Safety recommendation
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:
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.