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Showing results for tags 'Medical device'.
Found 335 results
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Content ArticleInsight into medical device and system failure and the teachings of Henry Petroski, a professor of civil engineering at Duke University, who wrote about failure analysis and design theory.
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Content ArticleThe European Network for Safer Healthcare (ENSH) joined forces with the European Association of Urology Nurses (EAUN) to work on a policy campaign to prevent catheter-associated urinary tract infections (CAUTI) in Europe as a path to improving patient safety and preventing anti-microbial resistance (AMR) through: Improvement of adherence to existing European guidelines to prevent CAUTI. Development of European indicators to support the European Centre for Disease Prevention and Control (ECDC) and/or national surveillance systems.
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Content ArticleIn this insightful and informative review by Dr Shaffi from Cleveland Clinic learn how you can target Zero catheter-associated urinary tract infections (CAUTI) through close attention to practice - from patient selection through management of the catheter lifecycle and delivery of data driven practice learn the changes that matter.
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Content ArticleBrian Edwards, Managing Director of Husoteria Ltd, shares his speaker abstract from the 5th European pharmacovigilance congress held 1-3 December 2021. To view all the speaker abstracts from the congress, published in the Therapeutics Advances in Drug Safety journal, download the attachment below.
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Content ArticleThis is an Early Day Motion tabled in the House of Commons on 5 September 2022, which calls on the Government to implement the recommendations of the Independent Medicines and Medical Devices Safety Review in full, in particular recommendation 4 of the report calling for the establishment of separate schemes to meet the costs of additional care and support to those who have suffered avoidable harm.
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Content ArticleSurgical mesh is a medical device that is used to provide additional support when repairing weakened or damaged tissue. The majority of surgical mesh devices currently available for use are made from man-made (synthetic) materials or animal tissue. This page on the US Food and Drug Administration (FDA) website outlines the types and uses of surgical mesh and the latest update on mesh manufacturers ordered to stop selling devices for transvaginal repair of pelvic organ prolapse.
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Content ArticleFor the first time since the 1990s, the Surgeons’ Hall Museums in Edinburgh has displayed a new pathology specimen—a transvaginal tape removed in April 2022 from a woman suffering complications of vaginal tape (or mesh) surgery performed in 2006. In this blog Louise Wilkie, the museums' Curator, explains how the device came to be displayed, the history of vaginal tape surgery and the controversy surrounding its introduction and regulation. She also highlights concerns about the subsequent treatment of women who experienced life-changing complications as a result of the procedure.
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In this joint blog, Patient Safety Learning and Sling the Mesh highlight several issues with the specialist mesh centres set up by the NHS to provide treatment and surgery for women who have been harmed by mesh. We identify key patient safety issues and look at what needs to be done to ensure women receive timely, compassionate and appropriate treatment for complications they face as a result of mesh implants. -
Content ArticleVaginal tapes, slings and meshes are medical devices that are surgically implanted to treat stress urinary incontinence (SUI) and pelvic organ prolapse (POP) in women. This report written on behalf of the Medicines and Healthcare products Regulatory Agency (MHRA) by York Health Economics Consortium, provides summaries of safety and adverse events related to vaginal tapes for SUI and POP. The summaries were developed using the data reported in systematic reviews of the effects and safety of vaginal tapes published in the 10 years up to 2012.
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Content ArticleThe Medicines and Healthcare product Regulatory Agency’s (MHRA) Annual Report and Accounts for 2021/22 has now been published. It provides an overview of MHRA's performance and the events that have had most impact on the Agency during the past year.
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Content ArticleAfter the US Food and Drug Administration (FDA) first warned in 2008 of serious complications associated with transvaginal mesh, thousands of lawsuits have been filed, most of which were compiled into seven federal multidistrict litigation cases against the major manufacturers. This blog by Meghann Cuniff for Forbes Advisor provides an update on the progress of these law suits. It also advises on how to file a vaginal mesh lawsuit and joining a class action lawsuit.
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Content ArticleIn this blog, Luke Yamaguchi describes his experience of hernia mesh surgery and the impact the procedure had on his health. He tells his story of having laparoscopic hernia repair using polypropylene (PP) mesh, which left him with severe chronic pain. After nine years, he underwent mesh removal surgery. Alongside his story, he describes the risks associated with surgical mesh and the use of PP as a material, highlights the lack of research about its side-effects and draws attention to the role of industry in promoting the use of mesh.
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Content ArticleThe APPG held their annual general meeting in Parliament. Baroness Cumberlege was re-elected as Co-Chair of the group and in light of Jeremy Hunt’s recent appointment as Chancellor of the Exchequer, Sharon Hodgson MP was elected as Co-Chair, having previously supported the Group as Vice-Chair over the last calendar year. Sharon is is an Officer of the APPG for Valproate and other Anti-Epileptic Drugs in Pregnancy and Vice-Chair of the All-Party Parliamentary Group on Surgical Mesh. The current serving Vice-Chairs were re-elected, with the addition of Baroness Ritchie also joining as Vice-Chair. The Group looked back on a year of significant activity and progress, including the appointment of Dr Henrietta Hughes as the first Patient Safety Commissioner in England, and agreed that a renewed focus on seeking the implementation of redress schemes should be a priority for the Group over the next year.
