Customer Return or Advisory Notice?

A

arios

#1
Medical Device folks, please let me have this question clarified.

A Hospital reports a complaint to a Medical Device manufacturer, then in lieu of sending the actual complaint sample back for analysis, the hospital decides to ship all of the stock in his posesion of that product back to the manufacturer for evaluation and replacement.

Should this event be classified as an Advisory Notice or not? Is the classification depending on who makes the decision to return the product? What if the decision was agreed by both the hospital and the manufacturer?
 
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sreenu927

Quite Involved in Discussions
#2
Hi Arios,

Due to change and understanding of the terminology (advisory Notice) from US to Non-US Regulations, I am not sure whether you are looking for such an answer below.

But, I'l try to present my views. Sorry, if you feel it is irrelevant.

What is that complaint about? Does it lead to any adverse event/MDR event?
Non-US:
If the complaint is an AE and the investigation has lead to report, then it falls under MDR reporting.
If the complaint has lead to perform some sort of field corrective actions, then a FSN and FSCA report have to be submitted.

As the type of the complaint is not known, if the investigation results that no action to be taken, just to inform the customers of corrective action,then notify customers with a User bulletin/Technical bulletin/customer advisory notice (no need to report to Authority)

US:
If the complaint is an AE and investigation resulted to report, then it falls under MDR reporting.
Otherwise, for any removal and correction, manufacturer must notify FDA within 10days after he becomes aware of that.
If the investigation has led to perform a recall, then actions to be taken accordingly (performing Health Hazard Evaluation, recall classification,recall strategy, pull back the products).

Thanks,
Sreenu
 
A

arios

#3
Hi Sreenu

This is a theorical situation. Please consider the definition of Advisory notice provided on ISO 13485.

What is your opinion?
 

chris1price

Trusted Information Resource
#5
Hi

You are mixing two different issues here.

A customer can return product to you for many reasons. In most cases this will have nothing to do with product safety. Just because they have returned product, either one piece or whole batches, does not automatically lead to a regulatory action, such as an Advisory Notice.

Advisory Notices are actions a manufacturer takes to inform customers of potential or actual issues with the product. It is for you as manufacturer to deterermine whether an Advisory Notice is required, not the customer.

I would suggest reading through the MEDDEV 2-12-1 for further guidance.

Chris
 
#6
Hi

You are mixing two different issues here.

A customer can return product to you for many reasons. In most cases this will have nothing to do with product safety. Just because they have returned product, either one piece or whole batches, does not automatically lead to a regulatory action, such as an Advisory Notice.

Advisory Notices are actions a manufacturer takes to inform customers of potential or actual issues with the product. It is for you as manufacturer to deterermine whether an Advisory Notice is required, not the customer.

I would suggest reading through the MEDDEV 2-12-1 for further guidance.

Chris
The proactive response of analysis and improvement which the manufacturer decides as necessary to be taken to the customers for the safe and effective use of the medical device constitutes the implementation of the advisory notice. In a case of customer complaint and return, if the analysis and root cause suggests that a notice to other customers would be beneficial for the safe and effective use of the device, the manufacturer decides to implement (make a brief and good notice) to all customers over and above the supplied manuals and instructions for use. A procedure to establish such a notice releasing activity would have been in place by the medical device manufacturer per the ISO 13485, 8.5.1 requirement.
 
A

arios

#7
My main concern is how to prevent making "Silent recalls", this is knowingly or not knowingly initiate activities that should rather be considered Field Actions, than simple returns. On this area I believe there exists a risk of making wrong decisions or perhaps documenting incorrectly right decisions.

Making "Silent recalls" could turn into Warning letters by the FDA, and could also lead to a Major non-conformance by a NB. I have seen instances in the FDA data base and I found worth to bring this subject to discussion here in order to have an opportunity to share opinions.
 
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