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Found 328 results
  1. News Article
    Scrapping the new Therapeutic Products Act (TPA) will leave thousands of New Zealanders exposed to ongoing harm from dodgy medical devices, warn patient safety advocates and legal experts. The act, which was due to come into force in 2026, would have modernised the regulation of medicines and natural health products, and made medical devices, as well as cell, gene and tissue therapies, subject to a similar regulatory regime as drugs. The industry has backed the move, saying the new law was heavy-handed and would stop people getting access to the latest lifesaving technological advances. However, Auckland woman Carmel Berry — who was left in constant knife-like pain from plastic mesh implanted during surgery — said she was “living proof” of the old system’s failures. It took more than 10 years of lobbying by her and the other founders of Mesh Down Under to get authorities to take action — a decade in which hundreds of other people were injured. She is horrified that the TPA, signed into law in only July, is on the chopping block. Beginning work to repeal it was No 47 out of 49 points on the Government’s to-do list for its first 100 days. “I’m horrified. After so many years of developing and rewriting the act and getting it through ... shame on them.” Read full story Source: New Zealand Herald, 18 February 2024
  2. News Article
    It is still unclear how unauthorised metal parts came to be implanted in a number of the 19 children with spina bifida who suffered significant complications after spinal surgery. But it has emerged that one child died and 18 others suffered a range of complications after surgery at Temple Street Children’s Hospital – with several needing further surgery, including the removal of metal parts which were not authorised for use. Parents of the children undergoing complex surgery were left distraught by the disclosures that emerged yesterday, after campaigning for years while the young patients in need of operations deteriorated on waiting lists. Gerry Maguire, of Spina Bifida Hydrocephalus Ireland, said “absolute horror is being visited on parents and their advocates”. He condemned as disturbing the information which is “being drip-fed to his group and “more alarmingly the families concerned”. One mother expressed concern about further delays in surgery and said children are too complex to be taken for care abroad. Read full story Source: Irish Independent, 19 September 2023
  3. Content Article
    In this article, investigative journalist Scilla Alecci reports on a court case brought against medical tech company Medtronic by a US whistleblower. Former Medtronic sales representative Leanne Houston alleges that between 2016 and 2018 she witnessed the company engaging in “unlawful conduct” by offering several US hospitals free equipment in exchange for the exclusive use of Medtronic products. She also claims that the company failed to acknowledge and deal with reports from surgeons that one of its surgical staple devices was causing harm to patients.
  4. Content Article
    As the Cumberlege Review and Paterson Inquiry made clear, having accurate and timely data on treatments and outcomes is critical to patient safety. NHS England is working to strengthen this data by implementing a central database to collect key details of implantable devices at the time of operation. The new Outcomes and Registry Platform will bring existing registries together for the first time and introduce new registries. In a blog for the Patient Safety Commissioner website, Scott Pryde, Programme Director for NHS England’s Outcomes and Registries Programme, and Katherine Wilson, Clinical Steering Group Chair of the programme, discuss the new National Registry of Hearing Implants, a registry specifically for cochlear implants. They highlight the importance of collaboration between patients, clinicians, regulators and medical device manufacturers.
  5. Content Article
    On the 7 February 2024, the Patient Safety Commissioner for England published a report considering options for redress for those who have been harmed by two of the interventions covered by the Independent Medicines and Medical Devices Safety Review: sodium valproate and pelvic mesh. In this blog, Patient Safety Learning sets out the background to this report, outlines responses from patient groups and campaigners, and reflects on how this work will be taken forward.
  6. Content Article
    The National Institute for Health and Care Excellence (NICE) pioneered the Health Technology Assessment (HTA) processes and methodologies. Technology appraisals (TAs) focus on pharmaceutical products and clinical and economic data, which are presented by the product manufacturers to the NICE appraisal committee for decision-making. Uncertainty in data reduces the chance of a positive outcome from the HTA process or requires a higher discount. This study in the BMJ Open aimed to investigate the quality of clinical data submitted by product manufacturers to NICE. The authors found that the primary components of clinical evidence influencing NICE’s decision-making framework were of poor quality. They argue that there is a need to generate robust clinical data for premarket and postmarket introduction of medicines into clinical practice, to ensure they deliver benefits to patients.
