ODEP and Hospitals
Nowadays most senior staff working in an Orthopaedic unit will have come across ODEP in one way or another. Not everyone will understand it completely and judging by our post box there are quite a few people who are misquoting us, sometimes quite understandably and sometimes not.
It must be always remembered that once a product has a CE mark, the manufacturer has the right to market it in all the EU states. Essentially this means that if anyone should stand in the manufacturer’s way is acting illegally. It can be also said that any organisation that sends out an edict which makes it difficult for the manufacturer to reach a market would also be acting illegally.
This is one of the reasons why ODEP does not make recommendations. We simply assess the quality of the submissions that a manufacturer makes in support of the ongoing use of their product.
As you will see from the rest of this website, we grade the strength of the submitted data with a letter and the length of time that the implant has been on the market by a number.
A low number does not mean that the implant is bad, it just means that there is not years and years of use / experience to back it up. Eventually a 3A prosthesis may be better than a 13A implant but it might also fall off the cliff at year 6 (for example).
Pre-entry and Pre-entry A*
Pre-entry alone is not a benchmark and the use of Pre-entry (alone) products will downrate a surgeon’s or hospital’s ODEP profile. On the other hand, Pre-entry A* is a benchmark. Pre-entry A* products are going through “Beyond Compliance” ("BC"). It is essential that any hospital using Pre-entry A* BC products fulfils all the responsibilities associated with Beyond Compliance products, particularly with respect to the BC consent form.
Where does NICE fit in to all this? Nice set up ODEP for Hips. They recommended a 10 and a 3 Year benchmark with a failure rate of <10% at 10 years and < 3% at 3 years. ODEP have fine tuned the guidance. More recently NICE were encouraged to raise the bar by saying that at 10 years there should be a revision rate of <5%.
From the beginning NICE stated that any product that does not have a 10A benchmark should be part of an ongoing surveillance programme.
THIS IS WHAT ODEP IS… AN ONGOING SURVEILLANCE PROGRAMME
NICE originally called this a clinical trial but that is an inaccurate description of what ODEP sets out to achieve. ODEP is essentially a service evaluation. ODEP is arguably the first monitoring system that requires data to be refreshed at regular time intervals. Implants being followed by ODEP are all being watched. However, it must be pointed out that:-
- NICE were never involved with ODEP for Knees or Shoulders. ODEP for Knees and Shoulders has come about because surgeons and manufacturers wanted it.
- NICE asked ODEP to implement their guidance as best as they could.
It is important to realise that ODEP benchmarks on a product code basis.
Thus all hospitals are of course most welcome to take note of ODEP ratings in their procurement but it is clearly important to realise their limitations.