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Showing results for tags 'Medical device'.
Found 335 results
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Content ArticleDiscussion on issues relating to vaginal mesh implants from 29 Jun 2022.
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Content ArticleComplications of surgical mesh procedures have led to legal cases against manufacturers worldwide and to national inquiries about their safety. The aim of this study from Keltie K et al. was to investigate the rate of adverse events of these procedures for stress urinary incontinence in England over 8 years.
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Blog - When diabetes devices fail (8 December 2020)
Patient-Safety-Learning posted an article in Diabetes
In this article for US magazine Consumer Reports, Rachel Rabkin Peachman looks at the incidence and impact of malfunctions and design flaws in continuous blood glucose monitors, insulin pumps and other diabetes equipment. She highlights the case of Pamela, a 64-year-old with diabetes who died when her insulin pump unintentionally gave her a massive dose of insulin overnight. The numbers of adverse events and deaths reported to the FDA regarding diabetes devices is far greater than for any other type of medical device—between January 2019 and July 2020, almost 400 deaths and 66,000 injuries in the US were linked to commonly used diabetes devices. Reports are spread across the different device manufacturers and demonstrate the complexities of trying to determine the exact cause of each adverse event. The article also includes information on how people with diabetes can protect themselves from device malfunctions and errors. -
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Two years after Baroness Cumberlege shared her damning report, 'First Do No Harm', which highlighted serious failures in response to reports about harmful side effects from medicines and medical devices, too many mesh injured women still continue to be let down by the healthcare system. Women who have been harmed by pelvic mesh surgery have shared a series of appalling accounts of how they have been treated by their doctors while desperately seeking help for their injuries and complications. In this blog, we examine how these comments reveal an underlying misogyny held by many doctors, and a failure to take women’s concerns seriously. -
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In this blog Patient Safety Learning considers the safety concerns highlighted by a recent report by the Healthcare Safety Investigation Branch (HSIB) into the administration of high-strength insulin from pen devices in hospitals. This blog argues that without specific and targeted recommendations to improve patient safety in this area, patients will continue to remain at risk from similar incidents. -
Content ArticleThis Healthcare Safety Investigation Branch (HSIB) investigation aims to help improve patient safety in relation to administering high-strength insulin from a pen device to patients with diabetes in a hospital setting. As its ‘reference case’, the investigation uses the experience of Kathleen, a 73 year old woman with type 2 diabetes who received two recognised overdoses of insulin while she was in hospital. On both occasions she became hypoglycaemic, received medical treatment, and recovered. Patient Safety Learning has published a blog reflecting on some of the key patient safety issues highlighted in this report.
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Content ArticleOver the past few years, concerns have been raised about the level of funding and intervention regulators have received from the pharmaceutical industry. In this article for The BMJ, investigative journalist Maryanne Demasi examines whether regulators of medical devices and medications have enough independence from the companies they are meant to regulate. She asked six of the world's biggest regulators about their funding and transparency and found that industry money permeates the world's leading regulators. This casts doubt on their ability to provide effective regulation, especially in the wake of a string of drug and device scandals.
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Content ArticleThis article highlights two written questions tabled in the House of Commons relating to recommendations of the Independent Medicines and Medical Devices Safety (IMMDS) Review concerning surgical mesh implants.
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Content ArticleFollowing the UK's exit from the European Union, the government aims to improve how medical devices and diagnostic devices are regulated through a new framework. The MHRA held a consultation on the future regulation of medical devices in the UK in autumn 2021 and this report outlines the government's response to the consultation. The consultation received 891 responses and aimed to collect views on developing a future legislation for medical devices which delivers: improved patient and public safety greater transparency of regulatory decision making and medical device information close alignment with international best practice, and more flexible, responsive and proportionate regulation of medical devices.
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Content ArticleIn this video, Michal Seres, who lives with Crohn's disease, talks about his experience of living with an ostomy bag and how he came to develop his own tools to help manage his treatment. Michael established 11 Health, a company which aims to create a collaborative community of patients, healthcare professionals and researchers to develop digital health solutions for patients with chronic illness. Michael talks about the importance of including patients in developing devices and treatments, and how positive, supportive relationships foster collaboration.
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Content ArticleThis study in the journal Medical Devices: Evidence and Research aimed to assess health system experiences of implementing Unique Device Identifier (UDI) systems for medical devices. Although the US Food and Drug Administration (FDA formalised the Unique Device Identification System Rule in 2013, parallel regulatory requirement for US health systems to use UDIs is lacking. Through semi-structured interviews, the authors identified barriers to implementing UDI systems and strategies to overcome them.
