Complaint Handling Procedure for Medical Devices

[sokku]

Dear Professionals

We are the medical devices company and implementing FDA QSR, As part of implementation, we need to implement complaint handling procedures.

Is there any different between customer feedback and complaint handling? If so

A significant compliant was received from the field regarding the performance of our device, this particular complaint was reported from a large number of customers.

What procedure do we follow to handle these complaints?

How would we decide whether to remove the affected device from the field?

I appreciate your valuable comments

-Sokku

[arios]

Hi Sokku

Based on your comments regarding the amount and type of complaints you may be facing a possible need to perform a Field Safety Corrective Action. The decision will have have to be based on a risk assessment taking in consideration the actual or potential impact on the patient, user or other persons.

About the other question about customer feedback and complaint handling, they are not necessarily the same. A feedback could be positive or a suggestion, thus not necessarily a customer complaint.

You will need to determine if the complaints represent reportable events (MDR's), document an investigation, and initiate your CAPA process.

Alberto

[sreenu927]

Hi Sukku,

To be in compliance with QSR, you must have documented procedures for Complaint Handling and Medical Device Reporting (MDR), apart from other SOPs.

As told by Alberto, feedback and complaint handling may or may not be iincluded in the single procedure.

For ur case, the complaint handing procedure shud capture the complaints, which you need to evaluate the complaint, whether or not it is reportable to FDA. If so, that triggers your MDR. During your investigation, if you decide to do any field action (relabel, modification, repair and/or recall), then a Field Safety Corrective Action procedure will be triggered. If no field action,then investigate the complaint and close CAPA.

Hope this helps.

Regards
Sreenu

[Dudes]

Hi Sokku,

let's try to answer your different questions...

In Reply to Parent Post by sokku

Dear Professionals

We are the medical devices company and implementing FDA QSR, As part of implementation, we need to implement complaint handling procedures.

Is there any different between customer feedback and complaint handling? If so

As other stated, feedback can be either positive or negative. Complaint would only be negative.

Although you have to document both, complaint handling will give you much more work. Once you have received a praise, there isn't much more you can do than document it, file it, and add to your monitoring for the management review.

When you receive a complaint, you have to investigate it. Is it relevant? Where does the problem comes from? Can you correct it? Can you find the ROOT cause and take preventive actions to be sure it doesn't happen again (CAPA)? ...

A good monitoring of your complaints shoud allow you to discover and address problem early on...

In Reply to Parent Post by sokku

A significant compliant was received from the field regarding the performance of our device, this particular complaint was reported from a large number of customers.

What procedure do we follow to handle these complaints?

The procedure would be the same for one complaint as for many. Depending on the risk (both to the patient/user and commercial), you may want to put more ressources in the resolution.

In Reply to Parent Post by sokku

How would we decide whether to remove the affected device from the field?

I appreciate your valuable comments

-Sokku

You have to perform a risk analysis. What are the risks of your device? Does it present any danger to the patient? In that case, you may have to notify it to your regulatory agency.

A recall, withdrawal or any other FSCA (field safety corrective action) has to happen based on this risk analysis.


I hope it helps

[Ronen E]

In Reply to Parent Post by sokku

Dear Professionals

We are the medical devices company and implementing FDA QSR, As part of implementation, we need to implement complaint handling procedures.

Is there any different between customer feedback and complaint handling? If so

A significant compliant was received from the field regarding the performance of our device, this particular complaint was reported from a large number of customers.

What procedure do we follow to handle these complaints?

How would we decide whether to remove the affected device from the field?

I appreciate your valuable comments

-Sokku

Dear Sokku,

After reading your post, I’m not 100% sure of your situation. Are you just preparing your QSR compliant procedures, or do you already have them in place?

If you already have written procedures in place, you should follow them. It sounds as if this is not a good time to start making changes. If you are unsure whether or not your current procedures meet the QSR, it is best to have someone experienced carefully examine them. It would be very difficult to tell, without actually reading your procedures, and you would probably not want to expose them in a public forum.

If, on the other hand, you still don’t have such written procedures, or you are in the process of preparing them (or upgrading existing ones to meet the QSR), then you shouldn’t be selling into the US market. If you are still not selling into the US market then you probably don’t have to report the FDA.

As to your questions –

Apart from customer feedback being possibly positive, another difference is that customer complaints are received passively, while you are expected to be active in gathering general customer feedback (sending out questionnaires, conducting annual survey meetings etc.). Sometimes a customer complaint is not declared as such by the source, and can be received as part of the general customer feedback collection system. It is recommended, however, to record any specific negative feedback received from the field, regardless of the way it was received, as a formal complaint, and handle it as such.

In handling customer complaints you should follow your documented customer complaints procedure. This, in turn, should be based on relevant FDA guidance. I think going to the source and studying it thoroughly is much better than relying on abbreviated second-hand advice. Having said that, here is some abbreviated second-hand advice

1. Formal MDR is required in the following situations:
· Your device may have caused or contributed to a death or serious injury, or
· Your device has malfunctioned, while recurrence of the malfunction in this type of device or a similar one, marketed by you, would be likely to cause or contribute to a death or serious injury.
“Significant” is a term that may have different meanings in different settings, and therefore can't be used for decision-making. The above, on the other hand, is FDA terminology and further elaborated definitions for the terms used are available from the FDA.

2. For a decision whether or not to remove the affected device from the field, it is best to consult the FDA guidance on RECALL (or your recall procedure, if based on FDA guidance).

3. To itself, the large number of complaints of a similar nature does not necessarily mean that the problem is severe (i.e. in risk terms). However, several incidents of a minor severity may call for a response similar to that given to a single major incident (similarly, several major may be equivalent to one critical).

Good luck,
Ronen.

[sueliu - 2012]

I have a question regarding FDA's requirement on complaint handling as well.

We just went through an ISO 13485/FDA inspection (combined) audit, the auditor mentioned we should have a question list to assess whether the patient health is at risk for each single complaint we get. I am wondering if anybody could show me the links or locations where I can find this question list. Or, if anybody can share me an example.

[Vincnet]

Sueliu

afssaps in France issued a very usefull document that we are supposed to use when declaring a vigilance event.
the last page of the document is a flowchart designed to help people decinding what it the impact of the compliant and what should be done.

I attached a copy if this doc here.
So far i never used it with non french clients so i do not have a translation but wording is very simple and google should be abble to translate it.

Hope this will help you

Vincent

[sueliu - 2012]

Thanks so much Vincnet. I wish I could read French now.