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Showing results for tags 'Medical device'.
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Content ArticleThis study in Clinical Epidemiology aimed to investigate the long-term complications associated with surgical mesh devices used to treat stress urinary incontinence (SUI) and pelvic organ prolapse (POP). The authors looked at rates of diagnoses of depression, anxiety or self-harm (composite measure) and sexual dysfunction, and rates of prescriptions for antibiotics and opioids in women with and without mesh surgery, with a diagnostic SUI/POP code, registered in the Clinical Practice Research Datalink (CPRD) gold database. The study found that mesh surgery was associated with poor mental and sexual health outcomes, alongside increased opioid and antibiotic use, in women with no history of these outcomes and improved mental health, and lower opioid use, in women with a previous history of these outcomes. The authors highlight the need to carefully consider the risks and benefits of mesh surgery on an individual basis.
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News ArticleThe Medicines and Healthcare products Regulatory Agency (MHRA) has issued a national patient safety alert for the NovoRapid PumpCart prefilled insulin cartridge and the Roche Accu-Chek Insight Insulin pump system following concerns raised about cracked cartridges and insulin leaks. Patients are being asked to check the pre-filled glass insulin cartridge for cracks prior to use. The cartridge should not be used if it has been dropped even if no cracks are visible. Closely follow the updated handling instructions in the pump user manual when changing pre-filled glass insulin cartridges. The device, which releases the insulin your body needs through the day and night, comprises a pump, tube, battery and a pre-filled glass insulin cartridge. In some of the reported leakage incidents, the cartridges were found to be cracked and provided an inadequate supply of insulin to patients. However, leakages also occurred in cases where no cracks in the cartridge were visible. In some patients there were consequences of not receiving enough insulin from their pump system, including reports of severely high blood sugar and diabetic ketoacidosis (a serious complication of diabetes when the body produces high levels of blood acids called ketones). Health care professionals are being advised to contact patients over the next six months using said device to discuss their individual needs and source an alternative pump where appropriate. Key patient recommendations are: Check the pump and cartridge regularly for damages, for example cracks or leakage. If you smell insulin (a strong antiseptic chemical smell) this could also indicate a leakage. Do not use the cartridge if cracks or leakage are seen or if the cartridge was dropped. Follow the instructions of your Accu-Chek Insight user manual for replacing a cartridge and for cleaning the cartridge compartment in the insulin pump. During the day and before going to sleep please carefully check that your insulin pump is delivering insulin and there are no leakages. Never change treatment delivery methods without first consulting a relevant healthcare professional. Failure of insulin delivery due to leakage may not result in an alert notification from the insulin pump and cracks and leakages may not always be visible. You should check blood glucose levels multiple times throughout your day whilst using pumps. Tell your healthcare professional immediately if you suspect a problem with your insulin delivery. Read full story Source: Gov.UK, 26 May 2022
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Content ArticleThe MHRA continues to receive serious reports of harm associated with insulin leakage for the NovoRapid PumpCart prefilled insulin cartridge in the Accu-Chek Insight Insulin pump. In some patients, there were serious consequences arising from inadequate supply of insulin, including diabetic ketoacidosis (DKA). Although the manufacturer Roche Diabetes Care (RDC) has implemented a number of risk minimisation strategies to reduce the incidence of these events, the impact of these is inconclusive and we are taking further action to protect patients. To protect patient safety, diabetes healthcare professionals should inform patients who use the Accu-Chek Insight of the risk of leakage. Clinical care decisions should be made to ensure patients are moved onto alternative pumps where possible.
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Content ArticleThe Queen’s Speech was debated on Tuesday 17 May 2022. Copied below is Baroness Julia Cumberlege's excerpts on fulfilling the recommendations of the Cumberlege Report for a redress scheme.
