EBME Forums Forums Management Medical Equipment Management Safety Test Results: To keep or not to keep?

Our current system is a mix between paper + paperless

- Initial inspection is logged / printed using our 601 Pro and attached to the Log book of the equipment

- Subsequent tests as part of PM / Repair etc are not printed using the 601 pro, but transferred into a seperate database which simply 'Refreshes' The Last inspected date of the downloaded records.

- Our main database is then automatically updated with the 'Last Inspected Date' of the device so we dont have to manually log those onto computer. Our log books are signed to indicate the tests have been done but the computerised side is pretty much automatic.

- The main database is then queried automatically to download the 'Location' 'Manufacturer' 'Serial Number' etc to "Freshen" our dedicated 601 Pro Database, so that when we go to inspect a department again, we can transfer a department to its memory and all we have to do is Scan/Enter the "Registered / Unique number of the equipment"

Its a reasonable system, as yet we havent added any Trend analysis or logging of this data automatically, but essentially its possible to download that data also. I supposed if it becomes mandatory for EBME technicians to keep xx years results (like x-ray units) then we may have to make some modifications to the 601 Transfer software / Database structures to hold them.

We record all safety test results as follows:

Equipment is tested on one of several 601 Pro,s. All jobs that have tests on a tester are flagged in our SEM's job confirmation area. Twice a week these jobs are formed into a group which attaches a template to them. The the 601's are downloaded in turn, the records confirmed and passed into history.
This gives us a record for each job and trend data.

Equipment is tested on one of several 601 Pro,s. All jobs that have tests on a tester are flagged in our SEM's job confirmation area.
>> like a flag for things that are electrically tested? I havent used/seen SEMS so sounds interesting

Twice a week these jobs are formed into a group which attaches a template to them. The the 601's are downloaded in turn
>> You mean you can transmit from your SEMS database to the 601 pro, telling it the device information/location/Serial no etc (Equivelent of Passing a DEPARTMENT to the 601's database?)

>>the records confirmed and passed into history.This gives us a record for each job and trend data.
Ah, do you use the biotek program to download the 'Results' of the tests to put in your SEMS database, or is there a 3rd party application that you use to do it?

IBS, who are the SEMs supplier provide a transfer program for the 601. They also provide transfer programs for several other testers.

If I understand the essence of this thread, the majority of replies seems to suggest the keeping of electrical safety results (which I also do) on the basis of 'what if we had to give evidence' in a coroners court.

Can I ask 2 questions:

Have any of you had to give evidence to ANY court of law in respect of safety testing?

Have any of you had to give evidence in respect of a devices maintenance?

The question of whether to test/not to test is not at issue - it is part of our raison d'etre, just as the correct training and fitting of parts, servicing, calibration of equipment is. Are these results any less important to patient safety/well-being? Do we record these with automatic test equipment so that 'evidence' can be seen not to be tampered with?

Yet what is the more likely if you are summoned to give evidence? I suspect that evidence of a devices correct maintenance/calibration, and technician competence/training will top the bill.

I agree with the legal principle that 'if it not documented, it did not happen' and 'good documentation = good defence', but what makes manually written statements about a devices calibration adjustments any less credible than the printout 'pass' from a safety analyser?

Why do we see it as acceptable to empower our technicians by virtue of their training,qualifications, to carry out such important tasks + take responsibility for their work, yet we insist that safety results must be hardcopy/tamperproof 'just in case'?

The argument for keeping results as a means of 'seeing a problem coming' is equally woolly.
In my (20 year )experience, I have seen the improvements in safety, borne through technological, standards, and materials advances. When I started, problems of insulation resistance/high leakage where common, gradual degradation could be seen at each inspection. Safety tests used to have a real purpose.
Today, components on the whole are far less likely to suffer degradation (except from the repeated hammering we give them with our analysers!!). If a device passes the acceptance test, then it has a very high chance of never failing.
The real problems are those caused in 'normal use' - crushed leads, fluid spillages etc etc. But even they are irrelevent to this arguement. It is still a question of justifying the need to record ACTUAL tests.


I remain to be convinced, and am currently risk assessing my whole programme. Keep up the healthy debate - hopefully we may reach an acceptable solution in the absence (as always) of central guidance.

Paul,

Risk Assessing..now there's a topic someone should start a thread on...

I've had to give evidence in a coroners court. The equipment was battery operated so safety testing wasn't an issue, but I was certainly asked about the servicing and calibration of the unit.
I said earlier in this discussion that my department safety test everything when it comes in to be mended. This isn't strictly true. We safety test any directly mains connected equipment which we have had to open up the case and delve around inside. The reasoning behind this is that if you've dismantled it, it's always possible that you haven't put it back together properly - or a wire has dropped off whilst you were struggling with the case - so a safety test confirms that all the earth connections are in place and nothing is making contact where it shouldn't be. We have even found trapped wires because of the increase in leakage current - so it does work and is worthwhile.
As to recording the results - I can only repeat that we found a mains transformer which was gradually breaking down (due to fluid getting into the windings) and had a replacement made and fitted before it got to the point of failing. Without actual results to work with, we couldn't have spotted the trend and wouldn't have known about it untill it actually failed the test - or went off with a bang ! Either way, the equipment would have been out of service for several weeks.