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

Hello

I am writing a risk assessment for adding a Fisher Paykel humidifier to a neonatal transport system. I am in contact with a few other services who have done this, but i wondered if anyone had any experiences they would like to share.

Thank you very much,

Ian Braithwaite
Senior Retrieval Nurse
EMBRACE, Yorkshire

No experience to date, but I'll be interested to hear how you get on, since one of our consultants wants to use a HFOV on retrieval, and I don't see how that will work with just an HME!

I'd wondered about the small 'home' humidifiers that some companies make to go with CPAP systems, as they tend to be smaller, lighter, easier to fix down and less liable to slosh water into the circuit when moved - but this is pure speculation and I haven't tried it!

Good luck, and please keep me posted!

Moira

Thanks. Having looked at various options I am hoping to trial a Fisher Paykel MR850 with a Babypac in the future. I have done comprehensive 'slosh' tests with 100ml of water, if you align the chamber holes along the long axis of the trolley you can turn it on its side without spilling a drop. Other services use the 'home' CPAP humidifiers successfully, but you have to be willing to accept a lower level of humidification and temperature, and possibly increased rainout. i'll let you know how it goes.

Other feedback welcomed!

Ian Braithwaite
Senior Transport Nurse
EMBRACE, Yorkshire

Inspiration Healthcare had a humidifier they were marketing a few years ago specifically for use in transport ventilation.

I discounted it at the time due to the manner in which they were suggesting that power be applied to it, therefore we never did get round to testing it at that time, but I believe they have overcome that problem since.

Might now be worth a look.

Regards,

Stephen

Hi Stephen

We used to sell a transport humidifier but because of the problems regarding CE if we connected it to the transport system, i.e. we would have taken over the CE for the entire transport system, we could not connect it ourselves, you had to. Anyway, it was removed from the market for a different reason and I recently saw a new picture of it but we are not involved with that product any more.

The humidifier I see on a transport system is either a 850 or more commonly the HC150, designed for home use and sleep apnea treatment.

Mark

Pity.

Could this be yet another case of over-zealous misunderstanding of the purpose (and, in my opinion, minimal significance) of the CE mark?

Or, worse yet, another "triumph" for the hand-wringing Nannies in charge at the Asylum?

Or even (simply put), hospitals being denied the use of perfectly good kit by the diktats emanating from the "liberally minded" lawyers (that is, not engineers, scientists or medics) in Brussels?

Maybe Geoff

As I understand it, if something is added (permanently) to another piece of equipment, either by a distributor or manufacturer, they then undertake the legal responsibility for the whole device. This is the reason we cannot add something, but if an EBME department wishes to, that is OK. I know that sounds really bizarre, but those are the rules.

Mark

For Information

Medical Device Directive (93/42/EEC)

Essential Requirements
The device must be designed and manufactured in such a way that, when used under the conditions and for the purposes intended, they will not compromise the clinical condition or the safety of patients, or the safety and health of users or, where applicable, other persons, provided that any risks which may be associated with their use constitute acceptable risks when weighed against the benefits to the patient and are compatible with a high level of protection of health and safety.The solutions adopted by the manufacturer for the design and construction of the devices must conform to safety principles.
In selecting the most appropriate solutions, the manufacturer must apply the following principles in the following order:
-eliminate or reduce risks as far as possible (inherently safe design and construction)
-where appropriate take adequate protection measures including alarms if necessary, in relation to risks that cannot be eliminated,
-inform users of the residual risks due to any shortcomings of the protection methods adopted.

Construction and environmental properties
Devices must be designed and manufactured in such a way as to remove or minimize as far as possible:
- the risk of injury, in connection with their physical features, and where appropriate the ergonomic features,
- risks connected with environmental conditions, such as magnetic fields, external electrical influences, electrostatic discharge
- the risks of reciprocal interference with other devices normally used in the investigations or for the treatment given,

If the device is intended for use in combination with other devices or equipment, the whole combination, including the connection system must be safe and must not impair the specified performance of the devices. Any restrictions on use must be indicated on the label or in the instruction for use.

A bit like "pass the parcel", then, Mark?

The last one gets left holding the baby, as it were. Or, put another way, if someone else adds another doodad since yours was added, then that's you off the hook?

Oh yes, very logical!

Solution (as you mentioned earlier):- leave it to the in-house techs to fit the thing!

Exactly Geoff!

It is unfortunate but I didn't write the rules, however, like you, I have to abide by them. Ask Paraid or Ferno for their advice on this as they will make a trolley for you to fit your extra devices but they won't actually fit them.

'tis a strange world we live in!!

Mark