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Showing results for tags 'Regulatory issue'.
Found 220 results
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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 t -
Content ArticleNHS and social care services are under extreme pressure. There have been record delays for people waiting for ambulances and treatment in hospital. To provide ongoing support to services managing the current challenges, the Care Quality Commission (CQC) have published a new online resource for system leaders and service providers. PEOPLE FIRST presents suggested actions for individual services and the wider system to help: make the best use of resources build capacity ensure safety remains a priority. Developed by CQC's National Emergency Medicine Specialist Adv
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Content ArticleMyth 1: HSE and LAs still have enforcement responsibilities for the safety of patients and people who use services. Myth 2: A specialised team in CQC is responsible for taking enforcement action. Myth 3: HSE and LAs still respond to RIDDORs. Myth 4: CQC inspectors don't need to gather evidence any differently to how they do currently, Myth 5: CQC inspectors share information with Local Authorities and Environmental Health Officers, Myth 6: CQC doesn't use incident selection criteria to decide when to proceed to enforcement,
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Content ArticleThis good practice guide is one of the key deliverables of the Agency’s medication error initiative and offers guidance on risk minimisation and prevention of medication errors. The guidance includes population-specific aspects in paediatric and elderly patients, as well as guidance on the systematic assessment and prevention of the risk of medication errors throughout the product life-cycle. The key recommendations: The potential for medication errors should be considered at all stages of the product life-cycle but particularly during product development. To minimise the ri
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News ArticleThe American Medical Association and three other major health groups have warned that patients across the nation could suffer “irreparable harm” due to the shattered legal landscape left in the wake of the Supreme Court’s decision to overturn Roe v. Wade. In a statement, co-authored with the American Pharmacists Association, the American Society of Health-Systems Pharmacists and the National Community Pharmacists Association, the groups said they were deeply concerned by state efforts to limit access to medically necessary medicine. Ongoing questions about state laws are already impacting
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The Professional Standards Authority for Health and Social Care (PSA) is an independent body which oversees the ten statutory bodies that regulate healthcare professionals in the United Kingdom and social care in England. Its aim is to protect the public by improving the regulation and registration of people who work in health and social care.[1] In its new report, Safer care for all – solutions from professional regulation and beyond, the PSA set out their view of the main unresolved challenges which impact the quality and safety of health and social care.[2] This is structured around fo -
Content Article
Working together to achieve safer care for all There are some big challenges ahead that need us all to work together to solve them. In our new report, 'Safer Care for All: solutions from professional regulation and beyond', we set out four key challenges for patient and service user safety: Tackling inequalities. Keeping pace with changes to technology and the delivery of care. Facing up to the workforce crisis. Addressing issues of accountability, fear and public safety. We suggest possible solutions as well as one major overarching recommendation: that eac -
Content ArticleThe report considers four main themes: 1) Tackling inequalities The report sets out that there are persistent, major inequalities in access to and experience of healthcare services. To help tackle this, it states that the system as a whole needs to improve the way it collects data about the protected characteristics of complainants, so that we can see start to identify any differences in how care is delivered, and how complaints are handled. 2) Regulating for new risks It highlights that the way health and care are funded and delivered is changing. There is an increase in ‘
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News Article
MPs to question government on failures over use of epilepsy drug in pregnancy
Patient Safety Learning posted a news article in News
Senior health officials are to face questioning over why pregnant women are still being prescribed sodium valproate despite its known risks as a cause of birth defects or developmental delays. Campaigners for families affected by the drug will also give evidence to the Health and Social Care Committee in a one-off session later this month. Alongside campaigners on sodium valproate, the Committee will also hear from campaigners from Association for Children Damaged by Hormone Pregnancy Tests and on behalf of “Sling the Mesh” campaign. MPs will examine government progress on recommenda -
News Article
NHS whistleblower Shyam Kumar wins case against regulator
Patient Safety Learning posted a news article in News
A doctor who was sacked for raising patient safety concerns has won a case against England's hospital regulator, the Care Quality Commission (CQC). Orthopaedic surgeon Shyam Kumar worked part-time for the CQC as a special adviser on hospital inspections, but Manchester Employment Tribunal found that he was unfairly dismissed. Between 2015 and his dismissal in 2019, Mr Kumar wrote to senior colleagues at the CQC with a number of serious concerns. They included a hospital inspection, at which he claims patient safety was significantly compromised when a group of whistleblowing doc -
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News ArticleKath Sansom, a former journalist from Lynn is raising awareness about the potential risks associated with vaginal and rectal mesh surgery. Mesh implant surgery is used to treat prolapse and incontinence in women usually following childbirth, and some men have also had the procedure. But pain and complications after the implants have left hundreds of people in the UK in pain and so a campaign in 2015 was launched which has led to the Government announcing a suspension in the use of vaginal mesh. Kath initiated the Sling The Mesh campaign in 2015 following her own experience of mesh su
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Surgical mesh is a medical device implanted to support organs in various procedures. Thousands of women in the UK had mesh surgically implanted to treat pelvic organ prolapse and stress urinary incontinence, until its use was suspended due to safety concerns in 2018.[1] Surgical mesh has been linked to a wide range of serious health issues including chronic pain, incontinence, painful sex, recurrent infections, loss of mobility and autoimmune diseases. Prior to the suspension, women injured by mesh had been raising concerns about the safety of the procedure for years and campaigning for change -
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EventuntilThis FDA/PQRI Workshop will bring together leaders from regulatory agencies, industry, and academia to discuss critical topics in distributed manufacturing and point of care manufacturing. Further information
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News ArticleAs the risk of cyberattacks on medical devices continues to mount, the Food and Drug Administration isn’t doing enough to ensure device makers include adequate security in their products, experts say. They charge that part of the problem is that the agency lacks the funds and the trained personnel to evaluate the cyber risk the devices carry and enforce the rules it does have on the books for approving devices. “I’ve spoken to device manufacturers, specifically product security people at device manufacturers, saying that they’ve been telling their organizations for the last year or
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