ODEP for Surgeons
Most surgeons will have heard of ODEP by now but of course there will always be surgeons new to ODEP.
Before we had ODEP, manufacturers had no obligation to look at their data. Whether you love us or hate us we have made the manufacturers take responsibility and being transparent about the performance of the implants they sell. We hope you consider this a laudable pursuit!
ODEP is not something that stands still and doubtless the data you are now reading will be refreshed within a couple of years if not before.
We were established in 2002 with hips and now we have knees and shoulders. Spinal implants, ankles and elbows are in the pipeline. We will always evolve and our evolution will be partly driven by the availability of long term data. The latest addition to the ratings is the 15 year benchmarks, (Knees autumn 2020 and hips spring 2021).
ODEP for revision hip prostheses is being worked up.
What it means for you
It should be remembered that at present if you are not using a 10A / 13A / 15A (or A*) prostheses it is deemed as being part of an ongoing clinical trial (NICE 2002). In the view of many of the members of ODEP this is a bit far-fetched and anyhow ODEP is a service evaluation and not a clinical trial. However, the point must be made that the performance of an implant where there is less than 10 years data must be tracked and therefore we all have a responsibility for making sure that our data is always uploaded in the NJR etc.
If you are using a product that is not registered with ODEP at all or has only Pre-entry status it will not be a positive count on your own ODEP rated usage. You will remember that your percentage use of ODEP rated products counts on your annual (personal) NJR profile. This is also part of the GIRFT project.
THERE ARE SOME NON ODEP RATED PRODUCTS USED IN THE UK
Beyond Compliance implants
When an implant is going through “Beyond Compliance” ("BC") it is awarded a Pre-entry A* rating. This is an ODEP rating and counts as a positive on a surgeons “use of ODEP rated products profile”. These products are being watched very closely and patients and surgeons should have the satisfaction of knowing this is the case. If you are one of these surgeons you will have signed up to the obligations that come with being a BC surgeon (see below), which include reporting back any problems and attending user group meetings when possible.
It is important that surgeons using BC implants know that they have taken on the responsibility of helping to introduce a new implant. Obviously they will only switch to a new implant if they feel it is better than a device they have been using previously.
• They must be registered as having been trained in the use of this implant by the champion surgeon / manufacturer.
• They must be fully understanding of the BC ethos and what it hopes to achieve.
• They must make sure all their patients have signed the BC consent form and informed BC that this is the case (most commonly via an automated pop-up box on the NJR data entry system).
SURGEONS NOT OBTAINING CONSENT DEGRADES THE BC PROCESS AND THEY WILL HAVE TO TAKE RESPONSIBILITY FOR LATE DETECTION OF FAILURE
ODEP benchmarks implants at product code level. This is to prevent “Camouflage” and manufacturers adding new lines (variants) of implants to a brand name with a well established ODEP rating. For example, if you use a "new" tray for a knee replacement inside one of the major brands you might find that your own rating will be reported as say, 3A rather than the 10A you were expecting. The ODEP rating for a knee replacement is the ODEP rating for the most recently introduced "improved" part of the construct. Thus if the femoral component is 13A* and the tibial tray is 3A the rating of this version of the brand is 3A.