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Showing results for tags 'Regulatory issue'.
Found 466 results
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News ArticleThe 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
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Content ArticleTwenty-six doctors were referred to the General Medical Council by a single hospital trust - no further action taken. BBC Newsnight investigated.
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Content ArticleThis 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.
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Content Article
A bitter pill: Primodos (Sky News, 3 January 2023)
Patient-Safety-Learning posted an article in Medication
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. -
Content ArticleThis blog by Carl Heneghan, Professor of Evidence-based Medicine at the University of Oxford and Clinical Epidemiologist Tom Jefferson, looks at safety and regulatory issues associated with Essure, a permanent contraceptive implant. Essure anchors inside the fallopian tubes and reacts with the tissues, causing them to become inflamed and scarred. The resulting scar tissue then blocks the tubes off, intending to prevent fertilisation. The devices are about 4cm long and contain a stainless steel, nickel and titanium inner coil and an expanding outer coil containing iron, chromium and tin. Essure has been shown to cause allergic reactions, lifelong inflammatory reactions and internal injuries. The authors examine how Essure came to be approved for use in the USA, the UK and the rest of Europe, highlighting regulatory failings and conflicts of interest with the medical tech industry. They also highlight how pressure from women harmed by Essure resulted in its use being banned in several countries. The blog then describes ongoing efforts to access UK data on reports of adverse events due to Essure that are held by the Medicines and Healthcare Regulations Agency (MHRA). Freedom of Information requests for this data have been denied.
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Content ArticleThe National Institute for Clinical Excellence (NICE) updated their guidance for continuous glucose monitoring (CGM) in 2022, recommending that CGM be available to all people living with type 1 diabetes. This review in the journal Diabetes, Obesity and Metabolism aimed to compare regulatory standards for CGM in the UK and Europe, with those applied in the USA by the Food and Drug Administration (FDA) and in Australia by the Australian Therapeutic Goods Administration (TGA). It describes the processes in place and highlights that the criteria applied in the UK for assessing accuracy do not translate into real-life performance. The authors offer a framework to evaluate CGM accuracy studies critically and conclude that FDA- and TGA-approved indications match the available clinical data, whereas CE marking indications applied in the EU can have discrepancies. They argue that the UK can bolster regulation, but that this need to be balanced to ensure that innovation and timely access to technology for people with type 1 diabetes are not hindered.
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Content ArticleThis episode discusses the role NICE plays in patient safety. The guests are: Professor Kevin Harris, senior responsible office for patient safety at NICE, and clinical advisor to the Interventional Procedures Programme and Professor Jane Blazeby, Professor of Surgery at University of Bristol.
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Dr Freya Smith, a Specialty Trainee in General Practice, reflects on the sinister and toxic side of medicine, using the recent Paterson and vaginal mesh scandals to demonstrate how patients have been let down by the system. In an honest and personal account, she shares with us the horror and sadness she felt at learning of these scandals and how she aspires to keep her future patients safe. -
Content ArticleIn December 2022, the All Party Parliamentary (APPG) for Whistleblowing heard evidence on the state of the NHS following the recent report on the avoidable deaths and life changing injuries caused to mothers and babies at the East Kent Trust. The culture at this hospital was described as one where “everyone knew the problems” and where whistleblowers were “thrown to the lions”. A culture attributed to 45 of the 65 baby deaths reviewed. This blog first appeared on the Whistleblowers UK website in December 2022.
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Content Article
Falsified Medicine Directive explained
Patient Safety Learning posted an article in Medication
As global trade and the Internet keep on growing it has become much easier for people to pass goods off as genuine. Counterfeiting in medicine products is becoming more prevalent and countries are now adopting systems to protect the legitimate supply of products to protect the industry and importantly the patients. Systems are already operating in America and Germany and the EU has formulated a directive for all European countries to adopt a system that protects all European citizens. The False Medicine Directive (FMD) registration database tracks all medicines from the manufacturer through to the patient in a unified way across the whole of Europe. Across the EU those who manufacture, sell or dispense medicines must comply with new track and trace regulations. Find out more from the FMD plus website. -
Content ArticleLinda Millband is the national practice lead for medical negligence at Thompsons Solicitors. She led the team responsible for fighting, and winning, a legal battle on behalf of 650 ex-patients of disgraced breast surgeon Ian Paterson. Ahead of the publication of the Independent Inquiry into Ian Paterson, Linda reflects on how it should be used as a catalyst for positive change in private hospitals.
