NJR Statement on the publication of The Cumberlege Report
The National Joint Registry (NJR) welcomes the report recommendations from the Independent Medicines and Medical Devices Safety Review, chaired by Baroness Julia Cumberlege. The NJR also fully supports the development of a wider implant medical devices registry to ensure greater patient safety.
The NJR is the largest joint replacement register in the world - with over 3 million records. Set up in response to the Capital 3M hip device failure 2002, the NJR collects, analyses and disseminates data on hip, knee, elbow, shoulder and ankle joint replacement surgery. Orthopaedics is one of the main users of medical device implants in the UK and the NJR is at the forefront of implant safety assessment and was recently cited as a ‘global exemplar’ of a medical devices register in UK Parliament, by the Under Secretary of State for Health and Social Care, Jo Churchill MP.
The NJR believes that the only way to safely introduce and monitor outcomes is to use clinical, scientific and professional expertise and has worked hard to achieve this effective way of working. Low-level general registers of implants do not work to this quality standard and are misleading as they do not detect failure or harm to patients. The critical feature of the NJR approach is to have appropriately knowledgeable and robust clinical input to scrutinise and analyse the relevant data in a timely and regular fashion. It is not enough just to register a device that has been used in patients; the progress and performance of the device must be monitored over time. The NJR monitors surgical outcomes for hospitals as well as the performance of individual surgeons who oversee the procedures; sharing results back through individual and hospital level reports incorporated into the surgeon clinical appraisal system; and implant outcome results also shared on a regular basis with medical device manufacturers. During the life of the NJR, the mortality following major joint replacement in the country has reduced by 50% and the rate of revision of hip and knee replacements has diminished significantly over the past decade.
The NJR was able to issue national patient guidance on metal on metal joint replacement, through the insight and understanding gained by monitoring performance of these implants. Working closely together with the British Orthopaedic Association, British Hip Society and Medical and Healthcare products Regulatory Agency, an early warning of failure was raised after analysing the detail of all registry and other results. The NJR was subsequently able to provide hospitals with the necessary information to support the tracking and recall of affected patients for immediate follow-up consultation.
The NJR supports and facilitates other key national programmes that drive quality improvement in orthopaedics through the contribution of registry data and outputs about patient outcomes. Examples include:
- The Orthopaedic Data Evaluation Panel (ODEP): Assesses whether individual implants have reached a satisfactory benchmark, making us the only country in the world to have set standards on the outcomes of joint replacement in this way. This process has helped guide the purchasing and use of effective and safe implants in the UK. The output of ODEP is now used internationally http://www.odep.org.uk/.
- Beyond Compliance (BC) The development of a unique partnership between the profession, regulators, industry and the lay public, which over the last seven years has ensured the enhancement of the safe introduction and usage of implants, protecting patients and supporting innovation in implant development. BC is an initiative that is potentially scalable to all branches of healthcare.
- Getting It Right First Time (GIRFT): An NHS Improvement clinically led programme, which brings together clinical, performance and financial data, for hospitals to see the relationship between outcomes and costs.
Laurel Powers-Freeling, NJR Chairman said, “As Chairman of the National Joint Registry Steering Committee, I was very pleased to appear before the Cumberlege panel, along with my colleagues Matthew Porteous and Elaine Young, to share the experience and positive impact on patient outcomes that the NJR has been able to achieve since our inception in 2002.
We at the NJR profoundly believe that gathering, analysing, publishing and—perhaps most importantly—acting upon high quality data is critical to delivering good patient outcomes, managing costs and ensuring well-informed progress for the implant industry. We believe the Cumberlege Inquiry will highlight the importance of this approach and the benefits it can confer to a wide range of procedures beyond orthopaedic implants.”