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
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