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Found 215 results
  1. News Article
    A network of specialist surgical mesh removal centres is to be set up around England, with a launch planned for April 2021. The move implements a recommendation of the review, chaired by the Conservative peer and former health minister Julia Cumberlege, into three treatments which caused avoidable harm. These included the use of transvaginal tape and pelvic mesh to treat pelvic organ prolapse and urinary incontinence. The review, which published its report in July, heard “harrowing” stories about women left with serious complications. The mesh is hard to remove and only a few surgeons in the UK are able to carry out the procedure. Read full story (paywalled) Source: BMJ, 25 November 2020
  2. News Article
    Lawyers have begun legal action on behalf of 200 UK women against the makers of a sterilisation device, after claims of illness and pain. The device, a small coil called Essure, was implanted to prevent pregnancies. Manufacturer Bayer has already set aside more than $1.6bn (£1.2bn) to settle claims from almost 40,000 women in the US. It has withdrawn the device from the market for commercial reasons but says it stands by its safety and efficacy. The metal coil was inserted into the fallopian tube to cause scarring, blocking the tube and preventing pregnancy. Introduced in 2002, it was promoted as an easy, non-surgical procedure - a new era in sterilisation. But many women who had the device fitted have now either had hysterectomies or are waiting for procedures to remove the device. Tracey Pitcher, who lives in Hampshire, felt she had completed her family and did not want any more children. Her doctor strongly encouraged her to have an Essure device fitted, she says. But after it had been, she began to feel very unwell. "I just started to have heavy periods, migraines, which I had only ever had when I was pregnant so they were hormonal," she says. "My back was so painful I'd wake up crying in the middle of the night with pains in my hips and my back." Tracey says she battled to persuade doctors to take her symptoms seriously. But the only information she received was from a Facebook group. "... there's nobody there, there's no support apart from people that we've found ourselves, no-one will listen, because it's just 'women's things'." Read full story Source: BBC News, 15 November 2020
  3. News Article
    The Medicines and Healthcare products Regulatory Agency (MHRA) has received its one millionth Yellow Card. The Yellow Card scheme is the UK’s system for reporting suspected side effects to medicines and adverse events with medical devices. This major milestone coincides with the launch of the 5th annual #MedSafetyWeek (2-8 November), which highlights the value of the Yellow Card scheme to the nation’s health, and the importance of reporting suspected side effects from medicines. The MHRA has seen an increased rate of Yellow Card reports and would like to continue to encourage more reporting this #MedSafetyWeek. MedSafetyWeek is a global campaign, with over 70 countries participating, worldwide. This year, the theme is ‘every report counts’. The MHRA will be calling upon patients and carers, as well as healthcare professionals and their organisations to report suspected side effects from medicines. Reporting helps to identify new side effects, as well as unexpected and serious safety problems. It also adds to existing information about known effects. By reporting, patients and the public can help the safe use of medicines for everyone. Read press release Source: GOV.UK, 2 November 2020
  4. News Article
    More than 200 people who went through hotel quarantine in Victoria, Australia, must be screened for HIV amid fears of cross-contamination from incorrect usage of blood glucose test devices. Several such devices were used on multiple people in quarantine between 29 March and 20 August, necessitating screenings for blood-borne diseases such as hepatitis B and C and HIV. These monitors, which take a small sample of blood from a fingertip, are intended for repeated use by only one person. While the needle is changed between usages, microscopic traces of blood can remain within the body of the machine, creating a low clinical risk of cross-contamination and infection. Safer Care Victoria, the state’s healthcare quality and safety agency, has assured the public there is no risk of COVID-19 spread as the disease is not transmitted by blood. These devices have since been taken out of circulation. In a statement, a spokesman for the agency said they have identified 243 people who had been tested by one of the shared machines during the timeframe in question, and will be contacted for screening. Everyone “who had conditions or episodes that may have required the test will also be contacted as a precaution”. The Victorian premier, Daniel Andrews, labelled the incident a “clinical error that was made some time ago”. “Safer Care Victoria have made some announcements in relation to a clinical error that was made some time ago, very low risk, but you can’t take any risks with these things. You have to follow them up properly and that’s exactly what has happened,” he said at a press conference on Tuesday. Read full story Source: The Guardian, 20 October 2020
  5. News Article
