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Showing results for tags 'Regulatory issue'.
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News Article
Global hernia repair devices market is estimated to grow at a CAGR
Patient Safety Learning posted a news article in News
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: -
News Article
Regulator withdraws midwifery programme accreditation
Patient Safety Learning posted a news article in News
The Nursing and Midwifery Council (NMC) has withdrawn its accreditation of the midwifery programme at a Kent university due to fears over quality and safety.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 -
News Article
Australia to ban recreational vaping in major public health move
Patient Safety Learning posted a news article in News
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 -
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. -
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. -
News Article
Almost one in three doctors investigated by GMC ‘have suicidal thoughts’
Patient Safety Learning posted a news article in News
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 -
News Article
NHS 'hamstrung by red tape' as it takes 50 steps to release patients
Patient Safety Learning posted a news article in News
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 -
Content Article
In this blog, Steve Turner reflects on why genuine patient safety whistleblowers are so frequently ignored, side-lined or victimised. Why staff don't speak out, why measures to change this have not worked and, in some cases, have exacerbated the problems. Steve concludes with optimism that new legislation going through Parliament offers a way forward from which everyone will benefit.- Posted
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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.
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News ArticleUnannounced 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
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News ArticleThe 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
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Content ArticleRecording of a recent Care Quality Commission (CQC) webinar. Hear from Mandy Williams, Interim Director of integration, inequalities and improvement as she updates on CQC's approach to assessing integrated care systems. During the Q&A session, Mandy is also joined by Helen Rawlings, Deputy Director of Integration, Inequalities and Improvement, Matt Tait, Head of Acute Policy and Dominique Black, Strategy Manager who answers attendees questions from the live chat.
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Content ArticleAt a recent Care Quality Commission (CQC) webinar, Kate Terroni, Deputy Chief Executive and Chris Day, Director of Engagement, gave an update on CQC's implementation timeline for their new regulatory approach and new provider portal. The webinar lets providers know when to expect the new regulatory approach to start impacting them and the steps taken to get there. Kate and Chris deliver a short presentation and are then joined by Amanda Hutchinson, our Head of Policy - Regulatory Change during the Q&A session.
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Content ArticleIn this article, critical criminologist Sharon Hartles looks at the ongoing fight for justice by families affected by the hormone pregnancy test (HPT) Primodos. Primodos was given to thousands of women in the 1960s and 70s which has been linked to miscarriages, birth defects and stillbirth. The Department of Health and Social Care (DHSC) and pharmaceutical company Bayer are applying to strike out court proceedings against them in a civil litigation case brought by the Association for Children Damaged by Hormone Pregnancy Tests (ACDHPT). This would prevent a five-day hearing scheduled to take place at the Royal Courts of Justice in May 2023 from going ahead. The article outlines the argument brought by the DHSC and Bayer that no additional evidence has been found to warrant the case being brought by the ACDHPT. It then goes on to highlight recent research that has established a causal link between HPTs and birth malformations and that therefore gives credence to the litigation. Sharon highlights the importance of the legal system acknowledging and confronting the damage inflicted upon the families affected by the use of Primodos, many of whom have been seeking justice for decades. Related reading Primodos, mesh and sodium valproate: Recommendations and the UK Government’s response (Sharon Hartles, August 2021) Sodium Valproate: The Fetal Valproate Syndrome Tragedy A year on from the Cumberlege Review: Initial reflections on the Government’s response (Patient Safety Learning, 23 July 2021)
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Content Article
In this article, published in the Future Healthcare Journal, Helen Hughes, Chief Executive of Patient Safety Learning, reflects on how avoidable harm continues to occur, ten years on from the Francis report into major patient safety failings at Mid Staffordshire NHS Foundation Trust. She describes an implementation gap—where safety concerns and issues highlighted in inquiries and reviews are not being translated into improvements in patient safety. The article outlines some of the key barriers to implementation and suggests what needs to change to ensure we truly learn lessons from patient safety scandals such as Mid Staffordshire. -
EventuntilThis one-hour webinar will be an opportunity for providers and professionals who work in health and social care services, organisations who represent them, other stakeholders, local authorities, integrated care systems and stakeholders that represent the public to hear about CQC's approach to assessing integrated care systems and what it means for them. The webinar will be led by Amanda Williams, CQC's Interim Director of integration, inequalities and improvement. Register
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Event
