IEC 60601-1-11 Requirements related to Storage and Distribution

[SGquality]

I am frustrated with our ISO 13485 auditor relating to the storage/distribution requirements for a FDA Class 2 Hearing Aids.

We have identified the values for temperature, humidity, and pressure in the Instructions for Use derived from the section 4.2.2 of the IEC 60601-1-11 standard and tested per the V&V testing to demonstrate that the product complies with the requirements of the standard. The instructions for use indicate the permissible environmental conditions of storage and transport of the medical device after the device has been removed from its protective packaging and subsequently between uses and does not apply for the device PRIOR TO SALE.

The Hearing Aids do not have any storage/transport requirements prior to sale and the auditor not familiar with the IEC standards is applying these "between uses" scenario to our distribution centers and transportation.

We explained him that the product has no requirements and is not stated in the label and labeling - and these artefacts have been cleared by FDA. But this individual is steadfast and uncompromising.

Could you please provide me guidance on how to address this issue?

 

[Peter Selvey]

Not sure I understand the issue completely.

Since the device passed the tests in 4.2.2 unpackaged, it should be OK for all forms of storage/transport. The (reasonable) assumption here is that a test unpackaged is more severe than packaged, and therefore a single test unpackaged would be representative of both cases.

In this case, a manufacturer would normally state in the IFU and mark on the packaging a single set of conditions for "storage/transport" which covers both cases (before and after removal from packaging).

Assuming this is correct, then I guess the issue is with the controls applied to make sure they stay within these limits?

My opinion would be that the conditions meet in 4.2.2 are fairly extreme so no special controls are needed. Only if a part is sensitive e.g. limited to +40°C or 0°C or <80%RH then there would be procedures to monitor to ensure the temperature/RH stays within the allowable range. But the values in 4.2.2 is so wide that it's not important. Is that the issue?

Or is it labelling? Or lack of testing with the packaging?

 

[SGquality]

Peter, sorry for not explaining clearly.

I believe the IEC 60601-1-11 requirements apply between the uses (at the Owner end) and not relating to prior to sale, correct?

There are no specific storage/transport requirements for the product and therefore not on the label/labeling that was cleared by FDA. The auditor is extending the IFU requirements to prior to sale and wanting us to map the temp, humidity and pressure requirements.

How do we justify?

 

[Peter Selvey]

Yes, IEC 60601-1-11 is actually for after removal from packaging.

Otherwise, normal "pre-use" transport and storage is covered by IEC 60601-1 Clause 7.2.17 and 7.9.3.1, which requires the range of permissible environmental conditions to be marked on the packaging and disclosed in the IFU. Maybe, the FDA/auditor are quoting the wrong standard?

In theory there will always be limits. However, I also understand that often the limits are way above those encountered in real world, so it's pointless to disclose them.

Unfortunately, IEC 60601-1 3rd edition does not allow for that, it says the range always needs to marked/declared in the IFU, there is no "if appropriate" preface in the requirement.

In practice for a home use device, it would be the same as the range specified for IEC 60601-1-11, Clause 4.2.2.

Note that in IEC 60601-1 2nd edition this was written in a different way and could be interpreted as needing this marking only if "special measures" are required. So if this is an older, legacy device, original tested to 2nd ed, upgraded to 3rd, this subtle change might not have been picked up.

Again we are looking at three issues here:
- labelling (package/IFU)
- testing (proof that the device can handle the range)
- controls (e.g. making sure the warehouse, delivery truck do not exceed the limit)

Which one(s) was the FDA/auditor raising an issue with?

 

[SGquality]

Thanks for the detailed explanation here, Peter.

Unfortunately this was not the FDA but the ISO 13485 auditor who firstly, did not have a clue on what IEC 60601-1-11 is all about but he is getting fixated on the storage/transport conditions because it is in the Owner's Guide (aka IFU). We had the ISO 13485 audit for our Distribution Centers and he is trying to extend the requirements from the Owner's Guide to the storage/transportation prior to sale. And yes, the auditor wants us to map our distribution centers and monitor during transportation these "broad ranges" to make sure the warehouse, delivery truck do not exceed the limit. How do I support this requirement when there is no requirement on the product?

I tried to convey multiple times that the requirements from IFU is not "product" requirements and therefore not on the label/labeling but he is not getting the point

 

[Peter Selvey]

I agree with your conclusion (controls are not required), but not the method.

The IFU range limits need to be disclosed for both before and after use. You can't get around this. It's not possible to say "there are no limits". But that's not the really issue.

The issue here is whether controls are reasonable (e.g. mapping/monitoring/actions).

I used to be an ISO 13485 auditor but it's been a while and I don't have the latest edition of the standard. Even so, I'd be very confident that the standard has an "as appropriate" approach of handling this situation. Which is to say, if the range is limited and could reasonably be exceeded without controls, then controls are appropriate. Usually for this kind of thing, if you check the exact wording in the standard there should be the term "as appropriate" or similar.

In this case the range is so wide (-25°C to +70°C, water vapour pressure 50hPa) that controls would be, in my opinion, a waste of time. So, not appropriate.

Auditors are required to quote a specific standard/clause when raising a non-conformity. You should check what is the precise clause they are referring to and find out if it has an "as appropriate" or similar wording.

Note that the auditor cannot refer to IEC 60601-1-11 or IEC 60601-1 because neither of those standard have anything to do with controls that may or may not be applied in actual warehousing and distribution. If the auditor is quoting these standards as evidence that controls are required, then they are off their tree. So to speak.

However, take care. Auditors are not always that bad. This could be a case of "shooting yourself in the foot". If a company procedure says that controls are required based on the IFU range, then the auditor can raise a valid non-conformity if there are no controls. The problem is not IFU range or the auditor, but the company procedure. The company procedure needs to be revised to incorporate the "as appropriate" terminology.

 

[SGquality]

Excellent points, Peter. Much appreciated