What gets my goat is what happened last Friday. An item came in for testing for a loan.
We were told about it at the last minute, but the surgeon had been approached at least twice beforehand to arrange and "sell" the product. EBME/Medical Physics is of course not important enough to be included in the arrangements. I actually told the rep that I was not impressed at the delivery note being seen as a rubber-stamping exercise...
The item was CE marked, but was evidently at least four years old (from an old safety test sticker).
When I asked for proof of a service history, I was told there wasn't one because it was not needed, as decided by the American parent company. The proof I was given for this lack of need was a proforma PPQ from 2003... with the service required box completed with "NO".
It would not be so bad, but the rep was describing it as a non-invasive item, even though connecting it involves electrodes in an ET tube and nerve stimulators/sensors applied directly during open surgery. That is pretty darned invasive in my book!
This machine is a glorified TENS/feedback system run through what looks like a privately-programmed 486 PC. Our hand-held stimulator devices from another company are not computer driven, but they get checked out regularly, as are TENS machines. So why should this unit be any different?
I asked for technical help, but apparently the rep thought he was sufficiently qualified as a technical advisor and a surgical trainer and everything else. There is no technical service in the UK, and there was no access to talk to the engineers in the Netherlands (where these items go if they need repairs - £10,000 of kit is worth repairing).
I would not like to be operated on by any surgeon however good if s/he was trying to use an unfamiliar piece of kit guided only by a non-surgeon desperate to make a sale.
The PPQ just allows the company to tell us about the equipment and their services. I think they should be used more to force the poorer-performing companies into providing a better service.
