Our first complete investigation relates to the implantation of the wrong prostheses (artificial body parts) during joint replacement surgery — a surgical never event. A never event is a serious incident that is entirely preventable.
The patient was a 62-year-old man who underwent hip replacement surgery. During his surgery, incompatible prostheses made by different manufacturers were used. The error was identified when data from the procedure was recorded in the National Joint Registry several days later.
Our investigation centred on how the error occurred and what safety recommendations we could make to reduce the risk of a similar event happening again.
The investigation focuses on hip replacement surgery but our findings are applicable to all orthopaedic joint replacements.
We made safety recommendations to NHS Improvement, the British Standards Institute, the National Joint Registry and the Department of Health and Social Care as a result of this investigation. All of these organisations responded to the safety recommendations within 90 days of publication of the investigation report.
NHS Improvement amends the national Prosthesis Verification Standard to incorporate the specific aspects of verification practice developed to mitigate error identified in this investigation.
Response received 11 July 2018.
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 received 21 February 2019:
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.
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.
Response received 17 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.
Response received 18 September 2018.
Mr Hampton, the patient at the centre of this investigation, shared his view on the investigation and his experience at the NHS trust where he was treated:
"I think it’s a good idea because a national investigation can make all hospitals better. They are good already but this could make them even better. As long as mistakes can be learnt from that’s what you want and so I think it’s brilliant there’s been a national investigation.
"I think the staff at the hospital are brilliant – from the surgeon to the people who cook the food. Everybody was fantastic to me. I don’t want any staff to get into trouble over a mistake, we all make mistakes."