safety Investigation Branch (HSIB) investigation aims to improve patient safety in relation to the decontamination of surgical instruments. It focuses on the work of sterile services departments (SSDs) in hospitals, where reusable medical equipment is cleaned, disinfected and sterilised to make it safe before it is used again. The investigation looked at the regulatory framework which SSDs work within, and their use of assurance models, which provide evidence that a service is running according to the relevant policies and procedures. These mechanisms are designed to keep patients safe and enable NHS trusts to manage risk within their organisations. For its reference case, the investigation used the case of a 56 year-old woman who underwent surgery to remove a kidney stone in her right kidney. During the procedure, 'black stuff' came out of one of the instruments being used, which was later analysed and found to be dried blood. The surgeon stopped the surgery immediately and proceeded with an alternative procedure to remove the kidney stone, for which the patient had already consented. The patient was tested for blood-borne viruses as she had been exposed to another person's dried blood, but tests did not show any evidence that she had contracted any.
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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 medical items on the Government's disaster relief list — which include drugs, tests, medical devices and personal protective equipment (PPE). The team found that 17% came from China in 2020, up from 6% before the pandemic. The report found up to a third of tests and diagnostic equipment and 30% of PPE used in the health service now come from China. Almost all paper masks used by medics in hospitals come from China (90%), more than half of all gloves (54%) and almost 80% of bandages. And 42% of emergency trolleys and wheelchairs are Chinese-made. Robert Clark, head of defence and security at Civitas, said: 'Things like gloves, monitors, wheelchairs and bandages all largely come from China rather than the UK. We are dangerously over-reliant on China." "Let's not be naïve about China. This is an urgent issue for health bosses with the risk that future geo-political spats could lead to the Chinese switching off critical medical supplies destined for the NHS." Read full story Source: Mail Online,17 May 2022
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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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EventuntilThis 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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EventuntilChoose 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 University of Huddersfield. Sian Fumarola, Head of Clinical Procurement at Integrated Supplies and Procurement Department, Stoke on Trent, NHS Supply Chains Katie Leek, Tissue Viability Nurse at NHS Register for the webinar
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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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EventuntilThe 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 ILAP partners. Along with presentations from some of the ILAP team, a patient representative will share their experiences as a member of the pilot ILAP Patient and Public Reference Group. There will also be a panel discussion session with plenty of opportunity for questions from participants. Register
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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 nearly two decades. The instructions for use in all of the company’s pelvic mesh implant packages "falsified or omitted the full range, severity, duration, and cause of complications associated with Ethicon’s pelvic mesh products, as well as the potential irreversibility and catastrophic consequences," Presiding Justice Judith McConnell of the appeals court said in a 3-0 ruling upholding the $302 million in penalties. The products, also called transvaginal mesh, are synthetic and surgically implanted through the vagina of women whose pelvic organs have sagged or who suffered from stress urinary incontinence when they cough, sneeze or lift heavy objects. Many women have sued the New Jersey-based company alleging that the mesh caused severe pain, bleeding, infections, discomfort during intercourse and the need for removal surgery. Read full story Source: Fox News, 12 April 2022 -
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 that could be exploited by hackers. The new document is still just a draft, and device makers won’t start using it until it’s finalised after another round of feedback. But it includes a few significant changes from the last go-around — including an emphasis on the whole lifecycle of a device and a recommendation that manufacturers include a Software Bill of Materials (SBOM) with all new products that gives users information on the various elements that make up a device. An SBOM makes it easier for users to keep tabs on their devices. If there’s a bug or vulnerability found in a bit of software, for example, a hospital could easily check if their infusion pumps use that specific software. The FDA also put out legislative proposals around medical device cybersecurity, asking asking Congress for more explicit power to make requirements. “The intent is to enable devices to be that much more resilient to withstand the potential for cyber exploits or intrusion,” Schwartz says. Manufacturers should be able to update or patch software problems without hurting the devices’ function, she says. Read full story Source: The Verge, 8 April 2022 -