  7. News Article
    A woman who described the time in her life after a pelvic mesh implant as "soul destroying" said proposed government compensation was "disappointingly low". Claire Cooper, from Uckfield, is one of around 100,000 women across the UK who had transvaginal mesh implants. England's patient safety commissioner suggested compensation could start at around £20,000. Ms Cooper, 49, was originally given the mesh implant as a treatment for incontinence after childbirth. However, after struggling with pain following the operation, Ms Cooper claimed doctors treated her as if she were "psychotic" and "a nuisance". She said her experience was one of being "mocked". "It was just soul destroying," Ms Cooper told BBC Radio Sussex. "I lost my fight because I was met at every turn with resistance so I just lost the ability to advocate for myself." Ms Cooper eventually had surgery to remove the mesh, which she said one doctor compared to "cheese cutting wire". She is still living with chronic pain. Read full story Source: BBC News, 15 February 2024 Further reading on the hub: Doctors shocking comments to women harmed by mesh
  8. Content Article
    Coloplast UK is a manufacturer of ostomy, continence, urology and wound care products. They commissioned the Patients Association to conduct a project to explore and recommend ways to better engage patients and carers in policymaking and the assessment of medical technologies for intimate healthcare. The Patients Association held a roundtable meeting and case study interviews with patients with intimate healthcare conditions and other stakeholders. They also conducted a survey of third-sector organisations who represent those patients and carried out desk-based research. This report summarises the findings of the project, which include that the existing mechanisms of engagement typically adopt a “patient involvement” approach where patients and carers do not have equal status as partners in the decision-making process. The report makes a number of recommendations to improve the way in which patients and their carers are engaged.
  9. News Article
    Families of children left disabled by an epilepsy drug and women injured by pelvic mesh implants should be given urgent financial help, England's patient safety commissioner has said. Dr Henrietta Hughes has called on the government to act quickly to help victims of the two health scandals. It follows a review which found lives had been ruined because concerns about some treatments were not listened to. It is estimated that, since the early 1970s, about 20,000 babies have been born with disabilities after foetal exposure to sodium valproate, which can harm unborn babies if taken in pregnancy. Scientific papers from as early as the 1980s suggested valproate medicines were dangerous to developing babies, yet warnings about the potential effects were not added to some packaging until 2016. Some families affected have been campaigning for decades to raise awareness of the potential effects of the drug, with some calling for compensation and a public inquiry. Dr Hughes was asked by the government to look into a potential compensation scheme for those affected by that scandal, as well as the one involving some 10,000 women who were injured by their pelvic mesh implants - a treatment for pelvic organ prolapse (POP) and incontinence. Read full story Source: BBC News, 7 February 2024
  10. Content Article
    In late 2023, the Minister for Mental Health and Women’s Health Strategy, Maria Caulfield MP, asked the Patient Safety Commissioner for England to explore redress options for those who have been harmed by pelvic mesh and sodium valproate. This report sets out the outcome of this project and is designed to help the government understand the options available for providing redress to those patients harmed by pelvic mesh and valproate.
  11. Content Article
    ECRI's Top 10 Health Technology Hazards for 2024 list identifies the potential sources of danger ECRI believe warrant the greatest attention this year and offers practical recommendations for reducing risks. Since its creation in 2008, this list has supported hospitals, health systems, ambulatory surgery centres and manufacturers in addressing risks that can impact patients and staff. 
  12. Content Article
    This National Patient Safety Alert has been issued by the NHS England National Patient Safety Team, co-badged by the Association of Anaesthetists, Royal College of Anaesthetists and the Safe Anaesthesia Liaison Group, instructing all relevant NHS funded providers to transition to NRFit™ connectors for all intrathecal and epidural procedures, and delivery of regional blocks. Transition should be completed by 31 January 2025.
  13. Content Article
    In November 2023, the UK hosted the first global summit on artificial intelligence (AI) safety at Bletchley Park, the country house and estate in southern England that was home to the team that deciphered the Enigma code. 150 or so representatives from national governments, industry, academia and civil society attended and the focus was on frontier AI—technologies on the cutting edge and beyond. In this Lancet article, Talha Burki looks at the implications of AI for healthcare in the UK and how it may be used in medical devices and service provision. The piece highlights the risks in terms of regulation and accountability that are inherent in the use of AI.
