Introduction to ODEP
ODEP's origins mostly go back to the failure of a particular brand of hip replacement used in the UK in the nineties; the Capital Hip made by 3M. It was essentially a copy of the very popular and successful "Charnley Total Hip Arthroplasty" but there were several differences. Initially these changes were not thought to be important but it turned out that they compromised the implant's performance, quite dramatically. As a result of this, the government requested the National Institute of Healthcare and Clinical Excellence (NICE) to prepare guidelines and summary recommendations on the use of different brands of hip replacement. This original guidance, published in 2000 (The guidance for "surface Replacements" was added in 2003), stated that surgeons should only use devices which had published data demonstrating a minimum ninety percent survivorship at ten years. This original advice was subsequently modified to include newer products that were showing a level of performance consistent with this advice (failure rates of less than one percent per annum) but they were all to be part of a "Clinical Trial".
NICE charged PASA (the Purchasing and Supply Agency) with the responsibility of setting a system to implement their guidance and under the direction of Andy Smallwood, John Warrington and several others ODEP was created. It was decided that it should be chaired by an Orthopaedic Surgeon and Keith Tucker FRCS was appointed to take the role.
PASA was subsequently replaced by NHS Supply Chain and then DHL, who, in 2018, passed the management responsibility on to Supply Chain Coordination Limited (SCCL).
The key issue, at the start, was to design the form for manufacturers to complete to make their submission for a benchmark. This was achieved with the co-operation of ABHI who were represented by Mick Borroff PhD.
The first round of submissions took place in 2002 and how different things were then! There was little in the way of registry data and we had to rely on publications, podium presentations and the results of trials.
From its early days ODEP has consistently evolved. It was clear from the outset that only having the original 3A and 10A ratings was never going to be adequate to provide the level of monitoring that would be required to meet the ambition that the panel wished to achieve. Within a year or so the Pre-entry, 5 and 7 year benchmarks were also introduced. These time points were chosen on the basis of previously observed failure patterns. Also, it was established that ODEP would be a never ending monitoring "rolling" process. ODEP ratings start from when their implant has just acquired its CE mark at the "Pre-entry level" or Pre-entry A* if the implant is being monitored by the Beyond Compliance process. They then have to re submit again at 3, 5, 7, 10, 13 and 15 years.
ODEP's use of A*, A and B in its assessment, is a method of grading the evidence that a manufacturer submits about their product, and the number is the number of years of data that is available in support of the benchmark (see section on ODEP Benchmarks). It is important to note, however, that while with a 15A* implant may have more evidence for its lasting power than say a 3A implant, it may be that in 20 years the present 3A implant surpasses the 15A* product it its performance. ODEP therefore considers that restriction of product usage based solely upon ratings already achieved may be misleading and may deter innovation.
It was decided early on that once a manufacturer has submitted to ODEP and gained a benchmark, they would have to resubmit at every ODEP rating milestone with new and up to date data. They are given a year's "grace" at each anniversary to make the submission but if they fail to do so they lose their rating. To date more than 100 implants have left the ODEP process for one reason or another.
In 2014 NICE, on ODEP's advice, revised the original benchmarks. ODEP had noted that over its first 12 years or so, the revision rate for implants had steadily fallen. Most manufacturers were submitting revision rates at 10 years of less than 5%. It was clear that massive improvements had occurred in hip surgery (except when metal on metal implants had been used). Thus all the ODEP ratings were revised and we continue to observe national and international revision rates so as to upgrade our benchmarks on a semi-regular basis.
In 2015 the Netherlands Orthopaedic Association (NOV) benchmarking system began a process of amalgamating with ODEP. Two specialist orthopaedic surgeons from NOV attend each meeting of ODEP for Hips, Knees and Shoulders.
ODEP continues to welcome opportunities for developing working relationships with other countries who have a joint registry of sufficient quality.
Knees and Shoulders
Up until 2014 ODEP confined its attention only to Hip Replacement. NICE were not supportive of ODEP's wish to instigate ODEP for knees when they were first approached in the years following ODEP's introduction. This resulted in the British Association for Surgery of the Knee (BASK), with the backing of the BOA to ask ODEP to benchmark knees in 2012. Subsequently BESS (British Elbow and Shoulder Society) coming on board in 2017.
Under consideration is an ODEP system for ankle, patello-femoral joint and elbow replacements. ODEP for Spinal implants is under development.
The orthopaedic surgeons on the panel are all unpaid. They have their expenses covered. Their COI (Conflict of Interest) declarations are all on this website and they sign NDAs (Non disclosure agreements) as required.
ODEP is independent from all other agencies.
ODEP assesses implants purely on their effectiveness and safety. It does not take account of price.
Neither does ODEP rank implants or say that one is better than another (please refer to the section ODEP and procurement for further details)