EBME Forums Forums Management Medical Equipment Management PPQ or no PPQ

Hi all.

I did let it in, because it was only on trial for one day and my team leader said that the indemnity form put all the onus onto the company. I suppose that is better than nothing but I still have reservations. I don't like reps who carry on as if I'm just being dumbly obstructive for the hell of it; I am trying to prevent a potential injury or death, for goodness' sake.

The equipment was not essential to the procedure - surgeons have managed to remove tumours and whole thyroids from patients perfectly OK without it in the past. My mother will tell you that!

If the surgeon does decide to buy it, I hope we manage to find out in time to get the Risk Management team to listen to the reservations from our department.

According to the rep, this model has been used for several years at two other local hospitals and nobody has flagged up the lack of a service schedule for it before. Though we all know what reps will say to try to get their equipment accepted, right?

Brian: The initial was right, but your guess is wrong! I daren't mention the company outright in a fairly public forum like this because there could be repercussions, for me, my hospital or both. I'm sure that you can appreciate that. A PM might be a different matter, especially if you are potentially facing accepting the same equipment.

Each and every one of us has "the power" to do the right thing, Mate, regardless of who we are or what is our status.

Claire, your team leader, and the "other hospitals" are all wrong ... and you're right! Myself, I've refused to accept cr*p on a number of occasions, and yes, I was given a bit of grief over it. But each time, when given the opportunity (by me) to sign in my stead, "they" (the surgeons, etc.) always "dipped the shoulder" (that is, didn't have the bottle to do it).

Rest assured that in the meantime your surgeon will do absolutely nothing to get all the boxes ticked (unless, that is, he happens to be "the exception that proves the rule"). Take my tip, always stick to your principles. If something feels wrong, it's usually (always) because it is wrong.

The rep wants his commission, the surgeon wants his toy (which, not long after he's bought it - with taxpayers' money - will be found languishing in the back corridor), your boss wants to "keep the peace", whilst you take the flak. That's the name of the game, in my experience anyway.

Sometimes biomeds just have to be tough!

Hi Clare

You are right to ask for ample time and details, so well done.
Safety Notice 2002 (17) is quite clear on these matters. For example 'service history' requirement, so the particular company you were dealing with were talking utter rubbish.

The link below is for this safety notice, all technical managers received this and no doubt told their Trusts that they action this. I doubt this in many cases, we are very strict in our Trust and we do not have the problem which you have had. As others have said here the Risk Manager and all medical staff are fully aware of the policy regardiing these matters, assuming that your Medical Devices Policy covers such matters, it should.

http://www.mhra.gov.uk/Publications/Safetywarnings/MedicalDeviceAlerts/CON008779

Go to the download section for our PPQ Supplement Forms 'A' and 'B', they serve their purposes very well for our Trust.
Your team leader needs to be a bit more robust to ensure from a risk perspective that the Trust and patient are always considered first and not the supplier.

Jim

I believe my team leader was right - the risk was squarely on the supplier, and the equipment passed its electrical safety check including patient leakages with flying colours. We are very strict here, which puts some reps off!

The real would be if the Trust chose to buy it. If we just take the comapny's word for it that there are no service requirements on this kit, I think we would be very silly. It would be us in the dock if there was an incident caused by lack of maintenance, however much we waved the PPQ.

Is ther anything beside the PPQ that gives the Trust a legal challenge to the statements companies make on the form? If a company days "it does not need servicing" but common sense says otherwise, how can we force the issue?

You do a risk assessment and refuse to okay the item on that basis.

Lee

I was expecting something like a British Standard or similar that said which kind of equipment could legitimately be described as "not needing servicing", or defining equipment that always should be expected to receive regular servicing.

While we can do a risk assessment, it would be nice to have something with a lot of clout behind it!

No, your team leader was wrong. As Jim suggested, a bit more "robustness" is in order. Just because a company carries insurance, that doesn't mean that everyone else should simply shrug their shoulders. In my humble opinion, if the rep can't demonstrate that the kit has been serviced, and, in fact, can't see any merit in equipment servicing at all (!), then the kit stays firmly outside the door!

Remember that you are the customer. You don't have to justify your actions to them (the vendor). The boot is squarely on the other foot! Any talk about "partnerships" and stuff like that is just BS. They are trying to sell their equipment, plain and simple. And they'll be laughing all the way back to the (sales) office if you allow them to "put one over" on you.

Meanwhile, take a look at this previous thread.

There are two scenarios:

Mrs Smith, we will not be using this new equipment on your husband as we do not feel it is safe to use.

Mrs Smith, we are sorry about the injuries to your husband caused by this new equipment, but do not worry the company is insured.

I know which I prefer.
Robert

DB 2006(05) says

In the notes it then says


So according to DB 2006(05) as the manufacturer says it doesn't need servicing (make sure its in writing) and it will not be used very often you don't need to worry?

Lee

Lee is starting to see the problem I was concerned about!

In this instance, the manufacturer reckons that - loaned or purchased - this machine will only ever need repairs when something obvious goes wrong, and does not need servicing at all.

So our hands are tied somewhat, by the very sort of document that should be helping us to reject equipment that is inadequately supported, if what Lee has found stands.

The MIA list on PASA seems to be viewed by some reps as a kind of free pass into the hospital. It is meant as a guarantee to the hospital that the fallback position of the insurance policy is in place, should the worst happen.

This is why I wanted to know if there was any British or International Standard covering when equipment can legitimately be described as "not needing servicing"; it does not seem to exist, except to give the manufacturer the last word!