Beyond Compliance is an optional service available to manufacturers of hip and knee joint implants. The service may be extended in the future to include other types of implant. Beyond Compliance is a joint effort between you the manufacturer, implanting surgeons adopting the use of your product and the Beyond Compliance Advisory Group, all of whom are looking to ensure the safe and stepwise introduction of new or modified implants to the market in the interest of patients.
An independent panel of experts, the Beyond Compliance Advisory Group work with you to assess the relative risk of any new product, and the rate at which it should be introduced to the market. The service collects data about patients who receive these implants and about their recovery following surgery. This data is made available to you the manufacturer, to surgeons using the implant, and to independent assessors from the Advisory Group, to provide real-time monitoring of the implant’s performance.
Having been through the Beyond Compliance process, it is anticipated that successful implants will progress to a level 3 ODEP benchmark rating.
Upon receipt of an expression of interest, we will set up a meeting or call to discuss the Beyond Compliance process, and its relevance to your product.
Stage 1 Assessment
Following initial contact, where the manufacturer wishes to proceed, we will then request, under confidentiality protection where required, details of the product, indications for use, and a summary technical dossier. This will provide an opportunity for nominated members of the Advisory Group to get to know the product, to start evaluating risk and rate of entry to the market, and assess whether any further expertise is required. A series of face to face or telephone meetings will be held as required by the manufacturer and the nominated members of the Advisory Group.
Through this Stage 1 Assessment process, the Beyond Compliance Advisory Group will define with the manufacturer:
- Nominated Rapporteur(s) to be assigned as the independent assessors from the Advisory Group.
- Product risk assessment.
- Market entry guidelines – the advised rate of introduction.
- Data collection requirements – the definition of data to be collected over and above that which is routinely collected by healthcare instructions.
For any product entering Beyond Compliance, the minimum data points collected, analysed and reported are:
- NJR Data for the primary and any subsequent revision of the primary;
- National Patient Reported Outcomes (PROMs) preoperative and 6 months post-operative EQ-5D and Oxford Scores;
- HES records relating to readmission or other relevant post-operative events;
- ONS mortality.
In addition, the Beyond Compliance Service provides the facility to upload additional data points such as, but not limited to:
- radiographic images;
- operation notes;
- discharge summary;
- outpatient notes;
- additional PROMs.
Beyond Compliance does not mandate the collection of additional data points. However, the data points to be collected for any Beyond Compliance Product will be agreed on a case by case basis between the manufacturer and the appointed Beyond Compliance Rapporteur(s), and will be based upon the level of risk associated with the product. Products with a risk level 2 or above are likely to be deemed to require additional data points to include follow-up PROMs beyond the 6 month time point.
In collaboration with the manufacturer, the appointed Beyond Compliance Rapporteur(s) will define the minimum level of additional data points to be collected for a Product entering Beyond Compliance. The manufacturer is, however, able to utilise the data collection facilities of the Beyond Compliance Service to collect data points over and above the minimum level agreed.
Data collected through Beyond Compliance is likely to result in an audit, a paper in a peer reviewed scientific journal or a presentation at a scientific meeting. In addition, detailed analysis of the data will be required in order to obtain an ODEP rating. The Beyond Compliance system provides comprehensive data collection and analysis functionality for this purpose.
Implanting Surgeons / Centres
The manufacturer will be required to identify surgeons and centres approved to use the product. Surgeons using the product will be expected to have undertaken appropriate training by either a champion surgeon, through attending appropriate training workshops or, ideally, through a combination of both.
Following Stage 1 assessment, where the manufacturer wishes to proceed, they are invited to enter into a contract for the provision of the Beyond Compliance System, supporting the collection and reporting of product performance and outcome data, in line with requirements defined during the Stage 1 assessment. The manufacturer and their approved surgeons will be issued unique usernames and passwords for access to the Beyond Compliance system.
It is the view of the Beyond Compliance Advisory Group that manufacturers commit to a 3-4 year process at the outset. Reports will include the results of all implantations. The anticipation is that each contract will be maintained at least until a 3 year benchmark is achieved, however, the cost will be recurrent, year on year, it is not expected that the fees for the whole 3 year period will be charged as an upfront cost.
Registering with Beyond Compliance and NJR
Details of the product, and catalogue numbers of all associated components must be registered with both the NJR and with Beyond Compliance prior to commencing data collection.
At agreed time intervals, the manufacturer will be invited to meet the appointed Beyond Compliance Rapporteur(s), to review data to discuss the performance of the product. All revisions will be reviewed, with examination of X-Rays. Where data other than that collected by Beyond Compliance is available, this will also be reviewed. These review meetings are minuted, but remain confidential between the manufacturer and the appointed Beyond Compliance Rapporteur(s). Agreement with regards to future expansion of the use of the implant will then be decided.
Adverse Incident Reports
For any adverse incident reports relating to the product, the manufacturer will be required to notify the Rapporteur(s) at the time that MHRA or other competent authorities are notified.
The relationship between the manufacturer and the Advisory Group can be as confidential as the manufacturer wishes. In the event of the product attaining “outlier performance” (as measured in the same way used by the NJR Implant Performance Committee) the MHRA will be notified.
Guidance for Marketing of Beyond Compliance hip and knee products
Beyond Compliance are supportive of manufacturers and distributors marketing products listed within the Beyond Compliance programme. Beyond Compliance would however like to provide guidance to ensure that any use of the Beyond Compliance branding is used fairly and consistently and follow the principle of ensuring that participation in the programme are not used to mislead current or potential customers in any way.
- In all marketing information (including but not limited to; posters, banners, presentations, leaflets, social media posts etc.) please ensure that www.beyondcompliance.org.uk website is referenced with the wording; Latest products participating in Beyond Compliance can be found at www.beyondcompliance.org.uk
- Any marketing material or presentation should be clear and unambiguous with regards to the product being referred to. This is especially important when producing marketing material for brand families.
- Unless express written permission has been given by the panel, new ratings should only be communicated externally of the manufacturer/distributor following publication on www.beyondcompliance.org.uk
- No reference should be made to competitor products within written marketing material, including reference to improved performance to existing products.
- No reference should be made within any material suggesting the support of either the Advisory Group or Steering Committee for a particular product or system.