UDI requirements for serialized medical devices with multiple configurations

[Java23]

Hi,
Not sure if I am in the right forum so sorry if not! I am working on UDI and the project charter / presentation etc. to start this project.

The devices I am referring to are Class II serialized, re-usable (reprocessed as we instruct to clean (wipe down) the device between patient use).

I began to make a list of the devices by model number thinking that each model would require a UDI. I thought I was on the right path until listening to a Reed Technology webinar where by the QA session addressed a question about serialized devices with multiple configurations.

I am now second guessing myself. The devices are built and depending on what fittings and adapters are requested by the customer, are shipped with those fittings/adapters which creates a new part number.

The base part is given a number ie; XXXX-XXXX-XXX. The middle 4 x's contain the base model number. The last 3 digits continuously change depending on the fittings and adapters.

The current label affixed to the device contains a serial number (which is for the base model).

The device is plastic on the surface so, I don't think etching will work - not sure of what other options may be available (other than a seperate UDI label).

Question: Is the UDI determined by the base model or would I need to apply a UDI to every possible configuration?

Question: Since space is limited (very small labels), and given that the device is re-usable, is it appropriate to apply the Direct Marking in the form of a label that is attached somewhere else on the device (on the side / under the current label)?

Question: If a seperate label is acceptable for Direct Marking, wouldn't it need to be validated or tested in some way to assure that cleaning/wiping does not affect the integrity of the label (since it needs to remain intact for the lifetime of the device which is approx. 12 yrs.)

I know I have asked a lot of questions here - sorry!! I am on "overload". I could use some help and definitely some training. So far, I have watched just about all the "free" webinars I can find. If anyone has information as to where I can get training, please let me know. Been to CDRH Learn, Reed Technology, GS1........I need more.

Thanks in advance to all - all help is much appreciate!

 

[Stijloor]

A Quick Bump!

Can someone help?

If your questions were answered here, please consider helping others.

Thank you very much!

 

[Java23]

I think I have found a bit of the information I needed. See IMDRF Final Guidance Document for Unique Device Identification................

10.5 Configurable medical device systems

For configurable medical device systems the rules listed below should be followed:

1. A UDI is allocated to the entire, configurable medical device system and is called the System
UDI.
2. The system UDI-DI is allocated to defined groups of configurations, not per configuration within the group. A group of configurations is defined as the collection of possible
configurations for a given product line as described in a regulatory file.
3. A system UDI-PI is allocated to each individual system. A later change of a component, sub-systems or accessory of the system does not change the UDI-PI of the system.
4. The carrier of the System UDI should be put on the assembly that most likely does not get exchanged in its lifetime and should be identified as the System UDI. Each component, sub-system or accessory that is considered a medical device and a distributed or supplied unit needs a separate UDI;
6. A new UDI-DI is required when the activities performed results in modifications to a previously marketed device intended for resale leads to a new medical device.
7. A new UDI-DI is not required when the activities performed do not result in a change/modification in performance, safety and/or intended use, of a previously marketed device intended for resale. The activities shall be performed in accordance with the manufacturer?s instructions. (looks like #5 was missing in the document).

 

[MPiska]

Hi, I believe the question was actually mine during the Reed webinar!
We have a possible 15 Million different configurations in total... Some of these will never get ordered and our configurator will flag up others that are non-valid (Chinese colour scheme with American Connector Scheme for example) however we still have a phenomenal amount.

Unfortunately the IMDRF guidance is just that, guidance. And it is guidance on a non-existant set of regulations. The only regulations that are concrete at this time are the FDA ones.

Question: Is the UDI determined by the base model or would I need to apply a UDI to every possible configuration?

The advice I have from various sources on this, including Jay Crowley, is that we will need a separate UDI for each configuration as it is a different product.
Even though it's registered under a single 510(k), the tracking and tracing requirements can be different for the different configurations.

Question: Since space is limited (very small labels), and given that the device is re-usable, is it appropriate to apply the Direct Marking in the form of a label that is attached somewhere else on the device (on the side / under the current label)?

The idea of "The Label" as a single label is misleading, you're free to add the UDI onto its own label on the device at any location on the device. We have small medical tools that will need to have a UDI, some that will require it to be laser etched.
There are only a very small number of devices that need PART marking.

Question: If a seperate label is acceptable for Direct Marking, wouldn't it need to be validated or tested in some way to assure that cleaning/wiping does not affect the integrity of the label (since it needs to remain intact for the lifetime of the device which is approx. 12 yrs.)

Yes - however this validation could be relatively simple depending on the reprocessing that you advise.

I hope this helps?

 

[MIREGMGR]

The device is plastic on the surface so, I don't think etching will work

Laser etching works very well on many plastics, including visible-light-transparent ones. We've been doing that for years.

 

[Java23]

MPiska - your questions from the Reed Tech training was what prompted my further need to understand the requirements - thank you

 

[Java23]

Thank you - I guess when I thought of etching, I didn't realize laser could be done to plastic. Thank you very much

 

[Bill Evans]

My understanding is the GUDID is the "Device Model" number NOT the actual production

From the FDA:
"Production identifiers are not submitted, not are stored in the GUDID, however, we do capture information about which production identifiers are on the label. So if on the device label there is lot number on the device label than in GUDID you would let us know that the production identifier that this device is"

How do we address replacement warranty items associated with the device?

 

[recruit]

About multiple configuration, I asked to FDA UDI Help Team. The answer is that we don't assign different DI for each configuration if multiple configurations are under one model and 510k. I copy the original answer as following:

Thank you for your interest in UDI. Your FDA UDI Help Desk case# has been reviewed by the FDA UDI Help Desk Team. If your device system is cleared/approved for multiple configurations, and you do not consider the different configurations to be different versions or models of the device, you are not required to have a different DI for each configuration.

Thank you for your submission. If you have further questions regarding this response, please DIRECTLY REPLY to this email. If you have other questions, please contact the FDA UDI Help Desk here: https://www.fda.gov/MedicalDevices/...ance/UniqueDeviceIdentification/ucm368904.htm.

Due to the Help Desk’s limitations, please keep all responses under 8 MB.

Sincerely yours,
FDA UDI Help Desk Team

 

[Java23]

Thanks recruit,

I also had sent FDA this question and they answered the same. I think this should make things much easier! Like all of us, I have been doing a lot of reading, attending webinars and speaking to others who are working on UDI. I prepared a "kick-off" presentation for UDI and am now working on one for the management team. Each time I read something new or speak to someone with more experience, I learn a bit more.

One of the things I learned from someone is that before choosing the barcode type (GS1 or HIBCC), we should determine what our customers are using for reading the barcodes. I am in the process of putting together a "customer survey" type letter to get a better idea as to which barcode type we need to choose.

Thanks for your input.