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Found 467 results
  1. News Article
    The reform of the UK’s Medical Device regulation offers a golden opportunity to drive innovation and growth in the UK’s Life Science sector while ensuring patient safety remains at the heart of the regulatory approach. But there is an urgent need for action to ensure we do not lose this opportunity. Senior members of the Life Sciences Council, Will Quince MP, Minister of State at the Department of Health and Social Care, Dr June Raine, CEO, Medicines and Healthcare products Regulatory Agency (MHRA) and Peter Ellingworth, CEO, Association of British HealthTech Industries (ABHI) have today announced a new agreement to accelerate the delivery of the future UK HealthTech regulatory system. Acknowledging the Chancellor’s priorities of stability and growth supported by regulatory reforms, and the importance of the success of the system to UK patients and the Life Science sector, they have formed an advisory group on behalf of the Life Sciences Council to drive the delivery of the ambition of the Life Sciences Vision to have a best in class regulatory system. The advisory group has agreed that aligned proposals will be published on three priority areas: international recognition routes for innovation system capacity. Read full press release Source; Gov.UK, 16 December 2022
  2. News Article
    The government has proposed new legislation to make patient visiting a legal right and also give the Care Quality Commission (CQC) fresh powers to enforce it. The Department of Health and Social Care has launched a consultation to seek views from patients, care home residents, families, professionals and providers on the introduction of new legislation which will require health and care settings, including hospitals, to accommodate visitors in most circumstances. It said the new visiting laws will also provide the CQC with a “clearer basis for identifying where hospitals and care homes are not meeting the required standard”, and enable it to enforce the standards by issuing requirement or warning notices, imposing conditions, suspending a registration or cancelling a registration. It said although the CQC currently has powers “to clamp down on unethical visiting restrictions”, the expected standard of visiting rules is not “specifically outlined in regulations”. Read full story (paywalled) Source: HSJ, 21 June 2023
  3. News Article
    Investigators have begun a further review of how a major trust handles disciplinary and professional standards cases, including allegations leaders had targeted some doctors with referrals to the medical regulator, HSJ has learned. The claims were part of a raft of concerns raised about University Hospitals Birmingham Foundation Trust over recent months, including BBC Newsnight reporting that a large number of General Medical Council referrals had led to no action; and claims of whistleblowing doctors “being bullied… by the threat of referrals to the GMC”. One external review of UHB, whose report was published in March, already examined the issue, and said it had identified 17 cases which contradicted Newsnight’s claim, with two referrals resulting in criminal conviction and removal from the medical register. It said there was “nothing exceptional” about the referral numbers or types at UHB, or their outcomes, but also noted that medical staff told the review about “dysfunctional processes for maintaining higher professional standards”, and “expressed a perception that there was a rather rapid process to escalate to a GMC referral”. Read full story (paywalled) Source: HSJ, 21 June 2023
  4. News Article
    The government should ‘relieve’ GP practices of being the sole controller for their patients’ data, a senior NHS England director has said. Tim Ferris, NHSE director of transformation, said it was a “challenge” that GP practices acted as the sole controllers of their patients’ data. Dr Ferris, whose background is as a primary care doctor in the US, was giving evidence to a Lords committee on integration of primary and community care today. He was asked whether it was time to revisit legislation on the control of GP patient data. He said: “Thirty years ago when the law was created, it made more sense. But I think it might no longer be fit for purpose… The idea that if I were a GP in this country, if I had legal liability for the exchange of data, I would be worried about that.” Dr Ferris agreed there would be merit to the committee recommending the government “relieve” GPs of the sole responsibility for data protection, and their data controller status. Read full story (paywalled) Source: HSJ, 20 June 2023
  5. News Article
    Some doctors in Australia are using the title “specialist general physician” despite not having completed the training required by law, potentially misleading patients with complex and chronic health conditions that require specialised care, physicians say. After completing a medical degree and postgraduate work experience, graduates can apply to the Royal Australasian College of Physicians (RACP) fellowship training program. All RACP trainees complete similar foundational training before choosing areas of advanced training to specialise in such as geriatrics, cardiology, general medicine or other areas. General physicians are different from general practitioners (also known as GPs). General physicians care for patients with unusual or complex conditions and see patients either in hospital or those who are referred to them, usually by the patient’s GP. Medical practitioners can only use titles such as “specialist general physician”, “specialist geriatrician” or “specialist cardiologist” if they have completed the advanced specialist RACP training in the corresponding field of practice and have registered with the Australian Health Practitioner Regulation Agency (Ahpra). But Dr Jenna Paterson, a specialist general physician working in Victoria and South Australia, said there are “many, many” doctors who advertise their services to patients as a “general physician” without the qualifications to do so. Read full story Source: The Guardian, 13 June 2023
