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Found 1,334 results
  1. News Article
    A campaign to reduce stillbirths, brain injury, and avoidable deaths in babies has failed to have any effect in the past three years, findings from the Royal College of Obstetricians and Gynaecologists show. The president of the college, Edward Morris, has urged maternity units across the UK to learn from the latest report and act on its recommendations. “We owe it to each and every person affected to find out why these deaths and harms occur in order to prevent future cases where possible,” he said. Read full story (paywalled) Source: BMJ, 19 March 2020
  2. News Article
    At least 20 maternity deaths or serious harm cases have been linked to a Devon hospital since 2008, according to NHS reports obtained by the BBC. A 2017 review which was never released raised "serious questions" about maternity care at North Devon District Hospital. The BBC spent two years trying to obtain the report and won access to it at a tribunal earlier this year. Northern Devon Healthcare NHS Trust (NDHT) said the unit was "completely different" after recommended reforms. A 2013 review by the Royal College of Obstetricians and Gynaecologists (RCOG) investigated 11 serious clinical incidents at the unit, dating back as far as 2008. The report identified failings in the working relationships at the unit, finding some midwives were working autonomously and some senior doctors failed to give guidance to junior colleagues. Despite the identified problems with "morale", the subsequent investigation by RCOG in 2017 expressed concerns with the "decision-making and clinical competency" of senior doctors and their co-operation with midwives. An independent review into midwifery in October 2017 noted "poor communication" between medical staff on the ward for more than a decade. The report identified a "lack of trust and respect" between staff and "anxiety" among senior midwives at the quality of care. Read full story Source: BBC News, 16 March 2020
  3. News Article
    Every week for nearly a year, Lorraine Shilcock attended an hour-long counselling session paid for by the NHS. She needed the therapy, which ended in November, to cope with the terrifying nightmares that would wake her five or six times a night, and the haunting daytime flashbacks. Lorraine, 67, a retired textile worker from Desford, Leicester, has post-traumatic stress disorder (PTSD). Her psychological scars due to a routine NHS medical check, which was supposed to help her, not leave her suffering. In October 2018, Lorraine had a hysteroscopy, a common procedure to inspect the womb in women who have heavy or abnormal bleeding. The 30-minute procedure, performed in an outpatient clinic, is considered so routine that many women are told it will be no worse than a smear test and that, if they are worried about the pain, they can take a couple of paracetamol or ibuprofen immediately beforehand. Yet for Lorraine, and potentially thousands more women in the UK, that could not be further from the truth. Many who have had a hysteroscopy say the pain was the worst they have ever experienced, ahead of childbirth, broken bones, or even a ruptured appendix, commonly regarded as the most agonising medical emergency. Yet most had no warning it would be so traumatic, leaving some, like Lorraine, with long-term consequences. But, crucially, it is entirely avoidable. Do you have an experience you would like to share? Join our conversation on the hub on painful hysteroscopy. We are using this feedback and evidence to help campaign for safer, harm-free care. Read full story Source: Mail Online, 3 March 2020
  4. News Article
    Hundreds of women have said they’ve undergone “distressing” diagnostic tests at NHS hospitals which were not carried out in line with recommended practice. Around 520 women who attended NHS hospitals in England to undergo hysteroscopies — a procedure which uses narrow telescopes to examine the womb to diagnose the cause of heavy or abnormal bleeding — have told a survey their doctors carried on with their procedures even when they were in severe pain. This is despite the Royal College of Obstetricians and Gynaecologists advising clinicians should offer to reschedule with the use of general anaesthetic, epidural or sedation if the pain becomes unbearable. The Campaign Against Painful Hysteroscopy patient group has surveyed 860 women who had had the procedure at an English NHS hospital, and shared the results with HSJ. Of them, 750 said they were left distressed, tearful or shaken by the procedure, with around 466 of them saying that feeling remained for longer than a day. Many of the women said their painful hysteroscopies damaged their trust in healthcare professionals, had made cervical smears more painful and had a negative impact on sexual relationships. Patient Safety Learning have connected with the campaigning group 'Hysteroscopy Action' on this issue. We have seen stories and comments posted on the hub from patients who have suffered similar distressing experiences. We are using this feedback and evidence to help campaign for safer, harm-free care. We welcome others to join in the conversation. Read full story (paywalled) Source: HSJ, 2 March 2020
  5. News Article
