ODEP for Procurement
ODEP supports the idea that procurement staff should be purchasing quality implants for their hospitals. The surgeons within ODEP would also like to stress that once surgeons have got used to getting good results with a particular implant they are are unlikely to want to change and risk patients suffering from a "learning curve" with an implant with which they, the surgeons, are unaccustomed.
It has also 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 or 10A(*) rating, implying that 10A 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(*) 13A(*) and 15A* ratings.
Some important points:
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(*), 13A(*) or even 15A(*) 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. B rated implants would include specially designed implants for replacements, such as in DDH or where a developer is introducing a novel device extremely cautiously and not generating cohorts of patients big enough to command an A or A* rating
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).
"A" ratings are awarded where there are smaller cohort past the benchmark than for a * rating and therefore the confidence intervals are wider
Pre-entry is not a benchmark it is simply an acknowledgement that the manufacturer has entered their product into the system.
Pre-Entry A* is classified as a benchmark for procurement purposes as it is being very closely monitored by the Beyond Compliance system.
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, rather opposite.