  6. News Article
    Twenty-four doctors have been disciplined by the UK medical regulator in the last five years after accessing and using information from patients’ treatment records without good reason. The General Medical Council (GMC) said it had struck off two of the 24 doctors it had sanctioned after finding that they had undertaken “inappropriate use” of medical records. Another 10 were suspended, 10 were warned about their future conduct, one had a condition imposed on their licence to practise medicine and the other had to undertake not to repeat their behaviour. The 24 cases were among 194 incidents of doctors allegedly accessing medical records without a clinical justification that prompted a complaint to the regulator between 2017 and 2022. Privacy campaigners said it was shocking that almost 200 people had made complaints to the GMC accusing doctors of violating patients’ confidentiality in that way. Read full story Source: The Guardian, 13 June 2023
  7. News Article
    The government has failed to change ‘restrictive’ legislation which would enable primary care reform – despite repeated announcements – a pharmacy leader has said. Currently, pharmacy technicians cannot take on dispensing tasks without supervision from a pharmacist but the government promised in 2019 to look at how legislation can be updated to allow pharmacy technicians to take more of a role in dispensing, as part of the current five-year Community Pharmacy Contractual Framework, which ends next year. The government has repeatedly announced and reannounced over the past five years that it wants to remove restrictions to give community pharmacy an expanded role. But in a new report shared exclusively with HSJ, the Company Chemists’ Association – the trade body with members including Asda, Boots, Lloyds Pharmacy and Superdrug – highlights that government has failed to make progress. Read full story (paywalled) Source: HSJ, 7 June 2023
  8. News Article
    A ground-breaking, mandatory national medical device outcome registry has been launched to collate detailed information on all procedures involving high-risk (Class III/IIb) devices, including pacemakers, hip joint replacements and breast implants. Led by NHS England’s Outcomes and Registries programme, and developed in partnership with NEC Software Solutions (NEC), the Medical Device Outcome Registry platform (MDOR) will capture data on over two million medical device procedures and more than 10 million unique devices used on patients each year across the NHS and independent healthcare sector, addressing recommendations from the Cumberlege review and Patterson inquiry. Collecting key details of the procedure, the clinicians involved and devices used, the registry will include clinical observational and patient outcome data, providing a single, comprehensive repository to improve patient safety and outcomes. Scott Pryde, delivery director for the Outcomes and Registries Programme, NHS England, said: “Millions of people receive high-risk medical devices and implants every year. Whereas most procedures are a complete success, when things go wrong it can result in serious harm for the patients affected. The Medical Device Outcome Registry will be responsive to concerns about the safety and outcomes of patients who receive high-risk medical devices, such as implants, and will use the data to actively detect, predict and prevent patient harm, and improve outcomes for patients". “The result will be in a step change in improving patient safety in these procedures, providing clinicians and healthcare teams with secure access to critical information they can use to inform clinical decisions and improve the experience of patients before, during and after their procedures.” Read full story Source: Clinical Services Journal, 31 May 2023
  9. News Article
    A group of doctors, including some GPs, has begun legal proceedings against the GMC based on what they say is a failure to act on Covid-19 vaccine misinformation. On Friday, the group, whose members wish to remain anonymous, sent a formal pre-action protocol letter to the GMC, which is a warning that legal action is imminent. In January, these doctors called on the regulator to investigate Dr Aseem Malhotra’s fitness to practise due to what they claim is his ‘high-profile promotion of misinformation about Covid-19 mRNA vaccines’. Dr Malhotra, a consultant cardiologist, campaigner and author, has over half a million followers on Twitter, with most recent posts focusing on the Covid vaccine. The upcoming action, which is led by lawyers from the Good Law Project, is based on the GMC’s refusal to carry out an investigation. Professor Trish Greenhalgh, a GP and academic in primary care at the University of Oxford who has been in touch with the group, told Pulse the ‘scandal is that the GMC do not think it’s their job to investigate doctors who have massive, massive followings on social media and who fan the flames of disinformation’. Read full story Source: Pulse, 5 June 2023
