Medical Devices: Initial Design - Sterile or Non-sterile

J

Jimmy the Brit

#11
We do, on the other hand, determine as an element of design control whether a product must be able to be sterilized.
I think this is a very pragmatic response and one that I will certainly consider. Whilst reusable devices present all sorts of challenges for the supplier (you have to be able to demonstrate that a specific cleaning regime is effective at removing a replica test soil, and then that the device can survive a specific number of cleaning/sterilization cycles)

However for a single use device that the customer may want to buy in bulk, non sterile (maybe in order to include in a theatre pack /ER pack of their own design before sterilization, as Roland suggests), ensuring that the device can be sterilized and stipulating the method, provides additional value to the customer, without adding cost that offers them no value, and may even increase their costs (if they have to repackage).

Thanks for the concept,

Jimmy
 
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