For every medical device, a clinic must be able to show that the whole chain is in order: the risk has been assessed, a PRI has been carried out where required, staff are trained and authorised, maintenance is current and the device has been technically and clinically released.
Many clinics track this in spreadsheets. That works as a reminder, but a spreadsheet cannot stop a device from being used while something is missing.
A register that can refuse
Rexium Quality derives each device's status from the underlying evidence and applies three rules:
- Incomplete safety requirements lead to automatic blocking.
- Complete requirements with technical and clinical release make a device released.
- An expired critical requirement leads to automatic re-blocking.
For incidents too
The same principle applies to the VIM incident register: a report can only be closed when the evidence exists, and an improvement action is only complete when a document is attached and its effect has been evaluated.