  14. Content Article
    The Medicines and Healthcare products Regulatory Agency (MHRA) has published a roadmap which outlines the intended timelines for delivering the future regulatory framework for medical devices.
  15. Content Article
    The objective of this systematic review from Benhamou et al. was to assess the clinical, economic, and health resource utilisation outcomes associated with the use of prefilled syringes in medication administration compared with traditional preparation methods. The findings provide new insights into clinical and economic benefits of prefilled syringe adoption. These benefits include improved medication delivery and safety, which can lead to time and cost reductions for health care departments, hospitals, and health systems. However, further real-world research on clinical and economic outcomes, especially in contamination, is needed to better understand the benefits of prefilled syringes.
  16. Content Article
    Mesh slings made of the same polypropylene plastic as the suspended women’s slings have been implanted into nearly 200 men across the UK suffering incontinence after prostate cancer. The operations were part of a trial in 28 hospitals where half the slings failed to fix men’s urinary leakage. Worse, just like the majority of women’s mesh implant trials, the full range of mesh-related pain was not logged in any paperwork.
  17. Content Article
    How would you feel if your doctor offered you a treatment your health condition with good results and very little risk? You might snap it up. But what if you subsequently found out your doctor took thousands of pounds from the treatment makers to write a scientific paper promoting it, attend an all-expenses paid conference to talk about it, or spent time working as their expert consultant? In America, industry must log payments which are published on the open database system. Reporting to this is backed up by law following the American Sunshine Payment Act (2013). Sling the Mesh is calling for similar legislation in the UK to provide up-to-date evidence on industry money exchanging hands we Kath Sansom discusses in a blog on the Patient Safety Commissioner website.
  18. News Article
    A surgeon has said it would have been "cruel and unacceptable" to have woken up a patient to get consent for a mesh operation. Anthony Dixon is accused of failing to provide adequate clinical care to five patients at Southmead Hospital and the private Spire Hospital in Bristol. He had pioneered the use of artificial mesh to lift prolapsed bowels. Mr Dixon appeared at a Medical Practitioners Tribunal Service (MPTS) hearing in Manchester on Thursday. He faces charges of performing procedures that were not "clinically indicated", failing to carry out tests and investigations and failing to obtain consent from patients. It followed complaints many had suffered pain or trauma after having pelvic floor surgery using artificial mesh, a technique known as laparoscopic ventral mesh rectopexy (LVMR). Giving evidence, he was asked why he did not consider waking up one female patient who underwent an LVMR, to get her consent to surgery. Mr Dixon said it would have meant giving her more drugs for pain relief and could have "multiplied the risks" to her. He is also accused of failing to advise patients about the risks of procedures, failing to discuss non-surgical options and dismissing patients' concerns when they experienced pain or other symptoms following surgery. Read full story Source: BBC News, 23 November 2023 Related reading on the hub: Woman’s mesh consent form was changed after signing – how can patients be better protected?
  19. Content Article
    Beyond Compliance is a service to support the safe and stepwise introduction of new or modified implantable medical devices. An independent panel of experts, known as the Beyond Compliance Advisory Group, work with the implant manufacturer to assess the relative risk of any new product, and the rate at which it should be introduced to the market. The service collects data about patients who receive these implants and about their recovery following surgery. This data is made available to clinicians using the implant, to the manufacturer, and to independent assessors from the Beyond Compliance Advisory Group, to provide real-time monitoring of the implant’s performance. The clinicians who agree to joining the advisory group are drawn from the most experienced and respected members of their field. Beyond Compliance is an optional service available to implant manufacturers. The service commenced in the field of joint replacement implants. Following the success of the introduction of Beyond Compliance to Orthopaedic there are now plans for it to be extended for use with other implantable medical devices.
  20. Content Article
    In her latest blog, Patient Safety Commissioner Henrietta Hughes discusses MHRA's Yellow Card reporting system and why, until we have mandatory reporting, including for devices that are working as designed, we will continue to see avoidable harm occurring to patients. She stresses that it is vital that the voices and views of patients, clinicians, manufacturer, and health providers participate in the design and delivery of devices. 
