Safety recommendation
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.
Safety recommendation
British Standards Institute (BSI)
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.
Response
British Standards Institute (BSI)
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 21 February 2019
Safety recommendation
The National Joint Registry (NJR)
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.
Response
The National Joint Registry (NJR)
Response received 17 September 2018.
Safety recommendation
Department of Health and Social Care (DHSC)
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.
Response
Department of Health and Social Care (DHSC)
Response received 18 September 2018.