O.K let us look at a scenario
Incident during a proceedure in Theatre gets traced to HSDU concerning a sterilization issue and a fault on a particular machine.
Tracing back through records it apeears the unit was tested by EBME and found that all results were correct at the time of testing.
After further investigation the chart recorder is found to be innacurate and it has come to light that it was calibrated "in house"
What standards was it calibrated to .... i.e what instruments were used to calibrate it and how do you know they are accurate?
What are you going to tell the Judge before he throws the key away?