It is hoped that in this section will be helpful to manufacturers understanding of ODEP, what we wish to achieve and what we need from them to make it happen. The section is organised under the following headings
• The rules about moving through the benchmarks
• The Process
• What is an acceptable modification whilst allowing a benchmark to be maintained
• Data sources
ODEP expect to be completely transparent in their dealings with manufacturers and expects manufacturers to accord ODEP with the same philosophy. It is essential that ODEP submissions are comprehensive and careful attention has been paid to the section concerning reports that might show inferior results, to the data that forms the basis of the submission.
Moving through the benchmarks
Although NICE never stipulated that an implant should move from a 3 to a 10 or a 15 year rating, ODEP decided the system would fail patients if manufacturers did not regularly submit data to support the continued use of their product at each of the time points.
ODEP have always realised that early data is less reliable in terms of predicting long term success of product than more mature data from a longer study. ODEP also profess that by having benchmarks at time points between 3 and 15 years means that manufacturers will keep a careful watch on their product’s performance.
Thus, the system has evolved, with manufacturers notifying ODEP at the time of the implant being introduced into the market for a pre-entry rating and then with time and with success of the implant achieving the 15A* (Hips and Knees) or 10A (Shoulders) rating.
(Pre-entry A* is awarded to a product which is going through the Beyond Compliance process).
ODEP does not expect an implant to “rest” and not continue to move through the benchmarks at the allocated time periods. If the implant does not continue to move up through the ratings it could be withdrawn. ODEP realise that data collection is time consuming and ODEP does understand that companies can face difficulties in obtaining data to deadline. We know that there is often a delay between the request and the delivery of data from some registries. Thus, a year of grace is available for manufacturers to obtain the necessary data for their next submission. ODEP will inform manufacturers when they are expected to submit and if after the appropriate reminders, the company does not submit their product will be de-registered and on the website the product will be noted as "lapsed". Manufacturers, whose product has been rejected or where the rating has lapsed are invited to make a comment on the website if they wish. The product may have been withdrawn and that will also be recorded against its listing on the website
With the maturity of registries ODEP may well make benchmarks, past the 15 year timepoint, available. Basically, these will keep pace with the data available in most of the national joint registries.
After an implant has achieved the highest benchmark, the manufacturer is expected to refresh their data every three years thereafter, to ensure good vigilance and surveillance of performance through data analysis. Regular reminders are issued to companies when their implants are approaching these gateways.
It is strongly recommended that manufacturers take note of all the sections of this website relating to benchmarks and what is required to complete a submission. The submission form and the "grid" showing the standards required for each benchmark will be pivotal planning an application.
The time lines for each round of ODEP are published under the section "Submit a Product", They include:
• the deadline for submissions,
• the data of the meeting,
• the date by which the manufacturers will receive the outcome of their submission,
• the deadline for appeals,
• the date of the appeals meeting
• the date when all results are released and the session has been closed
There is no restriction on making submissions in good time except availability of contemporary data. (ODEP expects registry data to be the most up to date from registries; this will usually be data since the registries last annual report).
Manufacturers are welcome to contact ODEP to discuss any difficulties they are having in completing the submission form. They are reminded that if they have a contract with NJR they are entitled to have free advice from NEC Software Solutions UK.
Manufacturers are expected to appeal to ODEP if they think ODEP has not judged them fairly or where the submission has been accepted but with caveat(s).
ODEP's consider Appeals very carefully. However, the decision at these Appeals meetings are almost always final. This means that further contact about that implant should be for the next meeting for that particular type of implant.
What will ODEP accept as a modification?
Or… Will ODEP allow a manufacturer to keep a product’s present benchmark when they want to modify the device?
It has always been ODEP’s view that if:-
• the implant is made of a new material,
• the working surface (the surface that is in contact with the patient’s skeleton) has been changed,
• the shape has been changed,
it will be usually be regarded as a new device and will have to start the ODEP process from the beginning, the pre-entry stage.
It has often been argued that there is no such thing as a “minor modification”. There have been instances of “minor modifications leading to major changes in performance, often for the worse”. These facts do colour our view about "minor modifications".
Manufacturers are well advised to let ODEP know of any “modification” they wish to make to one of their devices and it is much better that ODEP is informed rather than ODEP finding out.
Some modifications are acceptable and acceptance is allowed on an implant by implant basis after exhaustive discussion. Often this involves taking advice from expert bioengineers or other experts.
Field Safety notices (FSN)
ODEP expects to be informed by Manufacturers if their implant has been the subject of a FSN.
Camouflage is a word that entered Registry parlance when the problems with stemmed metal on metal hip replacements were finally identified as being dangerous. At that time registries categorized hip replacements as being either cemented, uncemented or hybrid. Hybrid is where one part of the joint was cemented and the other was not. The overall results for hybrid uncemented or cemented stems with uncemented cups was good. Most of these incorporated a metal head on a HDP bearing within a metal acetabular shell. At that time, all bearing surfaces came under the 3 types of hip replacement. The numbers were very large and when metal on metal bearings came in their poor results were camouflaged by the excellent results of the other bearing combinations.
Since then there have been other examples of camouflage or an implant being in the shadow of a large number of well performing ones. If a very effective knee replacement, which has been used very successfully thousands of times had one of its attributes altered there would be a risk of this attribute being unnoticed in a registry that was only looking at brands. The small number of the brand with this new part to it could fail repeatedly before the numbers were sufficient to alter the revision rate or PTIR (Patient Time Incident Rate) and come to the notice of the manufacturer or registry.
It was basically because of these issues with camouflage that the whole architecture of the NJR was redesigned in co-operation with the German Registry (EPRD). The NJR / EPRD database is now very much more granular and therefore more able to detect and investigate camouflage.
Thus, it is important that manufacturers declare all the product codes and their descriptors in an ODEP submission as increasingly ODEP are looking at product codes rather than just brands alone.
ODEP welcomes data from any source, where the data has been validated by one way or another. When ODEP started, there were few registries and most data came from peer reviewed, published studies. Increasingly manufacturers have made use of registry data, particularly where it is available through such electronic portals such as the NJR’s supplier feedback. Particularly for the early benchmarks such the 3 and 5 benchmarks ODEP welcomes more than one type of data.
Manufacturers are welcome to use data from Registries where the linkage between primary and revision procedures is secure. The data needs to be “cut” to the time point for which the submission is prepared. The International Society of Arthroplasty Registries (ISAR) have introduced standards for registries and ODEP takes careful note of the standing of a particular registry. ODEP is concerned about using data from a registry that does not account for patients moving from a hospital in one area to another hospital outside the catchment area of the registry involved. Our very strong preference only to use registry data where the linkage between primary and revision data is secure, preferably full proof.
Clinical Trials, RCTs, etc.
ODEP welcomes data from clinical trials. It is thought to be reliable and it is often good supporting evidence, particularly for early benchmarks, to be added to early registry data. When it all comes from the originator’s centre it needs added data from “other centres” to qualify for an A or A* rating.
Publications, Podium presentations and posters.
ODEP expects any publications, podium presentations and posters to only be submitted when they have been previously peer reviewed.
“In house data”
Some manufacturers have first class in house data collecting systems. Unfortunately they are not subjected to external validation and it is thought possible for patients to escape from their follow up process. However, as one of the driving forces behind ODEP was to ensure that manufacturers should collect and review data about their implants, ODEP supports the use of this data but with some caveats.
• It is important for manufacturers to make sure they don’t use data more than once. For example, data that is submitted from a clinical trial cannot be extracted again from a poster or podium presentation or even a registry.
• That they can complete all the cells on the submission form
• That the data is available for review by ODEP if requested.