    Hundreds of elderly and vulnerable social care residents have allegedly been sexually assaulted in just three months, a shock new report from the care regulator has revealed. According to the Care Quality Commission there were 899 sexual incidents reported by social care homes between March and May 2018. Almost half were categorised as sexual assault. In 16% of the cases members of staff or visiting workers were accused of carrying out the abuse. The watchdog said it was notified of 47 cases of rape and told The Independent local authorities were informed and 37 cases were referred to police for investigation. Kate Terroni, Chief Inspector of adult social care at the regulator, said: “Supporting people as individuals means considering all aspects of a person’s needs, including sexuality and relationships. However, our report also shows all too starkly the other side of this – the times when people are harmed in the very place they should be kept safe. This is utterly devastating, both for the people directly affected and their loved ones." “It is not good enough to put this issue in a ‘too difficult to discuss’ box. It is particularly because these topics are sensitive and complex that they should not be ignored.” Read full story Source: The Independent, 27 February 2020
  6. News Article
    More than 70 children and young people have been put at risk by long delays in treatment by mental health services in Kent and Medway, HSJ has learned. According to a response to a Freedom of Information request submitted by HSJ, 205 harm reviews have been carried out for patients waiting for treatment following a referral to the North East London Foundation Trust, which runs the child and adolescent mental health services in Kent and Medway. Of those, 76 patients, who had all waited longer than the 18 week target time for treatment, were found to be at risk of harm. One patient had to be seen immediately as they were judged to be at “severe” risk. Seven were found to be at “moderate” risk and 68 at “low” risk. The trust said “risk” meant a risk of harm to themselves or others. But it said none of the 76 patients had come to actual harm. Read full story (paywalled) Source: HSJ, 25 February 2020
  7. News Article
    Women in Scotland who have experienced complications following vaginal mesh surgery are to be offered an independent review of their case notes. Mesh implants have been used to treat conditions some women suffer after childbirth, such as incontinence and prolapse. However, many women experienced painful, debilitating side effects. Some of the women who have suffered complications met First Minister Nicola Sturgeon last November. She was told a number of them had understood the mesh would be completely removed but that had not happened, leaving some of the synthetic substance still attached. After hearing about their experiences, Ms Sturgeon has now written to the women she saw, confirming that in the spring they will be given the chance to sit down with an independent clinician for a review of their case notes. That will be followed up by a report and possible referral to specialist care. The case note review will initially only be offered to those who attended the first minister's meetings however, it may be offered more widely at a later date. Read full story Source: BBC News, 23 February 2020
  8. News Article
    Patient safety is at risk in “crumbling” NHS mental health hospitals starved of the money needed to improve dilapidated buildings, new data has revealed. Hundreds of vulnerable mentally ill patients are still being cared for in 350 old dormitory-style wards, 20 years after the NHS was told to provide all patients with en-suite rooms. A lack of funding to refurbish hospitals has also meant too many wards still have ligature points that patients can use to try to harm themselves. NHS leaders said the lack of cash from the government meant they could not deal with warnings issued by the Care Quality Commission (CQC), the sector’s watchdog. A survey of mental health trust leaders by NHS Providers has now found bosses are worried the state of psychiatric wards is undermining their ability to keep patients safe. Read full story Source: The Independent, 20 February 2020
  9. News Article
    This is the independent public statutory inquiry into the use of infected blood. The timetable and factsheet to provide information for those attending the hearings in London on 24-28 February have just been published. Go to this link for more information >> https://www.infectedbloodinquiry.org.uk/news
  10. News Article
    A doctor who worked at the same private healthcare firm as rogue breast surgeon Ian Paterson has been suspended, it has emerged. Spire Healthcare said Mike Walsh – a specialist in trauma and orthopaedic surgery – was suspended in April 2018 over concerns about patient treatment. Almost 50 of his patients from its Leeds hospital had been recalled. The details emerged following an independent inquiry into Paterson, who is serving a 20-year jail sentence. Earlier this month, an inquiry into the breast surgeon found that a culture of "avoidance and denial" had allowed him to perform botched and unnecessary operations on hundreds of women. Spire said in a statement that it acted after concerns were raised about Mr Walsh's work at its hospital in Leeds in 2018. The company, which contacted the Royal College of Surgeons to assist with its investigation, said it had reviewed the notes of fewer than 200 patients, of which "fewer than 50" had been invited back for a follow-up appointment. "Where we have identified concerns about the care a patient received, we have invited the patient to an appointment with an independent surgeon to review their treatment," a spokesman for Spire Healthcare said. "This is a complex case and the review is ongoing." It said that Mr Walsh, who was immediately suspended after the concerns were raised, was no longer working with Spire Healthcare. The company said any patients at its Spire Leeds Hospital who had concerns about their treatment under Mr Walsh should contact the hospital. It said its findings had also been shared with the Care Quality Commission and the General Medical Council (GMC). Read full story Source: BBC News, 17 February 2020
