A ground-breaking, mandatory national medical device outcome registry has been launched to collate detailed information on all procedures involving high-risk (Class III/IIb) devices, including pacemakers, hip joint replacements and breast implants.
Led by NHS England’s Outcomes and Registries programme, and developed in partnership with NEC Software Solutions (NEC), the Medical Device Outcome Registry platform (MDOR) will capture data on over two million medical device procedures and more than 10 million unique devices used on patients each year across the NHS and independent healthcare sector, addressing recommendations from the Cumberlege review and Patterson inquiry.
Collecting key details of the procedure, the clinicians involved and devices used, the registry will include clinical observational and patient outcome data, providing a single, comprehensive repository to improve patient safety and outcomes.
Scott Pryde, delivery director for the Outcomes and Registries Programme, NHS England, said: “The Outcomes and Registries programme is the first of its kind internationally to focus healthcare, policy, digital and data requirements, system-wide, on improving patient assurance, safety and outcomes.
“Millions of people receive high-risk medical devices and implants every year. Whereas most procedures are a complete success, when things go wrong it can result in serious harm for the patients affected. The Medical Device Outcome Registry will be responsive to concerns about the safety and outcomes of patients who receive high-risk medical devices, such as implants, and will use the data to actively detect, predict and prevent patient harm, and improve outcomes for patients.
“The result will be in a step change in improving patient safety in these procedures, providing clinicians and healthcare teams with secure access to critical information they can use to inform clinical decisions and improve the experience of patients before, during and after their procedures.”
MDOR integrates experience from exemplar device registries such as the National Joint Registry (NJR), National Vascular Registry (NVR), and has been developed using the NEC Software Solutions’ (NEC) registry platform. Information collated by the registry will provide healthcare professionals, patients, regulators and device manufacturers with insight into clinical practice and implant performance. The programme will provide patients with assurance that implants are closely monitored and will ensure care providers have an effective mechanism to quickly notify patients should any safety issues arise.
Key features such as native barcode scanning of the unique device identifier enable individual devices to be tracked to the relevant electronic patient record. Clinicians can access and validate the accuracy of key procedure details, when and where the procedure took place and the details of the clinician who carried out the operation. MDOR also supports digital patient-reported outcome measures (PROMs), enabling feedback on the outcomes of a procedure to be collected directly from patients themselves.
Richard Armstrong, head of registries at NEC Software Solutions, said: “Our partnership with NHS England has paved the way for a first of its kind national registry. MDOR will quickly become a critical information resource for clinicians, healthcare providers, regulators and device manufacturers to provide assurance on patient safety and inform clinical best practice.”
MDOR is focused on hospital providers in England, but the programme will integrate with similar initiatives across the UK and is already working to enable nation-wide data sharing and collaboration.
The technology behind the registry is modelled on a number of medical registries developed by NEC, including the National Joint Registry (NJR). NJR has been running successfully for 20 years and, with over 3 million records, is the largest registry of its kind in the world. A phased roll-out of MDOR is planned in selected hospitals and is due to be complete by spring 2024.
For more information, contact the NHS England Outcomes and Registries Programme at england.outcomeregistries@nhs.net