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Content ArticleMesh complications are rare and in most cases relatively minor. However, in a small number of cases they can be serious. These include mesh erosion/extrusion (when the mesh pokes through the vaginal wall or cuts through internal tissue), vaginal scarring, fistula formation, painful sex, bladder infection or perforation (piercing), bowel and nerve trauma and pelvic, back and leg pains. Some of these complications may occur years after surgery and can be difficult to treat. Serious complications are rare, given the tens of thousands of women who have had the implants, but can be life-changing for some women. As a result of concerns raised by mesh-affected women, in April 2018 the then Secretary of State for Health and Social Care, Jeremy Hunt MP, announced a review into the use of vaginal mesh. The review was led by Baroness Julia Cumberlege and recommendations made in the report of the Independent Medicines and Medical Devices Safety (IMMDS) “First Do No Harm”. The Government published its response to the IMMDS Review in July 2021.
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Content ArticleThis study in Best Practice & Research Clinical Rheumatology aimed to determine the systemic effects of surgical mesh implants. The study looked at patients referred to an autoimmunity clinic between January 2014 and December 2017 and concluded that mesh implants may increase the risk of developing autoimmune diseases by acting as an adjuvant (increasing the body's own immune response).
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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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Content ArticleKath Sansom’s surgery changed her life forever – and motived her to lobby for its halt.
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Content ArticleIn 2020, the Independent Medicines and Medical Devices Safety (IMMDS) Review made specific recommendations that the government provide justice and redress to thousands of women who have been harmed by surgical mesh implants. Surgical mesh, also known as transvaginal tape, is a medical device surgically implanted to support organs and tissue. It is primarily used to treat urinary incontinence in women, but is also used to treat hernias and to reinforce abdominal areas where women have had tissue removed to reconstruct their breasts after mastectomy. In this article for the Mail Online, John Naish highlights that two years after the IMMDS, none of its recommendations have been implemented properly and surgical mesh is still being used. He examines the case of Kelly Cook, a 37 year-old mother who has been left with constant pain, nerve issues and incontinence after mesh surgery in 2018. In spite of the impact the mesh is having on her life, she has been told she may not be seen at one of the new specialist mesh centres for two years due to the length of the waiting list. The article also highlights the fact that no financial redress has yet been offered to mesh victims, that women's pain is still not being seen as a serious issue, and that there is a concerning lack of research into the safety of mesh devices.
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Content ArticleFollowing the publication of the Independent Medicines and Medical Devices and Safety (IMMDS) Review in July 2022, the UK Government accepted a recommendation to appoint a Patient Safety Commissioner responsible for promoting safety in the context of the use of medicines and medical devices. At the Health Plus Care conference on the 19 May 2022, Patient Safety Learning's Chief Executive Helen Hughes and Marie Lyon, Chair of the Association for Children Damaged by Hormone Pregnancy Tests, considered the key challenges that will faced by the new Patient Safety Commissioner and the importance of implementing in full the recommendations of the IMMDS Review. See attached their presentation slides.
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Content ArticleSurgeons' News is a magazine for surgical, dental and allied healthcare professionals. Published quarterly by the Royal College of Surgeons of Edinburgh, it features comment and opinion from leading professionals, plus reviews and reports on subjects relevant to all career levels. In an article in the June issue (page 18), Maryanne Mariyaselvam describes some of the latest solutions being developed to protect patients and clinicians from potential errors.
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Medical misogyny by Iona Winters (30 May 2022)
Patient Safety Learning posted an article in Women's health
Twelve years ago, Iona Winters had a TVT-O (transvaginal tape through the obturator region) implanted to assist her bladder, after decades of gynaecological surgeries. Last year she had the mesh removed by two specialist surgeons. In this blog, Iona describes the pain she has to endure, her experiences of medical misogyny and discusses the international mesh scandal. -
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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The operation that ruined my life (BBC Panorama, 29 November 2022)
Sam posted an article in Women's health
Women across the UK are suffering after an operation they were told would transform their lives. Instead, some of them say their lives have been ruined. For years women have been fitted with mesh-like devices to treat prolapse or incontinence - often caused by childbirth. Although it's been a successful treatment for many of them, thousands of women in the US, the UK and Australia are now suing, after finding themselves in agony or suffering other serious complications.
