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ODEP for Procurement

 

It has been brought to the attention of ODEP that a number of regulatory and purchasing agencies are discouraging surgeons from using products that have not received a 10A(*) rating, implying that 10A(*) rated products perform better than other products.

 

This was never the intention of ODEP and is a misunderstanding and a misrepresentation of the philosophy of the system. Products with ratings at 3A(*), 5A(*), and 7A(*) are tracking to have outcomes in-line with a 10A(*) and 13A(*) rating§

 

Some implants, with fewer years of data (3, 5 & 7 year data) may actually be tracking to have better outcome results than some existing 10A(*) and 13A(*) rated products. Indeed, this may also be true of some products achieving a B rating. B ratings are usually assigned to boutique implants, where usage of these products has not normally been in large enough cohorts to command an A or and A* rating. They would include specially designed implants for replacements in DDH and where a developer is introducing a novel device extremely cautiously.

 

It must be noted that B ratings are awarded after the same rigour as being applied to an A* rating cohort (except for the size of cohort and the number of surgeons and centres).

 

One of the most important precepts that was embraced when ODEP was introduced and promoted by NICE that any benchmarking system used in the UK should not be designed to restrict the use of implants with less than 10 years of data – instead, the performance of all implants should be scrutinised at proscribed time points. ODEP is not designed to deter innovation, but rather opposite.

 

Understanding ODEP Ratings



 


§ ODEP is constantly evolving in line with the new technologies and availability of data from various arthroplasty registries. In March 2018 we introduced the new 13-year ratings (13B, 13A and 13A*). In 2020 it is likely there will be 15 year ratings.


It must be remembered that all ODEP benchmarked products used in the UK have a CE mark. Therefore, all organisations must abide by the rules and obligations which were established by the EU commission and any divergence from the rules invested in the CE mark will be illegal.


Should any procurement officer or any other person wish to discuss these policies with ODEP, they are welcome to contact us.

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