Managing Use Error Risk - FDA Position: Use Error is Manufacturer's responsilbility

Michael Malis

Quite Involved in Discussions
#1
FDA Position: Use Error is the Manufacturer's responsilbility

1. "Use error is still considered a non-conformity, because human factors and ...similar tools should have been considered during the design phase" - K. Trautman

So how do we identify and assess the severity and motigate errors in user-device interaction?

What conclusions, the results of these answers have have on device user interface and labeling?

What would be consider "enough information" when it comes to the use error risk management?
 
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Martin IT

Involved In Discussions
#2
Re: Managing use error risk

I'm not an expert about that, but I've had a problem with an incorrect use of a medical device by the user.
The most effective solution is the 'informative note' where the company explains how use the MD and explains what is the incorrect use and its effect. The second step is re-write the user's manual where you underline how to use the MD for that specific situation ( the company must be very clear with the customer in term of what is dangerous or not ). Third ( if is possible ) you change the project with the aim to have a check on the use of the MD ( in my case I've inserted a software control ).

I hope I have answered your question ( if I understand well what do you mean :lol: )
 

Michael Malis

Quite Involved in Discussions
#3
Re: Managing use error risk

... I've had a problem with an incorrect use of a medical device by the user... )
Martin,

You missing the point - new standard put the responsilility on the Manufacturer! So the issue is what can we do to prevent use errors?

Additional requirements in Design Input phase?
Use Error Management in PMA and 510(k)s?
Should we all adapt the use of AAMI standards (HE-48, HE-74, HE-75)?
IEC 62366 and IEC 60601-1-6?

What is the appropriate way to go? and this is before the Question about what would be exapmle of "good labeling" for user documentation?

Any takers?
 

Marcelo

Inactive Registered Visitor
#4
Re: Managing Use Error Risk - FDA Position: Use Error is Manufacturer's responsilbili

You must use a risk-management based usability engineering process, as detailed, for example, in IEC 62366 (or the AAMI documents, particularly the new revised HE-75).

In this process, which is based on ISO 14971, you identify hazardous situations related to the equipment and then control the risk of these hazardous situations. There are three methods of risk control:

1) the equipment has inherit safe regarding this situation, meaning it´s design to be safe;
2) if inherit safety is not possible, you can use protective measures like alarms systems;
3) if 1 or 2 is not feasible, then, and only then, you can use the last option, information for SAFETY, e.g. warnings in the instructions for use.

Keep in mind that the second and third option are risk control measures that depend on an external action, generally by the user, to keep the risk at control. Thus, using the second and third option in fact raises the risk of usability/human factors/use error.
 
Last edited:

Michael Malis

Quite Involved in Discussions
#5
Re: Managing Use Error Risk - FDA Position: Use Error is Manufacturer's responsilbili

You must use a risk-management based usability engineering process, as detailed, for example, in IEC 62366 (or the AAMI documents, particularly the new revised HE-75).

In this process, which is based on ISO 14971, you identify hazardous situations related to the equipment and then control the risk of these hazardous situations. There are three methods of risk control:

1) the equipment has inherit safe regarding this situation, meaning it´s design to be safe;
2) if inherit safety is not possible, you can use protective measures like alarms systems;
3) if 1 or 2 is not feasible, then, and only then, you can use the last option, information for SAFETY, e.g. warnings in the instructions for use.

Keep in mind that the second and third option are risk control measures that depend on an external action, generally by tje user, to keep the risk at control. Thus, using the seconf and third option in fact raises the risk of usability/human factors/use error.
Good information - does it relates thesame to Medical devices (not equipment) ?
 

Marcelo

Inactive Registered Visitor
#6
Re: Managing Use Error Risk - FDA Position: Use Error is Manufacturer's responsilbili

Medical devices (not equipment)
Are you saying medical "electrical" equipment? If that´s the case, I didn´t cite IEC 60601-1-6 because, in the near future, it will be replaced by IEC 62366, but yes, it´s the same thing.
 

Michael Malis

Quite Involved in Discussions
#7
Re: Managing Use Error Risk - FDA Position: Use Error is Manufacturer's responsilbili

Are you saying medical "electrical" equipment? If that´s the case, I didn´t cite IEC 60601-1-6 because, in the near future, it will be replaced by IEC 62366, but yes, it´s the same thing.
I am saying Disposable Medical Devices, not electrical equipment...

Therefore, IEC 62366 or 60601-1-6 should not apply...
 

Marcelo

Inactive Registered Visitor
#8
Re: Managing Use Error Risk - FDA Position: Use Error is Manufacturer's responsilbili

I am saying Disposable Medical Devices, not electrical equipment...

Therefore, IEC 62366 or 60601-1-6 should not apply...
Oh sorry, i misread what you said.

The usability engineering process is the same for all medical devices. For example, IEC 62366 was developed based on IEC 6060101-6 (which was only for medical electrical equipment) because there was a need for an international standard for all medical devices. The AAMI documents are for all medical devices.

So yes, it relates the same for all medical devices.
 

Martin IT

Involved In Discussions
#9
Re: Managing use error risk

Sorry I didn't understand your question!

In my opinion to prevent the incorrect use of MD the most important thing is the experience.

The Standard etc. aren't useful ( you can use it only to build a list of possible factor of hazards, but aren't really useful to detects possible uncorrect use of the MD )
 

Marcelo

Inactive Registered Visitor
#10
Re: Managing Use Error Risk - FDA Position: Use Error is Manufacturer's responsilbili

In my opinion to prevent the incorrect use of MD the most important thing is the experience.

The Standard etc. aren't useful ( you can use it only to build a list of possible factor of hazards, but aren't really useful to detects possible uncorrect use of the MD )
The regulations require that the manufacturer detect possible incorrect uses BEFORE putting the device into market. The experience with the use will show, among other things, if you were successful in this previous detection, or if you have to change your design due to not detecting.

The standards mentioned detail state of the art processes to perform this detection during product design.

The Standard etc. aren't useful
If you are so illuminated as to not need to consult a document which aims to help manufacturers implement their processes, congratulations, but i think the majority of manufacturers usually find the documents very useful.
 
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