  10. News Article
    People concerned about the safety of patients often compare health care to aviation. Why, they ask, can’t hospitals learn from medical errors the way airlines learn from plane crashes? That’s the rationale behind calls to create a 'National Patient Safety Board,' an independent federal agency that would be loosely modelled after the US National Transportation Safety Board (NTSB), which is credited with increasing the safety of skies, railways, and highways by investigating why accidents occur and recommending steps to avoid future mishaps. But as worker shortages strain the US healthcare system, heightening concerns about unsafe care, one proposal to create such a board has some patient safety advocates fearing that it wouldn’t provide the transparency and accountability they believe is necessary to drive improvement. One major reason: the power of the hospital industry. The board would need permission from health care organisations to probe safety events and could not identify any healthcare provider or setting in its reports. That differs from the NTSB, which can subpoena both witnesses and evidence, and publish detailed accident reports that list locations and companies. A related measure under review by a presidential advisory council would create such a board by executive order. Its details have not been made public. Learning about safety concerns at specific facilities remains difficult. While transportation crashes are public spectacles that make news, creating demand for public accountability, medical errors often remain confidential, sometimes even ordered into silence by court settlements. Meaningful and timely information for consumers can be challenging to find. However, patient advocates said, unsafe providers should not be shielded from reputational consequences. Read full story Source: CNN, 30 May 2023 Related reading on the hub: Blog - It is time for a National Patient Safety Board: Pittsburgh Regional Health Initiative
  11. News Article
    Complaints to the national medical practitioner regulator arising from telehealth appointments have increased by 413% in three years, a significant number of these relating to prescriptions. The data provided to Guardian Australia by the Medical Board of Australia comes as the body prepares to release new guidelines for health practitioners and companies that provide telehealth consultations with patients. Guardian Australia understands the guidelines, to be made public by Friday, will state that real-time video or phone consults are “preferred” over real-time text-based consults such as online chat because identification is harder to establish without video. The guidelines will not ban real-time text-based consults but they will mean online quizzes, for example, can not be used to diagnose and prescribe medications to patients. “Prescribing or providing healthcare for a patient with whom you have never consulted, whether face-to-face, via video or telephone is not good practice and is not supported by the board,” the draft guidelines state. “This includes requests for medication communicated by text, email or online that do not take place in real-time and are based on the patient completing a health questionnaire but where the practitioner has never spoken with the patient.” Read full story Source: The Guardian, 20 May 2023
  12. News Article
    Trusts must start submitting full data on surgeries which include a high-risk medical device into a new national registry by December as part of a national push to increase accountability and safety around surgery. NHS England is launching the new mandatory medical device outcome registry this month. The new registry was created in response to Baroness Cumberlege’s “First Do No Harm” review and initial data submissions about surgeries that include a high-risk medical device will begin in June. Details of the launch arrangements have been set out in a draft letter which HSJ has seen and understands is set to be sent to medical directors and other system leaders imminently. Relevant procedures include those, for example, involving either a Class III device, like an implant, or a Class IIb therapeutic device, such as drug-eluting balloon catheter. Read full story (paywalled) Source: HSJ, 16 May 2023
  13. News Article
    Up to 10 junior doctor posts will be reinstated at a small district general hospital after regulators agreed it had improved its learning environment. In 2021, Health Education England removed 10 doctors from Weston Hospital over concerns they were being left without adequate supervision on understaffed wards. The unusual move prompted University Hospitals Bristol and Weston Foundation Trust to launch a “quality improvement approach” to improve its learner and clinical supervision environment. The regulator said the trust had made significant improvements that included: Better staff engagement with the trust leadership at all levels. Better clinical supervision, particularly around shift handovers and senior oversight of clinical decisions. Better learner experience in new training settings in rheumatology and intensive care medicine. Read full story (paywalled) Source: HSJ, 10 May 2023
