Continuing with Medical Device Complaints

In the post “Helping A Client Understand Medical Device Complaints”, I shared some recent experiences with a small medical device company. As I mentioned, I’m trying to understand their hangups about complaints. I┬áspeculated:

  • 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.

The other day, I met with the client to discuss my retrospective review of the customer repair records. I shared with them my assessment, including which items I thought were potential complaints.

They disputed every single item I identified. They tried to argue why things were not complaints. I reiterated the definition of a complaint. Still–argumentative, agitated, frustrated. I tried in vane to explain to them why they needed to document these items as complaints. After I left and during my drive, I continued to think about this issue and how I could better explain to the client about documenting complaints.

I concluded one thing: The client has maintained their current business practices for well over 30 years. Getting them to a point where they realize and understand FDA complaint regulations and expectations will not happen overnight.

I’ll try again soon.

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