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Showing results for tags 'Regulatory issue'.
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News Article
US Supreme Court may overturn abortion law, leak suggests
Patient Safety Learning posted a news article in News
The US Supreme Court could be about to overturn the nationwide legal right to abortion, according to an unprecedented leaked draft of a court document. In a 98-page draft opinion, Justice Samuel Alito writes that the 1973 Roe v Wade decision legalising abortion across the US is "egregiously wrong". If the top US court strikes down the ruling, "trigger laws" could instantly make abortion illegal in 22 US states. The justices are not expected to issue a ruling until early July. It sparked immediate outcry from Democrats, and protests - by both pro and anti-abortion supporters- Posted
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News Article
Whistleblowing Bill launched in Parliament to widespread support
Patient Safety Learning posted a news article in News
The Doctors’ Association UK (DAUK) has expressed its support for the Whistleblowing Bill launched in Parliament last week, with its first reading in the House of Commons by Mary Robinson MP, Chair of the All Party Parliamentary Group for Whistleblowing. DAUK urged people to tweet their MP to show their support for the Bill. DAUK Chair Dr Jenny Vaughan said: "Healthcare staff need to be able raise patient safety issues all of the time. We’re trained to do that, expect it, point this out as best we can. But sometimes poor safety arises because of the way we are told to work. Then, it c- Posted
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News Article
Government to review the future of CQC and NHS England
Patient Safety Learning posted a news article in News
NHS England, the Care Quality Commission and other arm’s length bodies will be subject to an efficiency and performance review led by the Cabinet Office. The terms of a review into all government arm’s length bodies were set out this week, with minister Jacob Rees-Mogg insisting there is an “urgent need for public service reform”. The ‘public bodies review’ programme will consider whether ALBs “should be abolished or retained”, should continue to deliver all their functions, and whether they have an “effective relationship” with their relevant departments. Other ALBs include the- Posted
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News Article
Australia: National cosmetic surgery standards needed for patient safety
Patient Safety Learning posted a news article in News
More than 100,000 doctors in Australia hold the right to call themselves cosmetic surgeons, without having undergone the specific training to be competent and safe. President of the Australasian College of Cosmetic Surgery and Medicine Dr Patrick Tansley says cosmetic surgery does not form part of the traditional medical training undertaken in Australia, due to the practice being relatively new. “Society has moved faster than legislation has followed it,” he told Sky News Australia. Dr Tansley said he is advocating for the introduction of a national standard to endorse this area- Posted
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Event
Innovative Licensing and Access Pathway (ILAP) information and update
Patient Safety Learning posted a calendar event in Community Calendar
untilThe Medicines and Healthcare products Regulatory Agency (MHRA) will be holding a joint virtual Innovative Licencing and Access Pathway (ILAP) information and update session. This event will provide an opportunity for patient groups and patient experts to receive an update on the work of the ILAP, how the MHRA involve patient and public representatives, and future developments about how the MHRA are accelerating the time to market and facilitating patient access to innovative medicines. This event is open to all patient and public representatives who are involved in the work of any of the- Posted
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News Article
Medical regulator faces questions over board members’ links to drug firms
Patient Safety Learning posted a news article in News
The UK medicines watchdog has been urged to strengthen its conflict of interest policy after it emerged that six of its board members are receiving payments from the pharmaceutical industry. Board members involved in overseeing the regulator’s “strategic direction” also have financial interests in companies including US and Saudi drug giants and firms with ambitions to break into the UK’s healthcare market. Some offer consultancy services while others help run or own shares in drug and medical device firms, according to official transparency records. There is no suggestion of wrongdo- Posted
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News Article
Focus will shift from trust ratings to services
Patient Safety Learning posted a news article in News
Trusts leaders can expect more emphasis on inspection ratings for individual services in future — as opposed to overall organisational ratings — the chief executive of the Care Quality Commission has said. In an interview with HSJ, Ian Trenholm discussed the future of the inspection regime, his views on prosecuting trusts, and how integrated care systems could be regulated. Asked about the future of inspections, Mr Trenholm said he did not believe trust leaders would be satisfied with just looking at their overall rating. He said: “My appeal to chief executives would be look at -
Content Article
The six-week consultation outlines a number of key proposals that strengthen the current code of practice, to ensure that experts providing the MHRA with advice are independent and impartial, and that the processes in place to manage conflicts of interest are robust and clear to all. It also enables greater inclusion of patient experts in committee discussions so that individuals with lived and personal experiences can contribute to discussions more easily. The proposals include: A register of interests accessible to all (through GOV.UK), which will be updated to reflect any chang- Posted
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News Article
Non-compliant online STI tests put patients at risk, experts warn
Patient Safety Learning posted a news article in News
