ODEP for Patients
1. Discussing ODEP rating with your surgeon
2. Why are ODEP ratings important?
3. What is ODEP?
4. How do ODEP Ratings work?
5. What Products are ODEP Rated?
ODEP ratings provide a simple, independently verified assessment as to the performance of an implant. ODEP benchmarks implants against agreed standards. These standards are demanding, allowing clinicians to ensure that the implants they use are being monitored and comply with national guidelines.
ODEP is the Orthopaedic Data Evaluation Panel. It is an independent panel of experts comprised mainly of leading UK surgeons, but also non-clinical experts with deep experience of the orthopaedic industry.
The Panel was set up in 2002 by National Health Service Purchasing and Supply Agency as a response to National Institute for Health and Care Excellence (NICE) issuing guidance relating to Total hip replacement and resurfacing arthroplasty for end stage arthritis of the hip, first published in April 2000.
Since then ODEP has developed benchmarks for Knee replacements (2014) and Shoulder replacements (2017).
ODEP continues to evolve. At present the surgeon's expenses are paid by SCCL (Supply Chain Co-ordination Limited) who are also responsible for their indemnity. The day to day running of ODEP is in the hands of Northgate PS.
Implant manufacturers are invited to submit data regarding their orthopaedic implant products to ODEP in a defined format (an ODEP submission form). The Panel reviews this submission and rates the strength of the evidence presented by the manufacturer, resulting in the award (or not) of an ODEP rating.
Benchmarking starts before an implant is used in significant numbers. This is called the Pre-Entry stage. Full benchmarking starts at year 3 and manufacturers have to continue submitting data on a regular basis to achieve the higher benchmarks, as described below.
An ODEP Rating consists of a NUMBER and a LETTER, and a STAR (optional). It is demonstrated in the image above.
The number represents the number of years for which the product's performance has been evidenced.
15 - Fifteen years of evidence
13 - Thirteen years of evidence.
10 - Ten years of evidence - full compliance with NICE benchmark.
7 - Seven years of evidence - product is on-track to achieve the 10 year benchmark, but has not yet got sufficient data to evidence performance at 10 years.
5 - Five years of evidence - product is on-track to achieve the 10 year benchmark, but has not yet got sufficient data to evidence performance at 10 years.
3 - Three years of evidence - product is on-track to achieve the 10 year benchmark, but has not yet got sufficient data to evidence performance at 10 years.
The letter represents the strength of evidence (data) presented by the manufacturer.
A - Strong evidence - generally higher numbers of patients (giving greater confidence in the results presented), with all patients being subject to follow-up (their outcomes recorded).
B - Acceptable evidence - smaller numbers of patients than the A rating (giving less confidence in the results than A), but sufficient data to demonstrate compliance.
The star has been added to the rating system following revised guidelines from NICE in February 2014, in which a benchmark revision rate of less than 1 in 20 (5%) at 10 years was defined. The star is awarded where products have evidenced compliance with this benchmark. A* represents very strong evidence above A and B. Ratings without a star signify compliance to the prior NICE guidance of a replacement rate of less than 1 in 10 (10%) at 10 years.
Pre-entry – Products that are registered with ODEP for which there is insufficient data to evidence the three year entry benchmark have been listed as 'pre-entry', showing products currently undergoing clinical evaluation.
Pre-entry A* – Products which are registered with the National Joint Registry and are being evaluated through the Beyond Compliance initiative, a post market surveillance service supported by ODEP.
Pre-entry – Products not under Beyond Compliance, but which are registered with the National Joint Registry.
Implants are expected to progress through benchmarks from pre-entry through 3, 5, 7, 10, 13 and 15 year benchmarks as data becomes available. Failure to follow this progression within a defined timescale will result in removal of a product's ODEP rating.
It is important to note that ODEP rates evidence (data) presented to it by the implant manufacturer.
ODEP provides ratings for:
Hip Replacements including surface replacements. Femoral components and acetabular components are rated separately. (Please see Hips under the section on methodology for more information).
Knee replacement implants including Total Knee replacements (TKRs) and uni-condylar knee replacements. (please refer to the knee section in methodology for more detailed information).
Shoulder replacements including "Reversed", anatomic, resurfacing, glenoid replacements and trauma implants.
ODEP and Beyond compliance are developing systems for the benchmarking spinal implants and the introduction of new devices.
When it comes to detail, Spinal ODEP and BC will require a different approach form that we have used for other joints. For ODEP for spinal implants the basic ODEP philosophy will remain the same which means that manufacturers of spinal devices will have to collect data to be validated independently for their implant to have an ODEP rating.
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