The Global Medical Device Nomenclature (GMDN) Agency alongside several partners including Guy’s and St Thomas’ NHS Foundation Trust have announced a funding award from Innovate UK, part of UK Research and Innovation, to research improvements in capturing post-market medical device intelligence to improve patient safety within the UK.
The partners have been funded as part of a six-month discovery phase on a project called, transforming post-market intelligence to safely accelerate medical device innovation and adoption.
The project lead is Dr Emmanuel Akinluyi. He is a Deputy Chief Medical Officer and the Chief Biomedical Engineer at Guy’s & St Thomas’ NHS Foundation Trust. He is also a Consultant Clinical Scientist holding doctorates in Healthcare System Design and is the Head of Methodology & Deputy Director of an NIHR HealthTech Research Centre. As principal investigator, he will lead the Network, particularly its NHS-facing engagement.
“Medical devices impact every aspect of the public’s interaction with the NHS, for prevention, screening, diagnosis, monitoring, and treating of diseases. The safety and effectiveness of these devices is critical to the quality of health outcomes. Traditionally, the great majority of medical device testing is done before they are used on patients (“pre-market”). Manufacturers are required to monitor their devices in clinical use (“post-market”), but in practice this is mainly limited to voluntary reporting and feedback from users,” said project lead, Dr Emmanuel Akinluyi, from Guy’s & St Thomas’ NHS Foundation Trust.
“We refer to this ongoing information about medical devices in clinical use as “post-market intelligence” The way we approach post market intelligence, has barely changed in decades. However, recent technological innovations mean that post-market intelligence could be transformed.
“These innovations include sophisticated medical device software, connected devices, innovative sensors, and growing hospital medical device databases, which are often managed by trained healthcare scientist staff. We believe that new opportunities can be created by connecting these new and enhanced sources of data about device safety and performance.”
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The project partners are King’s College London, GS1 UK, UCL, the GMDN Agency, Radar Healthcare, Panoramic Digital Health and Guy’s and St Thomas’ NHS Foundation Trust.
John Wilkinson OBE, Chairman of the Board of Trustees at the Global Medical Device Nomenclature Agency, and former Director of devices at MHRA, said: “There is an opportunity for post-market-intelligence to provide much earlier warnings about devices that are not operating as they should, are difficult to use, unreliable, or seem to function poorly in sub-groups of patients.
“This data could be used by hospitals to better manage their services to patients and have greater confidence in deploying innovative devices in their services. Manufacturers could use data to rapidly detect and address any identified issues with their devices. Regulators could provide pathways that enable innovative devices to get to patients more quickly, by changing the balance of pre-market and post-market safety and performance evaluation.
“Our network of organisations will come together to explore this opportunity including how to incentivise adoption of this enhanced post-market vigilance by manufacturers and the NHS. Our network includes medical device manufacturers, companies and universities that specialise in developing standards and tools to connect organisations. It also includes NHS staff who might manage the data that we believe can unlock improvements to the way medical devices are developed, delivered, and managed.”