    When the pain in her shoulders and weakness in her right leg started two years ago, Giovanna Ippolito thought it was just part of getting older — that's until the 46-year-old's doctor ordered an X-ray that showed a five-centimetre long, broken needle embedded in her spine. It was a medical error that took more than a decade to discover — after medical staff at the time failed to report it. Exactly when the needle was left in Ippolito's spine is unclear, but she says she's only had something injected into her back twice — during the birth of her son in 2002 and her daughter in 2004. Ippolito says she believes the needle broke off when medical staff at Mackenzie Richmond Hill Hospital in nearby Richmond Hill (called York Central Hospital at the time) administered a spinal block or an epidural during one of the births. She's now locked in a battle with the hospital for answers and accountability. But experts say, with a system that's stacked against Canadians harmed by medical errors, it's likely no one will have to take responsibility. More than 132,000 patients experienced some kind of medical harm — something both preventable and serious enough to require treatment or a longer hospital stay — in 2018-19, according to the Canadian Institute for Health Information, an independent, not-for-profit organization that collects information on the country's health systems. Read full story Source: CBC, 5 October 2020
  6. News Article
    Tens of thousands of people infected with coronavirus were incorrectly given the all clear by England’s Lighthouse Laboratories, a High Court trial will be told next week. Court documents seen by The Independent show the labs are accused of unfairly selecting software that was shown in a test to produce significant numbers of errors and false negatives, samples that should have been positive or classed as needing to be re-taken. The two companies behind the Lighthouse Labs in England – Medicines Discovery Catapult Ltd and UK Biocentre Ltd – are accused of treating British company, Diagnostics.ai unfairly and giving preferential treatment to Belgian company UgenTec, despite the British firm’s software performing better in the test. The case, first revealed by The Independent in June, also includes a judicial review of the procurement decision against health secretary Matt Hancock – one of the first court hearings over the procurement processes followed by the government since the start of the pandemic. The Independent understands lawyers for Diagnostics.ai will accuse the laboratories of choosing a software solution that went on to produce tens of thousands of incorrect results which will have led to infected people going about their normal lives while at risk of spreading the virus. In June, UgenTec chief executive Steven Verhoeven told The Independent the suggestion its software had made errors was “incorrect”. The Department of Health refused to comment on the legal action but said in June that the UgenTec software had been used for several months and was subject to quality assurance processes, though it did not give any further details. Mr Justice Fraser will hear opening arguments in the case on Monday at the High Court. Read full story Source: The Independent, 25 September 2020
  7. News Article
    Hospitals have been warned hundreds of ventilators used to keep sedated patients alive are at risk of suddenly shutting down because of a fault, in some cases without warning. The Medicines and Healthcare products Regulatory Agency, which said there were approximately 303 Philips Respironics V60 ventilators used in the UK, has warned hospitals over a delay in replacement parts arriving in the UK to fix the problem. It has issued a safety alert to hospitals to make them aware of the increased risk. The regulator said it had received one report of a ventilator suddenly shutting down but said there was no report of any injury to patients. Read full story Source: The Independent, 23 September 2020
  8. News Article
    Healthcare workers and patients are being put at risk not only from COVID-19 but other deadly diseases as a result of an increase in sharps injuries due to the pandemic. Sharps injuries are accidents where a needle or other medical sharp instrument penetrates the skin with the potential to transfer blood borne viruses, including HIV or hepatitis B or C, from the patient to healthcare worker and vice versa. Sharps injuries cause increased costs and disruption in the healthcare system, which have all been exacerbated by the pandemic anyway. Sharps injuries also have a major emotional and mental impact on staff who always put patients first and literally have put their lives on the line during COVID-19. The European Biosafety Network has commissioned a survey to be published in June on the impact COVID-19 has had on sharps injuries in Europe. The preliminary findings of the survey by Ipsos MORI, covering more than 300,000 healthcare workers in 80 large public hospitals across Europe, show that the number of sharps injuries has increased by some 276,000 injuries (23%) over the last year: with 98% of respondents saying that the increase was a result of the increased pressure and stress due to COVID-19. Other recent published survey results also show that the number of reported sharps injuries has increased as a result of the pandemic. We need to ensure that other existing legislation and regulations which prevent sharps injuries are both understood and complied with. Read full story Source: The Brussels Times, 28 April 2021
  9. News Article
    Deborah Stanford is one of many women who have received a Boston Scientific implant and suffered complications. She has joined Shine Lawyers’ class action, which was filed today in the Australian Federal Court, to hold the manufacturers to account for the continuous pain she has endured since the Obtryx sling was implanted on 12 September 2012. Ms Stanford’s bladder was sitting in the birth canal and the sling was placed, on medical advice, to reposition her bladder. “It has been 9 years of suffering." “If I knew how hard this was going to be, I never would have gone through it,” said Ms. Stanford. Boston Scientific is the third pelvic mesh manufacturer to face a class action over their range of prolapse mesh and incontinence sling implants. Shine Lawyers has filed all three actions against Johnson & Johnson, Ethicon and American Medical Systems (AMS). Read full story Source: Shine Lawyers, 22 March 2021
