The Beyond Compliance Process
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The key aspects to Beyond Compliance process are:
The Advisory Process
The Beyond Compliance Advisory Group has been set up to advise an implant manufacturer of the level of risk exhibited by a new or modified device, and to reach agreement as to the rate at which it should be introduced to the market. A step by step approach provides the framework for the process, backed by standardised data collection and surveillance.
As part of a Stage 1 assessment, the Beyond Compliance Advisory Group will provide initial advice regarding the product risk and rate of entry to the market, and assess whether any further expertise is required. Each new device is assigned nominated Rapporteur(s) as independent assessors from the Beyond Compliance Advisory Group. Rapporteurs will be assigned for three years, or until such time a device has reached the ODEP level 3 evidence rating, or is withdrawn from Beyond Compliance.
Patient Consent
Surgeons using a Beyond Compliance product will be required to capture explicit patient consent from patients for whom they intend to use the product. This captures the patient’s consent for their data to the stored and used by the Beyond Compliance service. All other local consent processes and forms, such as consent to operate and NJR consent forms remain unchanged.
Data Collection
The Beyond Compliance Service is supported by a secure on-line surveillance system. Access to this system, and to underlying data within, is restricted to authorised users only. Beyond Compliance builds on data routinely captured within the National Joint Registry, but use of the Beyond Compliance system does not impact standard NJR data collection processes.
Reporting and Independent Scrutiny
Data collected through Beyond Compliance will be collated and used to generate analysis regarding the performance and outcomes of each product. These results will be available to the manufacturer, the nominated Rapporteur(s) and the implanting surgeon(s) only.
The nominated Rapporteur(s) will convene regular (at least six monthly) meetings with the manufacturer to provide ongoing scrutiny of product performance data, and to review guidance regarding the rate of introduction to the market.
If you would like to learn more about responsibilities and duties of a Beyond Compliance Rapporteur, please click here to read the document.
Explants
In the unfortunate event that a joint replacement has to be removed, it gives us the opportunity of examining it and this can often give us a lot of useful information about its performance. Beyond Compliance asks for patient consent that, should their joint replacement ever be removed, they agree to it being sent for analysis by a retrieval centre. All companies participating in Beyond Compliance are requested to ensure that there is every likelihood that all explants are forensically examined. It is important that all surgeons, surgical team members and representatives understand the process for the prosthesis to be sent to a recognised retrieval centre.
A collaborative effort, known as the Explant Alliance, representing all UK implant retrieval centres, met in February 2016 to discuss the process of obtaining high quality data on explants and achieving excellence in explant retrieval.
The minutes may be viewed by clicking here.
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