The Beyond Compliance Advisory Group will use available data to monitor the early performance of new or modified implants that come within the Beyond Compliance service, in order that any potential problems relating to a product or its surgical use can be identified before large numbers have been implanted. The Beyond Compliance Advisory Group recommends a step by step introduction to the market, the speed of which depends on the perceived “risk” that the group attaches to the product.
To act as an independent data monitoring committee
for post-market clinical follow-up data on new products being collected through the Beyond Compliance platform including an analysis and assessment of individual adverse events, looking for early signals of possible problems and advising on consequential actions. This involves regular feedback to both manufacturers and participating clinicians.
Is Beyond Compliance independent?
The governance structure of Beyond Compliance (BC) is in two parts. There is the overarching Steering Committee and the Advisory group.
The Steering Committee is responsible for policy and provides advice and guidance to the Advisory Group which follows these policies and applies the BC process, which principally involves assessing new implants and then monitoring them.
All members must make the appropriate declarations regarding any possible conflicts at every meeting and recuse themselves accordingly if required.
Independence of the Steering Committee
The membership of the Steering Committee (Stakeholders) comprises representatives from:
- Lay Representative
- The British Orthopaedic Association
- The British Hip Society (BHS)
- The British Association for Surgery of the Knee (BASK)
- The Medicines and Healthcare products Regulatory Agency (MHRA)
- The Association of British HealthTech Industries (ABHI)
- The Notified Bodies
- The National Joint Registry (NJR)
- The Chairman of the BC Advisory Group
- NEC Software Services (UK) Limited (NEC)
- Supply Chain Co-ordination Limited (SCCL)
Nobody on the Steering Committee is paid for their services.
Independence of the Advisory Group
The Advisory Group is entirely independent of industry, procurement and regulators and is principally made up of orthopaedic surgeon rapporteurs working with statisticians and data scientists to monitor, analyse and report on the performance and safety of implants. Should they require extra advice from bioengineers, toxicologists or other specialists for a particular reason they have a list of independent experts to go to.
The members of the Group have their travel and (where relevant) accommodation expenses re-imbursed for attending Advisory Group meetings and relevant conferences. They received no other funding or benefits in kind.
Independence of the data
The core data that the Advisory Group use comes from the National Joint Registry (NJR). Governed by the Healthcare Quality Improvement Partnership (HQIP), the data the NJR generates is independent from any agency that could gain advantage from biasing it. Likewise, data collected from other agencies feeding into the Beyond Compliance repository (such as x-rays or explant analyses from retrieval centres) is audited and is also not conflicted.
Fees and contracts for data processing and analysis
The data BC uses includes highly confidential and sensitive personal patient information as well as reports and analyses which are commercially sensitive. The secure management and processing of these data is the responsibility of NEC, acting as the data processor.
When a manufacturer engages with BC they contract to pay an annual fee to NEC for setting up and maintaining the repository where all the data about their implant is collected, processed and stored. The fee also includes the production of the reports for the Advisory Group, its rapporteurs, the manufacturer and the implanting surgeons.
This separation of duties (between the rapporteurs and data processor) ensures that the people providing the assessment of the performance and safety of an implant cannot be influenced by any financial incentives – thus ensuring and maintaining their clear independence.
Beyond Compliance prides itself on the independence of its analysis and advice, and the transparency of its processes. The surgeon rapporteurs who give their time to BC do so without any reward other than the personal satisfaction and knowledge that they are protecting patients whilst supporting innovation.
Chair of the Advisory Group