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When to issue a Customer Complaint related to efficacy of a Medical Device?

Q

QAManagerBE

#1
Hi everyone,

Here is a question we've been asking to ourselves for a couple of months.
Looking for some benchmark.

We launched one year ago a new product (therapeutic long term implant) and since June 2012, we've been communicating with end users (surgeons) in a very proactive manner.
I'm having phonecalls, emails, face-to-face meetings on a regular basis to get feedback from surgical experience and implant efficacy.

And of course I receive much more feedback than I would if adopting a "passive" behaviour.
And of course, there is often something to complaint about, from "surgery was difficult", "I'm a bit concerned about the size of the implant but time will tell" up to "I decided to remove it since I'm not happy with its performance" or even "I decided to remove the implant because an other disease/condition started and this might interfere with the implant".

Regarding performance, as for many other therapeutic devices, it's not all black or white.
Our device is part of a global treatment strategy and may work by itself or may need additional drug regimen to be successful. And this is the case for our competitors as well.

So my question is simple : regarding the product efficacy, does any of you have a list of "efficacy tresholds" that trigger a complaint and set the limit between "user feedback" and "user complaint"

We were, for example, thinking about "if implant removal happened, then it's a complaint".
Any other ideas? Suggestions?

We've always done our best to best very careful and responsible by getting as much feedback as we can during early lifecycle of the product, but at the same time don't want to create a burden of complaints by doing this.

Many thanks
Pierre
 
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Sidney Vianna

Post Responsibly
Staff member
Admin
#2
So my question is simple : regarding the product efficacy, does any of you have a list of "efficacy tresholds" that trigger a complaint and set the limit between "user feedback" and "user complaint"
I think your organization must be commended for being proactive and solicit all this feedback, instead of taking the reactive approach. However, and assuming that the product is being sold in a market where regulations exist for the medical device, you can't ignore the regulatory aspects of the device.

The FDA definition for "complaint" applies here and, it does not differentiate if the feedback was solicited or not. If you are under FDA's jurisdiction for this device, you have to abide by the definition of complaint and process it accordingly.

Complaint means any written, electronic, or oral communication that alleges deficiencies related to the identity, quality, durability, reliability, safety, effectiveness, or performance of a device after it is released for distribution.
PS. I moved the thread to another forum, to see if you have more replies.
 
Q

QAManagerBE

#3
Thank you for your answer,
Yes we do want to keep this proactive approach for sure and we do ackowledge and comply with the regulatory requirements that apply, so every complaint will be handled properly and following our internal SOP.

But... back to the FDA definition :
Complaint means any written, electronic, or oral communication that alleges deficiencies related to the identity, quality, durability, reliability, safety, effectiveness, or performance of a device after it is released for distribution.
So my point is exactly where do you put the limit between "a user providing feedback" and "a user alleging deficiency".

Any suggestions for therapeutic implanted devices that may substitute or work in combo with a drug?

Thanks a lot
Pierre
 

sagai

Quite Involved in Discussions
#4
Well, this "alleges deficiencies" is really a pain.
I have came across several instances where FDA audits were happy with the complaint system without considering the "alleges" part.
Other than that it looks bizarre to consider wishes as complaints.
It is slippery slope though.
Cheers!
 
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