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

EBME has been contacted by a concerned member interested in finding ways to reduce waste sent out with NEW equipment. This may include manuals, CD's, data sticks etc.

In some instances, hospitals buy large volumes of equipment and (because EU laws say manufacturers must provide information with every device) EBME Deptartments can be swamped with CDs, data sticks, manuals etc.

One example given was 300 thermometers all delivered with 300 CDs, and 300 user manuals (most of which went straight into the bin).

How can our members petition the EU to change the regulations on how device information is provided by manufacturers?

What do you, our members, think about this issue?

I am happy to work with you to take any ideas forward to the regulators. Let us have this debate here....

Hi all
It was me that raised this with John. I'm sure that all biomed departments have all done this. Ive thrown away masses of brand new manuals, CD's etc over the years, and it must be happening in every hospital in every country! Not only is thisi a waste of resources to produce stuff that goes in the bin straight away, its also included in the price you are paying for the new equipment, AND you also have to pay for it to be disposed of!

I raised the issue with the EU as its them that determine the laws about manuals. It took 6 months to get a reply, which Ive copied below.

Dear Mr Aldridge,

Thank you for your message.

We understand the situation specific to hospitals as well as the economic but also environmental implications.

However, it is a legal requirement for manufacturers to provide the user manual along with the medical device with no derogations to this rule.

We will certainly take into consideration your message and take note of this problem. We will bring this issue not only to the attention of our Unit but also to the attention of other services of the European Commission.

Best regards,


Eftychia Sideri

Eftychia.SIDERI@ec.europa.eu


European Commission
DG for Internal Market, Industry, Entrepreneurship and SMEs
Health Technology and Cosmetics
Unit GROW D.4

If you feel strongly as I do that this kind of waste should be stopped, please email Ettychia at the above email.
I would also propose that somehow as a collective we get a petition out to the EU and anyone else that might listen (suggestions?)
There are over 9000 members on these forums, which can be a powerful voice I hope.

Its 2020, so lets see if we can make a difference

Regards
Richard Aldridge
Lead Technologist, Royal London ACCU

Sorry guys, but this sounds like a "first world problem"* to me.

After all, for years many of us fought (figuratively speaking) to get "all available technical information" provided with new items of kit.

Why not just issue the user manuals to the users? No doubt they'll be asking for them soon enough, anyway (once they have become "lost", someone carries out an audit, following an "incident" etc., etc.).

By the way ... we're (the UK that is) leaving the EU shortly. Hopefully sanity will return to many areas soon.

* I hope you're impressed that I'm using the current woke terminology here.

Why don’t you just send the unopened Manuals and CD’s back to the supplier? If everyone did this, the message would filter from the ground up however the issue is bigger than that. Manufacturers, Hospitals and Trusts have an obligation to mitigate any risk associated with the use of the device and one of the go-to boxes to tick is the “User Manual” and all the associated use information.

Sadly, 2 ,3 and 5 yrs later most users won’t have access to these for various reasons, most of which are associated with the low level of value placed on an IFU. The old mantra “nobody reads the manual” still stands today even though searchable pdf copies means you don’t need to read it but should refer to it regularly ie the User Troubleshooting guide should be the starting point for a nurse or Dr to go to when they encounter a problem and not a note stuck on the device “ broken” and a biomed works request with limited details of the fault ( because they feel uncomfortable going into details as their make and model competence is limited )

This is not an individual’s or group problem – its everyone’s one problem including the patient when someone goes wrong ( something which manifests itself when you read how regulators [ MHRA , TGA, FDA, and others ]struggle to get equipment users to proactively report device issues .)

However, if you have the time ( and if you don’t go to https://www.bioclinicalservices.com.au/ ) having an intranet accessible User Manual Library will sort out some of the problems should you decide to send the extra 300 plus manuals back to the suppliers and help start the process to end this mindless process
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It would be interesting to hear from some hospitals who claim to be paperless as to how they handle this ?

Thanks george

Yes, on-line documentation is good ... but there again, so is user training.

Meanwhile, how about making users responsible for their equipment?

For as long as I can remember there has been too much "hand-holding".

