EBME Forums Forums Management Medical Equipment Management Reducing waste sent with NEW equipment

No, we don't hold paper manuals and certainly not user manuals for a device this simple. Anyway, don't you know the "golden rule" Geoff, reading the manual is an admission of defeat!

Dave

Be that as it may, "the manual wasn't available" was a ploy often proffered (particularly by surgeons) following a "blame the kit" incident. So a better Golden Rule (for in-house hospital biomeds, at least) could well be:- CYA.

Back in my contracting days, "client - or previous contractor - to hand over service manual plus x copies of user manuals for each type of equipment" was always a clause in our bid proposal. If not forthcoming (usually due to having been "lost" - *stolen, most likely - during the previous contractor's tenure) we used to obtain the required manual(s) and charge for same at our usual mark-up. At the end of our contract, we in turn had to hand over the manuals to the incoming contractor.

* "Back in the day" there used to be quite a "brisk trade" in service manuals (especially, ... but also to a lesser extent in spare parts), whereby they would be spirited away to certain countries by aspiring freelance biomed techs - guys planning to start up in the biomed game back home. "No names, no pack drill" as "they" say. But suffice to say that I was approached a few times - and admit to turning a blind eye as long as only photocopies were taken. Hopefully, the internet has largely put an end to all that (apart from the parts, that is).

Anyway, the "original" Golden Rule was:- "Do as be done by". But, unfortunately, for a while now it has become:- "Whoever has the gold, makes the rules"!

I have introduced , or more to the post am introducing a system where the supplier supplies one copy of the user and training manual in electronic format. I then broadcast this out on the larger installs. For kore specific installs i target the the same way but ask for a Manual copy ( one only ) , scan and do the same.

We have a policy of packaging return and ensure that the packaging once separated from the device is collected by the supplier or recycled more internally however in the order we ask that plastics are reduced and excess packaging is removed prior to delivery. It seems to work and we have halved our run

If companies don’t play ball we up their carbon footprint on the wall of shame and across the network.




Is

Hi Electric blobby
So how does this packaging return work then?
Do you somehow build the requirement into your purchase order?
I do believe that all manufacturers are obliged to take away all the packaging anyway.

My real question is what do you do with the extra manuals that you don't want / need? Do these go back with the packaging? How do you stop them sending more than are wanted?
Agree electronic is the way to go, but from my experience, you will always get a hard copy in the box with every device, or a CD.
The whole point of this thread is to try and get some support to try and stop this waste from those unpacking all the shiny new kit. If we could chose what manuals we have (hard copy, electronic, both) and how many it would reduce this senseless waste.

Richard

"I do believe that all manufacturers are obliged to take away all the packaging anyway."

Not sure I would agree with you there. I had this discussion, many moons back, with a private cardiology clinic who had just taken delivery of their new stress system. A very large crate (treadmill) and cardboard box (monitoring) where left over and they asked me to remove it. I politely declined, pointing out that, once you have finished your box of cornflakes, it is not up to the supermarket to take back and dispose of the box. You buy the device, you buy the box too.

Now, that being said, where I currently work we have a good recycling system set up out on the loading dock where all sorts of materials are sorted and packed up to be recycled. We, the biomeds, do our bit and when OEMs are doing install I am more than happy to point them in the direction of the correct disposal point. I have always found them happy to oblige.

Dave

Going back to John's original question about excess manuals etc, with the introduction of the Medical Device Regulations that come into force in May 2020, for any device that is CE marked. In Annex I the section on General Safety and Performance requirements there is a section t hat talks about device labelling. This Chapter III of the GSPR.
REQUIREMENTS REGARDING THE INFORMATION SUPPLIED WITH THE DEVICE

In section 23.1 (e) it states the following

Where multiple devices are supplied to a single user and/or location, a single copy of the instructions for use may be provided if so agreed by the purchaser who in any case may request further copies to be provided free of charge.

So you as purchaser can agree with the manufacturer to supply single copies of the IFU at the time of purchase.

Just as a general note the introduction of the MDR will bring lots of changes, and for those pointing out the UK is leaving the EU, if a manufacture wants to supply a CE marked device they will still need to comply and it is very likely that a version of these will be applicable in the UK

Jon

Hi John

Do you have a link to that document please?
Reading what you have said implies that in future we can chose how many manuals we want to have.

I think that we need to make as many people as possible aware of this, so that they can make a choice at the time of purchase.

Thanks

Richard

Below is the link to the document but please note this is the MDR document that replaces the current MDD. As you will see it covers a large area with responsibilities for manufacturers, notified bodies etc.


https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32017R0745&from=EN

That's a very useful link Jon, thanks for pointing to it. I think it is a good option/ solution for those hospitals not wanting a user manual with every device.

That's alright, but please be aware that when you are talking to companies about these, they might not be aware as the MDR is a large document taking a lot of companies focus but this is a very small paragraph in it. Provide hem as much information about it and suggest that they talk to their regulatory team about it. As companies are so use to sending IFU's with all product taking it out for a large order will be unusual for them and would be a change in the processes that they are likely to have in place