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Content ArticleThis editorial in the Journal of Patient Safety and Risk Management reflects on the achievements of the organisation Action Against Medical Accidents (AvMA) over the past 40 years and looks at the emerging role of Patient Safety Learning amongst organisations working for patient safety. Helen Hughes, Chief Executive of Patient Safety Learning, and Albert Wu, Editor-in-chief of the journal, reflect on the purpose and value of patient safety charities and not-for-profit organisations, highlighting the ways in which they channel and champion the patient voice and campaign to address specific areas of recurrent harm. They discuss the vital nature of the patient perspective in driving safety improvements in healthcare, and look at how these organisations amplify this. They also talk about the role of Patient Safety Learning and what it is doing to both drive system change at policy level, and share widely the knowledge of risk and good practice for safer care. They discuss the ways in which Patient Safety Learning delivers its aim to "listen to and promote the voice of the patient safety front line - patients, families and staff.”
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Content ArticleOn 9 November 2022, The Professional Standards Authority hosted the Safer care for all conference to discuss questions and issues highlighted in the report Safer care for all – solutions from professional regulation and beyond. This webpage contains video summaries of the conference sessions. The conference provided an opportunity to hear experts’ views as well as consider and contest the themes raised in the report, including the PSA's main recommendation, the creation of a health and social care safety commissioner in all four UK countries. Speakers and delegates came from both professional and system regulators as well as patient organisations, the ombudsman, the NHS, health and care sector organisations and major healthcare inquiries.
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Content ArticleThis paper in the Journal of Patient Safety and Risk Management addresses the issue of untested products being used on the basis of 'equivalent' products having undergone regulatory testing. Manufacturers of competing products often use each other’s evidence, arguing that the published evidence is generally applicable even if the original tests and trials were performed on only one specific product. In this study, the authors looked at prophylactic dressings for pressure injury prevention to demonstrate how patient safety may be compromised if study conclusions are projected onto unstudied products.
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News ArticleThe Care Quality Commission (CQC) has issued two fixed penalty notices to University Hospitals Birmingham NHS Foundation Trust totalling £8,000 for failing to seek consent to care and treatment of someone in their care. A 55-year-old gentleman who had diagnoses of epilepsy and autism was admitted to Good Hope Hospital in Birmingham on six occasions between 12 May 2019 and 6 October 2019. He had also been deaf since birth and communicated via British Sign Language (BSL) and lip reading. These fixed penalty notices relate to the trust’s care and treatment of the patient at Good Hope Hospital in relation to three medical procedures, which occurred in September, October and November 2019. CQC found that on these three occasions, the trust did not comply with Regulation 11 of the Health and Social Care Act 2008 (Regulated Activities) Regulations 2014, requiring registered persons to obtain the consent of the relevant person when providing care and treatment to them. Regulation 11 also states if someone is 16 or over and is unable to give consent because they lack capacity, the registered person must act in accordance with the Mental Capacity Act 2005. The three procedures where CQC found consent failures, were feeding tubes, aimed at providing nutritional support to the patient, who was struggling with food. Read full story Source: CQC, 7 October 2022
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News ArticleMinisters have been urged to launch a public inquiry into the care of mental health patients after The Independent revealed allegations that patients had suffered “systemic abuse” in inpatient units. A joint investigation with Sky News found that teenagers at facilities run by The Huntercombe Group had been left with post-traumatic stress disorder by their treatment despite hundreds of warnings to regulators and the NHS. Now the government is facing calls to review all mental health care services over fears that these cases are “the tip of the iceberg”. Labour’s shadow mental health minister Dr Rosena Allin-Khan has called for a “rapid review” by the government into inpatient mental health services, while Deborah Coles, the chief executive of charity Inquest, has called on the new health secretary Steve Barclay to launch a statutory public inquiry. Read full story Source: The Independent, 28 October 2022
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News Article
CQC inspection approach helping fuel emergency care crisis, says trust chief
Patient Safety Learning posted a news article in News
A trust chief executive says the Care Quality Commission’s (CQC) inspection regime is still overly focussed on individual organisations, rather than systems, and this is driving the “risk aversion” which is partly responsible for the emergency care crisis. Mid Yorkshire Hospitals Trust CEO Len Richards acknowledged the CQC has started to scrutinise system-wide issues but suggested the “heat” of its regulation is still on individual providers. Mr Richards told the House of Lords’ public services committee on Wednesday that care homes and nursing homes in his area have declined to take patients ready to be discharged from hospital, due to concerns it would put their CQC accreditation at risk. He said: “[Last winter] we asked nursing homes and care homes to take patients and they couldn’t take them beyond a certain limit because it would put their accreditation at risk. “We went to the CQC to try and create some flexibility. Their perspective was very much of an independent regulatory body that would look at the organisation and not look at the system. I think we’ve got an awful long way to go there. “I think regulation does drive risk aversion… [and] the heat of regulation right at the moment is on individual organisations. “Therefore, when the CQC come and look at my organisation, they will talk about congestion in the A&E department. They won’t talk about the assessment that we made around there being a greater risk in the community if we didn’t offload ambulances.” Read full story (paywalled) Source: HSJ, 28 October 2022 -
