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Found 468 results
  1. Content Article
    In this blog, Kath Sansom, founder of campaign group Sling the Mesh, outlines her concerns about three new mesh products for muscle and tendon injuries that have been given near automatic approval by the US Food and Drug Administration (FDA). She highlights that although the manufacturers claim the products have caused no sensitivity issues and no adverse responses in animals, there is no data on the potential long term impact of the mesh devices. Highlighting the knowledge that we now have about the potential for surgical mesh to cause severe injury and side-effects, Kath raises concerns about the lack of regulatory rigour and the potential for these degradable devices to cause fibromyalgia and other systemic issues. Read more about the approval of products for shoulder soft tissue repair
  2. Content Article
    Medicines can be purchased online from anywhere in the world. In 2021, nearly 53 million items were dispensed from online pharmacies in England, up 300% since 2016. In this blog, Dr Georgia Richards outlines the need for caution when buying medicines online, highlighting that online purchase of medications was cited in 16 Prevention of Future Deaths (PFD) reports between 2013 and 2019. She highlights coroners concerns concerns about: the ease of obtaining drugs via the Internet without any contact with the patient’s medical practitioner or access to the patient’s records. the inability to limit the volume or the frequency of ordering. issues with the regulation of supply, importation and delivery of controlled class A drugs via the international and UK postal system. lack of regulation of the dark web.
  3. Content Article
    The tragic and preventable death of Ruth Perry, headteacher at a school downgraded by an Ofsted inspection, has sparked calls for a review of regulatory oversight. While safety and quality must be assured, it’s crucial to consider the impact of regulatory inspections on the well-being of passionate workforces facing complex and challenging environments. In this blog, healthcare entrepreneur Vanessa Webb makes the case that as a potential cause of harm to staff, regulatory inspections in public services including healthcare should be subject to Health and Safety Risk Assessments. There should be a systematic process to identify hazards, evaluate the likelihood and severity of harm, and determine appropriate controls to prevent or mitigate those risks.
  4. Content Article
    Pharmacovigilance is the observation and monitoring of possible harms from exposure to a variety of pharmaceuticals, biologics and devices. In this blog, Professor of Evidence-based Medicine Carl Heneghan and Clinical Epidemiologist Tom Jefferson talk about a recent attempt to obtain data on the incidence of deaths following Covid-19 vaccination from the Medicines & Healthcare Products Regulatory Agency (MHRA) through a Freedom of Information request. They describe how the MHRA initially said they were unable to provide the information as it would cost too much to extract, and after sending a follow up request to the MHRA's Chief Safety Officer, they have not heard anything further after an initial promise to investigate. They argue that the MHRA is failing the public by failing to investigate the side effects of Covid vaccines using information from Yellow Card reports. This blog is paywalled once you have read a certain number of articles each month.
  5. Content Article
    The MHRA has been made aware that falsified medical oxygen has been provided to several dental practices across the UK.
  6. Content Article
    This article highlights three questions tabled in the House of Commons relating to the Yellow Card Scheme, the system for recording adverse incidents with medicines and medical devices in the UK.
  7. Content Article
    Probiotics are used for both generally healthy consumers and in clinical settings, but there have been adverse events as a result of their consumption. Concise and actionable recommendations on how to use probiotics safely and effectively are therefore needed, especially as increasing numbers of new strains and products come to market, and probiotic use increases in vulnerable populations. The International Scientific Association for Probiotics and Prebiotics convened a meeting to discuss and produce evidence-based recommendations on potential acute and long-term risks, risks to vulnerable populations, the importance for probiotic product quality to match the needs of vulnerable populations and the need for adverse event reporting related to probiotic use. This paper presents these recommendations to guide the scientific and medical community on judging probiotic safety.
  8. Content Article
    If you are faced with a Care Quality Commission (CQC) criminal investigation into you or your service it is vital that you take prompt action. In this article, Gemma Nicholas consider CQC’s criminal enforcement powers, how the CQC uses its powers and action providers can take.
  9. Content Article
    The 'Living with Long Covid' podcast series from Julie Taylor aims to raise awareness of Long Covid, and provide a platform of support, education and the lived experience.
  10. Content Article
    Should new draft legislation around the use of mesh in women regarding incontinence or prolapse and a new guidance on a national registry meaning every woman choosing mesh in the future must be logged on a database be extended? Haydn Wheeler argues that a broader database is in need.
