EBME Forums Forums Management Medical Equipment Management INDEMNITY

Question,
What testing do you do when a piece of loan equipment comes in, if any.
Do you insist on any records of testing from the loan company, e.g is the rep saying its ok acceptable?
Would you sign to say you have tested the kit at the point of delivery?
All the above assumes the correct Indemnity has been signed.

I personally visually inspected the machine (including the mains lead/plug) and electrical safety test it. An indemnity form is completed noting the Master Indemnity number, then the rest is up to the company, it’s their equipment and their responsibility.

Hello Karl

As always SN 2002(17)available on the MHRA website, received by all EBME bods in 2002. Completed by all of us, that we do as stated in this safety notice, which has not been replaced by any other notice and is thus still in place.

Service history is required for all loan, trials or evaluations.
Full testing is carried out at all times, documentation, etc.

Always surprises me (not) that the representatives say that they have never been asked for the service history before. I give them a copy of the Safety Notice for reference as they think I am being awkward.

So, it is all or nothing. All documentation, testing or it does not go into clinical use. Easy!

Jim

Trust you to have all the answers Jim - I'd thought you'd retired!
The same notice was sent out in Scotland by SHS. Unfortunately, due to ever increasing demands, I doubt that may depts follow this SAN to the exact word.
Here we perform EST and ask for a demonstation by the rep. This is really important as we may have never seen the device before, so how can we check it?
The Indemnity used south of the Border is not a legal document in Scotland. Hence Scotland has its own Master Indemnity Register and also its own Indemnity Form for those on on the Register.
All that from a Welshman Jim.

Hi Graham, you are older than me.

I did retire, but I did not tell them and they did not tell me. I am thus a victim of circumstances.

I was on a course not so long back and the head of another department told me that his department do an EST on ventilators when in on trial or commissioning. Asked him if he checked for leaks, volume, flow, I:E, pressure support, flow-by, cpap, simv, cmv, etc. 'No', just an electrical test.

Outstanding, what???

Jimbo

Mmmmm interesting so he could proove it was electrically compliant but the fact it gave a Vti of 1200mL when set on 300 doesnt really matter I suppose !!!
But then did the department concerned have gasmen or just soldering iron walers.
My main concern was that we've had a supplier in recently who asked us to sign that we had tested the kit when it was delivered on loan (fine) but they also wanted us to state what tests we had done.
Of cause we have this data on our MEMS for trust use, but never been asked for it before in the case of testing a loan device.
I wondered if such a supplier was intending to use the data given if there was any future problem to proove such and such a bod did such and such tests on such a day and it passed.

Hello Jim,

Not all EBME department do vents. Some do just the general ward type devices. In those circumstances, they cannot carry out a full functional.

Even in departments where they have the expertise such as yours, there will inevetably be devices that you cannot functionally test - Lasers for example.

I think in many cases an EST and visual inspection is adequate (alongside the indemnity form MIA number)

For On-Loan/Evaluation lasers that I'm unfamiliar with, from companies on the NHS master indemnity list, I request a PPQ, Delivery note/local indemnity form (rather than NHS "form A"/NHS delivery note), instruction manuals and technical literature (if available). Also any information relating to applicators/accessories being loaned/supplied and servicing options.

On receipt we do electrical safety tests, importantly we check the suitability/integrity of the PPE provided by the company, notify the Laser Protection Supervisor(s) on site, then the Laser Protection Advisor for the trust (who generates temporary policy and advises on safety aspects/use on-loan/Evaluation).

Obviously local laser policy should also cover devices on-loan/Evaluation that are new to the trust. If it doesn't then that's a problem. Operators and technical staff need to be aware of the predominant risks associated with class 3B/4 lasers in particular and with new applications.

For manufacturers that are not on the NHS master indemnity list then an indemnity "form A" and an NHS delivery note signed by authorised individuals, e.g. managing director of the supplying company, etc, are required in addition to the other stuff listed above to ensure that the trust is fully indemnified.

With lasers those carrying out the on-loan checks really need to be aware of the controls that should be in place to avoid unsafe practices. Ideally lasers should not be output tested or even serviced outside laser-controlled areas - not at all unless technical staff are trained/authorised to do so.

To prevent unauthorised operation outside clinical areas then Key-control, i.e. who has access to keys, is important.For new installations then I'd expect the manufacturer or agent to provide documentation relating to output checks, electrical safety checks and installation.

Isn't SN2002(17) intended for equipment on permanent loan (feeding pumps come to mind)?

What is deemed to be the "official guidance" these days for dealing with equipment (typically theatre equipment, and therefore carrying serious risk consequences in my view) brought in for a few days for "Mr. so-and-so" ( ... insert the name of your favourite surgeon here) to "trial"? (... or play with, or carry out one-off surgical procedures with clever kit "hired" free of charge - that's how I see it).

Personally, I have never been happy with this way of going about things, but I see it happening almost daily when I'm working in hospitals. Is the MIA number, and a quick electrical safety test enough? I don't think so, but I always seem to be in the minority on this issue. Does anybody know which piece of paper I should be pointing people towards?

Geoff
Para 3 of the document refers to equipment "on loan, rental or trial", so the equipment that comes in for trial before purchasing or "trial" for a one off particular patient is covered by the Safety Notice.
And as Richard says, if the company is not covered by the MIA number, the full Indemnity Form should only be signed by Board member of the Supplier. In all cases, whether its the full Indemnity Form, or the MIA receipt note, all details such as serial number must be completed.
Graham