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Showing results for tags 'Regulatory issue'.
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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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Content ArticleAn set of presentations and resources from the Erasmus School of Health Policy & Management.
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Content ArticleIn this blog, TranspariMED Founder Till Bruckner reviews The Truth Pill: The Myth of Drug Regulation in India, a new book that looks at problems with the medications regulatory system in India. The book's authors, Dinesh S. Thakur and Prashant Reddy T, draw on in-depth legal and regulatory analyses, numerous case studies and responses to hundreds of Freedom of Information requests to document glaring gaps in India’s legal framework and severe shortcomings in regulatory oversight and enforcement.
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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.
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Content ArticleVictoria Vallance, Director of Secondary and Specialist Care, provides an update on the Care Quality Commission (CQC)’s ongoing national maternity inspection programme and offers early insight into the emerging themes, including good practice examples to support wider learning across all trusts.
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Content Article
In this opinion piece, Kath Sansom, founder of Sling the Mesh, looks at why an audit of pelvic mesh outcomes due to be published in April 2023 has again failed to capture the true extent of the harm caused by the procedure. She outlines why the approach taken by the Government and NHS Digital was flawed and why it is so important to understand both the proportion of women who have experienced harm as a result of the procedure, and the nature of their injuries and side effects.- Posted
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Content ArticleHospitals and other medical organisations are being hit by a rising number of cyberattacks; ransomware strikes on healthcare doubled annually between 2016 and 2021, according to a study published in December in the Journal of the American Medical Association. After a cyberattack, hospitals are forced to cancel procedures, reroute patients to other facilities and resort to pen-and-paper record-keeping. In this article, Wall Street Journal reporter James Rundle looks at how cyberattacks and a regulatory push are increasing the pressure on medical device manufacturers to improve the security of their products.
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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 - twice the accepted failure rate of 3.5% set by the National Joint Registry. One study found the failure rate to be much higher at 17.6% - more than five times as high as the accepted level. This can have catastrophic consequences for patients, many of whom are elderly, as undergoing a second knee replacement operation poses a much greater risk. The knee replacement, called the Nexgen, is part of a family of Zimmer Biomet implant devices with 88 possible variants. In total, these have been given to over 183,000 people in England, Wales and Northern Ireland, and more than five million worldwide. Of these variants, three combinations have been proven to place patients at a dangerously high risk of joint failure. Read full story (paywalled) Source: The Telegraph, 5 December 2022 -
News ArticleThe 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 Ministry of Food and Drug Safety (MFDS), the national regulatory authority for medicines and vaccines, is operating at an advanced level of performance with continuous improvement Only about 30% of the world’s regulatory authorities have the capacity to ensure medicines, vaccines and other health products are produced to required standards, work as intended and do not harm patients. WHO’s benchmarking efforts identify regulatory authorities that are operating at an advanced level so that they can act as a reference point for regulatory authorities that lack the resources to perform all necessary regulatory functions, or which have not yet reached higher maturity levels for medical product oversight. “This is a great testament for Republic of Korea’s commitment for ensuring safe and effective medicines and vaccines, and investing in building a strong regulatory system,” said Dr Mariângela Simão, Assistant Director-General, Access to Medicines and Health Products. “We hope the achievement will be sustained and also help promote confidence, trust and further reliance on national authorities attaining this high level”. Read full story Source: WHO, 29 November 2022
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News Article
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 patients implanted with the device at Henry Ford Hospital between 2004 and 2009, they found that a significant number developed airway obstruction, trouble swallowing and respiratory failure, in some cases leading to death. The neck implant is just one of the products associated over the past decade with 1.7 million injuries and more than 80,000 deaths. A searing global investigation last year by the International Consortium of Investigative Journalists places much of the blame on significant failings in the FDA’s oversight. The agency’s laissez faire attitude has resulted in artificial hips that cause cobalt poisoning (which can damage the heart and brain); surgical mesh that cuts through flesh and organs, causing infections and haemorrhage; and defibrillators that repeatedly shock patients beyond human endurance. Safety problems have led to recalls of devices implanted in hundreds of thousands of people. And the devices can be difficult or impossible to remove if they go bad No wonder many patient advocates cheered when the FDA announced in November that it planned to make “transformative” changes in the way more than 80% of medical devices are cleared for sale in the United States. But the promised transformation is mere window dressing. Two key loopholes still exist, allowing most products to be approved for sale without clinical trials in humans. Read full story (paywalled) Source: The Washington Post, 4 January 2019 -