  11. Content Article
    This blog on the Sling the Mesh website provides an overview of research by Professor Carl Heneghan, Director of the Centre for Evidence-Based Medicine at Oxford University, into regulatory issues relating to pelvic mesh. It outlines issues uncovered by Professor Heneghan and his colleagues, including the fact that clinical trial data was not required in the regulation of mesh and that early evidence of complications was ignored in the approval of subsequent devices.
  12. Content Article
    In this blog, Patient Safety Learning considers key patient safety issues relating to complications from surgical mesh implants, highlighting further sources of opinion and research on the hub.
  13. News Article
    The Care Quality Commission (CQC) will restart inspections from 1 February with a focus on the urgent and emergency care system, the regulator has announced. In December, CQC postponed inspections of some services to support the acceleration of the vaccination booster programme. They also prioritised activity to help create more capacity in adult social care. However, considering the current situation – including the easing of restrictions across the country – they have reviewed and updated their regulatory approach. From 1 February the CQC will inspect where: there is evidence that people are at risk of harm. This applies to all health and social care services, including those where inspections were previously postponed except in cases where we had evidence of risk to life CQC can support increasing capacity across the system, particularly in adult social care a focus on the urgent and emergency care system will help us understand the pressures, where local or national support is needed, and share good practice to drive improvement. Much of their approach is unchanged and remains in line with the update from the Chief Inspectors on 10 December 2021. This includes: achieving their ambition to complete 1,000 infection prevention and control (IPC) inspections in adult social care rapid response to requests to set up new Designated Settings activity to rate adult social care services that are registered and not yet rated inspections of adult social care providers currently rated as Requires Improvement to identify where improvement has taken place and re-rate where possible. Alongside their risk-based activity, CQC will undertake ongoing monitoring of services. This helps to identify where CQC may need to take further action to ensure people are receiving safe care and offer support to providers. It also remains important that people share concerns or examples of good practice, CQC said. Read full story Source: CQC, 27 January 2022
  14. News Article
    At the age of 36, Nola Borcherds could hardly walk ten steps without gasping for breath. A viral infection years earlier had weakened her heart and left her with a constant wheezy chest. Her heart was failing and she needed a new one. No transplant was available, but the next best thing was an implant called HeartWare. Unlike pacemakers, which send an electrical pulse to keep it beating regularly, the device would attach to Nola’s heart and keep her alive by taking over its function, continuously pumping blood around the body. Brochures promised the gadget could be life changing. It was smaller, safer and more effective than others, and designed to last up to ten years, raising her chance of a transplant. When Nola’s pump was implanted in December 2018 it made a tremendous difference. “Two to three months after she had it fitted, she could virtually run up the stairs,” her mother, Jenny Kiddie said. But on 21 May 2021, two and a half years after the device went in, it stopped working. Doctors at Harefield Hospital in Hillingdon, west London, were carrying out maintenance when it failed to turn back on, cutting the supply of blood to her brain. “The hospital called and said, ‘Nola’s become very unwell. How quickly can you get here?’” her mother said. “By the time we arrived, she was already in the morgue.” What her family believe Nola did not know, and what the UK regulator, the Medicines and Healthcare products Regulatory Agency (MHRA), failed to react to, was that HeartWare pumps had already been linked to hundreds of deaths globally. As early as 2011 some doctors switched to alternatives. Yet the UK regulator allowed them to stay on the market — and they continued to be implanted on the NHS until last year. Some patients are still living with the pieces of equipment, because surgery to remove them is so risky. Families, medical experts and lawyers want to know why the MHRA failed to take firm action despite repeated warnings about the devices, which they believe could have contributed to patients dying. By Nola’s death last year, the health regulator had passed on at least 16 safety alerts to doctors warning of problems identified by the manufacturer. Read full story Source: The Sunday Times, 23 January 2022
  15. News Article
    A GP’s ethnicity has an impact on the level of leadership support it gets from regulators and external bodies, a new Care Quality Commission (CQC) report has suggested. In 2021, the CQC conducted research looking at concerns raised by some doctors that ethnic minority-led GP practices were “more likely to have a poorer experience or outcomes” from regulation. In a final report, the CQC has admitted ethnic minority-led practices are “not operating on a level playing field”, due to several factors including the fact they are more likely to care for populations with higher levels of socio-economic deprivation and poorer health. This can affect their ability to achieve some national targets used in assessments of quality, and increase challenges around recruitment and funding. The evidence gathered by the CQC also suggested that practices led by ethnic minority doctors “often lacked leadership support from other bodies and suffered from low morale”. Read full story (paywalled) Source: HSJ, 19 January 2022
