Usage of web articles in DHF (Design History File)

[renenatasha]

Good day!

I've a question concerning DHF.

I'd like to know if web articles (such as Wikipedia) can be used as part of the Design Output's evidence in the DHF.

For instance, my Design Input requirement says that sterilization process (EtO) should have minimal adverse impact on the environment and to support that, I'm using an article in Wikipedia as my Design Output. Is this permissible in FDA QSR's point of view?

I'm approaching a dead-end here and hence your invaluable advice is highly appreciated. Many thanks in advance!

 

[X.Liu]

Re: Usage of web articles in DHF

Do you mean you would like to use the article as verification/validation evidence for part of your design?
Or you would use it as part of rationale of your design?

 

[renenatasha]

Re: Usage of web articles in DHF

Liu, I'd like to use it as part of rationale in my design (design output in this case).

Is that permissible? Any idea?

Thanks.

 

[somashekar]

Re: Usage of web articles in DHF

If EtO sterilization requirement is the input, then an EtO sterilization process defined in your product specification is your output. You need no rationale here.

Coming to minimal adverse impact on the environment, again your web article etc can be your part of design input about how the EtO process has to be designed. This is a part of the process of sterilization where validation comes into application to demonstrate effective sterilization and supported by controlled process that shows a minimal effect on the environment.

At a DHF level, I do not think the minimal adverse impact on the environment has a place. In DHF, you are talking product design requirement.

 

[renenatasha]

Re: Usage of web articles in DHF

If EtO sterilization requirement is the input, then an EtO sterilization process defined in your product specification is your output. You need no rationale here.

Coming to minimal adverse impact on the environment, again your web article etc can be your part of design input about how the EtO process has to be designed. This is a part of the process of sterilization where validation comes into application to demonstrate effective sterilization and supported by controlled process that shows a minimal effect on the environment.

At a DHF level, I do not think the minimal adverse impact on the environment has a place. In DHF, you are talking product design requirement.

Thanks, Somashekar.

Well, I supposed we screwed up during the preparation of Design Input. The team agreed to have it stated as "EtO - sterilization process shall be of minimal adverse impact on the environment". So now that I'm in output stage, I'm trying to portray it by saying that EtO is a generally used sterilization process and as long as proper control measure is taken, there won't be an adverse impact to the environment. Hence in my design verification, I'll attach the Sterilizer's Air Emission Monitoring report stating that proper control measure has been taken and within spec. Is this OK?

Well, you're right, Somashekar. The thing is that the point I stated above is one of the Design Input Requirements where Environmental Impact is concerned. Having said that, we need to make sure that the Design Output meets the Design Input Requirement, which result in thus.

 

[somashekar]

Re: Usage of web articles in DHF

Thanks, Somashekar.

Well, I supposed we screwed up during the preparation of Design Input. The team agreed to have it stated as "EtO - sterilization process shall be of minimal adverse impact on the environment". So now that I'm in output stage, I'm trying to portray it by saying that EtO is a generally used sterilization process and as long as proper control measure is taken, there won't be an adverse impact to the environment. Hence in my design verification, I'll attach the Sterilizer's Air Emission Monitoring report stating that proper control measure has been taken and within spec. Is this OK?

Well, you're right, Somashekar. The thing is that the point I stated above is one of the Design Input Requirements where Environmental Impact is concerned. Having said that, we need to make sure that the Design Output meets the Design Input Requirement, which result in thus.

I have great concern to environmental issues and I am happy to note that in you too. However, in designing stages, if your product requires sterilization, you determine the method that best meets the product sterilization requirement.
If it is EtO then that is it.
If you have any other method apart from EtO, that can meet this sterilization requirement with same effectiveness and is still better than EtO in terms of environmental impact, please say that method.
How such a sterilization method must have minimal environmental impact is to be considered entirely in an other process and not in your product design. Hence your design output does not need to record this and no amount of web article will justify at this level.

 

[Ronen E]

Re: Usage of web articles in DHF

Hi,

Please note that Design Input is not carved in stone and can be revised, as long as you follow your controlled process for that.

Without going into the debate on whether or not a specific requirement belongs in the Design Input or not, from a regulatory standpoint I wouldn't rely on Wikipedia (or similar) as a reference to justify anything, though I highly respect Wikipedia as a remarkable endeavour for spreading human knowledge. It's just too easy to put anything (including unsubstantiated claims) in Wikipedia. I would much prefer to reference published standards or at least peer-reviewed articles / papers from reliable sources.

Cheers,
Ronen.

 

[BLSSETO]

Somashekar,
I don't think that a general literature article will be enough to support a design requirement. Also, the requirement does not provide a clear metric that allows you to compare it directly with the design output. I see a couple of options:
1) Revise your Design Input to eliminate the requirement. This should be the simplest and most straightforward.
2) In your design output document state that it is a bad requirement, is not relevant to the safety or efficacy of the device and, therefore, will not be addressed as a design output.
3) You should be able to go to your sterilization service and get a copy of a permit or letter stating that they comply with environmental regulations with regard to EO emissions. You may also be able to find out the level of emissions from your plant or the processing of one of your loads. The EPA has emissions requirements and so do many local regulatory bodies. You can use compliance to environmental regulations to support your conclusion.

 

[renenatasha]

Re: Usage of web articles in DHF

I have great concern to environmental issues and I am happy to note that in you too. However, in designing stages, if your product requires sterilization, you determine the method that best meets the product sterilization requirement.
If it is EtO then that is it.
If you have any other method apart from EtO, that can meet this sterilization requirement with same effectiveness and is still better than EtO in terms of environmental impact, please say that method.
How such a sterilization method must have minimal environmental impact is to be considered entirely in an other process and not in your product design. Hence your design output does not need to record this and no amount of web article will justify at this level.

Thanks, Somashekar.

Previously, we don't have this (Environmental Impact) in our Design Input form but ever since the EMS Audit, we've an MNC concerning this - the auditor noted that we should consider Environmental Impact during our early design stage (i.e. Design Input).

Thanks for the input though. Perhaps it's time to review the form (?).

 

[renenatasha]

Re: Usage of web articles in DHF

Hi,

Please note that Design Input is not carved in stone and can be revised, as long as you follow your controlled process for that.

Without going into the debate on whether or not a specific requirement belongs in the Design Input or not, from a regulatory standpoint I wouldn't rely on Wikipedia (or similar) as a reference to justify anything, though I highly respect Wikipedia as a remarkable endeavour for spreading human knowledge. It's just too easy to put anything (including unsubstantiated claims) in Wikipedia. I would much prefer to reference published standards or at least peer-reviewed articles / papers from reliable sources.

Cheers,
Ronen.

Thanks, Ronen.

You've been as helpful as other guys here. In a way, I do agree with that. So in this case, I'll look for the permissible exposure limit from OSHA and use that as the Design Output evidence. In Design Verification, I'll attach the sterilizer's Air Emission Monitoring report instead.

Thanks once again. - Rene