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Showing results for tags 'Regulatory issue'.
Found 467 results
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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.
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Content ArticleEvidence submitted outlining the issues relating to the protection of health and care workers. It explains how surgical masks are not 'protective' against airborne disease and represent a breach of COSHH Regulations.
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Open Letter to the Chief Executive, Health and Safety Executive
SafeDavid3 posted an article in Regulatory issues
Letter outlining potential legal non-compliance by persons involved in issuing Infection Prevention and Control Guidance. -
Content ArticleMany devices in current use were marketed before the US Food and Drug Administration (FDA) began regulating devices in 1976. Thus, manufacturers of these devices were not required to demonstrate safety and effectiveness, which presents both clinical and ethical problem for patients, especially for women, as some of the most dangerous devices—such as implanted contraceptive devices— are used only in women. This article from Madris Kinard and Rita F. Redberg investigates whether and to what extent devices for women receive less rigorous scrutiny than devices for men. This article also suggests how the FDA Center for Devices and Radiological Health could more effectively ensure safety and effectiveness of devices that were marketed prior to 1976.
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Content ArticleThe Medicines and Healthcare products Regulatory Agency (MHRA) share their Board meetings and public sessions. Follow the link to see previous Board agenda and Board papers and recordings of the sessions.
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Content ArticleLast week the Professional Standards Authority for Health and Social Care published a new report, Reshaping regulation for public protection, outlining their view on the implications of the Health and Care Bill for professional regulation.[1] In this blog, Patient Safety Learning looks at this report in more detail and explores the key patient safety aspects of this.
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Content ArticleIn 'Reshaping regulation for public protection', the Professional Standards Authority share their view on the implications of the Health and Care Bill for professional regulation. The Bill, currently going through Parliament, proposes new powers for the Secretary of State for Health and Social Care to abolish healthcare professional regulators as well as deregulate professions. In parallel with the progress of the Bill, an independent review, commissioned by the Department of Health and Social Care (DHSC), is looking at the regulatory landscape and will provide options for the exercise of these powers.
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Ineffective medical device recalls are a patient safety scandal
Kath Sansom posted an article in Women's health
A medical device is any piece of equipment, material or apparatus used to diagnose or treat a medical condition. When a medical device is recalled because of safety concerns, it can affect a large number of patients, often on a global scale. However, manufacturers and regulators of these devices don’t often have effective ways to ensure patients know about safety concerns, understand the risks or know what to do if their medical device is recalled. This blog by Kath Samson, founder of the Sling the Mesh campaign, looks at some of the issues around medical device recalls. She suggests ways that device manufacturers and regulators can improve their communication with patients and healthcare staff when a medical device is recalled.- Posted
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Transvaginal mesh timeline (7 December 2017)
Patient-Safety-Learning posted an article in Women's health
This blog sets out a timeline of the major landmarks for transvaginal surgical mesh since its first approval in 1996. -
Content ArticleThis guidance was updated on the 30 June 2022 to clarify how healthcare professionals should apply the term “unexpected or unintended” to decide if something qualifies as a notifiable safety event or not. Further detail is included below and you can find the full update here.
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Content ArticleAfter her infant son suffered due to a succession of medical errors, Sue worked tirelessly to prevent this from happening to others, starting by writing letters to the health care regulatory bodies until she and a group of mothers had formed a nonprofit and put out guidelines for the regulatory bodies to follow. In the midst of all of this, Sue’s husband was misdiagnosed as having a benign tumor, when it was later discovered to be a malignant sarcoma. With this she redoubled her efforts to lead us to a safer health system.
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Content ArticleNICE will speed up patients’ access to the latest and most effective treatments, and dynamic guideline recommendations will be put in the hands of healthcare professionals more quickly under plans unveiled by National Institute for Health and Care Excellence (NICE) in its 5-year strategy.
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Content ArticleThe Medicines and Medical Devices Bill has received royal assent and has become law. The new Act will enable the Department of Health and Social Care (DHSC) to implement a number of policies to amend the existing regulatory frameworks, although generally regulations under the Act must first be introduced. The potential changes include: Supporting the availability of medicines: enabling hub and spoke arrangements between different legal entities, to ‘support wider use of automation to bring increased efficiencies’; requiring manufacturers to provide electronic patient information leaflets; and increasing the professions able to prescribe and supply certain medicines. Protecting the public: developing a UK medicines verification system; introducing a national registration scheme for online sellers of medicines; and facilitating supply of medicines and medical devices during non-pandemic public health emergencies.
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Content ArticleThe Department of Health and Social Care (DHSC) published its consultation 'Regulating healthcare professionals, protecting the public' with proposals to modernise the legislation of the health professional regulators. Here the Professional Standards Authority gives their views of these proposals.
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In this opinion piece, Kath Sansom, Founder of the Sling the Mesh Campaign, argues that the UK regulatory systems for medicines and healthcare have not been fit for purpose for a number of years. Framed within the context of the Cumberlege Review, Kath uses evidence and personal insight to highlight flaws in the system, and to make the case for urgent reform. -
Content ArticleIn this blog, Patient Safety Learning outlines the key points included in its response to the Care Quality Commission’s (CQC) consultation on their new strategy from 2021, identifying the opportunities this presents for the health and social care regulator to help improve patient safety.
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Content ArticleThe Patients Association had not previously carried out work with patients on the topic of accredited registers, so in order to inform their response to this consultation they conducted an online survey of our members and supporters. Here are the results.
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Why investigate? Part 12: Ethics in research
Lara Carballo posted an article in Why investigate? Blog series
Ethics in medical science have been borne out of practices that occurred during the second world war, with the Nuremberg code being set up to prevent unethical experimentation on humans from being carried out. This was further supported by the Declaration of Helsinki that strengthened the protection of participants within medical research by setting out the stipulations that informed consent should be obtained before research. It ensured that data should be kept confidential so that medical research that ultimately requires input from human participants would be able to be carried out with minimal risk to the individual. Lara Carballo continues the 'Why investigate' blog series with a cautionary tale of why within Human Factors it is necessary to ensure that ethics are in place before embarking on research. -
Content ArticleThe rise in opioid overdoses warrants a review of the symptoms of akathisia writes Russell Copelan.
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Content ArticleIn this article in the Pharmaceutical Journal, Carolyn Wickware asks if liquid morphine should be reclassified. She cites research that Oramorph or oral morphine sulphate solution was directly linked to the cause of death in 13 reports since 2013.
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Content ArticleThe Care Quality Commission's (CQC) new strategy strengthens its commitment to deliver their purpose: to ensure health and care services provide people with safe, effective, compassionate, high-quality care and to encourage those services to improve.
