If A Reprocessed Medical Device Fails, Who Is Responsible for Investigating the Complaint?

Clearly the answer should be the reprocessor. Right?

I remember when reprocessors hit the scene several years ago. As a medical device product development engineer, the thought of a reprocessor cleaning, resterilizing, and reselling a medical device I designed for a single-use does scare me. The reprocessors will claim that the only reason a device is labeled for single-use is for financial gains for the OEM. Single use means more sales.

Sorry. Just not true. As a product development engineer, I designed quite a few airway and venous catheters. These products are made out of plastic, some polyurethane, some polyethylene, and so on. Sterilization alone can and often does have an affect on material properties. And we would always factor that in. We would do some worst case situations, exposing products to multiple sterilization cycles before doing performance testing.

Are reprocessors doing this same performance testing? Maybe.

So what happens when a device is designed, tested, and cleared on a 510(k) using gamma sterilization and then a reprocessor sterilizes using ethylene oxide? The answer is a big fat WHO KNOWS.

And what happens if there is an issue with the reprocessed device? Who will get the complaint? The reprocessor? The OEM? WHO KNOWS?

It just scares me. It scared me when FDA allowed this practice years ago. And it scares me even more now because I have a client who has uncovered evidence that one of their products has been reprocessed without their consent or prior knowledge. In this case, the product name and catalog number are identical to the original packaging. The product sample we retrieved is very concerning. One of the components has a curve–it was designed to be straight. We all became a little more concerned when we saw this. Because it is likely that a curved component will have performance issues.

 

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