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Content ArticleIn this letter to Maria Caulfield MP, the All Party Parliamentary Group (APPG) First Do No Harm raises concerns that several recommendations from The Independent Medicines and Medical Devices Safety (IMMDS) Review have not so far been taken up by the government. The IMMDS Review looked at how the health system responds to reports from patients about harmful side effects from medicines and medical devices. It specifically looked at the cases of Primodos (a hormone pregnancy test), sodium valproate (an epilepsy medication) and pelvic mesh, and found that significant harm had been caused as a result of problems in the regulatory system and the reporting of side effects. It made a number of key recommendations to the government. The APPG highlights the urgent need to establish a redress scheme for those who have suffered avoidable harm related to the products in the IMMDS Review, a recommendation for which there is widespread cross-party support. They also express disappointment that the government continues to promote the litigation route for those who have suffered harm, arguing that it is an adversarial and difficult process for patients and families who have already suffered significant harm. The letter does recognise that the government has decided to appoint a Patient Safety Commissioner, as recommended by the IMMDS Review, and highlights the significance of this step.
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Content ArticleThousands of patients worldwide have experienced extreme pain and life-altering side effects as a result of surgical mesh implants. This report was commissioned by the New Zealand Ministry of Health to evaluate the project ‘Hearing and responding to the stories of survivors of surgical mesh: Ngā korero a ngā mōrehu – he urupare’, which addressed issues raised by people injured by mesh in New Zealand. A restorative approach to addressing harm in healthcare seeks to provide a collaborative, non-adversarial approach to resolving disputes. It recognises the need for relational interaction and conversation to support healing. The project's restorative process was co-designed in 2019 by the Ministry of Health, advocacy group Mesh Down Under, and researchers and facilitators from Te Ngāpara Centre for Restorative Practice at Te Herenga Waka, Victoria University of Wellington. The evaluation was led by a team at the Te Ngāpara Centre, who evaluated the experiences of 230 people who took part in the restorative process. They aimed to find out if the project objectives were met and whether a restorative approach could be used in other health contexts.
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Content ArticleGB News interviews Kath Sansom, founder of Sling the Mesh, and Alec Shelbrooke, MP, on the thousands of lives that have been ruined by mesh implants.
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Content Article
“There’s no problem with the mesh”: A personal account of the struggle to get vaginal mesh removal surgery
Anonymous posted an article in Women's health
In this blog, a woman who has suffered from severe pain and complications for 17 years due to transvaginal mesh shares her experience. She talks about how the device has changed her life, how her symptoms have been repeatedly dismissed by surgeons, and the variation she has witnessed between different specialist mesh centres.- Posted
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News Article
The US is trying to fix medical devices’ big cybersecurity problem
Patient Safety Learning posted a news article in News
Medical devices are one major weak point in health care cybersecurity, and both the US Congress and the Food and Drug Administration took steps towards closing that gap this week —Congress with a proposed bill and the FDA with new draft guidelines for device makers on how they should build devices that are less likely to be hacked. Devices like infusion pumps or imaging machines that are connected to the internet can be targets for hacks. Those attacks can siphon off patient data or put their safety directly at risk. Experts consistently find that devices in use today have vulnerabilities that could be exploited by hackers. The new document is still just a draft, and device makers won’t start using it until it’s finalised after another round of feedback. But it includes a few significant changes from the last go-around — including an emphasis on the whole lifecycle of a device and a recommendation that manufacturers include a Software Bill of Materials (SBOM) with all new products that gives users information on the various elements that make up a device. An SBOM makes it easier for users to keep tabs on their devices. If there’s a bug or vulnerability found in a bit of software, for example, a hospital could easily check if their infusion pumps use that specific software. The FDA also put out legislative proposals around medical device cybersecurity, asking asking Congress for more explicit power to make requirements. “The intent is to enable devices to be that much more resilient to withstand the potential for cyber exploits or intrusion,” Schwartz says. Manufacturers should be able to update or patch software problems without hurting the devices’ function, she says. Read full story Source: The Verge, 8 April 2022 -
Content ArticleThis briefing examines the results of a US study which showed that 80% of patients that have an infection from a cardiac implant are not treated according to clinical practice guidelines, increasing their chances of death from infection. When patients with implantable cardiac devices have an infection, current guidelines state that these devices should be removed, however, this did not happen for the majority of the 1,065,549 Medicare patients included in the study that had a cardiac implant infection between 2006 and 2019.
