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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, so it is now well established. ODEP for revision hips is under development but 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 and begin by completing the front sheet which includes prosthesis details, technical design features, design history and the requested benchmark before going on to the rest of it. 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). 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 note is made of the hospitals where the replacement is used. The section on product codes must be completed to include the products descriptor and ODEP need to be sure that all the product codes coming 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 when it will be filed until it is sent on to the panel about 10 days before the panel meets.
Both the hip panel and the knee panel meet bi-annually and the members who are attending the meeting will review each submission prior to their arrival at the meeting.
A senior Panel member will have been selected to chair the scrutinizing 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 will be 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. Provisionally accepted means that acceptance is anticipated but a small amount of data needs to be added or a minor clarification is required. These clarifications will be dealt with at the time of the appeal meeting.
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 provisional are invited to appeal within one week of receiving their notification and submit data to answer the queries set by the panel. Manufacturers whose submission has been rejected can also appeal within the notified time frame.
The Panel reconvenes 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.
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 issue.
After the appeals have been completed the output is added to the ODEP website. ODEP welcomes comments and feedback at all times either verbally or by e mail.
The panel at work - December 2014