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Found 93 results
  1. Content Article
    During an online meeting with the Patient Engagement Advisory Committee of the US Food and Drug Administration, I was struck by the huge problems that continue to exist around medical device recalls. I have been campaigning on these issues since 2015 and progress has been painfully slow. Although the meeting had a US-focus, the issues addressed are global. Medical devices travel across the world to be implanted in or used by patients - we have the technology to keep track of them and if we don’t start using it, an increasing number of patients will be harmed. Here are some of the issues r
  2. News Article
    GP practices will be included in the remit of a new patient safety watchdog, due to come in from 2023 under the new Health and Care Bill, the Department of Health and Social Care (DHSC) has said. DHSC said that it expects the new Health Services Safety Investigations Body (HSSIB) to be ‘fully operational’ in England from April 2023 – ‘subject to parliamentary clearances’. It confirmed that the statutory independent body will investigate NHS care in GP practices, although it said that the HSSIB’s ‘focus is likely to be predominantly on investigating patient safety incidents in NHS trusts’
  3. Content Article
    From hearing aids and walking sticks, to insulin pumps and thermometers, for many of us, medical devices are an essential part of our everyday lives. We all want to know that the devices we use are safe and effective, so regulation of medical devices really matters, especially where fast-developing technology has changed, and continues to influence, the landscape for medical devices, bringing new, innovative devices to the UK market, including some health apps. The MHRA is the regulator for medical devices used in the UK. They are seeking views from across the medical devices and healthca
  4. News Article
    ‘Very heavy-handed, laborious and expensive’ inspections ‘have not been the right way’ of regulating hospitals, according to the Care Quality Commission’s (CQC) former chair. Speaking at a Royal Society of Medicine event on Wednesday, Lord David Prior, who is now the chair of NHS England, said “very few” physicians will have improved their work after reading a report from the regulator. He added that there is a role for the CQC to move in when “things are going wrong” although he is “sceptical” the regulator can actually drive improvement in hospitals. Lord Prior said: “I am hig
  5. Content Article
    Once upon a time there was a little boy. Let’s call him Albert. Little Albert had grown up in the hospitals until one day, when he was just 9 months of age, he was taken by a couple who gave him lots of interesting and friendly objects to play with. One by one, Albert was shown bunnies, puppies and little white rats amongst other fascinating objects. He was intrigued by these soft play things and enjoyed exploring the shapes and textures that were new to the enquiring infant. One day as he was about to play with his favourite rat, Houdini (poetic licence employed here), there came from be
  6. Content Article
    Before the coronavirus pandemic, the nation was struggling with escalating drug overdose deaths. Now, there are some who are convinced that the COVID-19 pandemic has led to further increases in opioid overdoses. Public services were disrupted. Some treatment programmes had to restrict access, reduce staffing, and increase supply between limited provider visits. Many addicts are homeless and do not have Internet or telemedicine contact. Social distancing may have prevented some individuals from having anyone around to administer naloxone (Narcan, Evzio). Inadequate border restrictions have like
  7. Content Article
    "Several concerns have been raised about the risk of overdose and death from oral morphine sulphate solution over the past few years, but they have gone unheard." In light of coroners reports of deaths related to abuse, or accidental overuse of Oramorph or oral morphine sulphate solution. the author argues for increased regulation. Commenting: "In the absence of any action from ministers, it seems that healthcare professionals are going to have to take the care of vulnerable patients into their own hands." My reflections on this are: Is this a signal for increased regulation or
  8. News Article
    Serious patient safety issues are being buried in confidential hospital reports, BBC Panorama has found. Freedom of Information requests revealed 111 reports, written by medical royal colleges, which NHS trusts have a duty to share. Eighty reports were given to the BBC but only 26 had been shared in full with regulators, and 16 published. The Department of Health would not comment on whether it might change the law to ensure publication. Since the 2015 Morecambe Bay maternity scandal in which 11 babies and a mother died, NHS Trusts are supposed to publish summaries of external r
  9. News Article
    Ten junior doctors have been removed from a struggling hospital over concerns they were being left without adequate supervision on understaffed wards. Health Education England (HEE) removed the 10 foundation year one doctors, all on a general medicine rota, from Weston General Hospital last month. The General Medical Council said the trust’s previous efforts to address the issues “have not been sufficient or sustainable”. University Hospitals Bristol and Weston Foundation Trust did not say which services HEE had removed the juniors from or what mitigations had been put in place. Howe
