It would appear that this discussion has two key questions:
1. What evidence do we keep for ensuring that our staff are competent?
For me registered staff should be on the VRCT (IPEM)and have records of training esternal and internal. Records of teaching back to a more experienced engineer how the equipment is serviced is a very good method.
2. CQC/NHSLA compliance
I too had a CQC interview recently. I started by asking them for a definition of safety. In the end they agreed that the IEC Guide 51 definition I gave them was right. Safety is 'freedom from unacceptable risk'.
All medical engineering teams either in a structured was or simply intuitively manage down risk. We have a structured approach in that equipment models are classified into 5 risk bands based on the 'immediacy of the impact on the patient'.
And we have a system of monitoring how well we are doing.
That's our model - it's the best we've come up with so far, but it's not the only model. there are things where we declare that we don't routinely service, but have a rationale why we don't.
The impression I get is that the CQC want to hear that medical engineering teams understand the challenges and risks, have a structure/model that addresses these to the best of our ability and resources.
Good records and a monitoring system are these days essential.
And is there a mechanism for passing up difficult problems (e.g. major risks) up the ladder, rather than hiding them within the local medical engineering team.
Last edited by chris hacking; 07/06/11 12:08 PM.