Product areas

ODEP

To ensure consistency and to enable easy data presentation and comparison, the Agency developed a pro forma for the manufacturers to use in submitting their data. The pro forma was accompanied by explicit guidelines for completion. It is recommended that trusts view these guidelines and submission templates for stems and cups so they can see what was expected from the suppliers. Finally, the Agency welcomes any feedback on the data, content, presentation or otherwise. Please forward your comments to phil.lewis@supplychain.nhs.uk. Following the publication in March 2004 of ODEP’s listing of products that comply with the 10 year benchmarks set by National Institute for Health and Clinical Excellence (NICE), the following database has been revised to include all products submitted to ODEP by industry in relation to all benchmarks set by NICE.

For 10 year benchmark products, ODEP placed products in one of four categories:

For products that fall below NICE’s 10 year benchmark, ODEP in consultation with industry, MHRA, BOA, BHS and RCS has chosen to look at evidence at three, five and seven years. Each level is split into three categories:

Products that are yet to meet NICE’s three year entry benchmark have been listed as ‘pre-entry’ so surgeons may see what is currently undergoing clinical evaluation.

Orthopaedic Data Evaluation Ratings Guidance

ODEP would like to advise that from 1st May 2015 any product receiving a Pre-entry A* rating will be considered to have a full ODEP benchmark.

The Pre-entry A* rating will be awarded to products that are launched in the UK under the Beyond Compliance initiative that provides a combined risk assessment and on-going performance review programme for all procedures conducted in England, Wales and Northern Ireland.

Products registered as Pre-entry A* can be viewed at www.odep.org.uk with products participating in the Beyond Compliance initiative detailed at www.beyondcompliance.org.uk

The full revised ratings are provided at www.odep.org.uk

Disclaimer

ODEP has had to rely upon the honesty of the submitting companies and has asked each company to state if their data is representative of the product’s performance. ODEP therefore makes no warranty that the data within the database is accurate, complete or current, only that their judgement is based upon the data placed before them.

The Agency shall, unless specifically stated otherwise, not be liable for any damages or loss arising out of, or in connection with, the use of the database including (but not limited to) direct or indirect consequential loss, loss of data, income or profit, loss of or damage to property and claims from third parties. This exclusion from liability does not apply to or affect the Agency's liability for death or personal injury caused by its negligence.

We believe this is the first time evidence data to support individual products has been collected on this scale and the Agency is grateful for the commitment suppliers have made in responding to this initiative.

By using the database you are indicating your acceptance of this disclaimer.

If you have any queries or comments in relation to this website, please contact:

Phil Lewis
Tel: 07769935178
E-mail: phil.lewis@supplychain.nhs.uk

 

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