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 had been five reported cases of shutdowns in the UK so far, none of which involved patient harm. Globally, there have been 389 reports of failures, including one where the patient died and four where they were seriously injured. In six of the total cases, the warning alarm didn’t sound. Philips Respironics is one of several manufacturers that increased production of ventilators during the pandemic. The MHRA brought in a fast approval process for ventilators and other medical devices in response to Covid-19. The MHRA said the root cause of the problem was not yet known and remained under investigation, but that Philips Respironics currently had “no permanent solution” to correct it. Helen Hughes, chief executive of Patient Safety Learning, said there was a “significant patient safety concern” that some Philips devices could remain in use until replacements were sourced. Read full story Source: The Guardian, 9 April 2022 National Patient Safety Alert: Philips Health SystemsV60, V60 Plus and V680 ventilators – potential unexpected shutdown leading to complete loss of ventilation
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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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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 acknowledged by NHS trusts across Britain. But from 2009 to 2019, it has paid out nearly £14 million in compensation settlements and legal fees. Fires such as these are often fuelled by leaking oxygen - and are caused by faulty machinery or sparking equipment. Campaigners are concerned that UK hospitals are lagging behind other countries in recording surgical fires and introducing protocols to reduce both their frequency and severity. Theatre scrub nurse Kathy Nabbie has spent the past five years trying to make colleagues more aware of the threat of surgical fires. In 2017 - after hearing how a woman in Oregon, USA, had suffered severe burns when her face was set alight in surgery - she made a simple safety checklist. Her Fire Risk Assessment tool allowed colleagues to check for the presence of elements that together might cause a fire to break out. But senior staff failed to implement the initiative and - when a surgical fire actually took place three months later - Kathy learned that her laminated checklist had simply been put in a drawer. “I couldn’t believe it,” she said. “After that they did start using it, but why on earth should it have taken an actual fire to persuade them?” Read full story Source: The Sun, 7 April 2022 Further reading What can we do to improve safety in the theatre? Reflections from theatre nurse Kathy Nabbie How I raised awareness of fires in the operating theatre - Kathy Nabbie
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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, NHSSC chief Andrew New said the 11 categories would be reduced to eight. Three of the new categories — personal protective equipment, “medical capital” (which combines large capital diagnostics equipment with smaller scale diagnostics, pathology and point of care testing categories) and “medical clinically complex” surgical products and services — would be managed in-house. The new model will come into effect in 2023-24 following a procurement process to find new suppliers for the revamped category structure, which starts on 11 April 2022 with the publication of the contract notice. Read full story (paywalled) Source: HSJ, 4 April 2022
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News Article
Online retailers stop sales of some blood oxygen monitors after investigation
Patient Safety Learning posted a news article in News
Amazon, eBay and Wish have stopped stocking some monitors that let people keep track of their blood oxygen levels after an investigation found they were not fit to be sold. The online marketplaces removed a number of pulse oxygen testing devices known as oximeters from sale after being alerted to flaws identified by the consumer organisation Which? Pulse oximeters have boomed in popularity as a result of Covid, with millions of people keeping one at home so they can quickly assess if their blood oxygen level has fallen worryingly low – a condition known as “silent hypoxia” – which is a common side-effect of the disease. Some of the devices were not legally fit to be sold in the UK, did not carry the CE quality Kitemark or wrongly claimed that they had been approved by the NHS. The Department of Health and Social Care (DHSC) said it would look into the unauthorised use of the health service’s iconic blue and white branding on the devices. It made clear that “the NHS does not approve or endorse any medical devices, including oximeters”. “The department strictly controls the NHS identity and takes unauthorised use or adaptation of the NHS logo and the letters ‘NHS’ very seriously”, a DHSC spokesperson said. Which? said that 11 of the cheap pulse oximeters it bought from those websites failed to comply with UK and European Union law when it examined them closely. “It is very concerning that our investigation found these medical devices for sale without the required safety markings or brazenly claiming to be approved by the NHS, and the biggest online marketplaces were not picking up on these red flags”, said Natalie Hitchens, the consumer group’s head of home products and services. Read full story Source: The Guardian, 26 March 2022 -
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 ArticleThe Guidance for Human Factors Evaluations in the Procurement of Medical Devices, Equipment and Technology document provides comprehensive recommendations on how one may integrate human factors evaluations into procurement processes. While it is a relatively new aspect to consider in healthcare supply management, and may entail robust change management to implement, incorporating human factors evaluation in purchasing will enable best value and outcomes in health care.
