Looking for examples of "User Training" - ISO 13485 section 7.2.1 d)

Ajit Basrur

Staff member
Admin
#1
In the ISO 13485, section 7.2.1, Determination of requirements related to product, it says "d) any user training needed to ensure specified performance and safe use of the medical device".

Can I know how this can be complied? Additionally, few examples would be great.

Thank you!
 
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Candi1024

Quite Involved in Discussions
#2
Are you asking what kind of medical devices would need user training?

A good example would be ultrasound. Ultrasound companies provide training in both written and class room methods. Over-use of ultrasound would be a safety issue that would be covered in that training.
 

Ajit Basrur

Staff member
Admin
#3
Thanks Candi1024.

So for a specification developer or a contract manufacturer with no connection with the commercialization of the medical device, how would this requirement be accomplished?

Is the training intended for internal employees?
 

Ronen E

Problem Solver
Staff member
Moderator
#4
7.2.1 Determination of requirements related to product
The organization shall determine:
[...]
(d) any user training needed to ensure specified performance and safe use of the medical device;
The way I understand it, this requirement is about determining requirements (it’s not spelled out but I take it as quite obvious that that involves documenting the same, too). It doesn’t talk about the implementation, thus I’d take it that it doesn’t matter whether the org is involved in the commercialization or not (BTW, spec developers may well be involved in that). Specifically regarding item (d), I think that it would be part of determining user needs (Design Input), and if not (ie training wasn’t obviously required upfront but is a result of the actual design) it should at least be part of the Design Output. Hence I think it is most applicable to whoever develops / owns the design, including spec developers and normally excluding contract manufacturers.

In simple words, the developing org is required to define what sort of user training will need to take place to ensure device proper performance and safety.
 
Last edited:

Edward Reesor

Trusted Information Resource
#5
Information For Use/instruction manuals, web based training platforms (PowerPoint, YouTube videos), webinars, other information sheets that you may want to generate and offer to the distribution network or end users.

I worked for a company that also held education sessions at the office which included the end users (physicians,nurses and respiratory therapists) as well as members of the biomedical technician team who would be performing checks and minor maintenance.

The requirement is for the development of training materials, not compliance or competency of the end user, however that goal should be addressed at some point in that discussion. I generated a "test sheet" for one end user/trainer to be completed by the staff after watching my training PowerPoint.

Trying to make the connection between training and competency when the device is actually used later on could be argued all day. Try not to get buried too deep in that quagmire.
 
#6
Do you have a Clinical Education person? That person would train end users on how to use your device in a safe and effective manner. For example, teaching a doctor how to use an ultrasound machine. The teaching method can be documented in a procedure.
 

locutus

Involved In Discussions
#7
The first idea with this because it is in Section 7.2.1 and not Section 6, is this is related to the end-user or customer training that would be required. According to the company (design inputs) they need to determine what type of training would be required. This can be "self-training" through the use of Instructions for Use, train the trainer where one representative would get training and train rest of staff, or train the end user. This needs to be determined by the company and then supported through internal procedures.

As an example, I worked with a CAD/CAM dental instrument company that before they could use the device (before we shipped it) the dentist and/or technicians had to attend a 3 day training course at the facility. We paid all their travel and such (though it was rolled into the cost of the device) and they only needed to spend the time. We had a Clinical Education person as snoopy mentioned that was responsible for setting up the whole training course - with their staff.

Others had good comments as well, just this Clause is focused on what type of training the end-user needs - from instructions of an OTC product to an onsite training for an MRI instrument. My final comment is be VERY careful about self-training activities such as blogs, facebook, or Youtube because these are also considered labelling by many regulatory agencies and have to be aware of making sure these are appropriate and applicable - do they generate complaints? Is the youtube video controlled through documentation?
 
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