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Content ArticleAir flowmeters attached to piped medical air outlets are primarily used to drive the administration of nebulised medication; typically for short periods to manage respiratory conditions. Most other uses of piped medical air do not require an air flowmeter. Due to the proximity of the piped medical air and oxygen outlets at the bedside, and the similarity in design of flowmeters, there is a significant risk when using air flowmeters that patients may be inadvertently connected to medical air instead of oxygen. A previous alert and additional communications have sought to minimise the use of air flowmeters by encouraging their replacement with compressor or ultrasonic nebulisers, alongside additional risk reduction methods if air flowmeters remained in use. However, despite the measures outlined above, 108 Never Events describing unintentional connection were reported in a recent three-year period ; over a third of incidents occurred in emergency departments. Consequences included respiratory arrest, cardiac arrest, collapse (requiring ITU admission and ventilation), and nine incidents of incorrect connection when responding to cardiac arrest, which will have impacted on the chance of successful resuscitation; six patients subsequently died.
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Content ArticleIn this episode of the Institute of Economic Affairs (IEA) Podcast, IEA Head of Political Economy Dr Kristian Niemietz discusses the findings of the Independent Medicines and Medical Devices Safety Review, and how the healthcare system in England responds to reports about harmful side effects from medicines and medical devices. Kristian speaks with Simon Whale, panel member and communications lead for the Independent Medicines and Medical Devices Safety Review and Dr Sonia Macleod, lead researcher, Independent Medicines and Medical Devices Safety Review. They discuss how the NHS, and other health bodies, could improve their services to address poor care and prevent harm.
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Content Article
This joint letter calls on Maria Caulfield MP, Parliamentary Under Secretary of State for Patient Safety and Primary Care, to implement in full the recommendations of the Independent Medicines and Medical Devices Safety (IMMDS) Review on behalf of those harmed by the side effects of Primodos, Mesh and Sodium Valproate. It is signed by Marie Lyon from the Association for Children Damaged by Hormone Pregnancy Tests, Kath Sansom from Sling The Mesh and Emma Murphy and Janet Williams from In-Fact. -
News ArticleCampaigners found to have been harmed by medical products have written to the health secretary warning that government inaction is "causing pain and destroying lives" by ignoring review recommendations. Some 18 months ago, an independent review recommended financial help for people damaged by some products and drugs that had been prescribed by UK doctors. The government - which set up the Independent Medicines and Medical Devices Safety Review in the first place - has chosen to ignore several of its recommendations. Alleged victims of vaginal mesh, and the drugs valproate and Primodos, have written to Health Secretary Sajid Javid and Maria Caulfield to say they feel ignored. The letter states: "Our members gave evidence to the two-year-long review, sometimes travelling long distances, often with disabilities." "Families shared intimate details of their medical problems, their daily struggles, their difficulties parenting, sometimes even their sex lives. The panel, led by Baroness Cumberlege, was set up by the government to listen, assess and direct policy towards the best course of action. "What was the point of this exercise and the hard work of the panel, if their key recommendations are then ignored by the government?" In the letter, campaigners say: "The decision not to offer an agency for redress (Cumberlege recommendation 3) means that the review has lost its teeth." "Still, no one is facing consequences of medical failures other than the patients. At a time when the public is being asked to put its faith in vaccines, this is a bad look for the government." Kath Sansom, of the campaign group Sling the Mesh, said: "Women must dutifully accept their health has been irreversibly shattered by a medical product they were told was safe, some now needing a disabled blue badge, and they must put up and shut up." Read full story Source: Sky News, 17 February 2022 MeshPrimodosSodiumValproate_LettertoMariaCaulfield_170222.pdf
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Content ArticleThis decision aid is for women who have complications caused by pelvic mesh that was used to treat their stress urinary incontinence. Pelvic mesh has also been called ‘tape’, ‘net’ or a ‘sling’. Stress urinary incontinence is when you leak urine accidentally, especially during exercise or when you cough, laugh or sneeze. This decision aid has been written for women who have been referred to a specialist centre to treat complications from mesh used for stress urinary incontinence.
