In December, working with our Clinical Safety Officer from Safehand Consulting Ltd we had the annual refresh of our documents for the England and Wales Safety Standard DCB0129.
The documents were uplifted and are now applicable to BEST Version 14.50, IMF, BEST Web and BEST Portal.
The three deliverables that are available to you as part of the requirement are:
- Clinical Risk Management Plan (“the Plan”)
- Hazard Log
- Clinical Safety Case Report (“the Safety Case”)
We also have a documented DCB0129 Clinical Risk Management Process and a Product Safety Incident Management Process.
DCB0129 is an ongoing assessment throughout the year. We have regular meetings with our Clinical Safety Officer to discuss and review the potential clinical risks in relation to developments that have been made to BEST to ensure that controls are added to our Hazard Log to mitigate these as required.
The documentation for the deliverables can be made available to you upon request.
