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.