News ArticleResearch led by Trinity College in Ireland has found that a regulation which came into effect in May 2021 with the aim of improving the oversight of medical devices in Ireland is leading to unintended consequences which may put some surgeries for children, and the treatment of rare diseases, at risk. The study has been published in the journal Pediatric Cardiology. Medical devices include a great diversity of technologies, which are evaluated and approved in the European Union (EU) according to a revised law that came into effect on 26 May 2021, known as the Medical Device Regulation or MDR (EU 745/2017). It has a transition period that allows products that were approved under the previous rules (the EU Medical Device Directives) to continue to be marketed until 26 May 2024 at the latest. As a result of a series of unforeseen factors, there is a possibility that the MDR may result in products becoming unavailable, with the consequent risk of a loss of some interventions that are reliant upon those devices. Devices that are used for orphan or paediatric indications are particularly vulnerable to this. The paper provides an example of one device, the Rashkind balloon catheter, first developed by Dr William Rashkind in 1966 to open the upper chambers in the heart in neonates with congenital heart disease. A number of these balloons were once available in Europe and now there is only one. This device may become unavailable next year. If this happens, it will not be possible to continue this procedure, and alternative surgeries or treatments are far less optimal. The paper also describes the timeline and cost of bringing the device to market in the EU, the US and Canada, and the cost and time needed to access the EU market has become much greater. Researchers believe there is now an urgent need for policy to be developed to protect essential medical devices for orphan indications and for use in children, to ensure that necessary interventions can continue, and to ensure a more sustainable system in Europe over the longer term. Read full story Source: Trinity College Dublin, 20 October 2022
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News Article
CQC taking ‘enforcement action’ against every fourth service it inspects
Patient Safety Learning posted a news article in News
A quarter of services the Care Quality Commission has recently inspected required enforcement action from the regulator, its chief executive has revealed. Speaking at the launch of the regulator’s annual State of Care report, Ian Trenholm called for a “long-term, sustainable funding solution” from the government to aid a service that was ”genuinely struggling to cope”. Mr Trenholm said “about a quarter of the services” the CQC has inspected in 2022 had resulted in it having to take “enforcement action”. Examples of action taken against NHS trusts in the last year included enforcement measures placed on Nottingham University Hospitals, University Hospitals Sussex, and Princess Alexandra Hospital. In response to a question from HSJ about the robustness of the CQC’s inspection regime following further care quality and safety scandals, Mr Trenholm said observers should not focus solely on the ratings given to trusts by the CQC as there was a lot ”work going on in the background, whether that’s enforcement or otherwise”. He added the CQC had significantly increased the amount of information it was gathering in relation to concerns about services. Read full story Source: HSJ, 21 October 2022 -
News Article
Digital mental health tools to be regulated
Patient Safety Learning posted a news article in News
Recent years has seen a large, and rapid, growth in the availability of digital mental health tools. Do an online search for 'NHS Mental Health Apps' and an abundance of options will appear. These online tools can be helpful for people experiencing mental health problems, however, the Medicines Health and Regulatory products Agency (MHRA) said, they "present regulatory challenges" - such as clarity around whether they are medical devices and, if so, which risk classification they fall under. "Digital mental health tools offer millions of people vital support and guidance to explore and help manage their mental health issues every day," said Johan Ordish, head of software and artificial intelligence (AI) at the MHRA. He pointed out, however, that there are a number of "regulatory complexities" in establishing when these products should be regulated and what evidence they must have to demonstrate safety and effectiveness. Minister for Mental Health, Dr Caroline Johnson, said: "Digital mental health tools can be incredibly useful to help build resilience and prevent problems worsening, but it’s crucial these are regulated properly." To address these vital issues MHRA and NICE will explore and produce guidance on regulating digital mental health tools, using £1.8m funding by Wellcome over 3 years. The project will review key aspects of medical device regulations to produce guidance that will support digital mental health in several significant areas – including: Determining what qualifies as a medical device. The risk classification the devices would fall under. A review of the current evidence base for the devices. The MHRA explained that to achieve this it will "engage with" and "learn from" those with lived experience, subject experts, and patients, to inform their conclusions. Read full story Source: Medscape UK, 11 October 2022 -
News Article
Residents 'not safe' at four-inquest care home
Patient Safety Learning posted a news article in News