  21. News Article
    A woman who suffered traumatic complications from a vaginal mesh implant has been awarded a record settlement of at least £1m from the NHS. Yvette Greenway-Mansfield, 59, was given a mesh implant at Coventry’s University Hospital in 2009 and went on to suffer serious complications. Her medical negligence claim against the hospital trust found that the surgery was carried out prematurely and unnecessarily and that her consent form had been doctored to include additional risks after Greenway-Mansfield had signed it. Greenway-Mansfield said that being awarded the compensation was a “huge relief”, but added that many other women who have suffered similar damage had received little or no compensation, and criticised the government’s failure to establish a financial redress agency for victims. “I’m not the only one. There are thousands of mes,” she said. “There should be a pot of money to provide damages for these women and a care plan in place as an automatic response to mesh-damaged people. It comes down to a perception of women and women’s health problems. We’ve all had enough of it.” Read full story Source: The Guardian, 13 November 2023
  22. Content Article
    During a fellowship rotation in gynaecology, Rebekah Fenton, asked the attending physicians what pain management options they could offer patients for insertion of an intrauterine device (IUD). Their answer surprised her: none.  The research on the effectiveness of pain management techniques during the procedure were not strong enough to warrant providing potential relief.  But Fenton knew the attending physician was wrong: she'd received the drug lidocaine during a recent visit to her own ob/gyn to get an IUD placed. The local anesthetic enabled her to avoid the experiences of many patients who often withstand debilitating cramping and pain during insertion, side effects that can last for hours after the procedure has ended.  By not teaching her how to administer pain treatment options such as lidocaine gel or injection, "they made the decision for me, whether I could give patients this option," said Fenton, now an adolescent medicine specialist at Alivio Medical Center in Chicago. Related hub content: See our Pain during IUD fitting community thread.
  23. News Article
    The boss of Britain’s biggest medicines courier has been told to urgently improve its complaints system by the NHS ombudsman amid concerns patients let down by missing deliveries are repeatedly ignored. In a highly unusual development, Darryn Gibson, the chief executive of Sciensus, has received a written warning from Rob Behrens, the parliamentary and health service ombudsman (PHSO). It says patients “should not be ignored” and must be “listened to and taken seriously” or he will consider taking further action. The PHSO investigates complaints that have not been resolved by the NHS or by private providers of NHS care. Sciensus is the single largest provider of homecare medicines services to the NHS and has contracts worth millions of pounds. In an email seen by the Guardian, Behrens told Gibson he had been unable to investigate most reports received about Sciensus because patients had not been able to complete the company’s complaints process. “That is not acceptable or fair to complainants,” Behrens wrote. In a statement, Sciensus said it worked “very hard” to ensure NHS patients received their medicines on time. Its services had “a 95% satisfaction rating”, it added. The move follows a Guardian investigation that exposed how Sciensus put NHS patients at risk of harm with delayed, missed or botched deliveries of medicines for conditions including cancer, heart disease, diabetes, dementia and HIV. It also uncovered how patients’ alarm at vital drugs and medical devices not arriving at their home was often compounded by a struggle to reach Sciensus to complain and fix the problems. Read full story Source: The Guardian, 19 October 2023
  24. News Article
    A man claims he lost his sight in one eye after routine cataract surgery left him in "unbelievable" pain. John Stabler, from East Yorkshire, is set to sue the maker of an artificial lens he had fitted last year and which was later recalled over safety fears. The 63-year-old said he felt like he had been hit "with a sledgehammer" after the operation and had suffered "catastrophic" loss of income. Manufacturer Nidek said it "profoundly regrets" any patient suffering. Mr Stabler is one of 14 patients seeking compensation over the company's EyeCee One Preloaded lens. He said he had suffered permanent nerve damage to his left eye after having the lens fitted at Hull and East Yorkshire Eye Hospital in October last year. He told the BBC: "About two days after, I was getting really bad pain. It was unbelievable. It was like someone was hitting me with a sledgehammer." NHS England issued a safety alert in January 2023 after Nidek announced a "voluntary and precautionary" global product recall of its EyeCee One and EyeCee One Crystal intraocular lenses. UK distributor Bausch + Lomb said there has been "a limited number of reports of elevated intraocular pressure in patients". Read full story Source: BBC News, 19 September 2023
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