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Showing results for tags 'Medical device'.
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Community Post
Birth with no cutting or tearing; decreasing avoidable harm in childbirth to both baby and mum
Dr Zenko Bilas posted a topic in Maternity
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We should all strive to keep antibiotics working for our NHS surgeons and future generations, by decreasing antibiotic use in medicine. It is mums themselves who could dramatically decrease antibiotic use, in the only medical specialty where this is possible - in obstetrics - by keeping skin intact; by being informed of the 10cm diameter that 'Aniball' and 'Epi-no Delphine Plus' birth facilitating devices, the mechanical version of Antenatal Perineal Massage, achieve by skin expansion (much like by 'earlobe skin expanders') prior to birth, for back of baby's head. This enables a normal birth for many more babies by shortening birth, with no cutting (episiotomies) or tearing, and much fewer Caesarean sections, as each Caesarean section requires antibiotics to be injected into mum, to kill any bacteria, which might have invaded a skin cell, from being implanted with that skin cell, deep into the wall of the uterus, by the surgeon's knife. There are around 750,000 births in the UK alone and three-quarters of mums are damaged during birth and at risk of developing infection; so a dramatic decrease in antibiotic use is possible. Empowering mums with knowledge; that both the skin and the coats of the pelvic floor muscles, which form the floor of the lower tummy, can be stretched painlessly, in preparation of birth, from the 26th week of pregnancy, so a gentler, kinder birth for both baby and mum becomes possible by decreasing risky obstetric interventions. Muscle can be stretched to 3 times its original length, if stretched painlessly over 6 or more occasions, and still retains its ability to recoil back, contracting to its original length. So there is no damage to mum. Baby's delicate head is not used to achieve this 'birth canal widening', because Antenatal Perineal Massage or Aniball or Epi-no Delphine Plus have already achieved this prior to the start of birth. In birth this stretching is rushed within the last 2 hours of birth, with risk of avulsion of pelvic floor muscle fibres from the pubic bone and risk of skin tearing or the need for episiotomy. The overlying skin will likewise stretch without tearing if done over 6 or more occasions. The maximal opening in the outlet or lower part of the pelvis is 10cm diameter, so 10cm diameter is the goal of the birth aiding devices and 'Antenatal Perineal Massage' or 'Birth Canal Widening' - opening doors for baby maximally. The mother reviews on 'Aniball' and 'Epi-no Delphine Plus' are impressive: Wanda Klaman, a first time mum, gives birth at nearly 42 weeks to a 4.4kg baby, with no need for episiotomy or forceps; Sophie of London, avoids episiotomy, when forceps are used to aid delivery for her baby who lays across her tummy - transverse lay, because the skin at this opening is so stretchy thanks to the birth facilitating devices. Cochrane Collaborate Report on Antenatal Massage https://pubmed.ncbi.nlm.nih.gov/23633325/ https://www.dailymail.co.uk/news/article-7450045/Fears-infections-pandemic-grow-NINETEEN-new-superbugs-discovered-UK.html https://www.mirror.co.uk/news/uk-news/mistakes-maternity-wards-setting-nhs-22702909- Posted
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Content ArticleIn this blog, Sling the Mesh founder Kath Sansom highlights the variation in medical treatment depending on where you live in the world. Describing patient safety advocacy as "like a giant game of chess—but a hideous version where innocent people get hurt," she describes recent developments in the use of pelvic mesh globally. New Zealand recently suspended the use of a particular type of pelvic mesh at the same time as a Canadian study recommended its use for stress urinary incontinence (SUI). Kath gives a brief history of mesh sling suspension and argues that patient safety needs joined up thinking to protect women around the world.
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Content Article
This is part of our series of Patient Safety Spotlight interviews, where we talk to people working for patient safety about their role and what motivates them. Kath talks to us about why she set up Sling the Mesh and the significant impact that campaigning has on her life. She also highlights the need to establish systems that will identify and prevent avoidable harm, including long term tracking to investigate trends of harm, reporting of industry payments to clinicians and making logging side effects mandatory for healthcare professionals. -
Content ArticleThis investigation aims to improve patient safety by supporting healthcare staff in a surgical setting to select and insert the appropriate type of implant (vascular graft) for haemodialysis treatment. The Healthcare and Safety Investigation Branch (HSIB) explored the factors that affect the ability of staff to safely select and insert vascular grafts for haemodialysis treatment. The national investigation focused on: The identification of factors within the healthcare system as a whole that influence patient safety risks associated with the selection and insertion of vascular grafts in an operating theatre environment. Exploration, using a systems approach, of the design of labelling and packaging used for the different types of vascular grafts for patients on haemodialysis treatment. Exploration of the impact on operating theatre teams of staff redeployment and repurposing of working environments in response to the COVID-19 pandemic.
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Content ArticleIn this blog post, Kath Sansom, founder of the Sling the Mesh campaign, looks at the issue of payments being made to doctors and lobby groups by pharma and medical tech companies. She argues that these payments are a patient safety concern as it can lead to doctors displaying bias in advising treatments, with benefits being overstated and risks downplayed. This is especially concerning when industry money is given to consultants or researchers trialling new treatments. Kath highlights an investigation carried out by the Observer into the issue and explains why Sling the Mesh have lobbied the UK Government for a UK Sunshine style payment act, which would allow the public to look up the names of doctors, surgeons and researchers to see if they have taken money from industry.
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Community PostWe are looking into introducing a new device to deliver CPAP at ward level into our trust. Currently we use NIPPY machines which can deliver some PEEP when in a selected mode, however the downfall to this is, it can only produce an oxygen concentration of around 50%. Often, the patient groups that require this intervention are on high oxygen requirements and so particularly in the early stages would benefit from a device that could deliver both. I have previously worked with Pulmodyne 02-Max trio which allows up to 90% oxygen and PEEP up to 7.5cmH20. Majority of patients responded very well to this treatment. I wondered whether any other trusts/ team have any other experiences/ devices that they may use and recommend? @Danielle Haupt@Claire Cox@Emma Richardson@Mandy Odell@PatientSafetyLearning Team@Patient Safety Learning@Patient safety Hub@CCOT_Southend
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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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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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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. -
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. -
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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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. -
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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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 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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