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Showing results for tags 'Regulatory issue'.
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News Article
Fraudster posed as doctor in UK for 19 years, court hears
Patient-Safety-Learning posted a news article in News
A “most accomplished fraudster” was paid between £1m and £1.3m by the NHS during the nearly two decades she posed as a qualified doctor after forging a degree certificate, a court has heard. Zholia Alemi, believed to be 60 years old, worked as a psychiatrist in the UK for 19 years after claiming to have qualified at the University of Auckland in New Zealand, a trial at Manchester crown court heard. The defendant is accused of 20 offences, including forgery and fraud, which she denies. The jury heard Alemi’s case was that she was appropriately qualified and documents demonstrating her -
News Article
FDA greenlights new Alzheimer's drug amid safety concerns
Patient-Safety-Learning posted a news article in News
The FDA is greenlighting the drug Leqembi after it appeared to slow cognitive decline in some early stage Alzheimer’s patients in spite of some potential risks. In this video, Kristen Dahlgren has more details about findings from the clinical trial. Watch full story Source: NBC News, 7 January 2023 -
News Article
NHS trusts in England have increased recruitment from low-income “red list” countries to make up for the post-Brexit loss of EU staff, despite a code of practice to safeguard health services in those developing countries. A report by the Nuffield Trust thinktank also identified shortages in vital specialist areas since Brexit, including dentistry, cardiothoracic surgery and anaesthesiology. It found that Brexit is still causing issues with the supply of medicines in Northern Ireland despite a change in the arrangements put in place by the EU last April. The report says that sinc- Posted
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Content Article
In 2015 the Government introduced a Freedom to Speak Up Guardian and a system of Local Speak Up Guardians in response to the recommendations made by Sir Robert Frances following the scandal at Mid Staffordshire. From the outset, this system has attracted significant criticism and the APPG has heard from whistleblowers who have been failed by local guardians sharing their experiences that included the disclosure of their identity to hospital management and boards – resulting in retaliation. The APPG has also heard from Local Guardians who were not supported and themselves the target of ret- Posted
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Falsified Medicine Directive explained
Patient Safety Learning posted an article in Medication
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I love and support the NHS. But when things go wrong for patients and service users, the system is often too slow to change or respond effectively. I have been through complaints, the Ombudsman and Inquest processes around the poor end of life care of my late mother. Those processes took years and were almost as stressful as those last few days of my mother’s life. I would not do it again. At the time, I reported the incident in detail to the CQC (inspectors), to the CCG (commissioners), to Healthwatch (local and national), but I noted no evidence of change. In fact, the CQC continued for- Posted
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Some integrated care systems (ICSs) still require “an awful lot of control” from the centre, Patricia Hewitt has told HSJ, tempering any expectations that her government-commissioned review will bring about a wholesale roll-back of national performance management. The former Labour health secretary, who is also an integrated care board chair, was commissioned in November by chancellor Jeremy Hunt and health secretary Steve Barclay to review ICS autonomy and accountability. In her first interview since she started the work, Ms Hewitt also said: She had not ruled out “legislat- Posted
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Life Sciences Council Joint Statement on Medical Devices Regulatory Reform
Patient Safety Learning posted a news article in News
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- Posted
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Event
Next steps for diagnostics and medical devices in England
Patient Safety Learning posted a calendar event in Community Calendar
untilThis conference from the Westminster Health Forum will focus on the future for diagnostics and medical devices in England - looking at developments and next steps for strategy and regulation. The discussion takes place in the context of the upcoming MedTech strategy from DHSC, and will be an opportunity to examine priorities for improving flexibility and transparency in MedTech supply and procurement, securing value for money, and supporting the adoption of innovation in healthcare settings. Delegates will discuss implementation of the MHRA update to the regulation of medical devices- Posted
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Content Article
Commissioned by the Department of Health and Social Care (DHSC) in February 2020, the Independent Investigation into East Kent Maternity services published its report last month highlighting patient safety failings in maternity and neonatal care services from 2009–2020 at two hospitals: Queen Elizabeth The Queen Mother Hospital at Margate and the William Harvey Hospital in Ashford. This is another devastating report detailing cases of serious avoidable harm and preventable deaths in the NHS, stating that it found that: “... those responsible for the services too often provided clinic- Posted
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News Article
More than 10,000 patients given faulty knee replacements
