Customer Complaint - FDA Definition of Complaint

[hitesh]

We are class II and Class III medical device manufacturers (OEM). Few of the medical devices we sell are re-sterilizable and non-sterile. These devices are used multiple number of times by the end-users. We provide 3 month warranty for some devices and 1 year warranty on the others.

Currently, we consider any concerns related to the identity, quality, durability, reliability, safety or performance of a medical device from the customers as a customer complaint eventhough the product is out of warranty.

What is industry standard practice? Is there any Medical Device OEM to help me clarify whether out of warranty products should be treated as complaint as per the FDA defination below or service call?

FDA Defination of Complaint: written, electronic or oral communication that alleges deficiencies related to the identity, quality, durability, reliability, safety or performance of a medical device that has been placed on the market.

Sincerely,
Hitesh

[MIREGMGR]

In Reply to Parent Post by hitesh

Currently, we consider any concerns related to the identity, quality, durability, reliability, safety or performance of a medical device from the customers as a customer complaint even though the product is out of warranty.

For the majority of our Class II disposable/single-use accessory products, the "warranty" period is equal to the stated sterile-barrier-packaging stability-lifetime, i.e. typically five years from date of manufacture.

We don't have a specific statement of policy in regard to the question you ask. If there's something wrong with one of our products defined above, it's likely to be discovered long before five years have elapsed. But, I think we would agree with your statement above, subject to the conditions you applied to it.

[Chris Ford]

In Reply to Parent Post by hitesh

We are class II and Class III medical device manufacturers (OEM). Few of the medical devices we sell are re-sterilizable and non-sterile. These devices are used multiple number of times by the end-users. We provide 3 month warranty for some devices and 1 year warranty on the others.

Currently, we consider any concerns related to the identity, quality, durability, reliability, safety or performance of a medical device from the customers as a customer complaint eventhough the product is out of warranty.

What is industry standard practice? Is there any Medical Device OEM to help me clarify whether out of warranty products should be treated as complaint as per the FDA defination below or service call?

FDA Defination of Complaint: written, electronic or oral communication that alleges deficiencies related to the identity, quality, durability, reliability, safety or performance of a medical device that has been placed on the market.

Sincerely,
Hitesh

Hi Hitesh,

I worked at a company that was classifying customer service calls the same way. The company manufactured Class II hearing screening analyzers and breath analyzers. When they'd receive a call on a device, they'd record the problem, determine whether it was reportable, then check its warranty status. If out of warranty, it was automatically placed in the "service call" queue and considered "normal wear and tear".

FDA did not like that, and for good reason.

That's not to say that the issues weren't addressed; this company actually had great customer service and responded very quickly to customer calls. However, there is no specified time frame for complaint classification. A complaint is a complaint regardless of whether you receive it during the warranty period or after the defined life of the product.

The first line of the regulation for servicing is very clear, "(a) Where servicing is a specified requirement, each manufacturer shall establish and maintain instructions and procedures for performing and verifying that the servicing meets the specified requirements."

Let's say you make a device that clearly states on its labeling, "results not valid after 10 uses."
Your company defines a service requirement for the device to be returned and "recharged" after 10 uses.
The customer uses the device 11 times and receives a false negative result the last time it is used. The customer calls to file a complaint with the company.

This is NOT a service call, because while it may relate to a specified service requirement, the customer is unaware of the requirement, and feels that the device has malfunctioned. Your complaint investigation should include a review of your labeling, and associated customer training material. The investigation may even continue internally, if your procedures require you to notify the customers when their service is due.

At any rate, this is one of the most common misconceptions I've found regarding the QSR. Both the complaint records and servicing regulations appear lacking in detail, until you start to uncover the nuances. Servicing is a planned activity, not to be confused with "my device is broken and I need it fixed"... that would be considered a complaint.

Remember... the definition for a complaint is: "any written, electronic or oral communication that alleges deficiencies related to the identity, quality, durability, reliability, safety or performance of a medical device that has been placed on the market."

So if it's a call that alleges a deficiency (including reliability, hence your warranty period is of no consequence), it's considered a complaint. If you receive a complaint for a device that's exceeded its intended life, it's still a complaint, but you probably won't be doing much of an investigation on it.

[howste]

In Reply to Parent Post by hitesh

Currently, we consider any concerns related to the identity, quality, durability, reliability, safety or performance of a medical device from the customers as a customer complaint even though the product is out of warranty.

What is industry standard practice? Is there any Medical Device OEM to help me clarify whether out of warranty products should be treated as complaint as per the FDA defination below or service call?

FDA Defination of Complaint: written, electronic or oral communication that alleges deficiencies related to the identity, quality, durability, reliability, safety or performance of a medical device that has been placed on the market.

Sincerely,
Hitesh

The definition of complaint is pretty clear. If the customer alleges deficiencies, then it's a complaint. How you handle it will be different if it's out of warranty. Out-of-warranty product may not need to be investigated though. 21 CFR 820 requires us to

In Reply to Parent Post by FDA

review and evaluate all complaints to determine whether an investigation is necessary. When no investigation is made, the manufacturer shall maintain a record that includes the reason no investigation was made and the name of the individual responsible for the decision not to investigate."

So if it's not in warranty that may be justification to not investigate and follow up.

[hitesh]

Thanks Guys,

Your feed back was really helpful.

[rlbate]

There was some very helpful information in this thread. We have been performing investigations on many of our class II devices long after the warranty period had expired. This has ultimately led to some pretty thin investigations and wasted time as the manufacturing techniques may have been improved many times since the device was manufactured.

Thanks for the insight.

[MIREGMGR]

Just my two cents, but I don't think the FDA is going to accept a no-investigation decision based solely on an "out of warranty" status, if the complaint pertained in some manner to safety or effectiveness.

Whether a complaint has any safety or effectiveness aspects is the first question to be decided in the investigation-needed decision process. If it does, our understanding is that an investigation must be done and documented.

I think Chris Ford discussed this effectively above.

[brandomenon]

Two more cents to add...

Even when a device is out of warranty, it's a good idea to consider risk for each complaint. You can often use a discussion of risk as an explanation for why you did not perform a thorough investigation. It will also help you to prioritize where you spend your time and effort.

If a complaint is more likely to lead to a serious health problem or a recall, then you would invest more time and effort on the investigation. If the complaint, in your expert opinion, has little opportunity to cause a negative health effect (or a limited health effect), then that is reason enough not to go overboard trying to investigate the problem. Of course if you end up with a bunch of complaints related to the same problem, the FDA would expect more follow-up. Frequency also factors into assessing risk!