Health Canada Recall Definition - Seeking Clarification

[blah01]

I'm hoping someone could provide some insights on interpreting the HC recall requirements when it comes to a hardware specification issue?

We have a certain assembly in our product that is certified to a certain test standard and for which we need to maintain traceability of certain raw components to an online database in order to retain our certification. We recently discovered that our supplier changed the sourcing of one of those components and now we cannot trace that component to the online database as required by the standard. There is no functional impact because the material composition of the component is the same. However we recently failed a source inspection by a standards inspector because of this.

I am wondering if this falls within the definition in GUI54 4.1.b which is as follows:

(b) may fail to conform to any claim made by the manufacturer or importer relating to its effectiveness, benefits, performance characteristics or safety

There is no functional or performance impact as a result of this issue, only that we cannot claim compliance with the standard. However we have product out in the field with this certification marking and I am therefore wondering if we have an obligation of notifying customers of this from a Health Canada perspective?

From an ISO 9001 perspective I believe we should notify customers. If we choose to do so because of ISO 9001, does this mean this enacts the HC recall requirements?

I appreciate any information anyone could provide regarding this.

Dave

 

[shimonv]

Hi Dave,
It appears you have an issue with quality and perhaps a regulatory issue as well; you might be dealing with two separate entities.

Keep in mind that standards are voluntary; regulation are law. In some rare occasions the regulator will adopt a standard to become a part of its law, like what HC did with CAN/CSA ISO 13485.

From QA/standard compliance viewpoint - it appears you have an issue with material traceability. You need to review the findings from the standard inspector and ask yourself what is the corrective action? What will the CAPA say? The thought process and the risk assesment will help you see more clearly if there is a potential safety issue at hand.

From a regulatory viewpoint - you need to review HC's definition for recall very carefully and almost separately from your dealings with the standards certification body. If you meet the regulatory definition or when it doubt, you had better report the event.

To say more than that will be presumptuous of me with the limited information at hand.

Goodluck,
Shimon

 

[blah01]

Thanks for the info. Here's some more detail which may help refine the feedback.

The issue has to do with a PCB and in particular the flammability rating of the PCB which we claim is V1 and was approved by UL. UL has a requirement that the PCBs have certain markings on them that identify the manufacturer and the PCB type traceable to their online directory. For some reason our supplier switched to another PCB supplier and these do not have any of these UL PCB markings so from the UL inspector's perspective they are not UL approved. However after verifying the specs of the PCB, they are actually V0 rated, which is better than V1 (the lower the number the better the flammability performance). Therefore materially, the PCBs are better than what we specify, but because they cannot be traced to UL's online directory, the inspector did not accept them. We are allowed to ship product with this PCB as long as we do not put the UL logo on the product.

The issue now is that we have product in the field with these PCBs and UL logo. From an ISO 9001 perspective we may have a requirement to notify those customers about the fact the product is not UL certified although performance is not affected. What's not clear to me is if this falls within the HC definition for recall, and more specifically with the following:
"...any actions taken by the manufacturer...to recall or correct the device, or to notify its owners and users of its defectiveness or potential defectiveness after becoming aware that: b) may fail to conform to any claim made relating to its effectiveness, benefits, performance characteristics or safety".

As stated, the PCBs actually have a better flammability rating of V0, therefore performance and safety are in now way affected in those units. The issue is simply that the units have the UL logo on them though they are not certified by UL.

Therefore does the act of notifying the customers of the labelling issue fall within the HC definition of recall?

Also, anyone know of who at HC I could contact to further discuss this without first having to submit a report?

I appreciate any feedback that could help clarify this.

 

[Mark Meer]

In my opinion, from what you describe, no customer notification is necessary.

As shimonv says, standards are voluntary.

So, it all depends on where your requirement for the v1 flammability came from, and how it is verified. If you have a design requirement of "Ul v1 flammability rating or better", and your verification for that was the UL listing, you only have to update your design documentation to show the evidence that you have for v0.

...but you do have some non-conformances to address:

As far as the PCBs: do the users even access the PCBs (and the mistaken UL marking)?
I would handle this internally through your non-conforming product process. Document that you've identified that units are non-conforming, and you can authorize a "use-as-is" decision based on an assessment of risk (sounds like there is none as the PCBs are, in fact, v0 - better than v1).

This sounds like it is also a supplier non-conformance as they failed to notify you of changes. Again, handle this through whatever supplier-control processes you have and apply whatever level of action you deem appropriate.

This is just my take/suggestion, and by no means authoritative.
But hope it helps for what it's worth!

MM

 

[shimonv]

Therefore does the act of notifying the customers of the labelling issue fall within the HC definition of recall?

Also, anyone know of who at HC I could contact to further discuss this without first having to submit a report?

Refer to Guide to Recall of Medical Devices (GUI-0054) - Canada.ca for HC Contacts for recall reporting.

Based on what you wrote - this does not seem to be a case of recall or of necessity for customer notification.
You are welcome to approach HC directly, but keep in mind that they will play on their "safe-side".


Cheers,
Shimon

 

[blah01]

Thanks for the feedback guys; very helpful.

The UL requirement is internally driven and we do have a risk management process compliant with ISO 14971, so I guess I will simply document this issue in our risk register which will include the data and justification for assessing this as negligible risk since the flammability rating is actually better than what we target. Hopefully this will satisfy the HC inspector next time they are in.