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Showing results for tags 'Medical device / equipment'.
Found 218 results
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News Article
Covid: Pulse oxygen monitors work less well on darker skin, experts say
Patient-Safety-Learning posted a news article in News
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 -
News ArticleThe 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
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Content Article
Jacqui Shaw, 54, underwent surgery for pelvic organ prolapse during which surgical mesh was inserted. She assumed the operation would improve her quality of life. Instead, her days are now blighted by agonising pain and despair. In this video, published on the Mail+, Jacqui bravely shares her story, and her uncertainty for the future. She describes how she found the support group Sling the Mesh, and subsequently many others who were also experiencing devastating consequences of surgical mesh. -
Content ArticleHealthcare Safety Investigation Branch (HSIB) looked into the suitability of equipment and technology used within maternity departments to conduct continuous fetal heart rate monitoring during labour and birth. Although there are multiple methods used to monitor fetal heart rate, the main equipment used is a continuous fetal heart rate monitoring is the cardiotocograph (CTG) machine. There has been some common safety issues identified with availability of equipment and functionality, staff understanding of the equipment and its purpose and an inability to understand and interpret the fetal heart rate. HSIB conducted an investigation into how cardiograph machines are used, any problems staff experienced while using them and problems that staff using them and how the equipment was purchased experienced, and how staff are trained and assessed as being competent to use them.
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Content Article
Needlestick injuries – making the point for safety
Becky T posted an article in Staff safety
An article outlining the significance of needlestick injuries - their risks to healthcare workers, their cost, and the importance of prevention. -
Content ArticleMedical device and drug safety recalls are on the up. But is there a way to predict which products will be recalled in the future?
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News Article
Alert over hospital air devices after 120 ‘never events’
Patient Safety Learning posted a news article in News
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 -
Content ArticleThis guide for people who inject insulin or GLP-1 to treat diabetes includes information on: how to correctly inject insulin where to inject to ensure insulin and GLP-1 medication enter the body correctly how to avoid ‘Lipos’ how to store medication correctly how to dispose of needles safely.
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Content ArticleThis checklist is for people who inject insulin or GLP-1 medication to treat their diabetes. It details the steps patients should take to ensure they inject their medication correctly and explains the impact of failing to take certain steps - such as moving injection sites and changing needles - on blood glucose control.
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Content ArticleTwo new factsheets from the Centers for Disease Control and Prevention (CDC) are intended to help healthcare workers, managers and purchase agents ensure the safe handling and disposal of sharps during the US's COVID-19 mass vaccination effort.
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News Article
Europe must act now to stop the spread of deadly diseases due to COVID-19
Patient Safety Learning posted a news article in News
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 -
Content ArticleSince Claire Griffiths underwent a rectopexy operation she has suffered almost constant, debilitating pain. In this article, published by Yahoo Style, she describes her experience and the devastating impact on her life. Also quoted in the article is Sling the Mesh’s founder Kath Samson, who says:"Nobody really knows how many are suffering because the NHS and the regulatory body the MHRA has not kept a database of how many women have had the operation and how many are suffering."
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Content Article
Kath Sansom, is a journalist and campaigner who, following a pelvic mesh implant, was left in intense pain and subsequently founded the Sling the Mesh campaign. In this powerful opinion piece, Kath highlights the lack of transparency and reporting around financial conflicts of interest in UK healthcare, and why this poses a serious threat to patient safety. Drawing on legislation that was introduced in the US and recommendations from the Cumberlege Review, Kath calls for urgent action to be taken to prevent patients from suffering harm in the future. -
Content ArticlePatient safety alerts are issued to providers of NHS care to support them to take specific actions to keep patients safe. Although some content of past alerts is outdated, some of the actions from previously issued alerts continue to be relevant and remain valid beyond the timescales of the original alert. Over 140 alerts issued up to November 2019 (including ‘notices’ or ‘rapid response reports’) were recently clinically reviewed to identify which actions within those alerts remain valid and should be considered as ‘enduring standards’. The review covered alerts issued by the NHS England and NHS Improvement National Patient Safety Team and its predecessor organisation, the National Patient Safety Agency (NPSA). The review also summarised other content from the alerts identified as general principles that can be applied more widely to inform wider ongoing safety improvement. The key elements from the review are highlighted. The pages do not set out any new actions for organisations to implement, but act as an aid to support providers to confirm that ‘enduring standards’ from previously completed alerts have been embedded locally, and that the general principles are considered within ongoing patient safety improvement.
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News ArticleDeborah 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
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News ArticleHospitals 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
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News ArticleIn 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
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News ArticleIn 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
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News ArticleAn 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
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Content ArticleEarlier 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.
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News Article
England set to open specialist surgical mesh removal centres in April
Patient Safety Learning posted a news article in News
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 -
Content ArticleAnnie'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.
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News Article
Essure: Women in England take legal action against sterilising-device maker
Patient Safety Learning posted a news article in News
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 -
Content ArticleThe 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.
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Content ArticleIn 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.
