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In-house (NHS) manufacture and use (by staff) of non-medical devices.. any regulations apply?

James

Involved In Discussions
#1
Hi all

I work for an NHS Trust. Our Clinical Engineering team have been asked to make a small number of products to hold a vial of vaccine upright during transportation. Its simply a flat plastic base with an upright pronged vial holder which is the correct size for the cool-bags that community vaccinators use. This product is low risk, and is not a medical device or an accessory for a medical device, but we plan to 'control' this development project as if it were.

This gotg me wondering about -in house' manufacture of 'products' for use by 'staff'. I've been looking at Consumer legislation and the concept of 'buying' makes this non-applicable to my context. The only thing that may apply is H&S at work Act and associated regs such as PUWER. We are risk assessing this device appropriately.

Just thought I'd put this out into the Elsmar community for views! Can employers essentially make products in-house for staff to use as part of their work, with consumer regulations not applying?

Cheers

James
 
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twanmul

Involved In Discussions
#2
This is allowed under "in-house exemption." There are some conditions you need to fulfill to be eligible, but yes this is completely permitted if you do. The MHRA have some fairly good guidance on this here.
 

James

Involved In Discussions
#3
This is allowed under "in-house exemption." There are some conditions you need to fulfill to be eligible, but yes this is completely permitted if you do. The MHRA have some fairly good guidance on this here.
Thanks for your contribution.. but this is not a medical device or for patient use. The MHRA guidance on HIE isn't great.. - IPEM have released some very useful 'best practice' guidance which is the stop gap reference in clinical science community
 

dgrainger

Trusted Information Resource
#4
There is an in-house exemption for medical devices when you are not placing a product on the market.
I would also have considered PUWER as the most appropriate regulation.

Be careful with your description, it could be considered as a device for "storing...liquids or gases for the purpose of eventual infusion, administration
or introduction into the body..."

Holding a vial upright during transportation wouldn't be a device.
 

James

Involved In Discussions
#5
There is an in-house exemption for medical devices when you are not placing a product on the market.
I would also have considered PUWER as the most appropriate regulation.

Be careful with your description, it could be considered as a device for "storing...liquids or gases for the purpose of eventual infusion, administration
or introduction into the body..."

Holding a vial upright during transportation wouldn't be a device.
Thanks.. the HIE doesn't apply in GB (only Northern Ireland).. Pretty much nothing applies as NHS institutions are a regulatory gap currently. Nevertheless, your comment is a useful one. We are making it very clear that our device does nothing apart from vial holding! PUWER was my view, so I feel more comfortable now someone has agreed (y)
 

mattador78

Quite Involved in Discussions
#6
Hi all

I work for an NHS Trust. Our Clinical Engineering team have been asked to make a small number of products to hold a vial of vaccine upright during transportation. Its simply a flat plastic base with an upright pronged vial holder which is the correct size for the cool-bags that community vaccinators use. This product is low risk, and is not a medical device or an accessory for a medical device, but we plan to 'control' this development project as if it were.

This gotg me wondering about -in house' manufacture of 'products' for use by 'staff'. I've been looking at Consumer legislation and the concept of 'buying' makes this non-applicable to my context. The only thing that may apply is H&S at work Act and associated regs such as PUWER. We are risk assessing this device appropriately.

Just thought I'd put this out into the Elsmar community for views! Can employers essentially make products in-house for staff to use as part of their work, with consumer regulations not applying?

Cheers

James
So technically you are making a "stillage for transportation" would that be close to the mark? So therefore would this not be more of a packaging procedure than a product as such and could be controlled that way through a generic risk assessments and PUWER as you say. We manufacture some of our jigs and trolleys for our own use here and just apply basic risk assessments to them, haven't had an issue so far with it and thats after the HSE coming into us due to a accident at work. I think the grey area is proving what you manufacture does not compromise the integrity of the vaccine vials.
 
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