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Showing results for tags 'Medical device'.
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Content Article
Patient Safety Commissioner redress project (July 2023)
Patient-Safety-Learning posted an article in Women's health
In 2020, the Independent Medicines and Medical Devices Safety Review (IMMDS), chaired by Baroness Cumberlege, highlighted the avoidable harm caused by both pelvic and sodium valproate. It also set out the devastating impact on people’s lives when patients’ voices go unheard. The Minister for Mental Health and Women’s Health Strategy, Maria Caulfield MP, asked the Patient Safety Commissioner (PSC) to explore redress options for those who have been harmed by pelvic mesh and sodium valproate. The work will focus on what a suitable redress scheme for those affected should look like, to meet the needs of those affected. The PSC will publish a public report of this work. Once the project is complete, the Government will consider the report and set out next steps. The project will engage with patients through: meeting patients and their representative organisations. an online survey to gather views, which will be launched in due course. -
Content ArticleThree years since Baroness Cumberlege published her damming First Do No Harm report and a new report will look into financial redress for women injured by pelvic mesh. The latest project, announced this week by Patient Safety Commissioner Dr Henrietta Hughes, will involve talking to patient groups and individuals to ask women what they want. The government will then make a decision on next steps. While it is tiring to see a report, following a report after a report, it is a step forwards from when the government refused to offer financial redress, instead promising to toughen regulations and systems to improve patient safety.
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Content ArticleThe author of this blog published by Sling the Mesh, writes that ever year new healthcare treatments are launched underpinned by flawed, mischievous, flimsy and fraudulent scientific evidence – also known as cheating. They look at different types of cheating and argue that cheating helped push surgical mesh implants as ‘gold standard’.
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Content ArticleFollowing an extensive process of internal and external engagement, the Medicines and Healthcare products Regulatory Agency has published their corporate plan for the next 3 years. Their priorities are: Maintain public trust through transparency and proactive communication Enable healthcare access to safe and effective medical products Deliver scientific and regulatory excellence through strategic partnerships Become an agency where people flourish alongside a responsive customer service culture.
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Content ArticleMaking data on medical interventions easier to collect and collate would increase the odds of spotting patterns of harm, according to the panel of a recent HSJ webinar. When Baroness Julia Cumberlege was asked to review the avoidable harm caused by two medicines and one medical device, she encountered no shortage of data. “We found that the NHS is awash with data, but it’s very fractured,” says Baroness Cumberlege, who chaired the Independent Medicines and Medical Devices Safety Review and now co-chairs the All-Party Parliamentary Group which raises awareness of and support for its findings. It was a challenge on which Professor Sir Terence Stephenson had cause to deeply reflect back in 2014. That was the year in which he was asked to chair an independent review of medical devices, following concerns about the safety of metal-on-metal hip replacements and PIP silicone breast implants. “The NHS stepped up to the plate really quickly and said: ‘Even if it’s a private hospital that put this in, we will take it out to protect your safety,’” recalled Sir Terence, now Nuffield professor of child health at Great Ormond Street Institute of Child Health and chair of the Health Research Authority for England. “But the big problem was they couldn’t identify who had which implants. No doubt somebody somewhere had written this down with a fountain pen and then someone spilt the tea over it and the unique information was lost.”
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Content ArticleDavina McCall’s documentary Pill Revolution missed an opportunity to validate painful experiences of intrauterine devices and promote better practice, writes Stephanie O'Donohue, Patient Safety Learning's Content and Engagement Manager, in an opinion piece for the BMJ.
