The History Behind The Initiative
In the early 1960’s Sir John Charnley, a pioneer of modern joint replacement surgery advised that a register of outcomes of all total hip replacements carried out in the United Kingdom should be established, so that performance of surgeons and implants alike could be assessed. Since those days several initiatives have been put in place around the world to try to ensure that the best outcomes are achieved. Despite this, over the past few years we have seen the recall of more than one popular joint replacement implant because of the significant incidence of associated device-related adverse events. A careful analysis of the reasons behind these failures, carried out by a taskforce assembled by The Healthcare and Medical Products Regulatory (MHRA) was undertaken. The main conclusion was that such events had been triggered by large volume usage of certain brands during the initial phase of product launch and before sufficient data had been generated to ensure that these products were fit for widespread use. This finding has resulted in the formation of a “Beyond Compliance” service. This comprises of a specialist team who will monitor performance of products within the service, paying special attention to the early results, until such time that sufficient data has been obtained and successful results evidenced. On reaching this point, existing initiatives such as the National Joint Registry and Orthopaedic Data Evaluation Panel (ODEP) continue to monitor brand performance on an ongoing basis.
The CE mark is “Compliance”. We are suggesting that companies go “Beyond Compliance”, entering a more stringent process before a product is made widely available.
Before any new brand of hip or knee may be freely marketed, the manufacturer must submit a technical file to a notified body for examination. If the data in this file is acceptable, then the manufacturer can affix a CE mark. It can then be freely marketed throughout the European Union. Joint replacement products are classified as class III devices (the highest risk level) and therefore as a consequence all technical files must contain three sections
1. A design file summarising all of the design history and testing data
2. An evaluation of the clinical data. This may be generated from the results of a clinical investigation or a literature review of another product which is already on the market and is substantially the same or “equivalent” to the device in question
3. A plan for post marketing surveillance (PMS) of the device
Due to the iterative nature of the development of hip and knee implants, the MHRA taskforce established that many recently launched devices have been CE marked based on standard laboratory performance testing against harmonised standards and a claim of substantial equivalence to an existing product. In some cases, the evidence for the claim of equivalence did not always appear to have been strong. Consequently, the safety and risks of such devices were ill-defined at the time that they were made available for general use, with little or no clinical data on the actual device.
In many cases, post-market surveillance is therefore the only tool for early identification of devices causing concern and is therefore of prime importance to continuing patient safety. The UK is in a unique position to collect, analyse and assess data from this phase of joint replacement use, with five existing mechanisms for collecting and analysing post-market surveillance information about joint replacement implants, these being:
- The England and Wales National Joint Registry (NJR) – the largest such registry in the world;
- The Orthopaedic Data Evaluation Panel (ODEP) – reviews submitted clinical data against NICE guidance for hip implants;
- National Patient Reported Outcome Measures Survey (PROMs) – collects baseline and six month post-operative patient outcomes.
- Joint replacement specific PROMS studies which are carried out by The NJR.
- Hospital Episode Statistics (HES) – providing admission and treatment data for all NHS patients in England. A similar system (PEDW) is used in Wales