Should design controls have prevented the recent reprocessing tragedy: Do we need new regulation?

Superbugs. Reprocessing. The White House. And Design Controls. Probably not a combo of topics you see grouped together very often. But we have them all for you on today’s Global Medical Device Podcast. This is the 2nd edition in our series focused on Design Controls and related topics within the Medical Device Industry. During this episode, we’ll surface some interesting and potentially controversial views on the subject with our three industry thought leaders. If you’re like many, you may very well have already heard about the high profile superbug outbreak connected to reprocessing. You may also have already seen some of the industry’s reactions with lawsuits being filed, FDA alerts being issued...and even the White House getting involved. That’s where we kickoff today’s conversation with our amazing guests Mike Drues, Jon Speer and Jason McKibbin along with moderator Bill Loss. All three guests share some very insightful and through provoking responses to Bill’s questions like: 1. What’s the background behind this reprocessing tragedy anyway? 2. How do our experts see the responsibility panning out at the manufacture’s level as well as those ultimately handling the reprocessing? 3. Could better orchestrated design controls have potentially prevented this tragedy? 4. Do existing design controls apply to problems like this, and if they don’t, should they? 5. Was this problem a design control failure or possibly different steps that should have been handled during the design review process? 6. How do you feel the Design Verification and Design Validation process should fall into place? You’re going to want to listen closely because these guys really dive deep on some important and controversial topics.