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Content ArticleIn this blog, Kath Sansom, founder of campaign group Sling the Mesh, outlines her concerns about three new mesh products for muscle and tendon injuries that have been given near automatic approval by the US Food and Drug Administration (FDA). She highlights that although the manufacturers claim the products have caused no sensitivity issues and no adverse responses in animals, there is no data on the potential long term impact of the mesh devices. Highlighting the knowledge that we now have about the potential for surgical mesh to cause severe injury and side-effects, Kath raises concerns about the lack of regulatory rigour and the potential for these degradable devices to cause fibromyalgia and other systemic issues. Read more about the approval of products for shoulder soft tissue repair
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Content Article
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This blog provides an overview of a Patient Safety Management Network (PSMN) meeting discussion on 9 June 2023. At this meeting, members of the Network were joined by Dr Henrietta Hughes, Patient Safety Commissioner for England. The PSMN is an informal voluntary network for patient safety professionals in England. Created by and for patient safety managers, it provides a weekly drop-in session with guests to talk through issues of importance to patient safety managers, providing information, peer support and safe space for discussion. Find out about the network. -
Content ArticleDoctors are taught from medical school about the benefits of IUDs, and often encourage patients that they are a good contraceptive option. However, recent media attention on the pain that some women suffer when having their IUDs fitted has started conversations about the need for cervical blocks and more honest counselling of women about the procedure. Rebekah Fenton, adolescent medicine fellow at Lurie Children's Hospital of Chicago, joins us to talk about how she counsels her patients, and why the most important thing is to make sure women are in charge of their reproductive healthcare decisions.
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Content Article
Transvaginal mesh case record review (20 June 2023)
Patient Safety Learning posted an article in Women's health
The final report on the Transvaginal Mesh Case Record Review. -
News Article
Mesh surgery women not given accurate advice, says report
Patient Safety Learning posted a news article in News
Women who underwent mesh surgery were not given accurate information before the life-altering procedure, a case review has found. The study also said poor communication between patients and doctors led, in some cases, to mistrust. Medical notes were often misleading or did not detail the surgery that had occurred or its outcomes. The review spent two years looking at the cases of 18 women who received transvaginal mesh implants. It has now called for a comprehensive register to be set up to keep track of women who have had operations to remove mesh in Scotland, abroad and privately. The Transvaginal Mesh Case Record Review by Glasgow Caledonian University makes a series of other recommendations, including: Better aftercare following surgery Clear language so patients understand exactly what surgery is going to achieve. Read full story Source: BBC News, 21 June 2023 -
Content Article
PIT stop (prosthesis/implant timeout) checklist
Nigel Roberts posted an article in Surgery
The PIT stop (prosthesis/implant timeout) checklist is Birmingham Women's and Children's NHS Trust's visual and aid memoir. It was launched to limit 'human error' and thus preventing never events (wrong implant/prosthesis). The four steps cover the intra-operative stages when implants are required. It works by recording what is requested on a small, hand held white board, and works in harness with the NatSSIPs 8, specifically step 5 of the infographic that has been previously developed. -
News Article
Self-propelling robot endoscope ‘could make bowel cancer screening comfortable’
Patient Safety Learning posted a news article in News
A soft robotic device that moves through the body like a worm could make bowel cancer screening much more comfortable by reducing pain and and discomfort, according to the scientists developing it. Researchers at Imperial College London said they have created a new type endoscope that is soft, flexible, and capable of extending and curling on its own inside the body. Around 900,000 colonoscopies – which involves an endoscope being passed through the bottom – are performed every year in the UK, the majority of which are for screenings for bowel cancer. The procedure is invasive and more than 75% of patients develop significant pain, according to Nisha Patel, a consultant gastroenterologist at Imperial College Healthcare NHS Trust in London, who is running clinical trials with the device. She said: “We know patients experience either discomfort or pain during the procedure and this affects uptake of further procedures and patient experience. The experts are also hoping that compared to current endoscopes, which requires specialist skills, their self-propelling robotic version will be easier to use and could, in future, be deployed in GP surgeries or outpatient clinics. Read full story Source: The Independent, 18 June 2023 -
Content ArticleMP Emma Hardy and Sling The Mesh drafted a letter to MP Maria Caulfield for an update on mesh centres, waiting times and outcome measures. The letter was sent in January 2023 and the reply has been received this week and shared by Sling the Mesh.
