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Mark Hughes

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  1. Mark Hughes
    The MHRA has published new guidance to medical device manufacturers on upcoming requirements around post-market surveillance
    New Post-market surveillance regulation for medical devices comes into force across England, Scotland and Wales on 16 June 2025 and introduces key new requirements around the monitoring of medical devices after they’ve entered the market.
    This includes more comprehensive data collection; shorter timeframes for reporting serious incidents and summary reporting to identify safety issues; and clearer obligations around risk mitigation and communication to protect user safety.
    Read full story.
    Source: Digital Health, 22 January 2025
  2. Mark Hughes
    The US Food and Drug Administration (FDA) has published draft guidance for manufacturers of pulse oximeters that offers recommendations for the clinical testing and labelling of these electronic medical devices.
    Pulse oximeters are small finger-clamp devices that estimate how much oxygen is being carried in the blood. Available both over the counter and by prescription, they grew in popularity during the Covid-19 pandemic. But many studies have revealed that pulse oximeters can measure blood oxygen levels as higher than they actually are for people with dark skin.
     
    One of the FDA's recommendations is to include “a diversely pigmented group of 150 or more healthy participants” in clinical studies of the devices, with at least 25% of participants falling within each skin color group on the system known as the Monk Skin Tone scale. Another is for manufacturers to “prominently display appropriate warnings” in the devices’ instructions, such as informing patients that “differences in skin pigmentation may cause differences in pulse oximeter sensor performance.”
    Read full article.
    Source: CNN, 6 January 2024.
  3. Mark Hughes
    Nearly one million people are set to be on a NHS waiting list in Scotland by next year, analysis has revealed, in projections that have been described as “terrifying”.
    The analysis produced by Edinburgh University shows NHS Scotland must treat at least 20 per cent more non-emergency hospital cases over the next three years to eliminate the backlog caused by the Covid-19 pandemic. And the research revealed the number of referrals waiting to be treated in Scotland topped 667,000 at the end of December 2023, covering an estimated 10 per cent of the population.
    Researchers warned that, without any increase in capacity, the waiting list will increase to nearly one million people by December 2026.
    Read full article.
    Source: The Scotsman, 10 January 2024
  4. Mark Hughes
    Around 20 hospital trusts across England have declared critical incidents with staff facing ‘mammoth demand’ due to the cold weather and flu.
    England’s top doctor has warned staff in hospitals are facing conditions similar to the “height of the pandemic” amid a national surge in flu cases on wards. NHS figures reveal there were an average of more than 5,400 patients with flu in hospitals each day last week, up 21 per cent from the previous week and more than three times the level seen at the same point last year.
    Visits to A&E also rose to an unprecedented level for December, making last year the busiest ever year for emergency departments.
    Professor Stephen Powis, the national medical director for NHS England, said: “It is hard to quantify just through the data how tough it is for frontline staff at the moment – with some staff working in A&E saying that their days at work feel like some of the days we had during the height of the pandemic.”
    Read full article.
    Source: Independent, 9 January 2024
  5. Mark Hughes
    Former health minister says medical examiners, who spot cases of intentional harm, could have been in place earlier. Jeremy Hunt has said ministers took “too long” to introduce medical examiners to investigate deaths in the NHS, as he apologised to the families of Lucy Letby's victims.   Giving evidence at the Thirlwall inquiry on Thursday, the former health secretary said he had “ultimate responsibility” for the NHS at the time Letby committed her “appalling crime” of murdering babies at the Countess of Chester hospital in 2015 and 2016. Hunt, who was health secretary from 2012 to 2018, said his government took “too long” to introduce independent medical examiners to the NHS after they were first proposed in 2004, six years before the Conservatives came to power.   Medical examiners are senior doctors who carry out independent scrutiny of deaths that are not investigated by coroners. They were introduced widely last September, 20 years after they were first proposed as a result of the Harold Shipman inquiry in 2004, then again by the Francis inquiry into the Mid-Staffordshire scandal in 2013.   Read the full story.   Source: Guardian, 9 January 2025
  6. Mark Hughes
    An independent review of Physician Associates (PAs) and Anaesthesia Associates (AAs) has been launched by the Health and Social Care Secretary Wes Streeting today to consider how these roles are deployed across the health system, in order to ensure that patients get the highest standards of care. Professor Gillian Leng CBE will independently lead the review.