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 Oklahoma are receiving safe products.” Exposure to extreme temperatures can degrade or weaken drugs, potentially changing their dosage or chemical makeup and rendering them ineffective or unsafe for patients. But while government oversight of how pharmacies store medications to keep them in defined safe temperature ranges is very detailed, an NBC News investigation in 2020 found oversight of shipping to patients — during which drugs might be exposed to heat waves and below-freezing temperatures — is largely a system of blind trust. Mail-order pharmacy is a booming business, with soaring profits for some of the nation’s largest companies last year and more than 26 million people receiving their medication by mail in 2017 — more than double the number two decades earlier, according to federal data. NBC News found that most state pharmacy boards, the regulators responsible for pharmacy safety, did not have specific rules for how pharmacies should ship customers’ medication, few asked about this process in their inspections, and many said it was simply up to the pharmacy to ensure safe shipping. Read full story Source: NBC News, 17 November 2022 -
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 stick together, making it no longer visible on the skin. When performed correctly on finer veins, known as “thread” or “spider” veins, the procedure is generally considered safe, provided no underlying issues are present. But beauticians and other non-healthcare professionals are also offering vein treatments for people with varicose veins, which can signify underlying venous disease, analysis of promotional materials shows. In such cases, treatments should be performed by practitioners in a regulated clinic, where specialists first use ultrasound scans to assess the area. Conducting vein removal incorrectly or when there are underlying problems can lead to complications including leg ulcers, nerve damage, blood clots, stroke, allergic reactions and scarring, the Joint Council for Cosmetic Practitioners (JCCP) said. Even in cases where only thread veins are visible, other problems may be present. Prof Mark Whiteley, a consultant venous surgeon and chair of the Whiteley chain of clinics, said he had seen cases of women with leg ulcers and permanent scarring after treatment for varicose veins from non-medics. In other cases, people had paid for treatment but saw no effect because the underlying cause was not tackled. “It’s totally disgraceful,” he said. Read full story Source: The Guardian, 20 November 2022 -
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”. They added among the four areas of concern health and care staff had raised with them was that confidential patient information may be being transferred from local record sharing programmes to third party hosted secure data environments. Secure Data Environments are data storage and access platforms where organisations can apply to access data for planning and research purposes. It is not clear what kind of patient data may have been unlawfully shared. Read full story (paywalled) Source: HSJ, 17 November 2022 -
News Article
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 Roberts. At the time of Claire's death, her parents were told she had a viral infection that had spread from her stomach to her brain. But in 2018 a public inquiry determined that she had died from an overdose of fluids and medication caused by negligent care at the Royal Belfast Hospital for Sick Children. The inquiry also concluded there had been "cover up" and the girl's death had not been referred to the coroner immediately to "avoid scrutiny". The case was then put to the Medical Practitioners Tribunal Service (MPTS), which rules on doctors' fitness to practise. When the case reached the tribunal stage Dr Steen twice applied to be voluntarily removed from the medical register and was twice refused. Had that been successful the tribunal would have been halted as she would no longer have been a doctor. However the tribunal continued and examined allegations that between October 1996 and May 2006 Dr Steen "knowingly and dishonestly carried out several actions to conceal the true circumstances" of Claire. Read full story Source: BBC News, 11 November 2022 -
News Article
Gene-edited babies: Current techniques not safe, say experts
Patient Safety Learning posted a news article in News
Current scientific techniques are not yet safe or effective enough to be used to create gene-edited babies, an international committee says. The technology could one day prevent parents from passing on heritable diseases to children, but the committee says much more research is needed. The world's first gene-edited babies were born in China in November 2018. The scientist responsible was jailed, amid a fierce global backlash. The committee was set up in response. Gene-editing could potentially help avoid a range of heritable diseases by deleting or changing troublesome coding in embryos. But experts worry that modifying the genome of an embryo could cause unintended harm, not only to the individual but also future generations that inherit these same changes. It made several recommendations, including: Extensive conversations in society before a country decides whether to permit this type of gene-editing. If proven to be safe and effective, initial uses should be limited to serious, life-shortening diseases which result from the mutation of one or both copies of a single gene, such as cystic fibrosis. Rigorous checks at every stage of the process to make sure there are no unintended consequences, including biopsies and regular screening of embryos. Pregnancies and any resulting children to be followed up closely. An international scientific advisory panel should be established to constantly assess evidence on safety and effectiveness, allowing people to report concerns about any research that deviates from guidelines. Read full story Source: BBC News, 4 September 2020 -