  11. News Article
    The Equality and Human Rights Commission have launched a legal challenge against the Secretary of State for Health and Social Care over the repeated failure to move people with learning disabilities and autism into appropriate accommodation. Their concerns are about the rights of more than 2,000 people with learning disabilities and autism being detained in secure hospitals, often far away from home and for many years. These concerns increased significantly following the BBC’s exposure of the shocking violation of patients’ human rights at Whorlton Hall, where patients suffered horrific physical and psychological abuse. The Equality and Human Rights Commission have sent a pre-action letter to the Secretary of State for Health and Social Care, arguing that the Department of Health and Social Care (DHSC) has breached the European Convention of Human Rights (ECHR) for failing to meet the targets set in the Transforming Care program and Building the Right Support program. These targets included moving patients from inappropriate inpatient care to community-based settings, and reducing the reliance on inpatient care for people with learning disabilities and autism. Rebecca Hilsenrath, Chief Executive of the Equality and Human Rights Commission, said: 'We cannot afford to miss more deadlines. We cannot afford any more Winterbourne Views or Whorlton Halls. We cannot afford to risk further abuse being inflicted on even a single more person at the distressing and horrific levels we have seen. We need the DHSC to act now." "These are people who deserve our support and compassion, not abuse and brutality. Inhumane and degrading treatment in place of adequate healthcare cannot be the hallmark of our society. One scandal should have been one too many." Read full story Souce: Equality and Human Rights Commission, 12 February 2020
  12. News Article
    The Streatham terrorist attack has again highlighted one of the most difficult decisions the emergency services face – deciding when it is safe to treat wounded people. In the aftermath of the stabbings by Sudesh Amman, a passer-by who helped a man lying on the pavement bleeding claimed ambulance crews took 30 minutes to arrive. The London Ambulance Service (LAS) said the first medics arrived in four minutes, but waited at the assigned rendezvous point until the Metropolitan police confirmed it was safe to move in. Last summer, the inquest into the London Bridge attack heard it took three hours for paramedics to reach some of the wounded. Prompt treatment might have saved the life of French chef Sebastian Belanger, who received CPR from members of the public and police officers for half an hour. A LAS debriefing revealed paramedics’ frustration at not being deployed sooner. A group of UK and international experts in delivering medical care during terrorist attacks have highlighted alternative approaches in the BMJ. In Paris in 2015, the integration of doctors with specialist police teams enabled about 100 wounded people in the Bataclan concert hall to be triaged and evacuated 30 minutes before the terrorists were killed. The experts writing in the BMJ believe the UK approach would have delayed any medical care reaching these victims for three hours. These are perilously hard judgment calls. Policymakers and commanders on the scene have to balance the likelihood that long delays in intervening will lead to more victims dying from their injuries against the increased risk to the lives of medical staff who are potentially putting themselves in the line of fire by entering the so-called 'hot zone'. First responders themselves need to be at the forefront of this debate. As the people who have the experience, face the risks and want more than anyone to save as many lives as possible, their leadership and insights are vital. In the wake of the Streatham attack the government is looking at everything from sentencing policy to deradicalisation. Deciding how best to save the wounded needs equal priority in the response to terrorism. Read full story Source: The Guardian, 7 February 2020
  13. News Article
    Reports of illegal teeth-whitening that could leave patients at risk of health problems including burns or lost teeth have increased, the BBC has found. General Dental Council (GDC) figures showed a 26% rise in reports last year. Teeth-whitening can only be performed legally in the UK by professionals registered with the GDC. One beauty school claimed to have provided "thousands" of candidates with illegitimate qualifications, an undercover investigation found. Failure to comply with the requirement to be registered can result in a criminal record and an unlimited fine. Untrained beauticians using teeth-whitening kits have been known to cause tooth loss, burns and blisters. Dr Ben Atkins, president of the Oral Health Foundation, said: "When things go wrong in dentistry, they can really go wrong. I've been that dentist with the full back up service when the patient's had that heart attack. It would be catastrophic for the patient and the person who's been trained and told it's legal to do it." Read full story Source: BBC News, 10 February 2020
  14. News Article
