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Found 225 results
  1. News Article
    An Independent Patients' Commissioner is set to be appointed to act as champion for people who have been harmed by medicines or medical devices. Baroness Cumberlege, who recommended the new role in a landmark report earlier this year, announced that the government had budged on the issue after initial resistance. She welcomed the move saying: "Had there been a patient safety commissioner before now, much of the suffering we have witnessed could have been avoided." But she added "the risk still remains" and further urgent action is needed to protect patients from potentially harmful drugs." At an online meeting of parliamentarians, the baroness described the testimony of a victim of the medical device vaginal mesh, which has left some patients in chronic pain. The woman had told her review team: "This device took everything from me. My health, my life, my job, my dignity, my marriage, my freedom." Reflecting on this the baroness added: "The scale of suffering we witnessed means nothing short of profound change is necessary. Not necessary in a couple or three years, but necessary now." Read full story Source: Sky News, 16 December 2020
  2. Content Article
    Earlier this week, Patient Safety Learning’s Chief Executive, Helen Hughes, looked back over 2020, highlighting some of the big themes in patient safety we’ve seen this year and our own work in these areas. This is the first of five mini blogs, where we give an overview of each of these themes in turn. In this blog, we look at the impact COVID-19 has had on patient safety. As an additional option to the text below, you might like to watch the following short video from our Business and Policy Manager, Mark Hughes.
  3. 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
  4. Content Article
    Annie's story is an example of how healthcare organisations seeking high reliability embrace a just culture in all they do. This includes a system's approach to analysing near misses and harm events – looking to analyse events without a blame and shame approach.
  5. 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
  6. Content Article
    The purpose of the US Joint Commission's National Patient Safety Goals is to improve patient safety. The goals focus on problems in healthcare safety in the USA and how to solve them. They include identifying patients correctly, improving staff communication, use medicine safely, use alarms safely, prevent infection, identify patient safety risks and prevent mistakes in surgery.
  7. Content Article
    In 2002 the UK Department of Health and the Design Council jointly commissioned a scoping study to deliver ideas and practical recommendations for a design approach to reduce the risk of medical error and improve patient safety across the National Health Service (NHS). The research was undertaken by the Engineering Design Centre at the University of Cambridge, the Robens Institute for Health Ergonomics at the University of Surrey and the Helen Hamlyn Research Centre at the Royal College of Art. The research team employed diverse methods to gather evidence from literature, key stakeholders, and experts from within healthcare and other safety-critical industries in order to ascertain how the design of systems—equipment and other physical artefacts, working practices and information—could contribute to patient safety. Despite the multiplicity of activities and methodologies employed, what emerged from the research was a very consistent picture. This convergence pointed to the need to better understand the healthcare system, including the users of that system, as the context into which specific design solutions must be delivered. Without that broader understanding there can be no certainty that any single design will contribute to reducing medical error and the consequential cost thereof.
  8. Content Article
    The need for radical investment and reform of diagnostic services was recognised at the time the NHS Long Term Plan was published in 2019. This report, commissioned by NHS England at that time, alongside a review of adult screening services, was nearing publication before the COVID-19 pandemic struck. However, while the recommendations made pre-pandemic still stand, additional actions will be needed to deliver safe, high quality diagnostic services in an endemic phase of the disease and to support the recovery of diagnostic services.
  9. 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
  10. Content Article
    Susan Warby, 57, was mistakenly given a glucose rather than a saline drip at West Suffolk Hospital after an operation for a perforated bowel in July 2018. Staff noticed a rise in blood sugar concentrations but gave her insulin to lower them rather than check the drip, which remained in place for 36 hours. In 2008 the National Patient Safety Agency made recommendations for safe arterial line management. In 2014 the Association of Anaesthetists published guidelines aimed specifically at preventing such events. Structured processes to prevent inadvertent use of a glucose-containing fluid to flush an arterial line and regular blood glucose sampling from a location other than the arterial line are only partial solutions. However, a survey of management of arterial lines undertaken in 2013 indicated that this was a common problem, that many of the NPSA recommendations were not widely implemented and that almost one third of respondents were aware of ‘wrong flush’ errors on their unit and a further third in other locations within their hospital. In this Rapid Response in the BMJ, Tim Cook says now is the time for patient representatives, clinicians, regulators and industry to work together to achieve widespread implementation of an engineered solution to prevent arterial line errors.
  11. 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
  12. 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
  13. Content Article
    Surgical instruments are essential for the delivery of modern healthcare. Their use is so widespread that they are easily taken for granted. The supplier base for instruments is diverse, including small, family owned businesses, and large multinational corporations. What they have in common are complex manufacturing processes, global supply chains, broad product ranges to suit varying clinical needs and product development with the capacity to innovate as required.
  14. 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
  15. Content Article
    In March 2020 Philips Health Systems released an FSN concerning V60 ventilators. This FSN concerned a hardware fault in the device, which can result in an unexpected shutdown. 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 to the user. If a device fails in use and does not alarm, the patient will not be adequately ventilated and there is a potential risk of brain damage or death, depending on how long it takes clinicians to become aware of the situation and respond. There has been a significant delay of replacement parts arriving in the United Kingdom, resulting in an increased risk of this failure occurring. The MHRA has decided to update the guidance issued in the Medical Device Alert published in June. The MHRA will continue to work with the manufacturer to improve the delivery time for replacement components.
