EBME Forums Forums Management Medical Equipment Management Inhaled gas humidification on neonatal transport

A new role for in-house biomeds, perhaps ... assembling systems from all the various component items.

A bit like the old MFI flat-packs (are they still around?).

Anyone fancy a bit of DIY?

Anyway, it gives a whole new meaning to the word "kit", I suppose?

Not at all!
The MDD directive is sound guidance. It clearly looks not just at medical devices in isolation, but when they become part of a medical system.
It’s not just the last person to add a device to a system is responsible; you clearly have the wrong impression Geoff.

Medical Devices CE marking is a costly business, I would wager that the cost of redesign to comply with the EMC directive is the main reason why any manufacturer would think twice.

And the view that a Manufacturer can suggest that its okay leave it to the EBME Dept to connect it, and thus devolve a Manufacturer from responsibility is flawed for obvious reasons.

OK then, but who does take overall responsibility (in the "manufacturer" sense) for a complete system made up of a number of distinct items of equipment?

Two examples that spring to mind are "theatre stacks" and (of course) transport incubators.

I am sure that many of us have encountered "lash-ups" of these ... especially the second example mentioned.

MDD and CE marking only applies if you are bringing it to the market place.
You do not have to get CE marking etc if you are making it for use by your own organisation.
We ahve just finished making a transport incubator system by bolting lots of bits together. Each one is a CE marked device and if we were selling it we would have to get the system CE marked - but we are not so no problem there.
RoJo

Yes, perhaps this will become a growing trend ... in-house biomeds assembling their own systems (as Mark and I have already suggested).

Who knows, that way hospitals might even end up getting the kit they actually want ... and we may return to well-known "labels" such as Nuffield, Radcliffe, Brompton, Warwick, Sheffield et al. And why not?

Thanks for your input everyone. we did look at the transport humidifier (the worringly titled "Lavabed") from Inspiration, but as Mark said it wasn't CE marked. Mark, do you know if anyone else has taken it on?

As far so the systems go, we buy our trolleys from a manufacturer telling them what equipment we plan on using, then we source the monitors, pumps etc separately and fit them ourselves, unmodified. Because our systems are relatively new, every piece on it and the trolley itself is serviced by a different manufacturer.

Ian Braithwaite
Senior Transport Nurse
EMBRACE, Yorkshire

And you can bet your life that if something "happens", each will be blaming the other!

Don't you have a servicing capability in-house then, Ian (or are you referring here to a warranty situation)?

If not, it sounds like you may like to consider an independent service provider.

PS: I am reminded of the Happy Days when manufacturers such as Vickers made (and were proud to support) the whole thing! So much for so-called "progress".

They are all still under warranty, when that expires i guess it will all come in-house.

I would love there to be a radical rethink on transport incubator designs. I've seen some exciting developments in Australia. Unfortunately when the user specifies equipment and the trolley manufacturer designs around that spec, it is hard for anyone to make significant steps forward which consider the system as a whole.

Ian

I know that things may have moved on a bit since the days of the Vickers Model 77, but at least it was what could be called a coherent design.

As I have mentioned a few times before, many transport incubator "systems" I have encountered have been little more than "lash-ups", so I can well understand why any "inspector" may not be overly impressed!

As mentioned in posts above, perhaps the way forward here is for specialists such as yourself to lay down the specs (the requirements) and either build the system(s) yourself, or have a third party put it together on your behalf, and service it (as a system) as well.

Any "issues" about CE marking, the removal of the "Made in China" stickers, the colour of the cables, the phase of the moon (and any other as yet unforeseen objection by Mr.Jobsworth) ... could (I am assuming - or rather, hoping) be overcome by folk such as yourselves (ie, government agencies) underwriting the whole exercise, and taking full responsibility.

OK, Ian ... start designing. I know "third party" people who would be happy to collaborate.
__________

PS: although it is appreciated that your requirements may be special in some regards, why not develop your "spec" right here on the forum? It could be our New Years Challenge! That is, to lay down a generic spec (and then progress to specifics of manufacturers and models for each component equipment) for a decent transport incubator system. Here's a start:-

1) Basic system to comprise:-
- folding trolley (lightweight - aluminium? lifting handles, straps) ... use big wheels!
- neonatal incubator (small size, transport type, removable, portable) - basically DC operated? If mains, system will need an inverter
- ventilator (limited, but adequate for purpose ... select with care! detachable, but can also move with incubator when that is detached)
- humidifier (again, suitable for the rigours of transportation ... DC operated?)
- monitor ... many to choose from (which parameters?)
... ECG
... oxygen
... SpO2
... temp
- suction (small DC pump ... but nice to have one powered by oxygen/air cylinder as well)
- storage space (drawers, boxes, tray(s), baskets - swing out?) for supplies, accessories and consumables (plus adaptor cables etc.)
2) Must be compatible with front line ambulance vehicles (voltage?) - are these standardised yet? (oh, I thought not!)
3) Must be compatible with air ambulances (voltage?) ... standardised? (I guess I already know the answer)
4) Must be able to perform for [ ] hours without power from the vehicle or mains electricity (that is, must have its own battery backup for):-
- complete system?
- heater and ventilator (plus humidifier) only? ... etc., etc.
5) Must carry own oxygen and air cylinders. Size? Duration? Also adaptable to ambulance (and hospital) PMG as well
6) Must work from mains power (of course) ... will a limited UPS be needed?
7) Power supply "box" to allow easy adaption (that is, possibility to operate from a variety of power sources ... such as, in a limited way, from an ordinary vehicle's "cigar lighter" socket, vehicle battery - 12 and 24 VDC - etc.). Also needs auxiliary outlets (for monitors, syringe pump ... laptop PC? ... and all the rest)

... etc., etc.

We have a lot of clued up and experienced folk who get on the forum, so why not kick it off?

See also earlier threads:-

One
Two
Three
Four
Five
Six
Seven
Eight
Nine

Mmmm. Good thoughts.

I used to work in Australia for a region transport service. They designed, built and maintained their own neontal systems inhouse as there was nothing on the market that met their weight + Gforce requirements. It was a very expensive and very long process that consumed a lot of resources.

The benefit was that they got a bespoke system that met their requirements. The power supply was very clever, able to prioritise and divert charging current to the various components to ensure that the max current draw was never exceeded. It would run off mains, DC and even Quantas! Even had a USB socket to charge your phone :o)

The downside was that the lead time was measured in years, and it is a process that they could only afford to go through as an organisation once a decade.

In comparison we were able to purchase 4 trolleys almost off the shelf and have the systems up and running in a matter of a few months. The downside is that they weight too much, they are not crash tested as whole systems and their design allows for no vibration damping. It's all a compromise.

I know a UK service that tried to design their own system, but even though they wanted 4 trolleys they would have had to order about 8 and would have lost 4 to destructive crash testing. It just wasn't cost effective within their budget.

I understand that there are already draft European standards for transport incubators which specify a weight and crash resistance parameters. Unfortunately we are not going to be able to meet these requirements unless we start considering the systems as a whole. The only system in the UK that passes at present is the paraid aeromedical trolley.

Joe O. Moseti, Senior Clinical Engineering Technologist at Nottingham University Hospitals NHS Trust is currently doing a national survey of neonatal transport systems, which will be interesting.

Lets keep thinking ... i might work on the spec in my downtime!

Thanks

Ian Braithwaite
Senior Transport Nurse
EMBRACE, Yorkshire