Trying to understand 7.2.1(d) of ISO 13485 - Medical Device User Training

stm08007

Starting to get Involved
#1
I would really appreciate it if someone can give me some clear examples about what it means by saying organizations must determine and document whether any "user-training" is required?

Is a statement in the IFU saying something along the lines of "the healthcare provider must be trained to and understand these instructions" sufficient?

I keep getting hung up on this clause, so any input would be much appreciated!!:)
 
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bjohnsonrli

Starting to get Involved
#2
Hi stm08007,

I would take a look at IEC 62366-1 Application of usability engineering to medical devices. Section 7 talks about training and materials for training required for the safe and effective use of a primary operation function of a device. Primary function is defined as a function that is directly related to the safety of the device or function that is frequently used. Examples they give are:
- inactivation of an alarm signal
- adjustable x-ray exposure parameters
- adjustable infusion parameters
- adjustable gas flow rates

As input into our design control, we use what we call a risk/safety questionnaire and consider questions related to intended use and reasonably foreseeable misuses. Information is then used as input into the design FMEA. If risk mitigation is to supply information for safety, its added to the IFU or labeling.

Hope this helps.

Regards,

Bryan
 

yodon

Staff member
Super Moderator
#3
If you just drop the device on your customer's doorstep, can they use it? Are you introducing any new technology, new methods, new information? Will your customer base normally have the skills to use the device (e.g., if your delivering an ultrasound device, your users will typically be ultrasound operators).

I think those are the types of questions to ask to determine if there are any training requirements needed to ensure safe and effective use.
 

stm08007

Starting to get Involved
#4
I guess my followup question would be if you do determine there are "training requirements" needed, is it sufficient to merely document that in the IFU? We've had an auditor who had told us we can't count on a customer reading the IFU and automatically point to that whenever there's a use error identified

If there was a complaint filed where the customer was determined to have misused the product (meaning they did not follow the IFU), does this requirement mean you need to send someone to give your customer hands on training?

I think our IFU covers just about everything, however I was thinking (perhaps incorrectly) that this 7.2.1(d) might require something a bit more formal than the IFU. I wouldn't really call the IFU "training" per-say either--- just because you give someone a set of instructions doesn't mean they are "trained"
 

Pads38

Trusted Information Resource
#5
There is an IEC standard on training and training materials:

IEC TR 61258:2008
Guidelines for the development and use of medical electrical equipment educational materials

From the abstract of that:
In particular, manufacturers might find this process useful in preparing the necessary markings, accompanying documents and other educational materials which will provide necessary information to operators of the equipment and encourage them to employ safe and effective practices.
 

yodon

Staff member
Super Moderator
#6
I guess my followup question would be if you do determine there are "training requirements" needed, is it sufficient to merely document that in the IFU?
Bear in mind that 7.2.1(d) is, effectively, a design input. When you develop your product, are there requirements for training the end user. Per my previous post, if you're introducing something novel into the market, you're probably going to establish requirements for training. Those requirements would be elaborated as training materials, training courses, etc. Training is not, IMO, the role of the IFU. And the IFU is a design output.

We've had an auditor who had told us we can't count on a customer reading the IFU and automatically point to that whenever there's a use error identified
This is exactly why the usability standard (62366) is getting more focus and the focus of several of the changes to 14971 (can't rely on labeling alone for risk reduction).

If there was a complaint filed where the customer was determined to have misused the product (meaning they did not follow the IFU), does this requirement mean you need to send someone to give your customer hands on training?
This brings the issue full circle. If you have a complaint then you need to assess it for risk, etc. If the complaint is with usability, you need to determine if the design is sufficient to ensure no hazards are realized and, if not, a design change is probably warranted. If you're following 62366, you'll have the tools in place to assess the UI and determine if this is a systemic issue or just a one-off. If systemic, you'll probably want to change the UI to reduce the likelihood of additional, similar complaints. If the UI is sound, you may then look to additional training methods.

I think our IFU covers just about everything, however I was thinking (perhaps incorrectly) that this 7.2.1(d) might require something a bit more formal than the IFU. I wouldn't really call the IFU "training" per-say either--- just because you give someone a set of instructions doesn't mean they are "trained"
We (in test) have a philosophy: if something can go wrong, there WILL be a user that will find it. IFUs are typically written from the 'expert' point of view, considering primarily the right way to do things. Users aren't so much the case! That's why the UI and design play such critical factors in usability and error prevention. Training is one tool in the toolbox but then you have to consider training effectiveness and training coverage (you may train one person in an office and then rely on them to train the rest of the staff... how effective can that be?).

Sorry for getting a bit off topic and babbling on about design stuff but, indeed, there's a big picture to consider when you talk about training and customer complaints.
 

bjohnsonrli

Starting to get Involved
#7
I'm going to assume we are talking about a prescription (Rx Only) device...

The manufacturer of a prescription device owes a duty to the physician to provide adequate information on how to properly use a device and about the risks associated. The physician owes a duty to the patient to apprise him/herself of the risk associated with a product and to exercise judgement in both the use of the device and informing the patient of the risk.

If you already haven't, take a look at GHTF/SG1/N70:2011 Label and Instructions for Use for Medical Devices. I'd post the link but I'm a few posts shy of being allowed to.

Your auditor's statement is correct. It's generally viewed as unacceptable to solely rely on the user to mitigate risk. I believe this comes from EN ISO 14971 in which the use of an information for safety (IFU, labeling, etc.) shall not atribute to any additional risk reduction.

You are probably correct in saying that your IFU covers everything and you may be overthinking things a bit.

Regards,

Bryan
 

Marcelo

Inactive Registered Visitor
#8
These requirements sucks, I´ve tried several times to remove them from the drafts, but my fellow experts did not agree with me :(... My main problem with the requirements is that they are only determned at the end of design, and althought requirements related to product can be defined in any stage, it typically is defined in the beginning, so it may consuse a lot of people that do not clearly understand 7.2.1 and 7.2.2.

Anyway, the requirement is related to device design. It´s also be an output of the usability engineering of IEC 62366-1.

Training may be a requirement if the design of the device user interface identify the need for training for the safe use of the product.

So, to comply with this requirement, you would need to perform the usability process and verify (as per IEC 62366-1 requirements) if training is a requirement or not, and input this into your design process.
 
Last edited:

Marcelo

Inactive Registered Visitor
#9
And yes, in the end you will also need to clearly specifiy the training requirements and how you

- provide the materials necessary for training;

- ensure that the materials necessary for training are available;

- make the training available; or

- make training available to the RESPONSIBLE ORGANIZATION that enables it to train its USERS

(again, as required by IEC 62366-1)

in the user manual, but the user manual information is onlçy the result of the entire process, so not, only putting it in the user manual is not enough.
 
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