ODEP Rating System
ODEP is the Orthopaedic Data Evaluation Panel, an independent panel of clinical and non-clinical experts with experience of the orthopaedic industry. The Panel was set up in 2002 by NHS Purchasing and Supply Agency in response to the National Institute for Health and Care Excellence (NICE) issuing guidance in April 200 relating to total hip replacement and resurfacing arthroplasty for end stage arthritis of the hip.
ODEP provides objective, systematic ratings of the strength of evidence supporting the performance of an orthopaedic implant. The evidence is provided by the implant manufacturer and assessed by ODEP against a set of benchmarks. ODEP does not to make recommendations about the use of one implant in preference to another but assesses the quality of evidence a manufacturer provides and determines if it reaches the relevant performance benchmarks.
Following the award of a CE / UKCA mark, the manufacturer of an orthopaedic implant is able to apply for a “Pre-entry level” ODEP rating. At agreed future time-points, based on previously observed implant failure patterns, the manufacturer then has to submit their evidence data at 3, 5, 7, 10, 13 and 15 years in order to achieve and then retain their ODEP Rating.
Originally created for hip implants, ODEP continues to evolve, and has since developed benchmarks for Knee replacements in 2014 and Shoulder replacements in 2017.
Implant manufacturers are invited to submit data regarding their orthopaedic implant products to ODEP in a defined format (an ODEP submission form). The Panel reviews this submission and rates the strength of the evidence presented by the manufacturer, resulting in the award (or not) of an ODEP rating.
Benchmarking starts before an implant is used in significant numbers. This is called the Pre-Entry stage. Full benchmarking starts at year 3 and manufacturers have to continue submitting data on a regular basis to achieve the higher benchmarks, as described below.
A lower ODEP rating number does not necessarily indicate that an implant is not as good as an implant with a higher number. Rather, it means that there is not the number of years of use / evidence at that point in time to support a higher value.
Similarly, the letters “B”, “A” and “A*” refer to the strength of evidence provided by the manufacturer – with registry data typically carrying more weight than a peer reviewed publication, which in turn would carry more weight than an in-house manufacturer-initiated study.
Implants are expected to progress through the rating benchmarks from pre-entry through 3, 5, 7, 10, 13 and 15, as data becomes available. Failure to follow this progression within a defined timescale will result in removal of a product’s ODEP rating.
ODEP reviews implant data at the product code (catalogue number) level. This is to prevent “camouflage” where variants of implants can exist within a well-established brand name. For example, a “new” tray for a knee replacement may be introduced within a well-established brand name but might be reported as (for example) 3A rather than (for example) 10A of the more established implants within the brand.
The table below summarises the various elements involved in a single ODEP rating.
What Products are ODEP rated?
ODEP provides ratings for:
- Hip Replacements including surface replacements. Femoral components and acetabular components are rated separately. (Please see Hips under the section on methodology for more information)
- Knee replacement implants including Total Knee replacements (TKRs) and uni-condylar knee replacements (please refer to the knee section in methodology for more detailed information)
- Shoulder replacements including “Reversed”, anatomic, resurfacing, glenoid replacements and trauma implants.
In the case of knees and shoulders, ODEP ratings apply to constructs rather than by individual components. A construct represents a unique combination of products (or catalogue numbers). Thus, ODEP may provide one rating for a Total Knee Replacement in which the patella is resurfaced and a different one where it is not. Ratings may be different to reflect the variety of surface coatings for a hip system within the same “brand”, or the different treatments applied to the polyethylene used in a tibial insert.
The ODEP rating for a knee replacement is the rating for the most recently introduced part of the construct. Thus, if the femoral component is 13A* and the tibial tray is 3A the rating of this construct is 3A. Some brands have over 40 separate ODEP ratings ranging from Pre-Entry to 15A*.
ODEP and Beyond compliance are developing systems for benchmarking spinal implants and the introduction of new devices.
For ODEP for spinal implants the basic ODEP philosophy will remain the same which means that manufacturers of spinal devices will have to collect data to be validated independently for their implant to have an ODEP rating
The ODEP method has been specifically designed to maximise patient safety whilst recognising the need to support innovation. ODEP has two special categories for devices that have had insufficient use in the UK to support 3 years of evidence. The first is “Pre-entry”. This is not a benchmark rating. Rather, it is where the manufacturer has obtained their UKCA/CE mark and has registered the implant with ODEP (in the expectation of applying for a benchmark rating at a future date). The second category is “Pre-entry A*”. This is a benchmark rating that indicates that the device has achieved its UKCA/CE mark and is also going through the Beyond Compliance* process.
This approach aims to help hospitals provide safe and effective care whilst also providing a means of continuous improvement.
*Beyond Compliance is a voluntary service evaluation programme manufacturers can elect to enter for their new or modified orthopaedic implant, which closely monitors its performance during the early years of use, where data alone may provide insufficient evidence of safe use and closer engagement with implanting surgeons is also required.