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Content Article
This is a joint blog by Patient Safety Learning and Sling the Mesh, highlighting key areas of concern included in their recent response to the Royal College of Obstetricians and Gynaecologists consultation on a new Mesh Complications Management Training Pathway. -
News ArticleThe US Food and Drug Administration (FDA) is warning healthcare providers, parents and caregivers of pediatric patients (children) who receive enteral feeding that there is a risk of strangulation from the use of enteral feeding delivery sets. The feeding set tubing can become wrapped around a child’s neck and cause strangulation or death. The FDA has received reports of two toddlers who died after being strangled by the tubing. Recommendations for parents and caregivers of children who use enteral feeding delivery sets: Be aware that the feeding set tubing can get wrapped around a child’s neck, which can lead to strangulation or death. To the extent possible, avoid leaving the feeding set tubing where infants or children can become entangled. Discuss with your child's health care provider: If your child has been tangled in their tubing before. Steps you can take to help ensure that tubing does not get wrapped around your child’s neck, such as keeping the tubing away from the child as much as possible. Any other concerns you may have about the risk of strangulation from feeding set tubing. If your child is injured by feeding set tubing, please report the event to the FDA. Your report, along with information from other sources, can provide information that helps improve patient safety. Recommendations for healthcare providers: Review this topic and the information noted above with your colleagues, care teams, and caregivers of pediatric patients who use enteral feeding delivery sets, to ensure they are aware of the potential risk of strangulation with the associated tubing and are taking appropriate measures to keep the tubing away from the child as much as possible. When caring for pediatric patients who receive enteral feeding and as part of an individual risk assessment, be aware of the risk of strangulation from the feeding set tubing and follow protocols to monitor medical line safety. If a patient experiences an adverse event related to enteral feeding set tubing, you are encouraged to report the event to the FDA. Prompt reporting of adverse events can help the FDA identify and better understand the risks associated with medical devices. Read full story Source: FDA, 8 February 2022
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Content ArticleThis is the transcript of a Westminster Hall debate in the House of Commons on fulfilling the recommendations of the Cumberlege Report.
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Content ArticleThis report looks at research commissioned by the Juvenile Diabetes Research Foundation (JDRF) to understand the varying pandemic experiences of different people affected by type 1 diabetes in the UK. It highlights an enormous withdrawal of NHS services during the pandemic, leading to highly unequal access to type 1 diabetes care.