    The review will look into the safety of these roles, how they support wider health teams, and their place in providing patients with good quality and efficient care. It will also look at how effectively these roles are deployed in the NHS, while offering recommendations on how new roles should work in the future. It will consider the scope of PA and AA roles, which currently include gathering medical histories, performing initial examinations, organising tests to support doctors and reviewing patients before surgery.
    To increase transparency in these roles, the review will also look into measures to ensure patients know when they are interacting with PAs or AAs, so they are clear on the type of clinician they are seeing and for what reason. 
    The review and next steps will be published in the Spring.
    Read full story
    Source: Department of Health and Social Care, 20 November 2024
    Related reading: Physician associates: What are the patient safety issues? An interview with Asif Qasim
  7. Mark Hughes
    Investigations into the unusually high number of healthcare-acquired COVID-19 incidents recorded during the pandemic's onset have concluded, says NHS Wales.
    Between March 2020 and April 2022, there were 18,360 suspected cases of healthcare-acquired COVID-19 in Wales. Despite being in healthcare settings, patients in hospitals and other in-patient environments faced an increased risk of hospital-acquired COVID-19. 
    In response to this, the National Nosocomial COVID-19 Programme was set up in April 2022 as a collective membership of health boards and trusts in Wales, supported by the NHS Wales Executive. Following the review process, a new report from NHS Wales has identified a number of 'national learning themes' which include the benefits of bereavement support, and the importance of clear family communication in times of restricted visits.
    Read full story.
    Source: South Wales Argus, 15 August 2024
  8. Mark Hughes
    A mental health trust has stopped accepting ADHD referrals for many adults, after integrated care board chiefs warned it was “unaffordable” to expand the service due to financial pressures, HSJ understands.
    Adults referred in Hertfordshire will now only be taken on by Hertfordshire Partnership Foundation Trust’s ADHD service if their case is considered complex, despite soaring demand. 
    The move comes as Hertfordshire and West Essex ICB, which commissions services in Hertfordshire, told HSJ that the scale of increased commissioning required to cope with “unprecedented demand” in the adult ADHD service was “unaffordable”, given its deficit position. 
    Read full story.
    Source: HSJ News, 15 August 2024
    Related reading
    Long waits for ADHD diagnosis and treatment are a patient safety issue (Patient Safety Learning, 15 May 2023)
  9. Mark Hughes
    The NHS has set out plans for a review into the safety of adult gender services, in response to detailed concerns raised by the author of the Cass Report on gender care for children and young people.
    Dr Hilary Cass, the leading consultant paediatrician, listed 16 separate points of concern about the quality of treatment being offered to adults with gender dysphoria in a strongly worded letter to NHS England.
    In response, NHS officials have committed to expediting a review of these services, and announced that clinic inspections would begin in September.
    Read full story.
    Source: The Guardian, 15 August 2024
  10. Mark Hughes
    An agreement to share patient data struck between a specialist trust and a start-up company does not comply with NHS England guidance, HSJ has discovered.
    The 10-year agreement between the Royal National Orthopaedic Hospital and population health company Naitive Technologies contravenes NHS England and government guidance, which warns against granting “exclusive” use of patient data to private companies.
    RNOH said it is currently in negotiations with Naitive to amend the agreement to reflect current NHS guidance, particularly around the exclusivity issue. It said it had “conducted [itself] appropriately at all times” and taken account of the guidance around exclusivity in subsequently agreed contracts.
    Read full story.
    Source: HSJ News, 16 August 2024
  11. Mark Hughes
    Victims of the contaminated blood scandal will begin receiving compensation before the end of the year, and some people will be entitled to more than £2.5m, the government has confirmed.
    An outline of the long-awaited compensation scheme was set out in May, after the final report of the infected blood inquiry laid bare what Rishi Sunak, the then UK prime minister, called “a decades-long moral failure at the heart of our national life”
    More than 3,000 people died and many more had their lives ruined because of diseases such as HIV and hepatitis C caused by infusions of contaminated blood given between the 1970s and 1990s. Campaigners spent decades urging successive governments to take responsibility, and compensate victims and their families.
