Class II medical device - When should a complaint be closed?

Darshan_Shetty

Starting to get Involved
#1
We make a Class II medical device and sell it in US and EU. Unless it is some application issue that can be fixed onsite, the defective device part or its accessories are replaced for the customer any time there is an issue. The defective part is then sent for repair to its OEM manufacturer. Once the part is fixed (this could take months), it is sent back to us for reuse and stored in our inventory.

Question is at what point of the process should the complaint be closed?

A. At the point when customer gets a replacement or
B. At the point when the specific defective part gets repaired and sent back to us
 
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Mikey324

Quite Involved in Discussions
#2
When is the root cause considered? I'm in automotive, so please ignore my ignorance of medical device standards. We consider a complaint closed when the root cause has been determined, corrective action has been implemented, and its effectiveness verified.
 

Darshan_Shetty

Starting to get Involved
#3
When is the root cause considered? I'm in automotive, so please ignore my ignorance of medical device standards. We consider a complaint closed when the root cause has been determined, corrective action has been implemented, and its effectiveness verified.
Isn't that the CAPA process to determine the root cause? Where is the difference between Compliant Handling Process VS CAPA Process. I would think that the prime objective of Compliant Handling process is to relieve the customer of any concerns, and that happens when we -Evaluate>Investigate>Replace. Root cause will always point to pre-market activities and that should be a CAPA not complaint. I dont know, Please correct me if I am wrong.
 

indubioush

Quite Involved in Discussions
#4
Complaints need to feed into the CAPA system. You should evaluate each complaint to determine whether corrective action is required. Corrective action could also encompass a recall.

It seems to me that you have a complaint here and also feedback. As for the complaint, the customer is satisfied after they receive their replacement. However, for your organization, you need to trend the issues and results of the repair. If you want to have a complaint be considered closed after the customer is satisfied, that is fine, but how will you close the loop on the repair results? You may want to have a separate complaint and feedback process or record. Go back and read ISO 13485 and see the difference between feedback and complaints.
 

Bev D

Heretical Statistician
Staff member
Super Moderator
#5
There is a substantial difference in how words are used between automotive and medical devices. there is also a substantial differences between being a supplier to the final producer and being the producer of the final product.

"Complaints" in the medical device industry are the same as warranty claims in the automotive industry. (they are also analogous to nonconforming material within your organization). The using customer only needs their 'problem' corrected. replace it, repair it, whatever.

If you have enough warranty claims, Customer complaints or non-conforming material occurrences, then root cause investigation and correction to prevent recurrence is in order.

Of course some final product producers try to impose 'root cause corrective action' on every single adverse event regardless of occurrence rate or severity.

hope this helps
 

Watchcat

Trusted Information Resource
#7
I don't think you close the complaint, although I know this is common jargon. I think you close the investigation. From that perspective, whether the customer gets a replacement part or a refund, or is told to bug off, is irrelevant.
 
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