NEWS
MHRA consulting on tighter safety standards for IVDs
The Medicines and Healthcare products Regulatory Agency (MHRA) has launched a four-week consultation which will support improved safety for certain high- risk IVD devices. Accurate performance and trust in the
quality of in vitro diagnostic (IVD) products is crucial to healthcare professionals considering their use in treating patients. The new policy the MHRA is consulting on would require manufacturers to comply with additional measures for certain high-risk IVDs, such as blood tests used to identify blood type before transfusions or tests which identify life-threatening diseases, introducing harmonised
requirements for these products. The MHRA says it is also seeking views on the removal of the Coronavirus
Test Device Approval (CTDA) process to avoid duplication of regulatory requirements for COVID-19 tests against the Common Specification requirements. The MHRA intends to incorporate updates to IVD common specifications within a draft Statutory Instrument as part of the future core medical device regulations to be published later in 2024. This includes recognition by the UK of approvals of medical devices from international regulators. The MHRA intends to recognise medical devices that have been approved in Australia, Canada, the EU and the USA. The updated regulations will then come into force in 2025. It follows from the publication in January this year of a regulatory ‘roadmap’, pointing the way ahead for new measures to support safe access to medical technology including AI and diagnostics.
Dr Laura Squire, MedTech Regulatory
Reform Lead and Chief Healthcare Quality and Access Officer, MHRA said: “We look forward to feedback on our consultation on common specification of IVDs, as we look to strengthen safety requirements around certain classes of crucial diagnostic devices.”
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Construction begins on new CDCs in Lincolnshire
Construction work is underway for two new NHS community diagnostic centres (CDCs) in Lincolnshire as part of a £38 million investment in services. The centres in Skegness and Lincoln represent a significant development in local NHS services, with the centre in Skegness believed to be the largest single NHS investment in the town in many years.
Julie Frake-Harris, Chief Operating Officer at ULHT, said: “The start of groundworks on the Skegness and Lincoln sites is a significant and exciting step forward in the delivery this programme for our patients. Working in collaboration with NHS Lincolnshire Integrated Care Board, we have involved patients and clinical teams at every stage of development to ensure we are creating an environment that is welcoming, modern and fit for purpose for the broad range of patient groups who will be able to use it.”
In Skegness, the CDC will have diagnostic facilities not previously
available in the area, including CT, MRI, echocardiograms and dental x-rays. Plans also include a chemotherapy service to reduce the amount of travel necessary for cancer patients.
The contract to build both CDCs has been awarded to MTX, a modern methods of construction specialist. Additional funding of £38 million has been provided by the Department of Health and Social Care to make the development possible. Both facilities will be run by United Lincolnshire Hospitals NHS Trust (ULHT). Skegness and Lincoln’s CDCs are expected to open to patients in autumn 2024.
ESCMID Global 2024 echoes multidisciplinary calls to action
Working towards a multidisciplinary approach to navigate the future of infectious diseases was a key theme at the 34th European Society of Clinical Microbiology and Infectious Diseases (ESCMID) Global 2024 congress. Key concerns such as climate change and antimicrobial resistance (AMR) were underscored, emphasising the need for collaborative efforts beyond traditional medical realms. Initiatives like Harmonise and the One Health approach were spotlighted for their potential in combating these complex issues, says GlobalData, a leading data and analytics company. Stephanie Kurdach, Infectious Disease Analyst at GlobalData, comments: “Some of the greatest challenges impacting infectious diseases include climate change and antimicrobial resistance. These are challenges that transcend the skills of scientists, researchers, and healthcare workers alone.” According to the World Health
Organization, climate change is one of the biggest threats to public health in the 21st Century. The direct effects of
JUNE 2024
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climate change include increasing global temperatures and extreme weather events, but the long-term impacts include food and water shortages, as well as the exacerbation and emergence of infectious diseases. Kurdach concludes: “In addition to multidisciplinary calls for action to navigate climate change and AMR, collaboration to advance and implement new technologies is also critical. ESCMID Global 2024 featured over 70 presentations which discussed the use of technologies such as artificial intelligence (AI), machine learning and robotics for the prevention, control and management of infectious diseases.”
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