News Article
Hernia mesh implants used 'with no clinical evidence'
Patient Safety Learning posted a news article in News
"Too many" types of hernia mesh implants are being used on NHS patients with little or no clinical evidence, the BBC has been told. New data shows more than 100 different types of mesh were purchased by NHS Trusts from 2012 to 2018 in England and Scotland, leading to fears over safety. The meshes can cut into tissue and nerves, leaving some people unable to walk, work or care for children. Currently, hernia mesh devices can be approved if they are similar to older products, which themselves may not have been required to undergo any rigorous testing or clinical trials in order to assess their safety or efficacy. In England, around 100,000 such operations are performed each year, the majority using mesh. Many go well. But the Victoria Derbyshire programme has heard from nearly 300 people who have experienced complications - including chronic pain, infections and organ perforations. International guidelines estimate one in 10 patients will experience "significant chronic pain" following a mesh repair. The director of devices at the Medicines and Healthcare products Regulatory Agency (MHRA), Graeme Tunbridge, told the BBC: "The benefits and risks of using mesh for hernia repair have been considered in detail by clinicians and the professional bodies who represent them. We continue to monitor and review evidence as it becomes available and will take any appropriate action on that basis." Mr Tunbridge said he recognised the system "does need strengthening" and said new legislation on medical devices would take effect from May 2020. Read full story Source: BBC News, 15 January 2020 -
News Article
JAMA editorial blasts FDA's reporting of medical device problems
Patient Safety Learning posted a news article in News
The US Food and Drug Administration (FDA) needs to do more to quickly and substantially reform its system for reporting adverse events caused by medical devices, two researchers wrote in an Editorial published in JAMA Internal Medicine. The editorial notes several instances where information on a medical device was withheld from the public or not reported fully. The current adverse events reporting system relies on device makers to voluntarily report adverse events, which the authors say does not place patient safety as a priority. The editorial specifically highlights a study involving Medtronic's Insync III model 8042 heart failure pacemaker, which the authors said caused a "high burden of serious adverse events (including death)." The authors said it took the FDA 19 months to recall the device after the first instance of the device failing was reported. The FDA also decided to classify the recall as Class II, which signifies a low probability of serious adverse events. "This long unexplained delay before the recall and the inappropriate recall classification raise concerns about patient harms that could have been prevented by speedier and stronger regulatory actions," the authors wrote. Read full story Source: Becker's Hospital Review, 10 January 2020 -
News Article
Somerset care home failed to notify health watchdog of deaths
Patient Safety Learning posted a news article in News
A residential care home failed to notify the health watchdog about the deaths of people they were providing a service to, its report has found. Kingdom House, in Norton Fitzwarren, run by Butterfields Home Services, was rated "requires improvement". The home cares for people with conditions such as autism. The Care Quality Commission (CQC) said the registered manager and provider lacked knowledge of regulations and how to meet them. Inspectors found the provider failed to notify the CQC about the deaths of people which occurred in the home, as required by Regulation 16 of the Health and Social Care Act 2008. The report also found people were at "increased risk" because the provider had not ensured staff had the qualifications, competence, skills and experience to provide people with safe care and treatment. Inspectors did, however, praise the "positive culture" at the home, that is "person-centred", and noted the provider was "passionate about their service and the people they cared for". Read full story Source: BBC News, 2 January 2020 -
Content ArticleThere are too many integrated care systems (ICSs) in some parts of the country, especially the South West and Midlands, writes Alastair McLellan and Dave West in this HSJ article. This means that effective integration will struggle due to limited resources, leadership capacity and ability to influence large providers. It is also a problem widely acknowledged at the centre and within the regions. The proposed structure for ICSs is overly complex, consisting of a partnership board with little statutory power, which is meant to give strategic direction to an executive board which in practice will be held accountable for all decisions, but which is also meant to give up as much power and money as possible to “place based” entities which remain ill defined and have no statutory standing.
