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Current regulations provide that the acceptance of CE marked medical devices on the Great Britain market were meant to end on 30 June 2023.
A statutory instrument has subsequently been laid in Parliament, which will enable an extended timeframe for acceptance of CE marked medical devices on the Great Britain market.
Subject to Parliamentary approval this will mean that CE marked medical devices will be accepted on the Great Britain market beyond the current deadline (30 June 2023). This will support the ongoing, safe supply of medical devices to Great Britain and is designed to ease the transition to a future strengthened regulatory framework for medical devices.
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England has become the first country in the world to launch clinical training in perinatal mental health using extended reality (XR) technology. Perinatal mental health conditions affect between 10 and 20% of people giving birth in the UK. While these problems are often mild and last for a short period, some can present as severe mental illness and without the right immediate support and care, can pose a high risk to parents and their babies. Treatment for perinatal mental health conditions relies on healthcare professionals being able to engage and communicate effectively with patients to determine the severity of their condition and make appropriate interventions.
However, there are often limited opportunities for learners to practice these skills in a safe learning environment where they can practice and reflect on their experiences. A ground-breaking patient avatar has been developed by Health Education England in partnership with Fracture Reality and allows healthcare learners to expand their skills interacting with people with perinatal mental health problems through a series of instructor-driven simulations. Using a headset, learners interact with the avatar, called Stacey, a virtual patient who is directed by an instructor and run as a simulation on Fracture Reality’s JoinXR platform. The technology can be used in augmented reality where learners are able to practice in their own clinical setting as well as virtual reality that offers students the chance to experience interacting with Stacey in her own home or other clinical settings.
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Patients across the UK are set to benefit from access to safe, effective and innovative equipment and medical devices as part of the first ever medical technology (medtech) strategy. The blueprint for boosting NHS medtech will focus on accelerating access to innovative technologies, such as the latest generation of home dialysis machines that enable patients to manage their own health at home and in their day to day lives.
It also sets out steps which need to be taken to ensure patients can access safe, effective and innovative technology through the NHS, which can help diagnose, treat and deliver care more quickly, freeing up clinician time. The NHS spends £10 billion a year on medtech including syringes, wheelchairs, cardiac pacemakers and medical imaging equipment such as X-ray machines.
Building on learnings from the COVID-19 pandemic and the rapid development of medical technologies during that time such as lateral flow tests and ventilators, this strategy will ensure the right product is available at the right price and in the right place. As a result, patients will continue to have access to high-quality care, alongside improved patient safety and health outcomes.
Read more: New strategy to boost NHS access to innovative medical technology
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NHS Hospitals remain under significant pressure with bed occupancy at the second highest level recorded this winter in January. More than 19 in 20 beds were occupied across adult general and acute hospital wards (95.7%) in the week ending 15 January, according to the weekly statistics.
Over 14,000 beds were taken up by patients who no longer needed to be there last week – the second highest ever recorded and 12% higher than the same period last year (12,498). The NHS continues to manage high numbers of patients in hospital who have flu with an average of 3,447 beds occupied each day by people with flu. (3,226 were in general and acute beds and 221 in critical care beds). However, the latest data indicates that flu numbers in hospital have fallen over the last two weeks, down from 5,441 in the week ending 15 January.
Read more: NHS pressure continues as hospitals deal with high bed occupancy
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Life Sciences Council Joint Statement on a new agreement to accelerate the delivery of the future UK HealthTech regulatory system.
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 announced a new agreement to accelerate the delivery of the future UK HealthTech regulatory system. Acknowledging the Chancellor’s priorities of stability and growth supported by regulatory reforms, and the importance of the success of the system to UK patients and the Life Science sector, they have formed an advisory group on behalf of the Life Sciences Council to drive the delivery of the ambition of the Life Sciences Vision to have a best in class regulatory system.
Read more: Life Sciences Council Joint Statement on Medical Devices Regulatory Reform
