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

M

Martin IT

#11
Re: Managing Use Error Risk - FDA Position: Use Error is Manufacturer's responsilbili

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.
This is realy obvious! Only the use of the MD will show if project is well done, but every designer know that the immagination of the stupid overtake the intelligence of the engeener, so the user will find a way to use the device in the incorrect way!

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.
[/QUOTE]

I'm not 'so illuminated'. The Standard can help you to check your project respect the principal hazards, but 'the uncorrect use' is an more difficult proble to manage. In this way is necessary the experience of the designer who knows how the MD device works, who knows the basic knowledge of the standar user etc.

In brief, to prevent an incorrect use is a vary hard task, it is the first goal of the post market surveillance.
 
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Marcelo

Inactive Registered Visitor
#12
Re: Managing Use Error Risk - FDA Position: Use Error is Manufacturer's responsilbili

every designer know that the immagination of the stupid overtake the intelligence of the engeener, so the user will find a way to use the device in the incorrect way
This is not what the facts say. The requirements and focus on usability were introduced due to the realization by authorities that the "user error" was, in fact, bad design (the "intelligent" engineer made a device so intelligent that only himself could use). That´s why nowadays the concept changed to "use error'. Sure, operators in general can always do stupid things, but the designer is generally as guilty as them.

The Standard can help you to check your project respect the principal hazards, but 'the uncorrect use' is an more difficult proble to manage.
First of all, i´m not sure what you mean with "incorrect use". If it´s "abnormal use" as defined by standards and regulations, you might know that they do not required that a manufacturer deals with them. What the regualtions and standards require are that foreseeable hazardous situations are identified and dealt with.

And, again, what the facts show is that manufacturers do not identify them as they should. That´s what Kimberly Trautman was saying in the quote of the first post of this thread.
 

Michael Malis

Quite Involved in Discussions
#13
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 )
Martin,

You need to use your experience to do the Risk Analysis properly. You have to understand how your device is working and potentially which way this product can be used by the end user. It is your ability to predict the posibility of the hazard and the occurance of it that make your Risk Analysis efFective or not...
 
S

S.Mario

#14
Re: Managing Use Error Risk - FDA Position: Use Error is Manufacturer's responsilbili

This is not what the facts say. The requirements and focus on usability were introduced due to the realization by authorities that the "user error" was, in fact, bad design (the "intelligent" engineer made a device so intelligent that only himself could use). That´s why nowadays the concept changed to "use error'. Sure, operators in general can always do stupid things, but the designer is generally as guilty as them.



First of all, i´m not sure what you mean with "incorrect use". If it´s "abnormal use" as defined by standards and regulations, you might know that they do not required that a manufacturer deals with them. What the regualtions and standards require are that foreseeable hazardous situations are identified and dealt with.

And, again, what the facts show is that manufacturers do not identify them as they should. That´s what Kimberly Trautman was saying in the quote of the first post of this thread.
I don't agree with you! The standard can be an useful guide, but in my experience the report of the commercial department was more useful. They explain us what is the most common error in the use of our product and what could be a dangerous behaviour! The ISO could help for the 'typical hazard' but a good designer can't be substituted by an ISO!

Of course is only my experience, but is a field experience!!
 
M

Martin IT

#15
Re: Managing use error risk

Martin,

You need to use your experience to do the Risk Analysis properly. You have to understand how your device is working and potentially which way this product can be used by the end user. It is your ability to predict the posibility of the hazard and the occurance of it that make your Risk Analysis efFective or not...
Well yes! I've worked at the Risk Analisys of our product and I've used the Standard and the experience too. At that process I've collaborated with the Post-Sales Manager, the product specialist, the Clinical Manager and the Quality Manager. All the point of view are important! In this way I mean that the experienc is realy realy realy important!
 

Michael Malis

Quite Involved in Discussions
#16
Re: Managing Use Error Risk - FDA Position: Use Error is Manufacturer's responsilbili

I don't agree with you! The standard can be an useful guide, but in my experience the report of the commercial department was more useful. They explain us what is the most common error in the use of our product and what could be a dangerous behaviour! The ISO could help for the 'typical hazard' but a good designer can't be substituted by an ISO!

Of course is only my experience, but is a field experience!!
S.Mario,

Yes, take this information from your commercial department and adapt it into useful Risk Management evaluation will not only allow you to know how to deal with the problem, but also helps anyone who comes after you to know how to deal with it. This is much better, than starting from scratch!
 
J

JaxQC

#17
Re: Managing Use Error Risk - FDA Position: Use Error is Manufacturer's responsilbili

I’d even go the step further of use trials. Get people who don’t know the product at all / well and have them try it. Is it “ATM simple”? ie I haven’t found an ATM where I couldn’t get my money out. Have it totally disassembled. Can they mix the connections? Start to run without it all hooked up?

A resource I didn’t see listed is the AIAG FMEA “blue book” 4th edition. www.aiag.org
A good documented FMEA is a great resource for the future as Malis notes so others know what was addressed, how it was addressed and what was overlooked.
 
M

Magdy

#18
Re: Managing use error risk

Well yes! I've worked at the Risk Analisys of our product and I've used the Standard and the experience too. At that process I've collaborated with the Post-Sales Manager, the product specialist, the Clinical Manager and the Quality Manager. All the point of view are important! In this way I mean that the experienc is realy realy realy important!
I'll show your post to my Quality Manager! :lmao:

I agree with you Martin, to perform an effective Risk Analysis is required involving more skills!
 

Michael Malis

Quite Involved in Discussions
#19
Re: Managing Use Error Risk - FDA Position: Use Error is Manufacturer's responsilbili

A resource I didn’t see listed is the AIAG FMEA “blue book” 4th edition. ...
Just want to clarify that FMEA, Hazard Analysis, etc. are all great tools to do risk analysis. However, the tools not necessarily help you to identify User Risk - your group of exp. people does!
 
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Marcelo

Inactive Registered Visitor
#20
Re: Managing Use Error Risk - FDA Position: Use Error is Manufacturer's responsilbili

Everyone used a lot of examples, but only JaxQC was the only one who remembered the main problem regarding this all: you need to talk to the users. You can ask anyone on the manufacturer staff, but they will mean nothing if you do ask the real users. A lot of problems arise when the staff of the manufacturer cannot translate the user requirements, including usability requirements, into product features that have high usability.
 
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