  16. News Article
    There are serious concerns over the standards of specialist care being provided to patients with the most complex mental health needs, a BBC investigation has found. Patients sent by the NHS to stay in mental health rehabilitation units say they have been placed in unsafe environments, often far from home, with untrained staff. Experts say not enough is being done to regulate the sector, which costs the NHS half a billion pounds a year. Lissa had spent years struggling with her mental health, having experienced traumatic life events. She was diagnosed with mixed personality disorder, depression and high-functioning Asperger's. So when the NHS sent her to a unit in Coventry run by Cygnet Health Care for a specialist talking therapy, she agreed. The hospital, however, was in special measures. There had been two deaths in the previous 20 months. In both cases there was found to be a failure to follow the patient's care plan and carry out observations correctly. Lissa says staff failed to treat her with dignity and respect. The system in England is regulated by the Care Quality Commission, (CQC). Some rehabilitation wards haven't been inspected for four or more years. John Chacksfield, who was a CQC inspector until late 2020, says greater scrutiny is needed. "Sometimes the private sector provides really excellent service, but there are certain units that really do need regular inspections just to make sure staff are being trained enough, or are having enough clinical supervision. It does worry me," he says. Read full story Source: BBC News, 18 January 2022
  17. News Article
    A trust has written to its registered workforce to reassure them of management support when delivering care in ‘extremely challenging circumstances’. Derbyshire Community Health Services Trust sent out a “statement of support for professionally registered colleagues”, in which it thanked them for their “continued efforts”, and explained how they would support staff from a “professional and regulatory perspective”, when delivering services that require “a high level of clinical knowledge and autonomous decision-making”. This week has seen NHS staff absences hit new highs – over 100,000 – and the military brought in to support care in London hospitals, in combination with very high community covid transmission rates and very busy acute trusts. The DCHST email, signed by executive director of nursing Michelle Bateman, executive medical director Ben Pearson and interim director of Allied Health Professionals Trish Bailey, said: “When services are at this high level of escalation it can mean that we are not always able to deliver care in the way we would like and that can challenge our professional values.” Helen Hughes, chief executive of charity Patient Safety Learning, said Derbyshire Community Healthcare’s message needed to be echoed by every trust in the country. “Without sufficient staffing resources, difficult decisions are required to prioritise care,” Ms Hughes said. “In some cases, delays in treatment as a result of these decisions could lead to avoidable harm.” She stressed it was “imperative” that future investigations into safety incidents “properly reflect the systemic nature of reasons for error or harm, not simply blaming staff for failures to provide safe care”. “Health professionals’ codes mean that they are not allowed to work outside their sphere of competence. But what if staff are being tacitly encouraged or required to work in an unsafe system? Staff need to be able to feel secure in raising any concerns they have, being listened to and being supported,” Ms Hughes added. Read full story (paywalled) Source: HSJ, 10 January 2022
  18. News Article
    The government has ordered an external review of whether the number of professional healthcare regulators should be reduced to ‘simplify’ the system. Newly published procurement documents reveal the Department of Health and Social Care has hired KPMG to make recommendations on whether the number of regulators “should be reduced and how this might be achieved”. The scope of the review covers the eight independent healthcare regulators – which include the General Medical Council, the Nursing and Midwifery Council and the Professional Standards Authority for Health and Social Care. It does not cover other healthcare regulators such as the Care Quality Commission, NHS England/Improvement, or the Medicines and Healthcare Products Regulatory Agency. According to DHSC there is ongoing work to “reform the healthcare regulators’ legislation” which has created an “opportunity to consider” if the regulatory landscape could be “simplified to provide better public protection in a more efficient way”. A spokeswoman for the DHSC told HSJ that “stakeholders” accepted that having nine separate professional regulatory bodies “can be confusing for the public”. She said: “We know health regulators play an integral role in our commitment to making sure everyone has access to safe and effective healthcare, and we will continue to identify opportunities to improve the professional regulation system.” In 2014, Sir Robert Francis, who chaired the inquiry into failings at Mid Staffordshire Foundation Trust, said there were too many healthcare regulators in the NHS. Read full story (paywalled) Source: HSJ, 5 January 2022
  19. News Article