    The government is expected to introduce regulations setting up the new scheme by 24 August, allowing survivors who were infected to start receiving payments before the end of the year. For those who have already died, payments will be made to their estates.
    A second set of regulations covering victims’ families and others affected will follow in the coming months, with payments for these individuals to be made, starting in 2025.
    Read full story.
    Source: Guardian, 16 August 2024
    Related reading
    Infected Blood Inquiry: The Report (20 May 2024)
  12. Mark Hughes
    One in five recent inspections of maternity services have raised concerns over “essential” breathing equipment for newborn babies, HSJ has found. 
    Care Quality Commission (CQC) inspectors have flagged fears over shortages and overdue maintenance of resuscitaire, a device commonly used by midwives if babies require additional support with breathing. Experts say the equipment should be immediately available to ensure safe resuscitation.
    The CQC itself said the lack of such equipment was impacting patient safety at some hospitals.
    Read the full story (paywalled)
    Source: HSJ, 31 May 2024
  13. Mark Hughes
    IT system failures have been linked to the deaths of three patients and more than 100 instances of serious harm at NHS hospital trusts in England, BBC News has found.
    A Freedom of Information request also found 200,000 medical letters had gone unsent due to widespread problems with NHS computer systems.
    Nearly half of hospital trusts with electronic patient systems reported issues that could affect patients. NHS England says it has invested £900m over the past two years to help introduce new and improved systems. Some hospital trusts have spent hundreds of millions of pounds on new electronic patient record (EPR) systems, but BBC News has discovered many are experiencing major problems with how they work.
    Quoted in this article, Clive Flashman, Chief Digital Officer of Patient Safety Learning, said, “If you look at the sorts of serious issues that are coming out around the country where patients are being harmed, in some cases dying, as a result of these systems not working properly, I would imagine there are tens of thousands of these that are happening that probably never get discussed”.
    Read the full story.
    Source: BBC News, 30 May 2024
    Read more about Patient Safety Learning's reflections on these issues and the importance of patient safety being at the heart of the development and implementation of EPRs here.
  14. Mark Hughes
    Next week (Thursday 15 May) the Scottish Parliament will be invited to nominate Karen Titchener to His Majesty for appointment as Scotland’s inaugural Patient Safety Commissioner.
    The role of the Patient Safety Commissioner will be to advocate for systematic improvement in the safety of health care in Scotland and promote the importance of the views of patients and other members of the public in relation to the safety of health care.
    Karen Titchener is currently serving as Vice President of Hospital at Home Operation in the USA and brings over two decades of senior leadership experience within the NHS, having also previously worked at Guys and St Thomas NHS Trust. Mrs Titchener is expected to take up post on 1 September 2025 for a fixed term of eight years.
    Read the full article.
    Source: The Scottish Government, 9 May 2025
    Related reading
    Consultation Analysis Report on the role of a Patient Safety Commissioner for Scotland (2 December 2021) Patient Safety Commissioner for Scotland: Consultation Response (Patient Safety Learning)
  15. Mark Hughes
    Patients are increasingly turning to private healthcare to escape a referrals “black hole”, GPs have warned, as the NHS struggles with a shortfall of available appointments.
    The most recent figures show GP practices make about 400,000 referrals a month to outpatient clinics that are fully booked. Some patients will be able to choose an alternative provider, some will be booked at a later date, but many end up being bounced back to their local surgery.
    GPs typically refer patients to ­outpatient clinics using the NHS e-referral service, which can also be used by the patient to book a suitable appointment. The most recent figures, for July, show there were more than one million appointments booked in England, but 407,173 cases in which no slots were available.
    The number of unavailable slots has risen by 78% since July 2018, when the comparable figure was 227,937. There were severe shortages of appointments in orthopaedics, cardiology and diagnostic imaging.
    Quoted in this article, Helen Hughes, Chief Executive of Patient Safety Learning, said there were concerns about the safety of patients unable to get timely specialist care. She said: “Patients waiting for care need to be monitored and reprioritised as their level of need is likely to change as they wait.”
    Read full story.
    Source: The Observer, 25 August 2024
  16. Mark Hughes
    Whistleblowers at the North East's scandal-hit mental health trust have raised serious concerns about a "faulty" medical record system rolled out this year.  