  14. News Article
    The rising prevalence of hernia disorders, technological advancements in hernia repair devices, growing adoption of mesh in hernia repair surgeries, rising geriatric population and high adoption of hernia repair surgical procedures are some of the key factors driving the global hernia repair devices market, reports Yahoo News. Leading players operating in the global hernia repair devices market are adopting both organic and inorganic growth strategies such as collaborations, acquisitions, and new product launches to garner a higher market share. For instance: In February 2023, TELA Bio, Inc announced the launch of two additional configurations of its OviTex LPR device. The new configurations are 15 x 20 cm and 15 x 25 cm ellipses designed for ventral and incisional hernias. In December 2022, Deep Blue Medical Advances announced that they have received an additional 510(k) clearance from the US FDA for its T-Line Hernia Mesh for the subway technique in open hernia surgery. However, in a recent Tweet, campaign group Sling the Mesh voice their concerns:
  15. News Article
    The Nursing and Midwifery Council (NMC) has withdrawn its accreditation of the midwifery programme at a Kent university due to fears over quality and safety. The regulator highlighted concerns that Canterbury Christ Church University students were not gaining the expertise needed to deliver safe, effective and kind care. An NMC director said the decision was made in the “best interests of women, babies, and families”. The university said the decision had “devastating consequences” for their student midwives. “Our absolute priority is the wellbeing of our students and staff, and ensuring that our students can continue to complete their studies and begin their future careers, to be the high quality, much needed midwives that this region needs,” a university spokesperson said. Sam Foster, NMC executive director of professional practice, said while the decision would impact students and the local workforce, the regulator's role was to uphold the high standards that “women and families have the right to expect”. Read full story Source: BBC News, 4 May 2023
  16. News Article
    Recreational vaping will be banned in Australia, as part of a major crackdown amid what experts say is an "epidemic". Minimum quality standards will also be introduced, and the sale of vapes restricted to pharmacies. Nicotine vapes already require a prescription in Australia, but the industry is poorly regulated and a black market is thriving. Health Minister Mark Butler says the products are creating a new generation of nicotine addicts in Australia. Also known as e-cigarettes, vapes heat a liquid - usually containing nicotine - turning it into a vapour that users inhale. They are widely seen as a product to help smokers quit. But in Australia, vapes have exploded in popularity as a recreational product, particularly among young people in cities. Vapes are considered safer than normal cigarettes because they do not contain harmful tobacco - the UK government is even handing them to some smokers for free in its "swap to stop" programme.But health experts advise that vapes are not risk-free - they can often contain chemicals - and the long-term implications of using them are not yet clear.Read full story Source: BBC News, 2 May 2023
  17. News Article
    Almost one in three UK doctors investigated by the General Medical Council (GMC) think about taking their own life, a survey has found. Many doctors under investigation feel they are treated as “guilty until proven innocent” and face “devastating” consequences, the Medical Protection Society (MPS) said. Its survey of 197 doctors investigated by the GMC over the last five years found: 31% said they had suicidal thoughts. 8% had quit medicine and another 29% had thought about doing so. 78% said the investigation damaged their mental health. 91% said it triggered stress and anxiety. The MPS, which represents doctors accused of wrongdoing, accused the GMC of lacking compassion, being heavy-handed and failing to appreciate its impact on doctors. Read full story Source: The Guardian, 27 April 2023
  18. News Article
    Britain is hamstrung by red tape in the NHS and workers are blighted by regulation, Boris Johnson’s former cabinet secretary has said. Lord Sedwill, who was head of the civil service for two years, said that the UK was “failing to fulfil its great potential” because of excessive regulation. He made the comments in a foreword to a report by the Policy Exchange think-tank which also highlights examples of regulation “passing on significant costs” to customers. Examples in the report include NHS rules instructing hospital staff to go through 50 separate steps to discharge patients, “leading to severe delays”. Read full story (paywalled) Source: The Telegraph, 23 April 2023
  19. News Article
