Helping A Client Understand Medical Device Complaints

FDA defines “complaint” as any written, electronic, or oral communication that alleges deficiencies related to the identity, quality, durability, reliability, safety, effectiveness, or performance of a device after it is released for distribution.  The ISO 13485 definition is very similar. For reference, FDA complaint regulations are covered in 820.198. ISO 13485 sub-clauses 7.2.3 addresses customer communication and 8.2.1 addresses feedback.

Recently, I’ve been working with some clients on improving their customer feedback / complaint handling processes. I’d like to share an example from one of these clients to help illustrate how important it is to effectively manage complaints.

This particular client was inspected by FDA a few months ago. The company has been manufacturing a class II device for decades yet has not documented a single complaint. Very suspicious, don’t you think? This fact tells me the company may NOT understand the definition of “complaint”. Their device is reusable. And the company had plenty of records where they had repaired devices in the field. Their claim was that the repairs were for normal wear-and-tear components and not an indication that the device was deficient in some way. Theoretically, this is very possible. However, the company lacked a customer feedback and complaint handling process. They did maintain records of device repairs. Yet, they had no records of any other customer communications about their products. FDA issued a 483 observation on this, later followed by a warning letter (both of which also included several other compliance issues and violations). Specifically, FDA requested that the company do a couple things: define the complaint handling (and related) processes and do a retrospective review of previous customer device repairs to determine if any could possibly be classified as complaints.

I got the opportunity to help the client with both tasks. But first, I had to train and educate them on complaint handling and other aspects of the Quality System Regulations. The training was fine–somewhat enlightening to the client. Which to me, is a little concerning. The company has been manufacturing medical devices almost for as long as I’ve been alive, yet they lack awareness of the regulations and requirements. I spent a great deal of time discussing complaints. They had lots of questions and specific examples to help better define what is and is not a complaint to them.

After training, I drafted a complaint procedure, including a process flowchart to better explain each step in the process. I also drafted a complaint form to mirror the process steps. I reviewed each with the client. Again, more questions about complaints and what is and is not a complaint to them.

Next step was to review the retrospective customer repair records. I focused first on their top few clients, which is what FDA reviewed. After reviewing the ~25 or so records, I determined that more than half could be considered as potential complaints. I forwarded this information on to the client for them to review. I indicated that if any of the items I identified as potential complaints are not, they need to document the justification and rationale to explain. I haven’t heard back from them yet.

As I’ve been working through this issue with the client, I’ve been trying to understand why the topic of “complaints” is so sensitive to them. I’m speculating, but here are my assumptions:

  • Indicating a product issue as a complaint suggests some sort of inferiority with the device.
  • Belief that identifying complaints would somehow put the company of FDA radar.
  • Logging the issue as a complaint was irrelevant because the company would make the repairs and address the issues.
  • Documenting complaints is time consuming and involves a lot of paperwork.

As I explained and hope to demonstrate in the coming days, implementing a robust customer feedback / complaint handling process will actually help them improve the overall quality of their product in the market. Time will tell, though, if they are willing to accept this revelation.


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