Facility Falsified Sterilization Data—Mike on Medtech

Facility Falsified Sterilization Data—Mike on Medtech

Mike Drues and Sean Fenske discuss troubling concerns over a sterilization provider in Italy.

By Sean Fenske, Editor-in-Chief07.27.21
In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we dig into a story about an Italian firm that reportedly falsified information related to sterilization certificates going back as far as 2016. On June 2, 2021, the FDA published a letter to industry regarding the firm Steril Milano. In the letter, the agency stated it was working with a number of manufacturers and other partners to determine the scope of medical devices affected and contact any potentially impacted firms. Specifically, the following questions are addressed:

  • How does this happen?
  • Is there anything a device manufacturer can do to verify whether information from their sterilization provider has been falsified?
  • If this happened to a device manufacturer whose products were used within healthcare facilities and a problem occurred, does this open them up to a liability lawsuit.
  • This seems like a situation where the agency would be just as interested in working with the device manufacturer to resolve the problem. What’s it like working with the FDA in this type of situation?
  • What recommendations would you make to a manufacturer who had used this sterilization provider?

Listen to this episode and see what you think of this sterilization situation. If you’d like to share thoughts, ask questions, or have a suggestion for a future topic for us to cover, please reach out to me at sfenske@rodmanmedia.com and we’ll see if we want to address your ideas/inquiries/suggestions in a future episode.

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