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Found 70 results
  1. 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
  2. News Article
    In a Letter to the Editor published in The Times yesterday, the All Party Parliamentary Group on First Do No Harm Co-Chair Baroness Julia Cumberlege argues in favour of the work of the Independent Medicines and Medical Devices Safety (IMMDS) Review and its report 'First Do No Harm'. "Inquiries are only as good as the change for the better that results from their work." Read full letter (paywalled) Source: The Times, 5 January 2021
  3. 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
  4. Content Article
    The pandemic’s effect on non COVID-19 care and treatment While the healthcare system has rightly focused its attention on the deadly effects of COVID-19, we made the case this year that we need to pay attention to patient safety now more than ever; the pandemic has both magnified existing patient safety issues and created new challenges. One major area of our focus has been the pandemic’s impact on non COVID-19 care and treatment, and the consequences for patient safety. To develop our understanding of this issue, in March we launched our #safetystories campaign, asking for patients with issues not related to COVID-19 – and yet facing new challenges because of it – to share their stories with us on the hub. Our aim was to find common themes and report to healthcare leaders with our insights, so we could help close emerging patient safety gaps as the health and care system prioritised COVID-19. Later that month, we published our first blog on the potential impact of COVID-19 on patient safety, outlining where we thought the pandemic would have the biggest impact on patient safety. The pandemic continues: identifying and addressing further risks to patient safety As the year progressed and we identified different risks to patient safety that were exposed by the pandemic, we urged: For patient safety considerations to be placed at the heart of the design and development of new ventilators for the NHS (March). At the time, the Government was focusing on the fast delivery of additional ventilators to meet increasing demand. This included development of ventilators, not just by established manufacturers, but also by companies who hadn’t previously produced them. For the Government to tackle patient and staff safety concerns arising from the increased pressure on social care (April). Social care was already under immense pressure well before the spread of COVID-19 but, as the pandemic took hold, the sector had to respond to additional risks, such as short supplies of PPE and the increased number of rapid hospital discharges. For trusts to address patient safety concerns impacting maternity services, particularly in relation to women choosing to have home births (April). This came after evidence suggested that more women were requesting to birth at home to reduce the risk of contracting COVID-19 while in hospital. For clarity around the large number of false negative COVID-19 test results (April). A high rate of false negative COVID-19 test results means that a significant number of people could be carrying the virus, wrongly assured they are not infectious. For the NHS to put in place a clear strategy to address the backlog of cases for elective surgery (June). We stressed the importance of this being done in a systemic way, with a published strategy that would help to ensure decisions regarding the priority of cases are made transparently and with patient safety at the forefront. Ensuring the voices of patients and staff are central to our work As our work in this area progressed, in May, we held a webinar with HealthPlusCare, titled ‘Patient safety: Time for questions? Non COVID-19 care and treatment’. Over 500 participants, including clinicians and patients, joined our discussion on the impact of the pandemic on non COVID-19 care and treatment. We used feedback from the discussion to inform our submission to the Health and Social Care Select Committee’s Inquiry, ‘Delivering Core NHS and Care Services during the Pandemic and Beyond’. Many issues we raised were highlighted in their report, published at the start of October. Looking forward As 2020 comes to a close and we move into the new year, the pandemic continues to hugely impact health and social care. We remain an independent voice for patient safety in this area, bringing attention to patient safety issues the pandemic exposes or creates, and engaging with partners to call for the NHS and Government to act urgently and reduce avoidable harm.
  5. 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
  6. Content Article
    This 5 minute video, from MedStar Health, focuses on the human cost to our healthcare workforce when we fail to cultivate a just culture and systems approach overall, but especially when managing unfortunate harm events. This story has inspired conversation and can be used widely as a teaching tool. When patient harm occurs, caregivers involved are often devastated along with the patient and family, yet many have had to navigate this storm alone. A systems approach in our healthcare workplace, along with the just culture, cultivates the sharing of knowledge and helps prevent patient harm from occurring altogether. If you'd like to share your thoughts on Annie's Story, the systems approach and building a just culture, please comment below or join the conversation in our forum – Analysing events without blame or shame.
  7. 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
  8. Content Article
    This paper from ABHI details the role of surgical instruments and how they bring value to the NHS. It highlights the vast range and number of instruments that are needed in the NHS at any one time and, to ensure that these instruments continue to be safe and fit for purpose, makes the following recommendations: Investment in the replacement of aged surgical instrument inventory should be considered as a priority for NHS spending. The procurement of surgical instruments should be based on overall quality and value, with the demonstration of strong ethical and resilient supply chains recognised and rewarded in purchasing decisions. There should be a focused, sustained and appropriately accredited programme of education into the management and maintenance of surgical instruments. Such a programme could be delivered in conjunction with industry.
  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. 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
  11. 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
  12. 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
  13. Content Article
    Actions required Primary actions to be completed by 7 October 2020: Identify and locate affected devices in your organisation. Identify alternative ventilators available on site. If no suitable alternative available, and capacity is an issue currently or expected imminently, follow protocol for resource shortage escalation set out by your local governance. Train all relevant staff on alternative ventilators and ensure training records are up to date. When actions 1–4 are complete, remove affected V60s from use and quarantine until repaired by the manufacturer. Place the alternative devices into service in place of the affected V60s. You may continue to use affected V60s if there is a risk of severe patient harm due to lack of ventilator availability. A thorough risk assessment must be completed, and additional monitoring must be used. A backup form of ventilation must be available at all times. Secondary action to be completed by 23 December 2020: 8. Review procurement and stock policies to ensure you are not reliant on one manufacturer or model of ventilator.
  14. Content Article
    During the debate on the second reading of the Bill there were contributions from a range of parliamentarians, reflecting on how it related to the recommendations in the recently published First Do No Harm report by the Independent Medicines and Medical Devices Safety Review, chaired by Baroness Cumberlege (also known as the Cumberlege Review). Some points of interest from the debate included: Baroness Cumberlege noting concerns that "rumours are absolutely rife of a ritual burial" of the First Do No Harm report. She noted plans to create a parliamentary group called First Do No Harm to ensure the recommendations of the report were implemented. She stated her intention to put down an amendment to the Bill to include a proposal to appoint a patient safety commissioner, one of the key recommendations of the report. In his closing comments Lord Bethell, Parliamentary Under-Secretary of State (Department of Health and Social Care), noted that this amendment had support from a number of members of the House of Lords and that they had sent "a clear message to the Government and the public that patient safety must be paramount in how we regulate medicines and medical devices". Follow the link below for the full transcript.
  15. 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
  16. 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
  17. Content Article
    Among the results reported by the Scan4Safety demonstrator sites, were: the release of 140,000 hours of clinical time back to patient care non-recurrent inventory reductions of £9m recurrent inventory savings worth nearly £5m across the six trusts.
  18. 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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