A care home that will close after admitting "shortcomings in care" and failures in leadership has been labelled "not safe" by inspectors. The Elms in Whittlesey, Cambridgeshire will shut later this month, and the Care Quality Commission (CQC) has found the service to be inadequate. In May, the BBC first reported the concerns of relatives about The Elms after their loved ones died in 2019, weeks after a meeting in which worries were raised about "poor care". Inquests into the deaths of the residents - George Lowlett, Margaret Canham and David Poole - remain ongoing. HC-One also apologised to the family of Joyce Parrott, who died in April 2020. Inspectors found "people were not safe and were at risk of avoidable harm" and described multiple occasions when people had "not received their medicines as prescribed". Other findings included: Staff had not referred all potential safeguarding events to the local authority A failure to "establish systems to ensure people were effectively safeguarded from abuse" The provider had failed to learn when things went wrong "Widespread and significant shortfalls" in leadership No reliable record of the staff that had worked at the home and a reliance upon agency staff, which "resulted in people not receiving consistent care" Read full story Source: BBC News, 5 October 2022 -
News Article
CQC triggers two reviews into whistleblowing concerns
Patient Safety Learning posted a news article in News
The Care Quality Commission (CQC) has commissioned an independent review into handling of a high-profile whistleblower case, and a wider internal review of how it responds when it is given “information of concern”. The independent review will be led by Zoë Leventhal KC of Matrix Chambers and will consider how the regulator handled “protected disclosures” from University Hospitals of Morecambe Bay Foundation Trust surgeon Shyam Kumar, alongside “a sample of other information of concern shared with us”. Mr Kumar won a tribunal against the CQC earlier this month, which found he was unfairly dismissed as a special advisor on hospital inspections after raising serious patient safety concerns. Between 2015 and his dismissal in 2019 Mr Kumar wrote to senior colleagues at the CQC with a number of concerns within his trust around bullying, patient harm and the quality of CQC hospital inspections. The tribunal drew particular attention to the two whistleblowing disclosures made by Mr Kumar about the CQC itself, which it found “clearly had a material influence on the decision to dismiss”. The CQC said in an announcement today that the independent review would aim to determine whether it took “appropriate action” in response to the information disclosed in Mr Kumar’s case and others. It will include consideration of whether the ethnicity of the people raising concerns impacted on decision making or outcome and is expected to conclude by the end of the year. Read full story (paywalled) Source: HSJ, 28 September 2022 -
News Article
Coffey warned of ‘significant risk’ posed by CQC restructuring
Patient Safety Learning posted a news article in News
Staff at the Care Quality Commission (CQC) have been left ‘in fear of speaking out’ against structural changes to the organisation which they believe ‘pose a significant risk’ to the CQC’s ability to regulate health services, trade unions have told the health and social care secretary. A letter signed by senior officers of Unison, Royal College of Nursing, Unite, Prospect and the Public and Commercial Services union has called on Therese Coffey to urge the CQC to pause its organisational change and enter into “meaningful discussions” with the unions. The unions have raised concerns that organisational changes to the CQC have been drawn up by consultants with no frontline experience in health and social care, or in regulation, and that staff have had limited input into the changes. They allege that staff raising concerns about the changes have been dismissed as being “disruptive” or “negative”, and significant numbers of experienced staff have recently left the regulator. The CQC said in response to the letter that the changes it was proposing were needed to enable the regulator to “work more effectively across the health and care system”, and that it has engaged with trade unions throughout the process. Read full story (paywalled) Source: HSJ. 23 September 2022 -
Content Article
I guess that a common feature linking most visitors to Patient Safety Learning is that they have a profound interest in two things. First, recognising and applauding innovations and ‘best practice’ in healthcare. Second, recognising, exposing and denouncing bad practice. The thing they have in common is the desire to learn from the mistakes in the past to do better in the future. When it comes to ‘bad practice’ in healthcare it is usually in connection with some adverse and damaging impact on patients. Our thoughts turn perhaps to certain medical failures, such as the ‘Mid‑Staffs scandal’. Seldom do we find the need to consider the adverse and damaging impacts on the doctors, nurses and all the other staff who work in the health and social care sector. However, those of you who watched the recent BBC Panorama programme, 'Forgotten heroes of the Covid frontline' will have been appalled at the scandal that now confronts so many frontline staff for whom we stood outside our front doors and clapped for so enthusiastically back in those dark days at the height of the pandemic. This blog is dedicated to those 'forgotten heroes'. I hope that it demonstrates that they are not, in fact, forgotten I hope that the resources linked to this blog may be of help to them. -
Content ArticleIn this blog, Carl Heneghan, Professor of Evidence-based Medicine at the University of Oxford and Clinical Epidemiologist Tom Jefferson look at the long-term consequences of inadequate regulation and approval of pelvic mesh devices. They argue that regulators and health systems around the world failed to heed the early warnings, which lead to thousands of women being irreversibly harmed. They highlight that as early as 1999, a study of 34 women who had ProteGen mesh implants showed that 50% of mesh devices had eroded through the vaginal wall. Boston Scientific voluntarily recalled 20,000 devices as a result. In spite of this, the FDA continued to approve vaginal mesh devices, citing ProteGen as their predicate device.