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News Article
Ayrshire MSP Katy Clark wants ban on surgical mesh use in hernia ops
Patient Safety Learning posted a news article in News
AN Ayrshire MSP has called for an end to surgical mesh being implanted in hernia patients in Scotland. A Freedom of Information request by Labour's Katy Clark has revealed that one in 12 of all hernia patients in NHS Ayrshire and Arran who have been implanted with surgical mesh since 2015 have been readmitted to hospital due to complications. And the West of Scotland MSP has backed a petition by constituents calling for the suspension of the use of surgical mesh until an independent review has been carried out. It follows the recent public health scandal over the pain and suffering endured by many women across Scotland implanted with transvaginal mesh. It took years of tireless campaigning by affected women before the Scottish Government took action, last year creating a mesh removal reimbursement scheme. Read full story Source: Irvine Times, 9 June 2023 -
Content Article
At Patient Safety Learning we believe that sharing insights and learning is vital to improving outcomes and reducing harm. That's why we created the hub; to provide a space for people to come together and share their experiences, resources and good practice examples. We’ve selected twelve useful resources about diabetes. Self-management is perhaps the most important aspect of treating diabetes effectively, so we've included some resources aimed at helping patients manage their diabetes too. Diabetes is a condition that causes the amount of glucose in a person's blood to be too high. When you have type 1 diabetes, your body can’t make any insulin at all, whereas with type 2, you either can’t make enough insulin, or it can’t work properly. There are also other types of diabetes including gestational diabetes, which some women develop during pregnancy, maturity onset diabetes of the young (MODY) and latent autoimmune diabetes in adults (LADA). It is important that people with diabetes are supported to maintain good blood glucose control through diet, insulin and other diabetes medications, to prevent both acute and long-term complications, -
News Article
New super registry: all implanted medical devices to be tracked
Patient Safety Learning posted a news article in News
A ground-breaking, mandatory national medical device outcome registry has been launched to collate detailed information on all procedures involving high-risk (Class III/IIb) devices, including pacemakers, hip joint replacements and breast implants. Led by NHS England’s Outcomes and Registries programme, and developed in partnership with NEC Software Solutions (NEC), the Medical Device Outcome Registry platform (MDOR) will capture data on over two million medical device procedures and more than 10 million unique devices used on patients each year across the NHS and independent healthcare sector, addressing recommendations from the Cumberlege review and Patterson inquiry. Collecting key details of the procedure, the clinicians involved and devices used, the registry will include clinical observational and patient outcome data, providing a single, comprehensive repository to improve patient safety and outcomes. Scott Pryde, delivery director for the Outcomes and Registries Programme, NHS England, said: “Millions of people receive high-risk medical devices and implants every year. Whereas most procedures are a complete success, when things go wrong it can result in serious harm for the patients affected. The Medical Device Outcome Registry will be responsive to concerns about the safety and outcomes of patients who receive high-risk medical devices, such as implants, and will use the data to actively detect, predict and prevent patient harm, and improve outcomes for patients". “The result will be in a step change in improving patient safety in these procedures, providing clinicians and healthcare teams with secure access to critical information they can use to inform clinical decisions and improve the experience of patients before, during and after their procedures.” Read full story Source: Clinical Services Journal, 31 May 2023 -
Content ArticleThis letter is a resource for patients to help GPs identify the complications of pelvic mesh. It explains signs and symptoms of women presenting with pelvic mesh-related conditions and if required, where to signpost them for further help. It has been issued by the Patient Safety Commissioner for England, developed in partnership with the patient campaign groups Sling the Mesh and the Rectopexy mesh victims and support.
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Content ArticleIn Australia, as in many other countries, the harms caused by transvaginal mesh surgery have prompted individual and collective attempts to achieve redress. Media outlets covered aspects of the rise of mesh surgery as a procedure, the experience of mesh-affected women and the formal inquiries and legal actions that followed, The authors of this article in the journal Health Expectations conducted a media analysis of the ten most read Australian newspapers and online news media platforms, focusing on how mesh and the interaction of stakeholders in mesh stories were presented to the Australian public. They found that mass media reporting, combined with medicolegal action and an Australian Senate Inquiry, appears to have provided women with greater epistemic justice, with powerful actors considering their stories. They argue that although medical reporting is not recognised in the hierarchy of evidence embedded in the medical knowledge system, in this case, media reporting has contributed to shaping medical knowledge in significant ways.