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Content Article
On Wednesday 26 January, the All-Party Parliamentary Group for First Do No Harm (APPG FDNH) held a virtual public meeting on the topic of redress schemes for those who have suffered avoidable harm linked to pelvic mesh, sodium valproate and Primodos. This meeting was an opportunity to hear from representatives of various patient groups about what victims need and what they are missing from current support mechanisms. The meeting heard from Kath Sansom, founder of the Sling the Mesh campaign. Attached is the speech she presented and results from the Sling the Mesh survey. View the recording of the public meeting -
News Article
I travelled to the US and paid £19,000 to have mesh implant removed
Patient Safety Learning posted a news article in News
Anne Monie is one of hundreds of Scottish women to have suffered painful, life-changing side effects from mesh implants. She was fit and healthy when she went to her doctor with anterior prolapse and mild stress incontinence in 2010. But an operation to fit transvaginal mesh left her in agony. With nowhere to turn for help in Scotland, the 69-year-old spent £19,000 travelling to the US to get her implant removed. Anne spoke to BBC Scotland as the Scottish Parliament looks set to pass a bill which would see her and others reimbursed for the cost of private surgery. That may bring financial concerns to an end - but she is by no means cured. And she worries about other women still trying to go through the mesh-removal process. Anne was offered a simple "gold standard" transvaginal mesh procedure when she first sought medical help 12 years ago. But after the operation to fit it, she began to suffer from a range of problems and was left in chronic pain. After years of frustration, she paid to go to Missouri to have mesh removal surgery with world-renowned expert Dr Dionysios Veronikis. "It's a massive amount of money to be paying out, especially when you're retired. But then, what price do you put on health?" Read full story Source: The Guardian, 25 January 2022 -
EventThis Westminster Health Forum policy conference: will examine what is needed to improve diagnostic speed and outcomes. It will also be an opportunity to discuss the future outlook for medical device regulation in the wake of Brexit, with the MHRA having consulted on a more transparent and flexible approach. Further sessions look at supporting continued research and innovation, with the Government launching strategic and funding plans, including investment in modernising diagnostics as part of wider efforts to address waiting lists. Additional areas for discussion include: industry partnerships staff recruitment and retention learning from the response to COVID-19 opportunities for driving efficiencies. Keynote sessions with: Professor Sir Mark Caulfield, Professor of Clinical Pharmacology, Queen Mary University of London; Chief Executive Officer, Barts Life Sciences; and former Chief Scientist, Genomics England Dr Sarah Byron, Programme Director, Centre for Health Technology Evaluation, NICE Professor Louise Jones, Chair, Genomics and Reproductive Science Specialty Advisory Committee, Royal College of Pathologists; and Professor of Breast Pathology, Barts Cancer Institute Stephen Lee, Director, Diagnostics Regulation, Association of British Healthcare Industries Professor Michael Messenger, Principal Scientific Advisor for In Vitro Diagnostics, MHRA Doris-Ann Williams, Chief Executive, British In Vitro Diagnostics Association Register
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Event
First Do No Harm APPG: Virtual public meeting on redress
Sam posted an event in Community Calendar
untilOn Wednesday 26th January from 10:30-12:00, the All-Party Parliamentary Group for First Do No Harm (APPG FDNH) will hold a virtual public meeting on the topic of redress schemes for those who have suffered avoidable harm linked to pelvic mesh, sodium valproate and Primodos. This meeting will be an opportunity to hear from representatives of various patient groups about what victims need and what they are missing from current support mechanisms. Officers and members of the APPG FDNH will also provide an update on the Health and Care Bill, which will have passed through Committee in the House of Lords earlier that month. The meeting will be Chaired by Baroness Cumberlege (Co-Chair, APPG FDNH), who will be joined on a virtual panel by representatives of the following patient groups, as well as Officers and members of the APPG FDNH: Sling the Mesh Organisation for Anti-Convulsant Syndrome (OACS) Association for Children Damaged by Hormone Pregnancy Tests (ACDHPT) Independent Fetal Anti-Convulsant Trust (IN-FACT) Attendees will have the opportunity to put forward questions during the meeting and are invited to follow the event on social media by using #Redress and #FirstDoNoHarm. Those interested in attending are welcome to express their interest by emailing the APPG FDNH Secretariat via fdnh@luther.co.uk. -
Content ArticleIn this blog for Patient Safety Movement, Pranjal Bora, Head of Product Management at Digital Authority Partners, looks at the ways in which digital technologies improve outcomes and safety in healthcare. The blog examines areas in which digital technologies are currently being used, and looks at the potential future uses of AI and other digital technologies.
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Content ArticleKath Sansom’s surgery changed her life forever – and motived her to lobby for its halt.
