Tips for Form Completion for Manufacturers
This guide has been created for manufacturers who submit forms to prevent frequently performed errors or mistakes. This advice will reduce the number of 'rejected' forms and the number of appeals.
The most common reasons for a re-submission:
• Product codes do not match the requested implant construct
• Not all product codes are provided for entire range
• Information on the registry used is not provided, or the date of data extraction
• The numbers provided in the reason for revision do not match data provided in the comments box
• Incomplete hospital name records are not provided
1. The Product
• The correct description on the front cover matches the submission sheet.
• The product codes all match the submitted device.
• The product codes for ALL sizes are provided. If not provided (such as a very thick poly that has never been used, please document why the product codes are not provided).
• There are is no mixture of prostheses in the product codes, e.g. all poly components must be same shape, material and fixation.
2. The Clinical reference data summary
• It is clearly stated which registry/journal article the data is extracted from.
• Clearly state the time at which the data was extracted from the joint registry
• If data is provided from a registry other than the UK NJR, please ensure that the outcomes in the NJR are similar. For instance, a well performing implant in a registry that is performing poorly in the NJR will not receive a rating.
• Published study data can be accepted but must meet the criteria required and appropriate data completed (where possible or with explanations when not possible). Data provided without Kaplin Meier confidence intervals is unlikely to receive a rating.
• The obligatory boxes are all completed.
• The number of centres box matches the final page containing the names of the centres. The names of the centres in the UK must be provided.
• If there is a particularly high (or low) death rate which may be considered unusual please provide further information.
• If there are unusual demographics (such as a large number of a certain sex or diagnosis), please provide further information.
3. Causes for Revision
• Carefully review the causes for revision.
• If there are a large number of ‘other’ causes, please provide further information.
• If there is an unusual finding, please provide further information.
• If the implant construct has a patella resurfacing, but there are cases in the ‘patella resurfaced as reoperation’ box please provide an explanation.
• Carefully review the mean follow-up and range to ensure these are consistent with the submission and the date of first use/design changes on the front page.
• If a product has been discontinued in a certain country and this is reflected in the follow-up range, please provide further information.
• Please ensure that the numbers in the ‘reasons for revision’ box match the number provided in the ‘number of knees revised for any reason’ box.
4. Survivorship and Confidence Intervals
• Carefully review the revision rate number to ensure it matches the requested rating.
• Carefully review the confidence intervals to ensure they match the requested rating.
• Please ensure that there were enough patients at the start and past the benchmark to reach the requested rating.
5. Comments box
• Please use this to provide further information.
• Do not provide information in this box that contains different numbers to others provided (such as reasons for revision).
• It is recommended that this box is only utilsed for clarification of points as listed above. Additional, conflicting information provided in this box may lead to a rejection of the form.
6. Combining Data Sets
Please see the appropriate guidance page.
To gain a rating, data can be combined for a single construct from multiple sources as long as the appropriate required data is provided.
Combining data sets of implant constructs with small numbers can be used if the same construct is performed with and without a patella. Please see the details for the requirements for acceptance.
Different patella resurfacings cannot be combined. The only exception to this is where the patella is made of the same material with the same fixation method with different shapes (such as round/oval).
7. The ‘Spirit’ of ODEP
• Please ensure that the rating applied for is appropriate. I.e. if an implant construct with enough implants to achieve a 10 year rating, this must be requested, rather than attempting to achieve a higher starred rating at a much lower time period (such as at 5 years)
• At further submissions for an implant construct, the rating requested should be higher than the previous rating. I.e. a construct with a 5A* rating that resubmits data after three years should be asking for a 7 year rating. A repeat 5 year rating will not be provided if sufficient numbers are available for a 7 year rating.
The Re-submission and the Appeals meeting
• Please review the comments from the ODEP panel members carefully.
• If the comments are not clear, please contact the team at ODEP for clarification in good time.
• If answers are not provided to all of the questions, the submission is likely to be rejected.
• Significant changes to the numbers, or new submissions will not be reviewed at the Appeals meeting. A new submission will be required at the next submission date.
• Further re-submissions are not allowed. A new submission will be required at the next submission date.