ODEP for Surgeons
Most surgeons have heard of ODEP but of course there will always be new surgeons coming along. 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 for the performance of the implants they sell.
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 ODEP for shoulders is starting as we write. The latest addition is the 13 year benchmarks, which were phased in during 2018, and ODEP for revision Hip prostheses and certain types of Shoulders will probably be next.
What it means for you
It should be remembered that at present that if you are not using a 10A / 13A prostheses the prostheses is deemed as being part of an ongoing clinical trial (NICE2002). This is a bit far-fetched and anyhow ODEP is a service evaluation and not a trial but the point must be made that the performance of an implant where there is less than 10 years data must be tracked.
YOU HAVE A RESPONSIBILITY TO FACILITATE DATA COLLECTION
Thus if a product you are using does not carry a 10A* (or above) rating the manufacturer will be tracking it through a registry (NJR) and maybe through an in house trial.
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 rating. You will remember that your percentage use of ODEP rated products counts on your annual (personal) NJR profile. This is part of the GIRFT project
THERE ARE 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.
THERE ARE ADDED RESPONSIBILITIES FOR SURGEONS USING BC PRODUCTS
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 the device they have been using.
- 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
- Make sure all patients have signed the BC consent form and informed Northgate Public Services that it has been done
IF SURGEONS DO NOT OBTAIN CONSENT LESSENS THE PROCESS AND WILL HAVE TO TAKE RESPONSIBILITY FOR LATE DETECTION OF FAILURE
ODEP are benchmarking implants at product code level. This is to prevent “Camouflage” and manufacturers adding new lines (variants) of implants to a brand name. Camouflage might allow a new implant to inadvertently have a higher ODEP rating than it deserves.
A SURGEON MAY FIND THAT USING A MODIFICATION WITHIN A BRAND THEIR ODEP PROFILE CHANGES
For further information please consult the rest of our website www.odep.org.uk