Handling Unsold Medical Devices

[MedtechQuality]

Hello,

A medical device made up of mechanical and electronic components remained in warehouse storage since the beginning of 2024 and was recently identified as unsold. The device was stored per defined requirements and remains within its shelf life. It has now been logged in the NCMR system.

From a quality and regulatory standpoint, is prolonged storage and delayed sale alone sufficient justification to raise an NCMR, or should this be addressed through inventory or process controls instead?

Looking for perspectives on how others classify similar situations.

 

[ChrisM]

What do the product's design requirements etc state about storage prior to sale, or was this overlooked? From what you have stated initially, it looks like everything is OK, so what's the issue?
If you are really concerned can it be put back through "final test" and if it passed, just given a new date of manufacture?

Without knowing the specifics - and therefore if there may be any legislative requirement regarding the timescale from date of manufacture to date of sale - it's hard to give you an exact answer.


Beyond this, you may want to check out your inventory control system to find out why the device remained in storage for so long.... is FIFO not working or is it just a slow-selling product?

 

[Tidge]

What was the non-conformance?

 

[Ed Panek]

FYI - In case you determine they cant be used. A local manufacturer made beds and wheelchairs for hospital patients. They had an inventory of non usable products. The Warehouse staff threw them into the trash per their QMS "Scrap" policies.

Well, those items were still worth tens of thousands of dollars so some employees of that company came back later at night and grabbed the items from the dumpster. Took them into their home garage, cleaned them up, and... sold them on eBay. A user of one of the "trash" devices was injured and a report made to FDA. The FDA found out how they were made available for use and came down hard on the OEM for lack of controls over NC materials. Use caution.

If you have NC materials "Throwing them away" may not be enough. This may not be relevant to you but NC materials handling is big area of risk control.

 

[d_addams]

Doesn't sound like an NCMR, since there is no stated material non-conformity. Even if it was beyond its shelf life, what is non-conforming, the passage of time?

What may warrant investigation:
Does the storage facility have an inventory management policy like FIFO and were they following it?
Does the storage facility have controls in place to ensure material beyond its shelf life are not distributed?
Does the storage facility have processes in place to identify short-dated materials? (some customers will not accept short-dated materials)

 

[MedtechQuality]

Hello,

A medical device made up of mechanical and electronic components remained in warehouse storage since the beginning of 2024 and was recently identified as unsold. The device was stored per defined requirements and remains within its shelf life. It has now been logged in the NCMR system.

From a quality and regulatory standpoint, is prolonged storage and delayed sale alone sufficient justification to raise an NCMR, or should this be addressed through inventory or process controls instead?

Looking for perspectives on how others classify similar situations.

@all thanks for your inputs.


Since 2024, a medical device has undergone changes such as design updates and additional testing. As a result, more information is now being captured in the Device History Record (DHR).

One of these design changes was significant enough to trigger a new 510(k) submission. This updated 510(k) reflects the new design and would ultimately supersede the previous cleared version once approved.

However, there is existing inventory that was manufactured in 2024 and is currently sitting in the warehouse. These devices were built to the previously cleared design, not the updated one described in the new 510(k).

My questions are:

1. Does the existence of an updated 510(k) submission mean that the previously manufactured devices are now noncompliant, even though they were built and documented under the earlier cleared version?
2. While the updated 510(k) is under FDA review and not yet approved, is it still permissible to market and sell devices that fully comply with the currently cleared 510(k)?
3. How should this situation be viewed from a compliance and inspection standpoint, especially regarding DHR alignment and inventory manufactured prior to the design change?

Any insight or references would be appreciated. Thanks!

 

[EmiliaBedelia]

@all thanks for your inputs.


Since 2024, a medical device has undergone changes such as design updates and additional testing. As a result, more information is now being captured in the Device History Record (DHR).

One of these design changes was significant enough to trigger a new 510(k) submission. This updated 510(k) reflects the new design and would ultimately supersede the previous cleared version once approved.

However, there is existing inventory that was manufactured in 2024 and is currently sitting in the warehouse. These devices were built to the previously cleared design, not the updated one described in the new 510(k).

My questions are:

1. Does the existence of an updated 510(k) submission mean that the previously manufactured devices are now noncompliant, even though they were built and documented under the earlier cleared version?
2. While the updated 510(k) is under FDA review and not yet approved, is it still permissible to market and sell devices that fully comply with the currently cleared 510(k)?
3. How should this situation be viewed from a compliance and inspection standpoint, especially regarding DHR alignment and inventory manufactured prior to the design change?

Any insight or references would be appreciated. Thanks!

Depends on why the change was made. Was it for safety reasons, to correct known issues? Is the previous clearance within the boundaries of the new clearance? Did you make the change to maintain product conformance to what you previously submitted, or are you adding something new?

Do you have traceability to differentiate between the different versions? Part number, version, etc. Traceability is my biggest concern here because you need to be able to show that you 1) didn't start selling the new device until you got clearance and 2) can maintain traceability in the case of a recall or field correction.

The existence of a new 510k doesn't mean anything, on its own. A 510k is not a QMS document and it generally doesn't contain/dictate much about how a device is actually manufactured - there's nothing magical about a clearance letter that suddenly makes your product unsellable. You need to assess the change to the device and disposition it accordingly. This is more of a design transfer question than a clearance question.

Some examples off the top of my head where I would be fine with selling existing stock:
- Packaging material change due to discontinuation of the existing material
- Sterilization change to a different method (eg, change from gamma to EBEAM)
- Change to add a new indication to the labeling
- Material change that isn't intended to impact performance of the device but still triggers a submission for biocompatibility or something like that.
- Shelf life duration increase (definitely traceability concerns here just for inventory management)
- Change from MR unsafe to MR safe/MR conditional
- A dimensional change or addition of a new feature, IF you change the part number and call it a Version 2.0

Some examples that might NOT be ok to sell (things in this category may even require an HHE and/or recall):
- Material change due to urgent issues in the field (metal on metal hip implants, Chinese titanium,)
- Adding a contraindication or warnings/precautions
- Addition of a new safety feature (eg, adding an alarm of some sort to an active device)
- Change to comply with a new standard or regulation that could impact product performance (e.g., if you never complied with ISO 80369 for luers, and you're finally updating the design to comply)

You should have some sort of disposition question as part of any design transfer - what would you do with ANY change, regardless of whether it had a submission or not? The only thing that a 510k changes about the situation is it basically guarantees that you'll get audited on it for your next MDSAP audit.