  16. 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
  17. Content Article
    A National Patient Safety Alert has been issued on the risk of foreign body aspiration during intubation, advanced airway management or ventilation. Foreign body aspiration can occur if loose items are unintentionally introduced into the airway during intubation, ventilation or advanced airway management. This can lead to partial or complete airway blockage or obstruction, and if the cause is not suspected, can be fatal. The most common types of foreign bodies identified in incident reports were transparent backing plastic from electrocardiogram (ECG) electrodes and plastic caps of unclear origin. The alert asks providers to reduce this risk by purchasing safer alternative equipment without loose and transparent parts. Providers are also asked to develop or amend local protocols to ensure pre-prepared intubation and advanced airway management devices are covered or protected until use; and that the ends of reusable breathing system hoses are closed between patient cases.
  18. Content Article
    This was a debate from the House of Lords on the 2 September 2020 on the second reading of the Medicines and Medical Devices Bill 2019-21. The intention of this bill is to confer power to amend or supplement the law relating to human medicines, veterinary medicines and medical devices; make provision about the enforcement of regulations, and the protection of health and safety, in relation to medical devices; and for connected purposes.
  19. Content Article
    Shanté Turay-Thomas, a young woman who had a nut allergy, died of an acute anaphylaxis after eating hazelnuts on 18 Spetember 2018. In this report, senior coroner ME Hassell, highlights 20 'matters of concern' surrounding her death and calls for action to be taken for future deaths to be prevented.
  20. Content Article
    An overview of the industry study by MxD and IAAE between February and June 2021 funded by FDA Office of Counterterrorism and Emerging Threats. The aim of the study was to gain an initial baseline to deepen FDA’s understanding of the factors that impact a manufacturer’s decision to invest in and adopt digital technologies by illuminating both perceived and demonstrated barriers from technical, business, and regulatory perspectives, and related cybersecurity considerations.
  21. News Article
    Inspectors raise ‘serious concerns’ about medical wards and emergency care at Shropshire NHS trust A patient bled to death on a ward at Shrewsbury and Telford Hospitals Trust after a device used to access his bloodstream became inexplicably disconnected, The Independent has learnt. The incident came to light as new concerns arose about quality of care at the Shropshire trust, with the Care Quality Commission (CQC) warning of “serious concerns” about its medical wards and emergency department following an inspection last month. Although the report from the inspection has not yet been published, it is understood that the trust has been served with a legal notice by the regulator to comply with more than a dozen conditions. It remains in special measures following the inspection and is rated inadequate overall. See full article in The Independent here
  22. News Article
    Ambulance chiefs are looking at alternative defibrillators after coroners highlighted confusion over how to correctly use their existing machines. London Ambulance Service (LAS) Trust has received two warnings from coroners since 2016 after the delayed use of Lifepak 15 defibrillators “significantly reduced” the chances of survival for patients, including a 15-year-old boy. Coroners found some paramedics were unaware the machines had to be switched from the default “manual” mode to an “automatic” setting. The first warning came after the death of teenager Najeeb Katende in October 2016. A report by coroner Edwin Buckett said the paramedic who arrived had started the defibrillator in manual mode and did not detect a heart rhythm that was appropriate for administering the device, so it was not used until an advanced paramedic arrived on scene 24 minutes later. The report stated the defibrillator had been started in manual mode but it needed to be switched to automatic to detect a shockable heart rhythm. The coroner warned LAS that further deaths could occur if action was not taken to prevent similar confusion. But another warning was issued to the LAS in March this year, following the death of 35-year-old Mitica Marin. Again, a coroner found the paramedic, who was on her first solo shift, had started the machine in manual mode and had not detected a shockable rhythm. It was suggested this caused a four minute delay in the shock being administered. Coroner Graeme Irvine said this was “not an isolated incident” for LAS and noted the trust had reviewed other cases of delayed defibrillation. They found that the defibrillator’s manual default setting was a “contributing factor” to the delays. Read full story (paywalled) Source: HSJ, 10 August 2020
  23. Content Article
    The International Electrotechnical Commission (IEC) is a worldwide organisation for standardisation comprising all national electrotechnical committees (IEC National Committees). The object of IEC is to promote international co-operation on all questions concerning standardisation in the electrical and electronic fields. This part of IEC 62366 specifies a process for a manufacturer to analyse, specify, develop and evaluate the usability of a medical device as it relates to safety. This usability engineering (human factors engineering) process permits the manufacturer to assess and mitigate risks associated with correct use and use errors, i.e., normal use. It can be used to identify but does not assess or mitigate risks associated with abnormal use.
  24. Content Article
    This report details the experiences of the Scan4Safety demonstrator sites. Six trusts implemented scanning of people, products and places over the two-year initiative, which was funded by the Department of Health and made extensive use of unique identifiers from GS1, a not-for-profit organisation that develops and maintains global standards for business communication. At these organisations, all patients have a barcode on their wristband which is scanned before a procedure. All equipment used for that procedure is also scanned – including implantable medical devices – and recorded against the patient and the location. At some trusts, staff even have barcoded badges which are scanned before a procedure so making it possible to identify which teams were identified in which procedures. The result is complete traceability alongside a full understanding of costs, at patient and clinical team level.
  25. News Article
    A national investigation has been launched into the equipment used by NHS staff to monitor babies heart rates during labour because of concerns they could be contributing to deaths and disabilities. The independent Healthcare Safety Investigation Branch (HSIB), which investigates systemic safety risks in the NHS, has opened an inquiry after reviewing hundreds of maternity incidents. It found equipment used to record cardiotocographic (CTG) traces were linked to 138 maternity investigations since 2018 with more than 238 separate findings referencing the use of CTG as a factor in the error. Read the full article here
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