Medical Device Hazard Risks - Normal Use Risks vs. Faulty Use Risks

2

20130523

#1
Hi All-
Can anyone think of a good explanation as to why Hazards were at one time categorized into Normal Use Risks and Faulty Use Risks, and what the benefit was of that breakout? Are there certain elements or info that could be missing by identifying the individual Hazard as the starting point? I see that most assesments now look at probability and danger to assess risk, and this makes sense. But when I look at older analysis tools I have saved on file, there are many that look at Fault and Normal, about 2002 and earlier.

Also, if anyone would like to share what they use, particularly for a class I disposable risk assessment, that would be great! I have several copies, but not any close to my industry.
Thanks!
 
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Stijloor

Staff member
Super Moderator
#2
Hi All-
Can anyone think of a good explanation as to why Hazards were at one time categorized into Normal Use Risks and Faulty Use Risks, and what the benefit was of that breakout? Are there certain elements or info that could be missing by identifying the individual Hazard as the starting point? I see that most assessments now look at probability and danger to assess risk, and this makes sense. But when I look at older analysis tools I have saved on file, there are many that look at Fault and Normal, about 2002 and earlier.

Also, if anyone would like to share what they use, particularly for a class I disposable risk assessment, that would be great! I have several copies, but not any close to my industry.
Thanks!
Can someone help with this one?

Thank you!

Stijloor.
 
M

Mr. Petey

#4
Specialized ignition sources such as lasers are utilized in oxygen-rich atmospheres, such as hospital operating rooms. Oxygen increases the threat of fire, but this is a Normal Risk.

A patient that smokes while using oxygen in a nursing home or in an apartment is a an example of a Faulty Use Risk.
 

yodon

Staff member
Super Moderator
#5
Not sure what you mean by categorized at one time into normal / faulty use risks. I think that's still the case and the FDA is continuing to push for more consideration of such risks.

You do need to consider likely misuse cases. Mr. Petey cites excellent examples of each and you should consider both in terms of eliminating / reducing risk. Using the example above, you probably can only put something in the User's Manual or accompanying literature that says "Don't smoke or operate around open flame." But you HAVE considered and addressed it.
 
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