    Patients are being "put in danger" by the new CITO records system at Tees, Esk and Wear Valleys Mental Health Trust (TEWV), two staff members have told the Northern Echo. 
    An anonymous worker, who is part of the trust's emergency mental health services, said they have had difficulty uploading and accessing next-of-kin information, allergies, triggers, risk ratings, and assessments for patients who are in the throes of a mental health crisis. 
    TEWV responded, saying patient safety was their "top priority", and that "the system is stable and functional" despite "localised issues". 
    Full story here
    Source: The Northern Echo, 1 August 2024
    Related reading
    Electronic patient record systems: Putting patient safety at the heart of implementation (Patient Safety Learning, 31 July 2024)
  17. Mark Hughes
    Patient safety must be central to the design, development and rollout of electronic patient record (EPR) systems, says Patient Safety Learning.
    An EPR system brings together different patient information in one place, making it easier to access for healthcare professionals. This information can include patients’ own notes, test results, observations by a range of different clinicians and prescribed medications.
    When safely implemented, EPR systems can help to support and improve care and treatment. However, in recent years there has been growing awareness of the significant patient safety risks also associated with their implementation and use.
    In a new report, Patient Safety Learning makes the case that patient safety can, and must, be put firmly at the heart of the design, development and rollout of EPR systems.
    Drawing on examples from the NHS and the findings of an expert roundtable, the report sets out the key patient safety risks associated with choosing and introducing new EPR systems. It identifies ten principles to consider for safer EPR system implementation.
    Commenting on the report, Patient Safety Learning Chief Executive Helen Hughes said:
    “EPR systems have significant potential to improve patient care and treatment. However, we are increasingly seeing cases where poor implementation of these new systems results in direct and indirect harm to patients. If we are to fully realise their benefits, patient safety must be at the heart of their design, development and rollout.
    To ensure the safety of EPR systems, it is vital that patient safety incidents associated with them are reported and acted upon. We need more transparency in reporting and sharing knowledge, of both errors and examples of good practice.
    We hope that this report can kick off an informed and transparent debate about these issues, leading to action that supports the safer implementation of EPR systems and reduces avoidable harm.”
    Read full story
    Source: Patient Safety Learning, 31 July 2024
  18. Mark Hughes
    Significant improvements have been made at the maternity unit at Swansea's Singleton Hospital but more are needed to ensure mothers consistently receive acceptable care, health inspectors have said.
    Healthcare Inspectorate Wales (HIW) had strongly criticised Swansea Bay University Health Board following a visit to the unit last September. The regulator highlighted "significant patient safety concerns" and said the health board had failed to ensure safe staffing levels for four years. It added that fewer than half the staff surveyed said they would be happy if their own family members received the same care. In response, the health board developed an improvement plan and invested hundreds of thousands of pounds in new midwives and maternity care assistants.
    HIW noted improvements to the leadership structure but said some positions were still on an interim basis. The health board, it said, must monitor and improve levels and the skills mix of staff throughout the maternity unit. However, it also said that at the time of the inspection staffing levels for midwifery and medical staff were appropriate.
    Read full story
    Source: Wales Online, 31 July 2024
  19. Mark Hughes
    The Department of Health and Social Care has announced that it will will recruit more than 1,000 newly qualified GPs thanks to action to remove red tape.
    Currently, under a scheme known as the Additional Roles Reimbursement Scheme, primary care networks (PCNs) can claim reimbursement for the salaries (and some on costs) of 17 new roles within the multidisciplinary team – meaning more specialists are available to treat patients.
    They are selected to meet the needs of the local population, but are currently prevented from using this to recruit additional GPs. The changes announced today means that newly qualified GPs  can quickly be recruited into the NHS through this scheme in 2024-2025.
    Read full story
    Source: Department of Health and Social Care, 1 August 2024
  20. Mark Hughes
    Treating failing eyesight and high cholesterol are two new ways to lower the risk of dementia developing, a major report suggests.
    Scientists have now identified 14 health issues which, if reduced or eliminated, could theoretically prevent nearly half of dementias in the world.
    Middle-aged people and poorer countries have most to gain from targeting these risk factors, says the Lancet Commission's latest report on the topic.
    It predicts that the number of people living with dementia could more than double to 153 million by 2050.
    Read full story
    Source: BBC News, 31 July 2024

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