    Dozens of women who thought they were having a "complete mesh removal" have discovered material has been left behind, the BBC's Victoria Derbyshire programme has been told. Some women have been left unable to walk, work or have sex after having the initial vaginal-mesh implants. Specialist surgeons say in some cases total or partial mesh removal can be beneficial. But some women said their symptoms had become worse. One was left suicidal. Vaginal-mesh implants remain available on the NHS in England but only when certain conditions are met. In Scotland, the use of mesh was halted in 2018. One paitent said her surgeon had promised her a "full mesh removal", but she has now been told more than 10cm (4in) could have been left behind. She had the mesh implanted several years ago to treat urinary incontinence and said she had woken after the surgery with "chronic pain in my legs, my groin and my hips". It is believed she suffered nerve damage. A year later – after being told by one expert a mesh removal would be unlikely to resolve her pain – she found a surgeon who told her the implant could be completely removed. She had two operations, each taking her half a year to recover from, and was told there had been a full removal. But "within a few months" the pain began to return and her health deteriorated and she found out that only 5–8cm had been removed. "My whole world turned upside down," she said, breaking into tears. She has since been told by a separate specialist her form of mesh was one of the most difficult to remove and could cause significant nerve damage if not removed properly. She said she had never been told this by her surgeon. The number of women affected is unknown but the Victoria Derbyshire programme understands there are at least dozens of such cases. The Royal College of Obstetricians and Gynaecologists said in a statement that it took "each and every complication caused by mesh very seriously". It said: "Women must be informed of all options available and the benefits and risks of each so they can make the best decision about their care." Read full story Source: BBC News, 6 February 2020
  15. News Article
    A whistleblower raised the alarm over patient safety at West Suffolk Hospital because of concerns about the behaviour of a doctor who had been seen injecting himself with drugs, the Guardian has revealed. The incident had already prompted internal complaints from senior staff at West Suffolk hospital, but the whistleblower decided to take matters a step further when the same doctor was later involved in a potentially botched operation. The whistleblower then wrote to relatives of a dead patient and urged them to ask questions about the conduct of the doctor and his background. When they did this, the hospital launched a widely criticised “witch-hunt” in an attempt to find out the identity of the leaker. The doctor’s drug use, which the trust has never acknowledged until now, helps explain why it demanded fingerprint and handwriting samples from staff – tactics which the NHS regulator roundly condemned in a hard-hitting report last week. Read full story Source: Guardian, 5 February 2020
  16. News Article
    Shipman, Mid Staffordshire, Morecambe Bay, and now Ian Paterson, the breast surgeon that performed botched and unnecessary operations on hundreds of women. The list of NHS-related scandals has got longer. It's tempting to say the health service has not learned lessons even after a string of revelations and reviews. But is that fair? asks BBC Health Editor Hugh Pym. The inquiry, chaired by Bishop Graham James, makes clear there were failings at every level of a dysfunctional health system when it came to patient safety. The public and private health systems did not compare notes about suspicious behaviour by a consultant. Staff working with Paterson thought that his surgical methods were unusual but, perhaps cowed by being ignored after raising concerns, kept their heads down. Add to that the power and status of a surgeon in the medical world and, in the words of the report, Paterson was "hiding in plain sight". So could it happen again? James says it's clearly impossible to eliminate the activities of determined criminals in any profession. He acknowledges that some improvements have been made on policing. But he says that a decade on from the Paterson scandal, he is not convinced that medical regulators, with a combined budget of half a billion pounds a year, are doing enough collectively or collaboratively to make the system safe for patients. The review chair notes tellingly that while regulators spoke of major improvements which should identify another Paterson, some doctors and nurses had told the inquiry that it was "entirely possible that something similar could happen now". Read full story Source: BBC News, 4 February 2020
  17. News Article
    A Surrey hospital trust has become the first in the country to appoint a nurse dedicated to preventing patient falls and medication mix-ups. The consultant nurse has been appointed by Ashford and St Peter's (ASP) Hospital NHS Foundation Trust to reduce the number of patients who are injured while being treated at its sites. This includes looking at ways to reduce the amount of people who fall over, suffer with venous thromboembolism or experience tissue damage while in hospitals in north west Surrey. The trust says the harms prevention nurse will be the first in the country hired for such a role and will also work with the team who look at incidents of medication mix-ups and mistakes. Read full story Source: Surrey Live, 4 February 2020
  18. News Article