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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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News Article
Ukraine’s hospitals ‘desperate’ for medical supplies as oxygen runs out
Patient Safety Learning posted a news article in News
Hospitals across Ukraine are “desperate” for medical supplies, doctors have warned, as oxygen stores are hit and other vital health supplies run low amid bombardment from Russian forces. UK-based Ukrainian doctors have issued an urgent appeal for donations of supplies as they travel to eastern Europe in response to reports of shortages of medical equipment and medicines. The World Health Organisation warned on Sunday evening that oxygen supplies in Ukraine were “dangerously low” as trucks were unable to transport oxygen supplies from plants to hospitals across the country. Dr Volodymyr Suskyi, an intensive care doctor at Feofaniya Clinical Hospital in Kyiv, told The Independent he had been forced to use an emergency back-up system to supply oxygen to a patient on life support after the area near plant which supplies his hospital was bombed. Dr Dennis Olugun, a UK-based doctor who is leading the group of medics from the Ukrainian Medical Association of the United Kingdom (UMAUK) to deliver medical supplies, said the situation was “desperate” in some areas. He said some hospitals did not have basic necessities such as rubber gloves. He told The Independent: “What they need in the hospitals is portable ultrasound machines, portable x-ray machines because they have so many patients they much rather walk around the wards and do whatever diagnostic work rather than transporting patients." The Association of the British Pharmaceutical Industry and European Federation of Pharmaceutical Industries and Associations have called for medicines, pharmaceutical ingredients and raw materials to be excluded from the scope of sanctions being levied against Russian trade. Read full story Source: The Independent, 1 March 2022 -
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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News ArticleA London mum says she has been left in "agony" and only able to walk 10 minutes at a time after a transvaginal mesh implant perforated her organs. Anna Collyer, 53, had a transvaginal mesh fitted in 2015 at St. Helier hospital in Sutton. The mesh is a net-like implant and aims to give permanent support to the weakened organs and to repair damaged tissue. The mesh implants are designed to be permanent, but last April, Anna started to experience severe pain when the mesh cut into her organs leaving her "unable to live any sort of life anymore," she said. Even when doctors partially removed the mesh last June - her symptoms persisted. Anna, who lives in Morden, told MyLondon: "I could feel something sharp inside me. The pain relief tablets were not touching it. I was in agony. "It's got to the stage now where 10 minutes is all I can walk, because the pain is excruciating. I have pain in pelvis, groin, hips, back and shooting pains in legs. The level is horrendous. I have to lie down all the time. The vaginal mesh procedure was once common place in the UK, with more than 92,000 women receiving one between April 2007 and March 2015 in England alone. But the treatment was “paused” and The Independent Medicines and Medical Devices Safety Review was ordered by the then health secretary, Jeremy Hunt, in 2018 amid mounting safety concerns. Women told the review team of “excruciating chronic pain feeling like razors inside their body" and felt dismissed when reporting complications including “unacceptable labelling of so many symptoms as ‘normal’ and attributable to ‘women’s problems’”, the report says. The new review accuses medial professionals of displaying “an institutional and professional resistance” to changing practice. The report concluded that “those harmed are due not only an apology, but better care and support through specialist centres”. Read full story Source: MyLondon. 22 February 2022
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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 IEEE Spectrum voiced concern. One, Ross Doerr, said Second Sight failed to contact any of its patients after its financial difficulties in 2020. "Those of us with this implant are figuratively and literally in the dark," he said. Another user, Jeroen Perk, had problems when his VPU system broke in November 2020. "I had no vision, no Argus, and no support from Second Sight," he said. Elizabeth M Renieris, professor of technology ethics at the University of Notre Dame, in the US, described the development as a cautionary tale. She told the BBC: "This is a prime example of our increasing vulnerability in the face of high-tech, smart and connected devices which are proliferating in the healthcare and biomedical sectors." "These are not like off-the-shelf products or services that we can actually own or control. Instead we are dependent on software upgrades, proprietary methods and parts, and the commercial drivers and success or failure of for-profit ventures." Ethical considerations around such technology should in future include "autonomy, dignity, and accountability", she added. Read full story Source: BBC News, 17 February 2022
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