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Content ArticleIn 2016, the Centers for Disease Control and Prevention published prescribing guidelines for opioids. Though intended to encourage best practices in opioid prescribing, these guidelines fueled providers’ fears of opioids and led to many clinicians abandoning patients who relied on opioids for pain relief. In this article, Antje M. Barreveld reflects on the harms he may have caused by underprescribing these drugs, not overprescribing them.
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Content ArticleV60 and V60 Plus devices are designed for in-hospital use. They can be used to provide average volume assured pressure support (AVAPS), pressure-controlled ventilation (PCV), continuous positive airway pressure (CPAP), and positive pressure ventilation (PPV) treatment to patients in critical care and high dependency unit (HDU) settings. The safety concern identified relates to a number of electrical faults in the devices, which can result in an unexpected shutdown, leading to loss of ventilation. There are two ways in which this shutdown can occur: The first will sound a warning to alert the user that the machine is shutting down. This will let the user know they need to switch to an alternative source of ventilation. There is a risk that the patient will be unventilated while this second source of ventilation is prepared. The second failure mode will cause the device to shut down with no warning alarm. If a ventilator fails in use and does not alarm, the patient will be unventilated until the clinician becomes aware and responds. If unnoticed by healthcare professionals, ventilation failure can have a severe health impact on patients. This can include hypoxia, which can result in long-term cognitive impairment to the patient. There is also a risk of death if a patient is without ventilation for a sustained period of time Philips has no permanent solution to correct this issue and as such we are issuing this alert to help hospitals manage the risk.
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Content ArticleTwo professionals who treated Jack Adcock before his death were convicted of gross negligence manslaughter, receiving 24-month suspended sentences. His nurse, Isabel Amaro, was erased from the nursing register; but after reviews in the High Court and Court of Appeal, his doctor, Hadiza Bawa-Garba, was merely suspended. Nathan Hodson explores the proposition that nurses are at greater risk of erasure than doctors after gross negligence manslaughter through a close reading of the guidance for medical and nursing tribunals informed by analysis from the High Court and Court of Appeal in the Bawa-Garba cases.
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Content ArticleCoroner regulations: Regulation 28 - Report on action to prevent other deaths. Regulation 29 - Response to a report on action to prevent other deaths.
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Content ArticleRule 43 reports were replaced on implementation of the Coroners and Justice Act 2009 with Reports on Action to Prevent Future Deaths (‘reports’) .For short they can be referred to as PFDs or PFD reports or Regulation 28 reports. These reports are important. Coroners have a duty not just to decide how somebody came by their death but also, where appropriate, to report about that death with a view to preventing future deaths. A bereaved family wants to be able to say: ‘His death was tragic and terrible, but at least it shouldn’t happen to somebody else.’ Broadly speaking reports should be intended to improve public health, welfare and safety. They should not be unduly general in their content; sweeping generalisations should be avoided. They should be clear, brief, focused
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Content ArticleA letter to the Chair of the Commons Health and Social Care Select Committee expressing concern that written evidence provided to the Committee's “Coronavirus: Lessons Learned to Date" inquiry was not properly considered and opportunities to protect healthcare workers from disease were missed.
