We support medical implant suppliers in the routine post-market surveillance of their implants. Information on implant outcomes is also made available to clinicians, patients, hospital management and the MHRA through a range of analyses and outputs. Data on implant performance is published as part of the NJR Annual Report each year.
Implant Outlier Process
As part of the NJR Accountability and Transparency model, the NJR identifies hip and knee implants which fall outside the designated patient time incidence rate (PTIR) confidence intervals. The aim of this process it so act as an early warning of any issues relating to patient safety to allow appropriate action to be taken. Analysis of data is undertaken twice a year in March and September and is reviewed by the NJR Implant Scrutiny Committee.
There are two levels of implant notification to manufacturers:
Level 1 implant outlier notification process – triggered when an implant has a patient time incidence rate (PTIR) of at least twice the overall PTIR, for implants that have been used in at least 100 primary operations in the NJR
Level 2 implant outlier notification process – triggered when an implant has a PTIR of at least twice the overall PTIR, for implants that have been used in less than 100 primary operations in the NJR. It can also be triggered when an implant has a PTIR of at least one and a half times the overall PTIR, for implants that have been used in at least 100 primary operations in the NJR.
As part of this process, we write to manufacturers and ask them to review the relevant data. In the case of level 1 outliers, we also work with the MHRA to ensure that any appropriate action is taken. In recent years, the NJR has undertaken a yearly data quality audit within both the NHS and independent sector to ensure that all analysis of outcomes is supported with high quality data. Alongside the implant outlier process, we also have a range of services available where suppliers of implants are able to access data on the outcomes of their products.
Data and Research Requests
All manufacturers are also able to submit a data access request or research request for data not available as part of supplier feedback. Further information on how to submit a request can be found by clicking on this link.
NJR Supplier Feedback allows prosthetic implants suppliers to download NJR data extracts. These provide information on the outcomes of procedures using their products on a monthly basis.
To access supplier feedback, you will need to register by clicking on this link. Once your request has been submitted, it will need to be approved by the NJR Service Desk to ensure that only legitimate users are able to access sensitive data about their own implants.
For further support or information, you are also able to contact SupplierEnquiries@NJRcentre.org.uk