Lurking manufacturer responsibilities relating to user error & informing other manufacturers

Errek

Registered
In some dusty corner of my memory, from when I first was trained on / came into contact with 21 CFR and FDA, I have the notions that:
- When I am a manufacturer and I find an issue with the device of another manufacturer, I need to inform that other manufacturer.
and
- When I investigate an incident as a manufacturer, and find that the incident was caused by user error, I need to inform the user, so that they do not repeat the error.

I remember seeing these topics being prescribed, as text, coming from FDA. I have searched (including preamble) 21 CFR 803 and 820.198, the 1997 and 2016 guidances but have come up with nothing.

Can any of you remember the same and/or point me in the direction of any such written indication? Or am I just plain wrong?

Thanks for your thoughts.
 

yodon

Leader
Super Moderator
- When I am a manufacturer and I find an issue with the device of another manufacturer, I need to inform that other manufacturer.
and
I don't think there are any regulatory positions here, but from a morals and ethics position, I think you'd want to report it to prevent harm.

- When I investigate an incident as a manufacturer, and find that the incident was caused by user error, I need to inform the user, so that they do not repeat the error.
That's probably short-selling and it's why, I believe, the regulatory bodies are looking much more closely at UE/HFE. Can you design out the potential for this user error? I don't recall any specific regulatory position here, but this falls under ongoing risk management.
 

Errek

Registered
That's probably short-selling and it's why, I believe, the regulatory bodies are looking much more closely at UE/HFE. Can you design out the potential for this user error? I don't recall any specific regulatory position here, but this falls under ongoing risk management.
There unfortunately are market actors that would like to use "user error" as a get-out-of-jail card for as many issues as possible, in order not to have to spend resources on finding and resolving the real root cause.
The way I always interpreted this was as an additional measure, a way for FDA to confront those market actors with their customers, and by way of (anticipated) customer reaction reduce their urge to blame the user.

Thank you for your response. So helpful to have a sanity check.
 

Tidge

Trusted Information Resource
AFAIK: The obligation is for (employees of) a medical device manufacturer to report deficiencies for their own devices (to their complaint handling department); there is not an obligation to report deficiencies with other devices. The onus is then on a manufacturer's complaints handling group to do an investigation and determine if the event is reportable or not.

I believe there are public avenues for reporting issues without contacting the manufacturer, but I can't imagine that these have more tangible benefits than "shouting at the sky", especially if the harms are neither particularly serious nor widespread. It is of course possible for a small number of voices to get a disproportionate amount of attention if certain "power players" can get interested.
 
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