User departments should have their own "library" of manuals (just a shelf in one of the offices or store rooms, or a cupboard somewhere handy); and it should be checked at each "audit" (accreditation) or (better still) at each "walk-through inspection" by the biomed(s).

The Head Nurse (and equivalent in other departments) should keep a simple log-book to record who within the domain has been trained from time to time on each piece of kit, with a signature to confirm that the user manual has been referred to (or better still, read) at each refresher session.

This is not Rocket Science, guys.

Change always happens slowly! This is not about Training (although that is important) it is about reducing waste.
I agree online documentation is good Geoff, and having a library of physical user manuals has never worked in any hospitals I have ever worked in, they get lost, become out of date etc.

Moving to a system where it is the responsibility of the supplier to provide an online resource that they keep updated is surely preferred in these days of smart phones, tablets, and PC's.

This would allow the users to access the information wherever they are and reduce waste.
There are always storage issues in every ward/department I have been in, so keeping a library of books in every dept is not practical, there are also a potential infection control risk (over time) with bugs growing on the 'physical users manuals'.

Online is the way forward in my opinion.

George, sending stuff back by post..., interesting idea, I wonder what the suppliers would think?

All very well (maybe) until the supplier "no longer trades" (aka, goes bust) or the manufacturer decides that "this equipment is no longer supported".

Relying on the internet is never a safe (or wise) policy ... in short, you are relying upon the "goodwill of others". Personally, I would rather have the manual in my hand.

The internet is brilliant when it works ... but (like all tools) it has its limitations; and what works in London may not seem so clever in [insert some random location somewhere in the world here].

On the other hand, having a library of user manuals available "on-line" over the hospital's internal network is a good idea ... but it sounds like more work for the biomeds (to create, and then maintain it).

Back to waste ... don't most hospitals these days have an incinerator? Sending stuff back by post sounds like a higher "carbon footprint" option to me (after all, its a long way to China) - it sounds like a lot of "effort" (and expense) too.

Hospitals have not been incinerating for around 20+ years. There are a few dotted around who have limitations on what can be incinerated though. A recent example in my last week was the delivery of a battery (x4 AAA) inside a box that would fit a small TV. This is common for manufacturers and its normally a case of one person finding the part on a shelf, then placing that package along the line that then gets packaged again as its for shipping, then the courier will place it in another box as required by the contract with the manufacturer. I have complained to the manufacturers about this but they are so far removed from the "process" that nothing gets done. A lot of it is to do with storage systems-a square box sits better on a shelf inside a warehouse than a circular shaped device.
We pay for this P&P and then pay to dispose of it. Start requesting free P&P!
Try your best to recycle correctly and make use of the larger boxes by using them when sending a device away. Also worth offering them to other staff on an internal intranet system, lots of people often use them when moving.
With regards to various CD's, this is a real problem as its not sensible to stick them in landfill, and trying to negotiate an online library of manuals is a tricky one unless you have a good education/IT department. My suggestion is that you give them back to the Reps.
I imagine the costs of sending the waste back to the manufacturer would leave you out of pocket quickly, its also counter productive carbon footprint wise. Work with your waste management and do some joined up thinking by ensuring that its recycled or re-used. A great former colleague of mine would often use the mantra "work smart, work lean, work clean".

There seems to be some drift away from the original topic here.
I'm not advocating no hard copy manuals as I think that they are of use. However if Ive ordered 300 infusion pumps, I don't want 300 manuals. They are rarely consulted, so no point in each ward having them. Electronic manuals that everyone has access to makes far more sense, and saves going round the whole building if updates come out. I actually think that its far less work for a biomed dept to add to a central library than distribute hard copies to all wards. Maybe this is a 'first world' issue, but the majority of large hospitals are in the first world, and I defy anyone in a Biomed dept in a large hospital to suggest a reasonable way of disposing of unwanted manuals in whatever format they come to you. Surely the best way to stop this is for the customer to chose how many manuals they want in the first place. Even if you send them back, the supplier has already charged you for them. They are obliged by law to supply them, and don't really care what you do with them once you have them on site.

I was hoping for more of a hear,hear I agree, where do I sign the petition type of response to this!