CQC's new regulatory approach webinar
Patient Safety Learning posted an event in Community Calendar
untilThis one-hour webinar will be an opportunity for providers and professionals who work in health and social care services, organisations who represent them and other stakeholders to hear the latest updates about CQC's new regulatory approach. The webinar will be led by Kate Terroni, CQC's Deputy Chief Executive and Chris Day, director of engagement. There will be a presentation and time to answer your questions from the live chat. Register -
Event
CQC: Local authority assessments webinar
Patient Safety Learning posted an event in Community Calendar
untilThe Health and Care Act 2022 gives the Care Quality Commission (CQC) new powers that allow them to provide a meaningful and independent assessment of care at a local authority level. This one-hour webinar will be an opportunity for providers and professionals who work in health and social care services, organisations who represent them, other stakeholders, local authorities, and stakeholders that represent the public to hear about CQC's approach to assessing local authorities and what it means for you. Register -
Content ArticleOn 24 August 2022, the Employment Tribunal found that Mr Shyam Kumar, a consultant orthopaedic surgeon employed at University Hospitals of Morecambe Bay NHS Foundation Trust (UHMB), had been disengaged from his role as a Specialist Advisor within the Care Quality Commission (CQC) on account of having made “protected disclosures” to the CQC. This means he had raised concerns with CQC about the health of patients and other important issues and had done so in the public interest. The Employment Tribunal found that the fact that he had raised these various concerns with CQC had materially influenced its decision to disengage him. It awarded him £23,000 in damages for injury to feelings, on account of what it described as “the inevitable impact” of CQC’s actions upon Mr Kumar’s reputation among his peers and the shock, confusion and concern it caused to him. The CQC has accepted these findings and apologised to Mr Kumar. CQC’s Chief Executive, Ian Trenholm, issued a public statement on 6 September 2022 about what occurred, including a recognition of the importance of the concerns Mr Kumar raised, the importance of the information raised by staff and the public generally, and the “vital role” played by Specialist Advisors in CQC’s inspections. Following this, Zoe Leventhal KC was appointed by CQC’s Executive Board to carry out an independent review into whether CQC took appropriate action as a regulator in response to the protected disclosures that Mr Kumar made, and whether it dealt appropriately with a sample of other instances where concerns have been raised with CQC.
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Content ArticleFrom April 2023, the Care Quality Commission (CQC) will have power to assess integrated care systems, implementing a phased approach to develop the necessary competencies and relationships needed to assess these complex systems. This briefing summarises the interim guidance on the CQC's approach, and shares the NHS Confederation's analysis and viewpoint.
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News Article
CQC’s ICS ratings put on hold
Patient Safety Learning posted a news article in News
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 -
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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News Article
Revealed: experts who praised new ‘skinny jab’ received payments from drug maker
Patient Safety Learning posted a news article in News
The drug giant behind weight loss injections newly approved for NHS use spent millions in just three years on an “orchestrated PR campaign” to boost its UK influence. As part of its strategy, Novo Nordisk paid £21.7m to health organisations and professionals who in some cases went on to praise the treatment without always making clear their links to the firm, an Observer investigation has found. Among the vocal champions of the Wegovy jabs was a clinical expert who gave evidence to the National Institute for Health and Care Excellence (NICE) and others who publicly praised the so-called “skinny jabs” as a “gamechanger”. The revelations come as the Danish drug giant is investigated by the UK’s pharmaceutical watchdog after it was found to have breached the industry code seven times in relation to a “disguised promotional campaign” of another of its weight loss drugs via online webinars for healthcare professionals. Prof Allyson Pollock, professor of public health at Newcastle University, said Novo’s campaign was “not unusual” in the drugs industry and called for measures to improve trust. “The public really aren’t being made aware enough about the potential for bias and over-claiming,” she said. Read full story Source: The Guardian, 12 March 2023 -
Content ArticleAn set of presentations and resources from the Erasmus School of Health Policy & Management.
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Content ArticleEvery year more than 12.7 million healthcare and veterinary workers in the European Union are potentially exposed to hazardous medicinal products (HMPs) which are carcinogenic, mutagenic and reprotoxic (CMR). HMPs are used mainly in cancer treatment, but also as antivirals, vaccines and immuno-suppressants, for treating such diseases as multiple sclerosis, psoriasis and systemic lupus erythematosus (an auto-immune disease) and in organ transplant. Studies show that hospital workers who handle these HMPs are three times more likely to develop malignancy and that nurses exposed are twice as likely to miscarry. Increased genetic damage has been demonstrated particularly among day-hospital nurses, who handle HMPs most during their administration. In an article for Social Europe, Ian Lindsley, Tony Musu and Adam Rogalewski examine the revised directive and new guidelines on hazardous medicinal products and discusses why awareness still needs to be raised to protect workers.