  10. News Article
    Regulators have sent an improvement director into a North West acute trust amid multiple allegations of poor care and ‘cover up’ across different specialties. University Hospitals of Morecambe Bay Foundation Trust, which spent 18 months in special measures midway through the last decade, is again now the subject of significant regulatory intervention from NHS England. The regulator has appointed Simon Bennett as a board-level improvement director, which comes after he undertook a similar assignment at the struggling Stockport FT. It comes amid ongoing external investigations int
  11. Content Article
    Falling asleep at the wheel causing a multiple car crash is considered such a serious offence in law that the driver could face up to 14 years in prison.[1] When it comes to falling asleep at the medical regulation wheel, however, causing major harm to patients, the result appears to be a review, knuckles rapped, a few negative media reports and then business as usual. Campaigners celebrated when Baroness Cumberlege called for urgent reform of the way healthcare treatments are regulated in her First Do No Harm Report.[2] But really, this is old news. As long ago as 2005, th
  12. Content Article
    The UK model of regulation for healthcare professionals is rigid and complex and needs to change to better protect patients and service users, support our health services and to help the workforce meet future challenges. This consultation seeks views on proposals to modernise the legislation of the healthcare professional regulators. The proposals have been developed in partnership with the professional regulatory bodies, the Professional Standards Authority for Health and Social Care and tested with key stakeholders across the health and care system. The proposed reforms cover four key areas.
  13. Event
    until
    While the pandemic didn’t cause all the shifts happening in healthcare, it had a major hand in accelerating and shaping the changes that will alter the healthcare landscape far into the future. Join Fierce Healthcare as we examine the tectonic transformation across healthcare. We’ll explore changing consumer expectations in access to care, the moves by major tech players and providers to reach their customers and strategies for actually paying for everything. Register
  14. Content Article
    In January the CQC published a formal consultation on its new strategy from 2021.[1] The future aims and ambitions of England’s health and social care regulator clearly have important implications for improving patient safety. It not only plays a key role in assessing and holding organisations to account on safety issues, but also has the influence and reach to promote and spread patient safety improvements and good practice more broadly at a system level. Here we will briefly overview the aims and ambitions of the CQC’s new strategy, before then reflecting on the key points we included i
  15. News Article
    A regulator has admitted “concerns” over the software Babylon Healthcare uses in one of its digital health solutions and is exploring how to address this. The Medicines and Healthcare products Regulatory Authority’s (MHRA) concerns relate to Babylon’s symptom checker “chatbot” tool. This is used by thousands of patients, including those registered with digital primary care practice GP at Hand. Two senior figures within the agency set out the MHRA’s concerns about the tool in a letter, seen by HSJ, which was sent to consultant oncologist David Watkins following a meeting between the p
  16. News Article
    The development of coronavirus vaccines tweaked to target new variants will be fast-tracked in the UK and four other countries, Britain’s regulator has said, adding that “robust evidence” on effectiveness and safety will still be required for authorisation. The approach, similar to the regulatory process for the modified flu vaccine, will not need a brand new approval or “lengthy” clinical studies, the Medicines and Healthcare Products Regulatory Agency (MHRA) said on Thursday. This will "significantly reduce" the length of time it takes for the vaccines to be ready, with concern mou
  17. News Article
    Health secretary Matt Hancock has said integrated care systems (ICS) will be rated by the Care Quality Commission (CQC). The government’s recent white paper for a new NHS bill did not discuss any change in the CQC’s legal framework to allow it to rate ICSs, which sparked uncertainty around how ICSs would be regulated. However, speaking in the House of Commons today of the “crucial” role the regulator plays in rating hospitals, Mr Hancock said: “I think that it is vital that the CQC has a similar role when it comes to ICSs.” The CQC has not confirmed what, if any, legal changes i
  18. Event
    Here is how to obtain a quick overview of the new Acceptable Means of Compliance (AMC) and Guidance Material (GM) addressing software published in October 2019 (Reference: ED Decision 2019/022/R). Note: Participation to Basics of regulation on the 02/03/2021 is recommended if you don't know what are AMC, GM and structure of 2017/373. Register
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