BOA statement on The Independent Medicines and Medical Devices Safety Review
The British Orthopaedic Association (BOA) welcomes this report from Baroness Cumberlege and the Independent Medicines and Medical Devices Safety review. This comprehensive review has demonstrated the impact on the physical and mental health of patients when implants fail. The review shows that there is a clear need for detailed surveillance of implants, and we welcome the recommendation for the establishment of more National Implant Registries.
The BOA supports the highest quality surveillance of implants and the need for registries to track the patients in whom they are used. Registries are important tools in monitoring and understanding the performance of all implants and they have been used in orthopaedic joint replacements since 2003. When established, they rely on complete data capture combined with clinical interpretation to set standards and review outcomes in order to detect failure and prevent harm to patients.
The UK already has a highly successful National Joint Registry (NJR) (www.njrcentre.org.uk) holding details of over 3 million joint replacements. Established in 2003, the NJR collects comprehensive details of hip and knee, shoulder elbow and ankle implants and analyses and disseminates data across England, Wales and Northern Ireland, with a separate system in Scotland. This is complemented by the Orthopaedic Device Evaluation Panel (ODEP) which assesses whether individual implants have reached a satisfactory benchmark and produces standards that are now used worldwide.
The ‘Beyond Compliance’ programme is another successful British innovation to ensure the safest introduction of new orthopaedic implants into clinical use. It supports safe innovation while maximising safety and protection for patients, by providing enhanced follow up and data collection as new implants are introduced. It is a partnership between the BOA, the regulators, industry, and the public that protects patients and supports innovation.
Alongside the NJR, Trauma and Orthopaedics has a strong track record in collection and use of data, with the National Hip Fracture Database (NHFD), Trauma Audit Research Network (TARN), the British Spine Registry and the Scottish Arthroplasty Project (SAP) already being well-established and further registries in development across the T&O field.
The BOA, together with our established partners, would welcome the opportunity to share knowledge and expertise to help develop a comprehensive system to ensure patient safety and follow up all healthcare implants.