    A culture of "avoidance and denial" allowed a breast surgeon to perform botched and unnecessary operations on hundreds of women, an independent inquiry has found. The independent inquiry into Ian Paterson's malpractice has recommended the recall of his 11,000 patients for their surgery to be assessed. Paterson is serving a 20-year jail term for 17 counts of wounding with intent. One of Paterson's colleagues has been referred to police and five more to health watchdogs by the inquiry. The disgraced breast surgeon worked with cancer patients at NHS and private hospitals in the West Midlands over 14 years. His unregulated "cleavage-sparing" mastectomies, in which breast tissue was left behind, meant the disease returned in many of his patients. Others had surgery they did not need - some even finding out years later they did not have cancer. Patients were let down by the healthcare system "at every level" said the inquiry chair, Bishop of Norwich the Rt Revd Graham James, who identified "multiple individual and organisational failures". One of the key recommendations from the report is that the Government should make patient safety a the top priority, given the ineffectiveness of the system identified in this Inquiry. Read full story Source: BBC News, 4 February 2020
  19. News Article
    An independent inquiry is expected to call for major changes in the way private hospitals supervise doctors after hundreds of women were put through unnecessary operations by a rogue breast surgeon. Ian Paterson was jailed for 20 years in 2017 after being convicted of 13 counts of wounding with intent and three counts of unlawful wounding. But his surgical malpractice may have harmed more than 750 women over more than a decade. He carried out unnecessary surgery for breast cancer on women who did not have the disease, and put other women who did at risk by using his own unofficial technique, which left behind partial breast tissue. On Tuesday an inquiry chaired by the Bishop of Norwich, the Right Reverend Graham James, will be published and is expected to make recommendations about how doctors are allowed to work across both the NHS and private sector with minimal supervision and oversight. One key area of focus is expected to be a process known as “practising privileges”, where private hospitals allow clinicians to carry out their own activities within the hospital, similar to self-employed contractors. They effectively rent the hospital space for their work. Read full story Source: The Independent, 2 February 2020
  20. News Article
    The hospital at the centre of a whistleblowing inquiry has been downgraded by the care watchdog and issued with a warning notice amid concerns over leadership and patient safety. West Suffolk Foundation Trust has been rated requires improvement by the Care Quality Commission (CQC) in a damning report having previously been rated outstanding since 2017. The trust, whose Chief Executive Stephen Dunn received a CBE for services to patient safety in 2018, has faced criticism after bosses threatened senior doctors with a fingerprint and handwriting analysis to try and identify a whistleblower. In a new report published today, the CQC inspectors said they had significant concerns about the safety of mothers and babies in the trust’s maternity unit and the criticised the culture of the trust leadership referencing what they called “threatening” actions. In the West Suffolk hospital maternity unit the CQC found staff had not completed key safety training, did not protect women from domestic abuse, and staff did not always report safety incidents. They also found maternity staff were not taking observations and the unit lacked enough staff with the right qualifications to keep women safe. The trust was issued with a warning notice by the trust demanding it make improvements before the end of this month. On the trust leadership the CQC report said: “The style of executive leadership did not represent or demonstrate an open and empowering culture. There was an evident disconnect between the executive team and several consultant specialities." Read full story Source: The Independent, 30 January 2020
  21. News Article
    Harry Richford's death underlines the need for the health secretary to bring back the national maternity safety training fund – and there are other issues that require urgent attention – The Independent reports. Harry Richford had not even been born before the NHS failed him. An inquest has concluded he was neglected by East Kent University Hospitals Trust in yet another maternity scandal to rock the NHS. His parents and grandparents have fought a tireless campaign against a wall of obfuscation and indifference from the NHS. In their pursuit of the truth they have exposed a maternity service that did not just fail Harry, but may have failed dozens of other families. As with the family of baby Kate Stanton-Davies at Shrewsbury and Telford Hospitals Trust, or Joshua Titcombe at the University Hospitals of Morecambe Bay Trust, it has taken a family rather than the system to expose what was going wrong. It is known that there are about 1,000 cases a year of safety incidents in the NHS across England, including baby deaths, stillbirths and children left brain damaged by mistakes. Last week, the charity Baby Lifeline, joined The Independent to call on the Department of Health and Social Care (DHSC) to reinstate the axed maternity safety training fund. This small fund was used to train maternity staff across the country. Despite being shown to be effective, it was inexplicably scrapped after just one year. There are other issues that also need urgent attention. The inquest into Harry’s death, which concluded on Friday, lasted for almost three weeks. Without pro bono lawyers from Advocate, Brick Court Chambers and Arnold & Porter law firm, the family would have faced an uphill struggle. At present, families are not automatically entitled to legal aid at an inquest, yet the NHS employs its own army of lawyers who attend many inquests and can overwhelm bereaved families in a legal battle they are ill-equipped to fight. Even the chief coroner, Mark Lucraft QC, has called for this inequality of legal backing to end, but the government has yet to take action. Read full story Source: The Independent, 26 January 2020