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Content Article
Patient survey: Halfloop medical device app
Patient Safety Learning posted an article in Apps for health and care
Halfloop are a team of senior doctors and developers building a digital platform where patients can store information securely about their medical implants and share their progress and outcomes securely with their clinical team. They would like to hear your views by asking you to complete their short survey. -
News ArticleA brand-new genetic research resource, known as a ‘biobank’, will be piloted by the Medicines and Healthcare products Regulatory Agency (MHRA) in a joint venture with Genomics England to better understand how a patient’s genetic makeup can impact the safety of their medicines. The Yellow Card biobank, which will contain genetic data and patient samples, will operate alongside the MHRA’s Yellow Card reporting site for suspected side effects and adverse incidents involving medicines and medical devices. It forms part of a long-term vision for more personalised medicine approaches, as scientists will use the repository of genetic information in the biobank to determine whether a side effect from a medicine was caused by a specific genetic trait. This will in turn enable doctors to target prescriptions using rapid screening tests, so patients across the UK will receive the safest medication for them, based on their genetic makeup. Adverse Drug Reactions (ADRs), or side effects, continue to be a significant burden on the NHS and account for one in 16 hospital admissions. Understanding the underlying mechanism of an adverse reaction would support the development of pharmacogenetic testing strategies, such as the screening tests enabled through the information provided by the Yellow Card biobank. These strategies would in turn provide the opportunity to prevent rather than react to adverse drug reactions. The biobank pilot will officially begin on 1 June 2023 with participant recruitment commencing later this year, on 1 September. Read full story Source: MHRA, 25 May 2023
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Content Article
Medical device safety: effective testing is key
NicholasTHFarr posted an article in Medical devices (new)
In this blog, University of Sheffield based researcher Dr Nicholas Farr explains why investing in the development of testing methods is key to ensuring medical devices are safe to use. His current work focuses on how the materials used in medical devices react within the body. Most recently, he has looked at mesh implants and how they degrade and change over time. Nicholas and colleagues at the University of Sheffield have developed innovative testing methods that mimic key features of the human body within the lab. He believes this will improve our understanding of the materials being used in the development of medical devices at an early stage in the process – saving time and money, and reducing the risk of patient harm. -
Content ArticleStandardised data and integration of systems are vital for full traceability, improving patient safety, and enabling swift action in healthcare incidents. The PIP breast implant scandal was not the first and transvaginal mesh will not be the last. In fact, the next national patient safety scandal is likely manifesting today. “There needs to be better processes to ‘track and trace’ patients who have received a device when a problem arises,” says Professor Sir Terence Stephenson, Nuffield professor of child health at UCL Great Ormond Street Institute of Child Health and chair of the Health Research Authority for England, in the Scan4Safety 2020 report. “Clear strategies and channels are needed to inform patients, the public and clinical professionals to help improve safety.” One common denominator among such incidents is the lack of traceability – limited visibility of the devices used, when and where they are used and, most importantly, in or on which patients. This is where standardised data comes into play. There is no shortage of data in the NHS. However, the ability to standardise and share that data between systems and organisations is something the health service as a whole still lacks. Today, achieving full traceability remains a key challenge for the NHS, with repercussions that continue to have a detrimental effect on patient care.
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Content ArticleAccording to a recent report by Growth Plus Reports, the global female pelvic implants market was valued at US$ 232.50 billion in 2022 and is expected to surpass US$ 318.58 billion by 2031. Request the full report and find out more via the link below.
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Content Article
Transvaginal Mesh, Part 2: Deadly Devices (17 May 2023)
Patient_Safety_Learning posted an article in Women's health
In this opinion piece for Trust the Evidence, Carl Heneghan and Tom Jefferson draw on data to argue that a 'smokescreen of safety' has long been used in marketing mesh products.
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