  10. News Article
    Hospitals across Europe, including Britain, as well as the Middle East and Africa are scrambling to replace millions of pieces of equipment used to treat patients, as fears grow that they could cause infections after a company was discovered to have falsified sterilisation records for more than a decade. The Independent has learned the problem affects more than 230 different types of infusion lines, connectors and associated kit, along with six infusion pumps used to deliver medicine and fluids into patients’ veins. Medical devices company Becton Dickinson, or BD, has issued a recall of six of its Alaris infusion pumps as well as related tubing and kit after an investigation found a company it uses was intentionally falsifying sterilisation records, meaning BD could not be certain the tubing and pumps were free from contamination. Hospitals across the UK have been given until the end of this month to stop using the pumps and quarantine any of the affected equipment. Any NHS trusts struggling with a lack of supply have been told to seek “mutual aid” from neighbouring trusts. Public Health England told The Independent it had not identified any large scale infections linked to the IV lines but said it could not rule out smaller isolated infections. Read full story Source: The Independent, 22 March 2021
  11. News Article
    In July last year, the Independent Medicines and Medical Devices Safety Review – chaired by Baroness Cumberlege— published its landmark report, First Do No Harm. It followed a two-year review of harrowing patient testimony and a large volume of other evidence concerning three medical interventions: Primodos, sodium valproate and pelvic mesh. Yesterday, in a written statement to Parliament, the Minister for Patient Safety, Suicide Prevention and Mental Health, Nadine Dorries, gave an update on the government’s response to the recommendations of the Cumberlege Review. In an article in The Times today, Baroness Cumberlege welcomes that the government has now accepted the need for a patient safety commissioner for England and the amendment to the Medicines and Medical Devices Bill, which is being considered in the House of Lords today, which she hopes "will swiftly become law". However, she also states that "... a full response to the review's is still outstanding 6 months after publication. Action is urgently needed to ensure we help those who have already suffered and reduce the risk of harm to patients in future". Read full story (paywalled) Source: The Times, 12 January 2021
  12. News Article
    After three Covid-19 patients died at the make-shift Nightingale Hospital in London following a breathing tube mix-up, NHS trusts in England could be issued tougher ventilation guidance. In each of the cases, filters which prevent the build-up of fluid were not attached to the machines, resulting in dangerous blockages, but it has not yet been determined if these incidents contributed to their deaths. Coroner Nadia Persaud has said the way the machines vary from model to model can be "confusing" and may lead to future deaths, also ruling that the classification and colour coding was "worthy of review, simplification, and standardisation". The original coroners report, carrying advice from an independent expert said "In my opinion, the non-standardised colour coding used by manufacturers of these filters, the number of different types of filters with different names, the variable optimal position of the filters, and whether a wet or a dry breathing system is being used, results in an extremely confusing situation. One of the leading manufacturers of these filters produces HMEs that are blue, which is the same colour as the non-HME filters supplied by another company. In my experience, few doctors and nurses working in ICU are knowledgeable about all these different filters and which ones should be used for any given breathing system." Inquests into the deaths are scheduled for October. Read full story. Source: The Daily Mail, 17 August 2021
  13. News Article
    Experts have warned that a device used to detect signs of oxygen level drops may not work as well on darker skin. According to NHS England and MHRA, pulse oximeters may sometimes overestimate oxygen levels. Now, NHS England is updating their guidance advising patients patients from black, Asian and other ethnic minority groups to seek advice from their healthcare professional, but to continue using pulse oximeters. "We need to ensure there is common knowledge on potential limitations in healthcare equipment and devices, particularly for populations at heightened risk of life-changing illness, this includes black, Asian and diverse communities using pulse oximeters to monitor their oxygen levels at home," says Dr Habib Naqvi, director of the NHS Race and Health Observatory. Read full story. Source: BBC, 1 August 2021
  14. News Article
    The Medicines and Healthcare products Regulatory Agency (MHRA) are warning that thermal cameras and other such “temperature screening” products, some of which make direct claims to screen for COVID-19, are not a reliable way to detect if people have the virus. In July 2020 the Agency told manufacturers and suppliers of thermal cameras that they should not make claims which directly relate to COVID-19 diagnosis, and now are reminding businesses to follow Government advice on safe working during COVID-19. Graeme Tunbridge, MHRA Director of Devices, said: "Many thermal cameras and temperature screening products were originally designed for non-medical purposes, such as for building or site security. Businesses and organisations need to know that using these products for temperature screening could put people’s health at risk. These products should only be used in line with the manufacturer’s original intended use, and not to screen people for COVID-19 symptoms. They do not perform to the level required to accurately support a medical diagnosis." Read full story Source: BBC News, 27 July 2021
