ODEP and Beyond Compliance
Beyond Compliance was established in 2012 following the problems of metal on metal hip replacements.
Concern had been expressed by several parties within the Orthopaedic fraternity that the monitoring of implants, particularly immediately post CE mark, was not sufficiently robust. Everyone was aware that once an implant had a CE mark it could be traded in all EU states and that any suggestion of hindrance to that right would be against EU law.
The CE mark is “Compliance”. What if we invited manufacturers to go “Beyond Compliance” in a completely voluntary way? That turned out to be the basis of the introduction of the “Beyond Compliance” system. Beyond Compliance had the backing of MHRA, ABHI, the BOA from the outset. The then Minister of Health, the Rt. Hon. Jeremy Hunt supported it (paywall).
Peter Kay FRCS was appointed to head the steering committee.
ODEP was approached and asked if they would provide the manpower to staff the advisory group which Keith Tucker was asked to chair.
The duties of the advisory group include
1. Perform an in depth assessment of new Hip and Knee replacements that were brought to it by a manufacturer
2. Arrange the monitoring of the device through the NJR
3. Oversee the performance of the device by arranging appropriate reviews and user group meetings for the implant.
BC and ODEP
If when a manufacturer submits to ODEP for “Pre-Entry” status and their implant has fully completed an agreed a BC assessment, they will be eligible for “Pre-Entry A*”.
Pre-entry is not an ODEP benchmark, it is a signal that an implant has entered the process. “Pre-entry A*” is classified as a benchmark and this means that a hospital is using an ODEP benchmarked implant.
Many manufacturers elect to enrol into BC “Safeguard” after they have achieved their ODEP 3A or 3A* rating. Safeguard gives the manufacturer the added assurance that BC is still keeping a watchful eye on the performance of their implant. This cohort of patients can be used for submission for further ODEP benchmarks as time goes by.