    Unannounced and out-of-hours spot-checks on mental health services are set to ramp up following a string of abuse scandals, The Independent can reveal. The Care Quality Commission’s new mental health chief Chris Dzikiti said he was “saddened” by “unacceptable” scandals in the last six months, warning the regulator “will use the powers [it has] to hold people to account.” He said the organisation will be carrying out more unannounced inspections of providers, including inspections launched out of normal hours, with the aim to have the “majority” of spot-checks carried out this way. In his first interview since joining the regulator in November Mr Dzikiti, who is mental health nurse by background, said: “I talk to chief execs of mental health services, I talk about [how] as a regulator, we will use the power we have, when [we] see poor practice, we will definitely hold people to account. “In our inspection programmes, we are also increasing the unannounced inspections out of hours inspections, because we need to try and get really deep into the culture of mental health services, especially those areas where we think there’s a higher risk of poor practice. “I will not rest until we get people safe.” Read full story Source: The Independent, 24 April 2023
  20. News Article
    The medical device complaint management market is experiencing significant growth due to the increasing focus on patient safety and regulatory compliance. As medical devices become more complex and the regulations governing them become more stringent, it has become essential for manufacturers to have effective complaint management systems in place to ensure the safety and satisfaction of their customers. The global medical device complaint management market is expected to grow at a CAGR of 6.3% from 2021 to 2026. One of the key factors driving the growth of the medical device complaint management market is the increasing emphasis on patient safety. In recent years, there has been a growing awareness of the potential risks associated with medical devices, and patients are increasingly demanding higher levels of safety and quality. This has led to a greater focus on complaint management among medical device manufacturers, who are now investing in advanced complaint handling systems to ensure that they are able to identify and address issues before they become major problems. Read full story Source: Digital Journal, 20 April 2023
  21. News Article
    Plans for integrated care systems (ICSs) to be given Care Quality Commission (CQC) ratings are on hold, and no ratings will be issued until summer 2024 at the earliest, HSJ understands. The government had previously said ICSs would be given ratings – after pressure from Jeremy Hunt, then Commons health committee chair and now chancellor – and there was an expectation the process would begin next month. However, while legislation says the CQC will review and assess ICSs, it does not require it to give ratings. HSJ understands the Department of Health and Social Care supports the CQC beginning early work on assessing ICSs shortly, but does not plan to sign off on ratings being issued, nor set any date for that to happen. It means that, at the very earliest, more detailed reviews leading to ratings could happen from spring/summer 2024. One source with knowledge of the decision said there was not strong support for ratings work to start, and the CQC still needed to do a lot of work to adapt its approach to ICSs. Read full story (paywalled) Source: HSJ, 27 March 2023
  22. News Article
    The UK is supposed to have one of the best systems in the world for preventing vulnerable people being exploited for their organs. How then did one of its biggest hospitals become embroiled in the macabre trade of kidney harvesting? The UK’s first trial organ trafficking trial has exposed alarming vulnerabilities to a illegal trade that makes up 10% of transplants worldwide. The case has highlighted how poverty can tempt some people to sell their body parts to those willing to exploit an acute global shortage of organs for donation. The case heard that doctors at a private renal unit at London’s Royal Free hospital and the regulators, the Human Tissue Authority (HTA), were fooled by Dr Obinna Obeta, into approving his kidney transplant in July 2021. As the prosecutor, Hugh Davies, said: “If there’s a lesson to be learned here – those clinicians need to set the index of suspicion for safeguarding somewhat lower.” Dominique Martin, a professor of health ethics at Australia’s Deakin University who studies organ trafficking, said the case highlighted the need for robust vetting by hospitals and regulators. She said: “There is a level of complacency, including in the UK, the US and Australia regarding the risks of organ trafficking happening within our borders. Screening programmes may not be as strong as we assume or as consistently implemented as we might expect.” Read full story Source: The Guardian, 23 March 2023
  23. Content Article
    Twenty-six doctors were referred to the General Medical Council by a single hospital trust - no further action taken. BBC Newsnight investigated.
  24. Content Article
    This summary of how a National Patient Safety Board (NPSB) will benefit patients and families was coproduced by the NPSB Advocacy Board with Patients for Patient Safety US. It outlines how the NPSB would ensure more comprehensive learning from patient safety incidents, ensure patients and families have a core role in governance and priority setting and that data is used to better understand patient safety in the US.
  25. Content Article
    This Sky News investigation looks at one of the pharmaceutical industry's biggest scandals—the hormone pregnancy test Primodos which was prescribed to pregnant mothers in the UK between 1958 and 1978. Primodos was found to lead to birth defects, miscarriages and stillbirth, and regulatory failings led to avoidable harm to thousands of babies.
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