  15. News Article
    NHS trusts are to be told to remove devices linked to more than 120 never events caused by ‘unconscious errors’. A national patient safety alert from NHS England which urges trusts to remove all air flowmeters from wall medical gas outlets. It is likely to be published next month. The alert comes after 121 never events in the last three years involved staff members accidentally connecting patients to air instead of oxygen. This number is close to 10% of all never events recorded during that period. These types of never events have been recorded by 57 NHS organisations during 2018-19, 2019-20 and 2020-21. The incidents took place mostly on medical wards and in emergency departments. They occurred despite NHSE issuing a patient safety alert in 2016, which recommended removing the flowmeters from wall outlets when not in active use. According to NHSE documents - seen by HSJ - the never events often went undetected “for some time”, even when other staff responded to deteriorating patients or took over their care. The regulator concluded this makes it more likely that there have been other unreported incidents. Read full story (paywalled) Source: HSJ, 17 May 2021
  16. 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
  17. 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
  18. 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 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
  19. 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
  20. 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 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
  21. Content Article
    People with diabetes are increasingly using medical devices to help manage their condition, including devices for monitoring glucose and delivering insulin. However, healthcare professionals are finding that they cannot always access up to date information about a person with diabetes and the data from their medical devices. This makes it harder to provide the best advice and support. The Professional Record Standards Body (PRSB) was commissioned by NHS England and NHS Improvement to produce two standards for sharing diabetes information between people and professionals across all care settings, including self management data from digital apps and medical devices (for example, continuous glucose monitors). The Diabetes Information Record Standard which defines the information needed to support a person’s diabetes management. It includes information that could be recorded by health and care professionals or the person themselves that is relevant to the diabetes care of the person and should be shared between different care providers. The Diabetes Self-Management Standard which defines information that could be recorded by the person (or their carer) at home (either using digital apps or medical devices) and shared with health and care professionals.
  22. Content Article
    When critically ill premature infants require transfer by ambulance to another hospital, they frequently require mechanical ventilation. This observational study investigated acceleration during emergency transfers and looked at whether they result from changes in ambulance speed and direction, or from vibration due to road conditions. It aimed to assess how these forces impact on performance of neonatal ventilators and on patient-ventilator interactions. The authors found that infants are exposed to significant acceleration and vibration during emergency transport. Although these forces do not interfere with overall maintenance of ventilator parameters, they make the pressure-volume loops more irregular.
  23. Content Article
    This study in the journal Medical Devices: Evidence and Research aimed to assess health system experiences of implementing Unique Device Identifier (UDI) systems for medical devices. Although the US Food and Drug Administration (FDA formalised the Unique Device Identification System Rule in 2013, parallel regulatory requirement for US health systems to use UDIs is lacking. Through semi-structured interviews, the authors identified barriers to implementing UDI systems and strategies to overcome them.
  24. Content Article
    Tracey Cammish, Patient safety, Clinical Intelligence and Partnership Lead, explains why patient safety is central to everything NHS Supply Chain does, and why clinical and end-user experience is so important.
  25. Content Article
    The use of pelvic mesh was paused in the UK in 2018 after some patients developed complications and severe pain following the treatment. In this report for CNA, a Singapore-based news channel, Kath Sansom, founder of campaign group Sling The Mesh, talks about the severe pain and life-changing side effects she experienced after pelvic mesh surgery. The report highlights the risks associated with mesh removal surgery, the fact that women harmed by mesh have been dismissed and ignored by the healthcare system, and concerns that the number of patients who experience complications from pelvic mesh has been underestimated. It also outlines the need for stronger medical device regulation in the UK, and looks at issues with compensation and redress for patients harmed by mesh.
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