If a re-usable medical device cannot be labelled directly due to the effect it will have on it's safety, is a manufacturer obliged to inform customers to record the UDI from the associated packaging to enable traceability?
I think this is a question that should be directed at your local authorities. It may be that in UK they have a different set of expectations than either the US or the EU. My understanding is that the UK is currently thinking that they will be somewhat different than either FDA UDI or EU MDR. Generally speaking, the healthcare regulators recognize that DPM cam be difficult. They have extended deadlines for marking reuseables with DPM to allow for testing, equipment installations, programming, etc.
I've posted this into the EU Medical Device Regulations forum as the UK are still a part of the EU and therefore governed by EU Regulations for medical devices, I have, up until now, heard nothing to the contrary. Can you tell me how you have the current thinking that the UK will be somewhat different than EU MDR? Also, what is DPM? I feel that this is probably something I should already know, so I'm hoping I have another initialism for it.
DPM is Direct Parts Marking, the term used for laser, dot peen type barcodes that are permanent on the product.
Regarding EU and UK regulatory, I recently saw a reference to the UK Minister of Health, Cost and Import Control and a request to add 20 additional fields to the UDI database specific to UK. EU requested an added 60 fields. I may have jumped to an incorrect assumption that UK was paving their own trail somewhat.
Looking at the new MDR annex VI (UDI), for reusable devices there are exceptions to direct marking of devices paragraph 4.10 reads "Devices that are reusable shall bear a UDI carrier on the device itself. The UDI carrier for reusable devices that require cleaning, disinfection, sterilisation or refurbishing between patient uses shall be permanent and readable after each process performed to make the device ready for the subsequent use throughout the intended lifetime of the device. The requirement of this Section shall not apply to devices in the following circumstances:
(a) any type of direct marking would interfere with the safety or performance of the device;
(b) the device cannot be directly marked because it is not technologically feasible."
Therefore if you can show in your risk managemnt process that DPM would adversely affect safety, you can justify not DPM.
As Mikem suggested DPM can be in different forms, we use an inkjet printer, i have seem laser etching on stainless steel surgical instruments,
Here is an example (from a google search) Sic Marking | Datamatix marking, dot peen datamatix marking, laser datamatix marking
As for Brexit, i doubt very much that we (UK) will replace these regulation beforehand.
I know that we don't have to do it, and I can certainly justify via risk assessment the reason why, but I'm wondering whether if the device is not uniquely identified a system should be in place to ensure that it can be traced. For example, the device is put into use in a hospital that is full of previously ordered devices that they have purchased from us before, and nobody records the serial number from the packaging and assigns it to it's location. A few weeks later we discover that there is a manufacturing fault associated with a certain batch of raw material in our product, and need to recall the affected devices. On contacting the hospital that has received one of the affected devices, how can they identify it amongst all the others? Is it just enough to accept the fact that all devices must be returned? Is the onus on the customer to have a system of traceability at their facility, or us as the manufacturer to inform them to do so?
As long as you are complying with the regulations and giving the customer the means to trace the device i.e. LOT or batch number is on device, either as human readable information or in the form of a barcode, there is little more than you can do. Traceability to the point of use by the manufacturer would be an impossible task. The new MDR article 25 requires (my interpetation) traceability to the healthcare institution or healthcare professional, no further.
The Health institution has to record UDI for class III implantables and Member states may require that records are kept for other classes of devices:
9. Health institutions shall store and keep preferably by electronic means the UDI of the devices which they have supplied or with which they have been supplied, if those devices belong to class III implantable devices.
For devices other than class III implantable devices, Member States shall encourage, and may require, health institutions to store and keep, preferably by electronic means, the UDI of the devices with which they have been supplied.
Member States shall encourage, and may require, healthcare professionals to store and keep preferably by electronic means, the UDI of the devices with which they have been supplied with.
I agree with Rob's opinion. You can only do what you can do (and are responsible for).
Whether the hospitals actually take advantage of the easy traceability is up to them - and of course their accrediting agencies, their insurance companies and government regulators. All of these players have an interest in promoting best practices. Here in the US we have JACHO, CMS (Medicare) and the FDA in those roles. Eventually, untraceable devices will be in the rear view mirror.