The Process in a nutshell – from Submission to Publication
The ODEP Process
The ODEP process has evolved and been refined since 2002 for Hips, with a similar approach used for Knees since 2014 and Shoulders since 2017. ODEP for Spinal implants, Ankle replacements, patello-femoral joints, elbow replacements and revision hips is under development. The aim is that the process should essentially be the same.
Manufacturers who want to have ODEP benchmarks download the submission form from the ODEP website (from 2021 submissions will only be made "on line") and begin by completing the front sheet which includes prosthesis details, technical design features, design history and the requested benchmark. There is also a section about disclosure of poor results and FSNs (Field Safety Notices). For the second sheet they will need data from registries, peer reviewed papers, podium presentations or posters. Sometimes in-house data is acceptable (please see data sources under ODEP explained to manufacturers). They will have to state the number of surgeons using the implant and the number of centres where it is being used. A lot of detail is required about the cohort they are submitting. Manufacturers should use separate forms for each data submission.
It is very important that all the cells (questions) are completed. It is also important that the hospitals where the implant is in use are stated. The section on product codes must be completed to include the product descriptor and ODEP needs to be sure that all the product codes listed under a particular brand name have the same pedigree and were all introduced at the same time. There is ample space in the comments section for manufacturers to explain, comment etc.
The submission should then be sent electronically to ODEP where it will be filed until it is sent on to the Panel about 10 days before the panel meets.
The hip knee and shoulder Panels meet bi-annually and the members who are attending the meeting will review each submission prior to their arrival at the meeting.
If anyone of the Panel has a conflict of interest with any of the submissions they will always declare it and sit out the discussion for that implant
A senior Panel member will have been selected to chair the scrutinising of each submission. They will lead the discussion and all members will contribute to the decision as to whether a benchmark is awarded to an implant or not. A contemporary log is kept of the decisions and comments that have been made about each product. The submissions will be recorded as being marked as “Accepted”, “Provisionally accepted” or Rejected.
Shortly after the secretary will forward the log for members to check. Once this has been done the decisions are forwarded to the manufacturer for each product.
Manufacturers whose products have been marked "Provisionally accepted" are invited to appeal within one week of receiving their notification and submit data to answer the queries raised by the panel. Manufacturers whose submission has been rejected can also appeal within the notified time frame.
The Panel reconvenes for the appeals meeting, usually using teleconference facilities between 3-4 weeks following the original meeting. All the appeals are carefully discussed and the manufacturers informed of the decisions after the output has been re-checked a day or so later.
It is ODEP's policy not to encourage another appeal after a failed appeal.
All its output is ratified by SCCL for indemnity purposes prior to it being sent to the manufacturer.
When it comes to the next benchmark against which the product needs to be judged, ODEP will remind the manufacturer in good time that a new submission is due.
Where it is thought necessary the chairman or one of the Panel members will speak to the manufacturer about any outstanding issues.
After the appeals have been completed the output is added to the ODEP website. ODEP welcomes comments and feedback throughout the process, either verbally or by email.
Finally, all the data related to that particular meeting is archived.