NHS Improvement
NHS Improvement amends the national Prosthesis Verification Standard to incorporate the specific aspects of verification practice developed to mitigate error identified in this investigation.
The national Prosthesis Verification Standard is one of thirteen standards identified in the National Standards for Invasive Procedures (NatSSIPs) published in September 2015. NHS Improvement established a NatSSIPs Reference Group when the standards were originally developed which continues to meet. It was recognised when the NatSSIPs were launched that these standards would require regular review and update to reflect current practice and the Terms of Reference for the Reference Group are currently being revised to incorporate this requirement within it’s remit.
This safety recommendation will be brought to the attention of the NatSSIPs reference group for consideration with a view to an amendment being issued to the current version of NatSSIPS. The amendment will be issued on the NHS Improvement website and promoted through the NHS Improvement Bulletin and shared with the relevant Royal Colleges and professional associations.
The next NatSSIPs reference group meeting is planned for 23 October 2018 so the amendment will be published by 31 October 2018. There is currently a thematic review into Never Events, commissioned by Secretary of State for Health and Social Care, being undertaken by CQC with the support of NHS Improvement which is expected to report in Autumn 2018 and potentially make recommendations regarding the contents of the NatSSIPs. A revised version of the NatSSIPs will be published by Summer 2019 to provide time to also incorporate any additional actions identified from the thematic review and other sources of intelligence that have been brought to the attention of the Reference Group.
Response received on 11 July 2018.
British Standards Institution
The British Standards Institute amends existing standards for prosthesis labels to include details of design that make them easier to read in operating theatres. The American Society for Testing and Materials’ ‘Standard Guide for Presentation of End User Information for Musculoskeletal Implants’ is a useful reference.
BSI, as the UK’s National Standards Body (NSB), acknowledges the Safety Recommendation 2018/002 made by the HSIB. Subsequently we have reached out to the International Organization of Standardization (ISO) and their relevant technical working groups (ISO/TC 210) – who are responsible for the international standards dealing with “information supplied by the manufacturer” and “symbols & labelling” – and shared the recommendations with them to review and determine any action required. We will keep the HSIB informed of the results of these meetings.
Response received on 21 February 2019.
The National Joint Registry
The National Joint Registry (NJR) changes the response when data is entered into the registry suggesting the wrong prosthesis has been implanted due to incompatible manufacturers, so that it is consistent with the response when data indicates the wrong size or side has been implanted.
The NJR intend to implement the above change to the alert wording by the 30 November 2018. A communications plan will be put in place to ensure that all data entry staff and surgeons are aware of the changes to these alerts.
Alongside the HSIB recommendation, the NJR intend to work with manufacturers to update the NJR with details of those implants from different manufacturers which are compatible and approved for use. This will ensure a robust approach so data entry staff at hospitals do not receive unnecessary alerts.
Following publication of the report and recommendations, the NJR will work with other bodies to whom recommendations have been made where appropriate. An initial meeting has taken place with the Department for Health and Social Care to discuss how the NJR can assist with the implementation of recommendations 2018/004 and 2018/2005.
Response received on17 September 2018.
Department of Health and Social Care
The Department of Health and Social Care expands the remit of the working group consisting of Derby Teaching Hospitals NHS Foundation Trust’s Scan4Safety Programme, the National Joint Registry (NJR), and the Medicines & Healthcare products Regulatory Agency to include alerts to identify wrong prostheses prior to implantation.
The Department of Health and Social Care commissions the development and implementation of an interim basic scanning system to identify wrong prostheses prior to implantation.
DHSC expands the remit of the working group consisting of Derby Teaching Hospital NHS Foundation Trust’s Scan4Safety programme, the National Joint Registry and MHRA, to include alerts to identify wrong prostheses prior to implantation.
The working group consisting of Derby Teaching Hospital NHS Foundation Trust, the National Joint Registry (NJR) and Medicines Healthcare Products and Regulatory Agency (MHRA) has already expanded their scope to include the development of early warning systems to identify wrong prostheses prior to implantation using barcode scanning in conjunction with information from the NJR.
The next Derby/NJR/MHRA working group meeting will take place on 2 October 2018 and a member of the DHSC Scan4Safety team will attend.
DHSC commissions the development of an interim basic scanning system to identify wrong prostheses prior to implantation.
The NJR has advised that it can develop and make available an app utilising the compatibility data it already holds and maintains in its systems. The app would enable the surgical team, prior to undertaking joint replacement surgery, to proactively undertake joint component compatibility verification based on scanning the barcodes already provided by industry on product packaging. In the event of incompatibility, the app would provide an alert. The alert would provide decision support information to the surgeon who would retain the option to select joint replacement components based on clinical need.
There are therefore a number of options on how to respond to take this work forward. The full costs to develop and implement a solution will be determined through further work involving DHSC, NHS Improvement, NHS Digital and the working group consisting of Derby Hospital, the NJR and MHRA. It should be recognised that this approach may provide an interim basic solution, pending a future introduction of a more comprehensive solution to address multiple use cases (such as traceability and costing) across multiple product groups.
In conclusion, NHS Improvement, NHS England, NHS Digital and DHSC will use the outputs from the working group to pilot an initial working solution and work to develop a longer term solution to meet this recommendation.
DHSC will provide periodic updates to HSIB detailing progress to meet all of these recommendations. Please let us know if you have any queries about any of the information provided.
Response received on 18 September 2018.