    The former chairman of the UK competition regulator has condemned the market for PCR tests for travellers, describing it as a “rip-off jungle”. After the reimposition of the requirement to take the tests on return from abroad, Lord Tyrie accused the government of once again allowing the companies offering PCR tests to manipulate the system by making them available at unrealistic prices. “For this policy to get into a mess once might be seen as a misfortune but for it to resurface again after all the warnings over the summer would have to be described as carelessness,” he told BBC Radio 4’s Today programme. “It was a scandal waiting to happen and it’s now happened and it needs very urgent action.” Last week, the Guardian revealed that a slew of the cheapest deals on PCR tests had been removed from the government website amid concerns travellers were being misled by companies advertising the coronavirus testing service for less than a £1. Private companies offering day two tests for travellers are listed on a government website for consumers to search. However, most of the deals were found to not be suitable for most travellers as they were often offered in only one location, on limited dates and only available to those who could attend in person. “It appears that some of the worst practices – misleading online advertisements, overpricing, unacceptably poor service among them – are still widespread,” said Tyrie, the former head of the Competition and Markets Authority, and the ex-chair of the Treasury select committee. Read full story Source: The Guardian, 8 December 2021
  20. News Article
    A loophole in the law is leaving vulnerable patients at risk of abuse and sexual assault by unregulated private ambulance staff, The Independent has revealed. While many private ambulance providers are regulated, a small number, such as those providing services at events, those providing first aid, and those who are subcontracted, fall outside the reach of the Care Quality Commission (CQC). This is due to a loophole in the legislation, which means that organisations providing healthcare at events are not required to be CQC registered. The Independent has learned that around 10,000 patients a day are seen by ambulance workers who are unregulated and not part of any registered professional body. Alan Howson, chief executive of the Independent Ambulance Association, said he was concerned about healthcare providers that “operate outside of the scope” of the care watchdog and in “plain sight and unchecked”, leaving patients at risk from staff who might “seek to misuse their power”. His concerns were in response to an internal report by the CQC, completed last year, which identified specific risks around sexual harm in relation to private providers, as well as “inconsistency” in providers’ recording of incidents. Read full story Source: The Independent, 14 November 2021
  21. News Article
    Thousands of women are being missed off the breast implant registry, new figures suggest. Data from NHS Digital, which manages the register, implies that around 8500 women across England and Scotland have not been added to the register after they were fitted with an implant last year. The register was recommended as a result of the breast implant scandal which saw some women fitted with faulty implants. It records the details of every person who has breast implant surgery in case of a product recall or another safety concern. But the latest figures suggest that many are being missed off the register and NHS Digital has asked women undergoing such treatment to ensure their surgeon has registered their details. The figures show that operations on 10,500 people were recorded in 2020. But officials have estimated this represents around 55% of the total number of cases. This means that approximately 8485 people were not added. Lee Martin, NHS breast surgeon and chairman of the Breast and Cosmetic Implant Registry steering group, said: "We want all patients, past and present, to be aware that the registry exists and ensure they are included by speaking to their surgeons." "As a surgeon, I know first-hand the importance of patient information being included on the registry, it's crucial in providing good patient care and provides patients with assurance that they will be followed up with if there are issues with their breast implants in the future." Read full story Source: Medscape, 10 November 2021
  22. News Article
    The High Court in Canberra, Australia, has ruled against big pharma giants Johnson and Johnson's application to appeal the Federal Court’s decision in favour of the survivors of their defective medical devices in November 2019. This means the decision of the Full Federal Court, in favour of the Lead Applicant and group members, will stand. Shine Lawyers', which has led the class action, has launched further actions against American Medical Systems (AMS), another manufacturer of mesh and tape implants supplied in Australia. The AMS implants, which are used to treat pelvic organ prolapse and stress urinary incontinence, have left many Australian women with severe complications. The legal group has also moved against Boston Scientific for defective vaginal mesh and sling implants received by women in Australia and opened a second Ethicon / Johnson & Johnson’s on behalf of women implanted with a defective mesh product on or after 4 July 2017. The class actions were filed in the Federal court and MIA believe other class actions, including hernia mesh, are underway. Kath Sansom, founder of the Sling the Mesh campaign, said "Brilliant news from Australia! Johnson & Johnson Loses High Court Appeal against the pelvic mesh verdict of 2019. This means J&J can no longer appeal the verdict! I realise compensation may still take time to be awarded to the 10,000+ mesh injured but at least the appeals are over! Congratulations to all the Australian mesh campaigners!" Read press release
  23. News Article
