Headline-Generating Medical Device Safety Concerns—Mike on Medtech

Headline-Generating Medical Device Safety Concerns—Mike on Medtech

Mike Drues and Sean Fenske discuss some recent news about unsafe medical devices and falsified test data.

By Sean Fenske, Editor-in-Chief05.02.24
In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we’re reviewing a few stories in the news that tie into the safety of medical devices. First, a story regarding plastic syringes made in China that were deemed not to be used by the FDA. The other story is about a report indicating third-party testing lab data may be unreliable and, in some cases, falsified. Specifically, the following questions are addressed:

  • Can you give some additional insights into each of these news items and explain how they are connected?
  • Given the medtech universe and all the different types of devices it encompasses, a syringe seems somewhat low on the list of advanced devices. What can we learn from this device?
  • If a basic device like a syringe cracks or doesn’t function properly, how realistic is it that the issue is reported to the manufacturer or FDA?
  • If my device includes a syringe but it’s not manufactured by one of the companies that received a warning letter (or maybe it’s not even made in China), do I have anything to worry about?
  • Do you have an example to help illustrate this?
  • Looking beyond syringes, obviously virtually all device manufacturers rely on testing data. If the FDA is warning makers about third-party labs providing fabricated, duplicated, or otherwise unreliable data, what should companies do who use third-party testing labs?
  • What are the takeaways?

Listen to this discussion and see what you think of these concerns regarding device safety. 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.

Listen to the podcast streaming via the player or get the podcast on the Medtech Matters channel via your preferred vendor of podcasts, such as Apple Podcasts (iTunes) or Spotify.

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