ODEP ASSURE
From time to time, manufacturers approach ODEP to say that they would like to make a modification to an implant but that they do not want it to lose its ODEP rating.
ODEP takes any modification very seriously. Historically, some so called “Minor Modifications” have led to disasters, but ODEP realise that making improvement must not be frustrating.
Thus when a manufacturer wants to modify a product and keep its ODEP rating they should notify ODEP. The modification will then be very carefully assessed by members of the panel and a decision will be made as to whether the modification cannot be accepted under the present benchmark or not.
Only if the panel decide that the modification is not going to significantly alter the performance of the device will ODEP ASSURE be offered.
In this way, the reader will see that it is system that can be introduced so that can ASSURE everyone that the decision to allow the benchmark to be maintained was correct. By monitoring the performance of the modified variant against its parent, any problem will be detected promptly and the risk of the performance of the new version will not be camouflaged by the good results of the original implant.
Essentially the methodology is similar to the monitoring of implants in Beyond Compliance.
It must be emphasised that it can only be introduced if the panel consider the risk to the performance of the implant to be insignificant or minimal.
To make this distinction clear to surgeons, procurement managers and other users of ODEP, Reference Products and their Modified Variants are listed separately on the ODEP website. The Reference Product retains its ODEP rating, displayed in the usual way. The Modified Variant carries the ODEP Assure badge in place of a rating badge, making it immediately apparent that the variant is under active monitoring and does not independently hold an ODEP benchmark. The two listings are linked, so that the relationship between the Reference Product (“parent”) and the modified variant (“child”) is transparent.
For more details click here.