    A decade after scientists identified a link between certain implants and cancer, the US Food and Drug Administration has ordered “black box” warnings and a new checklist of risks for patients to review. Federal regulators have placed so-called black box warnings on breast implant packaging and told manufacturers to sell the devices only to health providers who review the potential risks with patients before surgery. Both the warnings and a new checklist that advises patients of the risks and side effects state that breast implants have been linked to a cancer of the immune system and to a host of other chronic medical conditions, including autoimmune diseases, joint pain, mental confusion, muscle aches and chronic fatigue. Startlingly, the checklist identifies particular types of patients who are at higher risk for illness after breast implant surgery. The group includes breast cancer patients who have had, or plan to have, chemotherapy or radiation treatments. That represents a large percentage of women who until now were encouraged to have breast reconstruction with implants following their treatment. Reactions to the new requirements were mixed. While some doctors welcomed the new warning system, others worried that the potential risks and side effects would not be conveyed adequately by plastic surgeons who were eager to reassure patients the procedure is safe and that the new checklist would be handled in a dismissive manner. But Dr. Mark Clemens, a professor at M.D. Anderson Cancer Center in Houston who serves a liaison to the F.D.A. for the American Society of Plastic Surgeons Society, said the black box warning and checklist represented “a huge step forward for patient safety and implants.” Read full story Source: The New York Times, 27 October 2021
  24. News Article
    The Care Quality Commission (CQC) has published State of Care. The report, which draws on the experiences of care people have shared with Healthwatch England, has found that health and social care services face some highly concerning challenges, including: A workforce drained in terms of resilience and capacity, especially in social care, where the staff vacancy rate has risen; A rising number of people seeking emergency care, leading to unacceptable waiting times; and Tackling the health inequalities that the COVID-19 pandemic has exacerbated. The report welcomes the additional funding that the Government has allocated to help the NHS and social care address their challenges. However, CQC has called for the extra investment to be used to: Develop new ways of working and don’t just prop up existing approaches and plug demand in acute care; and Improve the training, career development and terms and conditions of social care workers to help attract and retain more staff. CQC has also recommended that the short-term funding - currently in place to help discharge patients who are no longer in need of hospital care but may still require care services - be extended. The HealthWatch response Responding, Sir Robert Francis QC, Chair of Healthwatch England said: “During the pandemic, people have told us about the challenges they have faced. Whether this not being able to access dental care, problems using online GP services or being discharged from the hospital without the proper support. It’s great to see this report drawing so much on the experiences people have shared with us. “We urge Government to act on this report. The health and care system upon which we all depend is facing a hard winter, but, as this report makes clear, the longer-term picture is also challenging. “The steps the CQC are recommending, like extending the extra funding to help people leave hospital safely and ensuring there is enough dental capacity, will help give services the breathing space they need to get through this winter. “However, come spring we need to grasp the opportunity to build a better NHS and social care system. A system that tackles heath inequalities head-on, ensuring that no matter who you are or where you live, you can access high-quality care that meets your needs. A system that is sustainable, is designed round the needs of people and breaks perennial cycle of winter crises.” Original source: HealthWatch CQC report here
  25. News Article
    The care model run by independent sector mental health and learning disability hospitals is ‘inherently risky’, a Care Quality Commission (CQC) chief inspector has warned. Speaking at the NHS Providers conference, Ted Baker, chief inspector of hospitals for the Care Quality Commission, unveiled the regulator’s plans to change how it inspects health and care services. When asked by HSJ how its new “streamlined” approach would be applied to inpatient units run by the independent sector for people with mental health and learning disability, Professor Baker said: ”One of the things we’ve been doing during the pandemic, and will continue in our transitional approach, is target risk. And one of the risks we have been targeting is exactly this, patients with learning disability and/or autism in some of these small units that have got closed cultures." “I think we do recognise that model of care is an inherently risky model of care and so we have been inspecting many of those under this risk driven model and taking action against many of them. But there is ongoing concern about that model of care and in a few weeks’ time we will be publishing a report on our assessment of that model of care and the importance of it being changed for the benefit of the people being looked after. The model of care needs to be improved but we need to make sure we are tackling the risk.” The chief’s comments come ahead of the regulator’s state of care report, which is due to be published next week. In its report published last year the CQC highlighted a concern regarding the quality and safety of independent learning disability and autism units. In particular it warned these were at a higher risk of developing closed cultures. Read full story (paywalled) Source: HSJ, 7 October 2020)
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