Patient Safety Learning posted a news article in News
More than 10,000 patients have been given a faulty knee replacement which doubles the risk of joint failure, The Telegraph has disclosed. The implant, which has been in use since 2003, was withdrawn from the market by its manufacturer in October. The Telegraph has learnt that UK health regulator the Medicines and Healthcare products Regulatory Agency (MHRA) is now preparing to issue a field safety notice, prohibiting its use. Available across multiple NHS trusts, the implant, manufactured by Zimmer Biomet, a US firm, has been shown to fail in up to 7% of patients after ten years- Posted
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You can access the following videos of conference sessions: Welcome remarks from Caroline Corby, the PSA's Chair and Alan Clamp, PSA Chief Executive Is regulation keeping people safe? Health and Social Care Safety Commissioners: a solution to bridge the safety gaps in all UK countries? Are learning cultures compatible with individual accountability and candour? Should health and care professionals have a duty to tackle health inequalities? Parallel session A: Does regulation need to change to deliver the workforce of the future? Parallel session B: A- Posted
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News Article
The World Health Organization (WHO) announces that the Ministry of Food and Drug Safety, Republic of Korea, has achieved maturity level four (ML4), the highest level in WHO’s classification of regulatory authorities for medical products. WHO has formally assessed the medical product regulatory authorities of 33 countries, of which only the Republic of Korea is listed as attaining this level in regulation for both locally produced as well as imported medicines and vaccines. This achievement represents an important milestone for the Republic of Korea and for the world, signifying that the M- Posted
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The FDA is still letting doctors implant untested devices into our bodies
Patient Safety Learning posted a news article in News
When Kathleen Yaremchuk, Chair of the department of otorhinolaryngology (ear, nose and throat) at Henry Ford Hospital in Detroit, began getting calls about mysterious cases of respiratory distress, she launched a study to figure out what was going on. All these patients, it turned out, had a small device implanted in the top of their spines to relieve pain. The object, used to hold a protein that stimulates bone growth, was cleared for sale by the Food and Drug Administration in 2003 without clinical testing in humans. When Yaremchuk and her colleagues reviewed the records of all 260- Posted
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News Article
Oklahoma proposes landmark rule to keep mailed medications safe
Patient Safety Learning posted a news article in News
Patients in Oklahoma, USA, who get their prescription medications by mail may soon have better protections for the safety of those drugs than any other state. On Wednesday, Oklahoma regulators proposed the nation’s first detailed rule to control temperatures during shipping, according to pharmacy experts. “This is a huge step,” said Marty Hendrick, executive director of the Oklahoma State Board of Pharmacy, after the board voted to approve the rule Wednesday. “We’ve got a tremendous amount of prescriptions that get mailed to patients. … What we did today was make sure our patients in Okl- Posted
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News Article
Scars and ulcers among risks from boom in beauticians treating varicose veins
Patient Safety Learning posted a news article in News
The adverts promise beautiful legs, zero risk, and treatment in as little as 15 minutes. But unregulated injections to “eliminate” varicose veins are putting clients at risk of serious health complications, surgeons have warned. Vein removal treatments costing as little as £90 a session are being offered by beauticians without medical supervision across the UK, Observer analysis has found. Promoted with dramatic before and after photos and billed as a quick fix, microsclerotherapy involves the injection of a chemical irritant to disrupt the vein lining. This causes the vein walls to- Posted
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News Article
ICSs may be breaching patient confidentiality, watchdog warns
Patient Safety Learning posted a news article in News
The health service’s independent data watchdog has issued a warning to local NHS bodies over concerns confidential patient information is being shared unlawfully with third parties, including for ‘population health’ analysis. In a letter to integrated care systems (ICSs), National Data Guardian Nicola Byrne and UK Caldicott Guardian Council chair Arjun Dhillon said they had both “been made aware that within some local record sharing programmes, organisations could be processing confidential patient information without ensuring that the processing does not breach confidentiality”. The- Posted
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Dr Heather Steen to be removed from medical register
Patient Safety Learning posted a news article in News
A senior doctor is to be removed from the medical register after she was found to have attempted to cover-up the circumstances of a young girl's death. Paediatrics consultant Dr Heather Steen was found to be unfit to practise after an investigation into the death of nine-year-old Claire Roberts in 1996. A medical tribunal examining the doctor's case ruled that the majority of allegations against her were true. Claire's mother said it was "just the start of getting full justice". "I am angry at Dr Steen for putting us through 26 years of mental torment," said Jennifer Robert- Posted
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