What Is A Medical Device Complaint?

We’ve talked about medical device complaints before:

Remember, 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 820.198ISO 13485 sub-clauses 7.2.3 addresses customer communication and 8.2.1 addresses feedback.

It seems like several client engagements in recent years have had some dealings with complaint handling. In my experience, it’s a topic that nearly every medical device company struggles with on some level. And I wish, I as the consultant to these companies, possessed all the answers and solutions to address the issues. However, I’ve found that each medical device business is as different as the products they manufacture and sell.

The fall back is the FDA definition of complaints. By strict interpretation of this definition, every time a company receives a phone call, email, letter, etc. claiming some sort of product issue / deficiency then a complaint should be documented. Is this a practical approach?

I say not really. How many times have you heard something along the lines of “. . . the device doesn’t work . . .” only to find that the product had been used and abused when received from the customer. Is it really fair to consider these types of scenarios a complaint? And what about those times when you were diligent in tracking down as much information about the alleged issue only to reach dead end after dead end?

My advice on this topic is to interpret complaint requirements and regulations and for the company to define their complaint handling procedures. With one recent medical device company which manufactures a reusable device, we crafted a process that made sense for their business. Especially considering that they offer device repair services to fix product issues. They have years of data and know that some of the components are prone to wear and tear. Anyway, we had to fix the company’s approach–mostly because they received 483 observations and warning letter indicating their procedures were deficient. We got this resolved and a “blessing” from FDA.

We began working with another company which also manufactures a reusable medical device. We began drafting a procedure and process, leveraging our past experiences. Seems pretty straightforward, right?

Here comes the curveball. FDA came back in to re-inspect the initial device company mentioned above. The inspector seemed to have all kinds of concerns about how the medical device company is addressing complaints, or at least this was the impression he gave on day 1 of the re-inspection. He fell back to the basic FDA definition of complaints: EVERYTHING is a complaint. Rather than just take it, I decided to use this opportunity to ask lots of questions. The answers would not only help the client going through yet another FDA inspection, but also the second client, along with future clients. I offered several “what if” and hypothetical scenarios, such as customer says the device doesn’t work but when received you notice it has been run over by a truck (which is an actual case and not a hypothetical). I asked the inspector if he would consider this a complaint. His response was “yes” but that the company may determine that no additional investigation is required. Several more questions all corroborating the assertion that any report of product issue equals complaint.

Interesting. When I got home that evening, I realized I might need to redirect complaint process improvements for client #2. In fact, I shared my new bit of wisdom instilled upon me by a FDA inspector with this client.

A day or two passes, along with a weekend. FDA inspection at client #1 resumes. And out of the gate, the FDA inspector shared that he had done quite a bit of thinking about the topic of complaints over the weekend. He recanted some of what he shared a few days prior. He now stated that not everything is a complaint. That the company should be maintaining a log of calls and reported issues. However, the company can decide once receiving the product back and/or after additional evaluation if the issue is a complaint (provided they follow their procedures). I wanted to laugh out loud hysterically but refrained. I was rolling with laughter on the inside. The inspector’s revelation about complaints was basically identical, or at least very similar to the process in place at customer #1 and what I was advising at client #2.

You tell me. What is a medical device complaint? How can industry be clear on this topic when FDA inspectors seem to struggle with it too?

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