The NJR continued to support Beyond Compliance, an external initiative to help protect patient safety in the UK ~ this section is authored by the Beyond Compliance Steering Committee
Beyond Compliance is now live and is a new service that has been set up in the interest of patients. 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 who take 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 and notified bodies and the Department of Health.
Progress
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.
The service is now collecting and reporting data on seven new implant brands, with a further fourteen expressions of interest from suppliers wishing to register products. It is very encouraging to see the positive levels of interest and support in the service, across both large and small orthopaedic device manufacturers, with most, but not all organisations, opting to engage with the service.
The Beyond Compliance Steering Committee would like to take this opportunity, in the NJR’s 11th Annual Report, to thank the Beyond Compliance team, who are unpaid and give their time freely to support this important initiative.
Details of the implants currently registered can be found at the Beyond Compliance website www.beyondcompliance.org.uk.