There are initiatives that are not included with the NJR but which are dependent upon NJR involvement and support.
The NJR continued to support Beyond Compliance, an external initiative to help improve patient safety in the UK - this section is authored by the Beyond Compliance Steering Committee.
Beyond Compliance has been set up in the interest of patients and its aim is to support the safe and stepwise introduction of new or modified medical implants such as joint replacements. It represents a landmark achievement as Beyond Compliance is the first independent body recognised by regulators, professionals and industry alike to collect and scrutinise this type of data.
Beyond Compliance collects and analyses outcomes data on the in-market performance of some new UK orthopaedic implants. It uses NJR data and data from other sources including information about patients who receive these implants and about their recovery following surgery. This data is made available to surgeons using the implant, to the manufacturer and to independent assessors from the Beyond Compliance Advisory Group, to provide real-time monitoring of the implant’s performance.
Beyond Compliance Advisory Group
An independent panel of experts, known as the Beyond Compliance Advisory Group, work with the implant manufacturer to assess the relative risk of any new product, and the rate at which it should be introduced to the market.
The group also monitors the early performance of new implants, in order that any potential problems relating to a product or its surgical use can be identified before large numbers have been implanted. The initiative supports graduated implant introduction, with the agreement of the manufacturer, to reduce the likelihood of widespread dissemination of implants before any weaknesses are identified in real-world use.
Beyond Compliance Steering Committee
The initiative has a Steering Committee which takes responsibility for determining the overall policy for the process. It is made up of representatives of all the stakeholders. The concept of “Beyond Compliance” was introduced by the British Orthopaedic Association (BOA) and the Medicines and Healthcare Products Regulatory Agency (MHRA) with support from the Association of British Healthcare Industries (ABHI). The Steering Committee chairmanship and structure reflects its origins. Other stakeholders include patients, the British Hip Society (BHS), the British Association for Surgery of the Knee (BASK), the NJR, notified bodies, and the Department of Health.
Beyond Compliance operates in an environment underpinned by European law affecting both the product CE marking, and also procurement legislation on the selection and purchasing of products within public sector entities. It is important, therefore, that Beyond Compliance is not seen to be a mandatory service, rather an optional service available to manufacturers.
Beyond Compliance is currently collection data and reporting on 43 new implants and there is a full pipeline of requests from manufacturers to enter more implants into the Beyond Compliance process.
Further information about Beyond Compliance and the details of the implants currently registered for the service can be found at the Beyond Compliance website www.beyondcompliance.org.uk.
The Orthopaedic Data Evaluation Panel was established in 2002 to monitor National Institute for Health and Care Excellence (NICE) guidelines on primary hip implants. This was extended to knees in 2014 and a pilot for the inclusion of shoulder implants for reverse shoulder arthroplasty will take place in 2017/18. The results of the pilot will only be shared with suppliers and not published on the ODEP website. These ratings will only be published when the system has been fully tested.
ODEP assigns ratings to implants based on a simple and independently verified assessment of implant performance, assessed against national clinical guidelines. ODEP uses data from multiple sources to make those assessments, including data from the NJR.
The NJR supports ODEP both by providing support to its meetings and by providing data to suppliers, via NJR Supplier Feedback, which can form part of the evidence submitted by manufacturers to ODEP as part of the assessment process.
The NJR also maintains ODEP ratings for prostheses (currently hip stem and hip acetabular cup only) in its database which are used for its reporting services. One of the indicators published as part of the Clinical Outcomes Programme (COP) is the use of ODEP rated hip stems and cups.
The NJR will be undertaking work in 2017 to change the way in which it can hold data about ODEP ratings. ODEP has traditionally assigned an ODEP rating to a ‘brand’ of components but applying ratings at the brand level for knees is impractical. This is because of the numerous possible combinations of devices available within each knee system. For knees, therefore, ODEP ratings will be applied at the construct level. In order to report ODEP ratings for knees, the NJR will to be able to store details of those constructs and link then to recorded uses in the NJR. The data structure will also enable the NJR to hold similar data about shoulder constructs and, if ODEP should start to apply ratings at the construct level for hips, hip constructs.
For further information about ODEP and ODEP ratings, please visit the ODEP website at www.odep.org.uk.