  22. News Article
    The Care Quality Commission (CQC) missed multiple opportunities to identify abuse of patients at a privately run hospital and did not act on the concerns of its own members, an independent review has found. Bosses at the CQC have been criticised in an independent report by David Noble into why the regulator buried a critical report into Whorlton Hall hospital, in County Durham, in 2015. His report published today said the CQC was wrong not to make public concerns from one of its inspection teams in 2015. “The decision not to publish was wrong,” his report said, adding: “This was a missed opportunity to record a poorly performing independent mental health institution which CQC as the regulator, with the information available to it, should have identified at that time.” Read full story Source: The Independent, 22 January 2020
  23. News Article
    "Too many" types of hernia mesh implants are being used on NHS patients with little or no clinical evidence, the BBC has been told. New data shows more than 100 different types of mesh were purchased by NHS Trusts from 2012 to 2018 in England and Scotland, leading to fears over safety. The meshes can cut into tissue and nerves, leaving some people unable to walk, work or care for children. Currently, hernia mesh devices can be approved if they are similar to older products, which themselves may not have been required to undergo any rigorous testing or clinical trials in order to assess their safety or efficacy. In England, around 100,000 such operations are performed each year, the majority using mesh. Many go well. But the Victoria Derbyshire programme has heard from nearly 300 people who have experienced complications - including chronic pain, infections and organ perforations. International guidelines estimate one in 10 patients will experience "significant chronic pain" following a mesh repair. The director of devices at the Medicines and Healthcare products Regulatory Agency (MHRA), Graeme Tunbridge, told the BBC: "The benefits and risks of using mesh for hernia repair have been considered in detail by clinicians and the professional bodies who represent them. We continue to monitor and review evidence as it becomes available and will take any appropriate action on that basis." Mr Tunbridge said he recognised the system "does need strengthening" and said new legislation on medical devices would take effect from May 2020. Read full story Source: BBC News, 15 January 2020
  24. News Article
    The Urological Society of Australia and New Zealand (USANZ) supports recommendations in the Hearing and Responding to Stories of Survivors of Surgical Mesh report released by the New Zealand Ministry of Health in response to complications resulting from the use of surgical mesh in a range of operations, including for stress incontinence and pelvic organ prolapse. The Ministry of Health commissioned the review, in which New Zealand urologists participated alongside a wide range of consumer and other health groups, to provide a plan “to minimize future risk to consumers and support those harmed by it”. “The Urological Society acknowledges that complications from the use of mesh for treating stress urinary incontinence and pelvic organ prolapse has caused considerable physical and psychological harm in some patients, which we feel is unacceptable, said USANZ President, Dr Stephen Mark. "We also acknowledge and accept findings that there were deficiencies in technical and communication skills of some surgeons. We recognise the distress caused to these patients and want to be part of the solution in helping these people, as well as ensuring no patients are harmed in future." “Further research is necessary to achieve best practice outcomes and help us understand why, when, and in which patient complications may occur. For this reason, USANZ supports participation with Australia in a mesh registry. By collaborating with Australian researchers, we can be part of a substantial database that would underpin ongoing research in the interests of patient safety." Read full story Source: New Zealand Doctor, 13 January 2020
  25. News Article
    The US Food and Drug Administration (FDA) needs to do more to quickly and substantially reform its system for reporting adverse events caused by medical devices, two researchers wrote in an Editorial published in JAMA Internal Medicine. The editorial notes several instances where information on a medical device was withheld from the public or not reported fully. The current adverse events reporting system relies on device makers to voluntarily report adverse events, which the authors say does not place patient safety as a priority. The editorial specifically highlights a study involving Medtronic's Insync III model 8042 heart failure pacemaker, which the authors said caused a "high burden of serious adverse events (including death)." The authors said it took the FDA 19 months to recall the device after the first instance of the device failing was reported. The FDA also decided to classify the recall as Class II, which signifies a low probability of serious adverse events. "This long unexplained delay before the recall and the inappropriate recall classification raise concerns about patient harms that could have been prevented by speedier and stronger regulatory actions," the authors wrote. Read full story Source: Becker's Hospital Review, 10 January 2020
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