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Content ArticleAn HSIB guest blog post from Henrietta Hughes introducing her vision for her new role as Patient Safety Commissioner.
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Content ArticleVaginal mesh implants were introduced in the late 1990s as a routine treatment for stress urinary incontinence and pelvic organ prolapse, common complications following childbirth. However, these flexible plastic scaffolds have led to life-altering complications for many women including nerve damage, chronic pain, and several reported deaths. This blog outlines the story of vaginal mesh, from the 1990s to the present day.
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Content ArticleThis report by the US non-profit organisation the Emergency Care Research Institute (ECRI) was commissioned by the US Food and Drug Administration (FDA) to determine the safety profile of polypropylene (PP) mesh used in a variety of surgical procedures. ECRI performed a comprehensive literature search and systematic review to identify the current state of knowledge about how patients' bodies respond to PP mesh.
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In this blog, Kath Sansom, founder of the Sling the Mesh campaign, unpacks the findings of a medical device performance study into polypropylene mesh published by the Emergency Care Research Institute (ECRI) in the US. The document highlights significant gaps in evidence about the risk of complications associated with polypropylene (PP) surgical mesh. -
Content ArticleWe need a public register to show if healthcare professionals are in the pay of industry – or more patients will suffer, writes Margaret McCartney following the publication of the Independent Medicines and Medical Devices Safety Review. Hospitals in England are meant to publish registers of interest of staff – but a 2016 study shows that only a minority give the details they should. A publicly accessible digital register, updated at least annually and compelled by the regulator, would create transparency and get rid of the huge amount of work that campaigners have had to do to untangle where conflicts lie. Declarations alone can’t sort the problems of conflicted medicine. But a public register would allow us to know whose advice isn’t independent. We will still need to be alert to the unintended consequences of a register, and research will be needed. The UK is lagging behind. Kath Sansom, a journalist who founded the Sling the Mesh campaign, told Margaret: “I had no idea that I couldn’t trust my doctor or surgeon to give the best advice. It is essential that medics declare industry funding.”
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Content ArticleThis article outlines how the first trials relating to harm caused by the LifeCell Strattice biologic patch will proceed. The Strattice patch is a form of surgical mesh used to treat hernias, but unlike other polypropylene mesh devices, it is composed of pig skin preserved in a solution that chemically links together proteins in the tissue. Patients involved in the US litigation complain that they suffered painful injuries from the Strattice patch. They claim that the manufacturer knew it had problems following multiple reports from patients, but failed to act to stop its use. The US Food and Drug Administration (FDA) received at least 450 adverse event reports on Strattice from September 1990 until September 2020. Among those reports were six patient deaths and 340 patient injuries, and many patients have had to undergo mesh removal.
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Content ArticleThe Medicines and Healthcare products Regulatory Agency (MHRA) is reviewing its approach to engagement with healthcare professionals to improve the safety of medicines and medical devices. It wants to ensure that healthcare professionals are receiving actionable information and guidance on safe use of medicines and medical devices that they can take into their working practice, providing timely advice to patients. The MHRA wants to hear from you to enable them to transform how they communicate with you and how they work together with you for the common goal of greater patient safety. The consultation closes 18 January 2023.
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Content ArticleThis article* is an update from Dr Henrietta Hughes, Patient Safety Commissioner for England.
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Content ArticleThis article* is an update from Dr Henrietta Hughes, Patient Safety Commissioner for England.
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Content ArticleSpecialist centres for those affected by mesh implants, as recommended by the Independent Medicines and Medical Devices Safety Review, became operational formally in April 2021. HSJ analyses how they performed in their first year.
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Content ArticleThe last 10 years have seen substantial growth in medical devices that can help people with diabetes to manage their condition, including the development of automated insulin delivery (AID) systems. Regulatory approval has been granted for the first AID systems, and a community of people living with type 1 diabetes has created its own systems using a do-it-yourself approach. This consensus report from the Joint Diabetes Technology Working Group of the European Association for the Study of Diabetes and the American Diabetes Association offers a review of the current landscape of AID systems and recommends targeted actions.
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Andrew Stroud's daughter Bia has type 1 diabetes, and in this blog, Andrew talks about his family's experiences supporting Bia to manage her diabetes. He describes the huge value of technology in improving diabetes management and reducing the mental burden of the condition on people with diabetes and their parents and carers. However, like all technology, medical devices for diabetes can fail, and Andrew highlights the need to be prepared for this situation to ensure the person with diabetes is safe while they cannot use the devices they rely on every day.
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