Patients are being put at risk in the UK because very few sexually transmitted infection (STI) tests offered online meet official standards, experts have warned. The NHS provides free in-person tests for STIs via its network of sexual health and genitourinary medicine clinics. Patients can also order tests via the internet from both NHS-commissioned and private providers, a practice that has become increasingly popular during the pandemic. However, new research in the Sexually Transmitted Infections journal published by the BMJ found that few online STI test services meet national re- Posted
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- Sexually transmitted infections
- Testing
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News Article
The US is trying to fix medical devices’ big cybersecurity problem
Patient Safety Learning posted a news article in News
Medical devices are one major weak point in health care cybersecurity, and both the US Congress and the Food and Drug Administration took steps towards closing that gap this week —Congress with a proposed bill and the FDA with new draft guidelines for device makers on how they should build devices that are less likely to be hacked. Devices like infusion pumps or imaging machines that are connected to the internet can be targets for hacks. Those attacks can siphon off patient data or put their safety directly at risk. Experts consistently find that devices in use today have vulnerabilities- Posted
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News Article
Two thousand ventilators being used in UK hospitals are at risk of suddenly shutting down due to electrical faults that have led to a global safety alert. Hospitals have been ordered to source replacement ventilators after Philips Respironics said its breathing support devices could suddenly stop working, in some cases without activating a warning alarm. The Medicines and Healthcare products Regulatory Agency (MHRA) said the problem related to “a number of electrical faults in the devices, which can result in an unexpected shutdown, leading to loss of ventilation”. It said there- Posted
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- Ventilators
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Content Article
All actions to be completed by 31 May 2022 1. Urgently identify and locate affected devices in your organisation. 2. Identify alternative ventilators available on site. a. If no alternatives are available, use local procurement procedures to acquire suitable alternative devices. b. If no suitable alternative is available, and capacity is an issue currently (or expected imminently), additional devices are available for NHS organisations. Details for how to access these devices can be found in the ‘Additional information’ section of this alert. 3. Train all relevant staff on alter- Posted
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- Ventilators
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News Article
NHS regulator ‘not fit for purpose’ for dismissing baby deaths scandal warnings
Patient Safety Learning posted a news article in News
The healthcare regulator has been branded “not fit for purpose” after dismissing warnings of the biggest maternity scandal in NHS history, The Telegraph can reveal. Letters seen by this newspaper show that the Care Quality Commission (CQC) told grieving parents it would not support an independent inquiry into baby deaths, just months before such an investigation was ordered. Rhiannon Davies wrote to the watchdog in Dec 2016, alerting the regulator to 19 avoidable deaths of mothers and babies at the Shrewsbury and Telford Hospital NHS Trust, as well as a string of cases where lives we- Posted
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- Maternity
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News Article
Online retailers stop sales of some blood oxygen monitors after investigation
Patient Safety Learning posted a news article in News
Amazon, eBay and Wish have stopped stocking some monitors that let people keep track of their blood oxygen levels after an investigation found they were not fit to be sold. The online marketplaces removed a number of pulse oxygen testing devices known as oximeters from sale after being alerted to flaws identified by the consumer organisation Which? Pulse oximeters have boomed in popularity as a result of Covid, with millions of people keeping one at home so they can quickly assess if their blood oxygen level has fallen worryingly low – a condition known as “silent hypoxia” – which is- Posted
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- Medical device / equipment
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News Article
UK to bring in licensing scheme for Botox and filler procedures
Patient Safety Learning posted a news article in News
People administering Botox or fillers will be required to have a licence under new laws after an “unacceptable” rise in reports of botched cosmetic procedures in the UK. The legislation to protect against rogue practitioners will make it an offence to perform such non-surgical work without a licence after Sajid Javid said “far too many people have been left emotionally and physically scarred” when things have gone wrong. The health secretary recognised that most of those in the aesthetics industry “follow good practice” when it comes to patient safety but said it was time to think ab- Posted
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News Article
A London mum says she has been left in "agony" and only able to walk 10 minutes at a time after a transvaginal mesh implant perforated her organs. Anna Collyer, 53, had a transvaginal mesh fitted in 2015 at St. Helier hospital in Sutton. The mesh is a net-like implant and aims to give permanent support to the weakened organs and to repair damaged tissue. The mesh implants are designed to be permanent, but last April, Anna started to experience severe pain when the mesh cut into her organs leaving her "unable to live any sort of life anymore," she said. Even when doctors partially rem- Posted
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- Patient harmed
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Content Article
Open Letter to the Chief Executive, Health and Safety Executive
SafeDavid3 posted an article in Regulatory issues
Failings in connection with respiratory protection (RPE) of healthcare workers.- Posted
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- PPE (personal Protective Equipment)
- Virus
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