Implant manufacturers are invited to submit data regarding their orthopaedic implant products 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.
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.