Medical Device Intended Use Document - Risk Analysis Documentation Requirements

[vishal.cpdm]

Hello,

During a casual discussion about risk analysis documentation I was advised to freeze on a intended use document as a first step for the ME device we will be developing.

Clause 4.2 in the ISO14971 document says, "For the particular medical device being considered, the manufacturer shall document the intended use and reasonably foreseeable misuse. The manufacturer shall identify and document those qualitative and quantitative characteristics that could affect the safety of the medical device and, where appropriate, their defined limits."

It would be greatly appreciated if someone can please help me or advise me further with a sample intended use document so that I can get an idea of how to document this (in terms of its structure, content titles, etc.).

Thanks in advance.
Vishal.

 

[yodon]

We don't create a separate intended use document, just a statement (paragraph or so) on intended use. That's generally propagated throughout various documents.

Certainly you need to have a common understanding of intended use to ensure the review is properly focused.

Things to consider when establishing your intended use (just winging it here - maybe someone can fill in with a more comprehensive list): level of expertise of operator (does the operator need to be trained), type of patient (children, adults, seniors, etc.), environment the device will be used in (indoors, OR, outdoors, etc.), and so on. Of course, you need to also identify what the device does (what condition are you treating / action are you performing, etc.).

The intended use goes well beyond supporting a risk assessment; you will need to be able to substantiate any claims you make in the intended use so wordsmith wisely. Input from a regulatory consultant / expertise is recommended.

 

[vishal.cpdm]

Thank you Yodon! That is a good insight.

And yes, the point about being wise about intended use claims is noted!

If I understand well, (sorry if i'm being dumb) all the points mentioned should be covered in the paragraph/statement itself? Shouldn't it be under separate headers (like intended use, contraindications, stakeholders, description, operating parameters, etc.)? Please advise and clarify.

Many thanks!
Vishal.

 

[yodon]

First off, you're not being dumb. We all had to go through the learning curve.

Second, it sounds like you're getting a good handle on the documentation. The intended use is typically just a few paragraphs focusing on what the device treats. I mentioned stakeholders because it's sometimes necessary to frame the intended use; e.g., a trained clinician will operate an ultrasound device for detecting tumors. Contraindications, description, stakeholders, and operating parameters are generally covered in the IFU.

 

[Ajit Basrur]

Thanks yodon

 

[Ronen E]

Have a look:

http://www.fda.gov/downloads/Medica...onandGuidance/GuidanceDocuments/ucm082166.pdf

Intended Use statement is the basis for the entire regulatory compliance process. One can't overestimate its importance -- every word matters.

Input from a regulatory consultant / expertise is recommended.

If you need a hand, give me a buzz .

Cheers,
Ronen.

 

[vishal.cpdm]

Thanks Yodon and Ronen! Thank you for your advice, help and encouragement!

This brief discussion has been very helpful.

 

[Marcelo]

The importance of intended use in ISO 14971 is really not clear stated, in my opinion. Besides being the basis for the regulatory compliance process as Ronen mentioned, it´s really the base for all risk management activities.

Most of the time people ask me why risk management is focused in thinking about anything that can happen to a medical device, so it´s a pointless activity. I answer that if your device can be used for anyone, by anyone, everywhere, you really need to risk manage the entire world. However, if you have a clear definition of patient, user, use environment, and other factors, you really need to manage those situations (which might be many, but not the entire world).

Standards speaking, intended use for medical devices is better defined in IEC 62366 where it requires, for the specification of intended use, the following information:

- Device description
- Medical purpose
- PATIENT population
- Part of the body or type of tissue applied to or interacted with
- Intended USER
- Application

For each of these, several different info is required (for example, for application, environment conditions and frequency of use. For intended use, expected experience, knowledge or education).

Without this information, any risk management is really pointless

So, my suggestion would be to use IEC 62366 and other usability/human factors standards, guides and techniques do develop your device intended use.

 

[vishal.cpdm]

Thank you for the suggestions Marcelo!

So if I get this rite from the discussion, intended use is a definitive set of statements that should be scripted and completed before starting the risk management activities. It could become an individual document (although a very small doc) in itself which should be referred to through out the risk documentation activity. Correct?

 

[Marcelo]

So if I get this rite from the discussion, intended use is a definitive set of statements that should be scripted and completed before starting the risk management activities. It could become an individual document (although a very small doc) in itself which should be referred to through out the risk documentation activity. Correct?

Yes, that´s a way to view it. If you have a separate document (and this is important enough for you to have so, with analysis and other info) you need to include it in the risk management file.

Just mind you - it´s not really "statements" only, but a base for device design. And device risk management. And device usability. And any device claims......and there goes!