UDI-PI requirements on reusable surgical device, do we need serialisation?

P

pointer_mike

Registered
#1
#1
Hi,
We are currently adding UDI information across our products and are unsure what we should do.

We manufacture a reusable surgical devices that has an element that is removable and can be autoclaved. The removable element has its own SKU.

We are unclear as to whether or not we are required to serialise the UDI-PI that is permanently marked on the device, we can see benefits to doing so but it will be a major headache logistically (with significant cost implications as well) given the numbers requiring marking and creating unique artwork for the marking sub contractors (I think all stakeholders agree that when we bring the process in house there are tangible benefits to the customer and us to serialising the devices) currently we engrave a human readable code but we are getting feedback from our distributors that they would prefer a machine readable 2D barcode.

So put simply, are we able to stop serialising them temporarily until we bring the process in house?
 
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P

pointer_mike

Registered
#3
#3
On rereading MDR Annex VI part C The UDI system (part 1) Definitions I realise now that I was getting overly hung up on the word unique and taking that to mean that serialisation was required.

It specifically states that "The word ‘Unique’ does not imply serialisation of individual production units. "

However, Annex VI part C The UDI system (part 2)
6.2. Reusable devices requiring cleaning, disinfection, sterilisation or refurbishing between uses

6.2.1. The UDI of such devices shall be placed on the device and be readable after each procedure to make the device ready for the next use.

6.2.2. The UDI-PI characteristics such as the lot or serial number shall be defined by the manufacturer.
Click to expand...
Seems to suggest that we can define what goes on the reusable element and it is unlikely that a risk assessment would conclude anything other than serialisation being required as multiple probes from the same batch might be in the same kit and/or new probes may be added at a later date and theater staff would need to be able to identify which are sterile and might need to be able to identify which probe has been used on whom, it's also possible that I am over thinking this and thinking of serialisation as a solution to a problem that hospitals don't even know they have!
 
planB

planB

Super Moderator
#4
#4
Device traceability and preventing mix-up of re-usable devices at the healthcare facility is the sole responsibility of the healthcare facility, irrespective of whether you define lot or serial numbers for your devices.
 
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