{"href":"http://player.captivate.fm/services/oembed?url=http%3A%2F%2Fplayer.captivate.fm%2Fepisode%2F8ecf1c2c-ff51-4085-b04a-c00c5f80ab1c","version":"1.0","provider_name":"Captivate.FM","provider_url":"https://www.captivate.fm","width":600,"height":200,"type":"rich","html":"","title":"Should design controls have prevented the recent reprocessing tragedy: Do we need new regulation?","description":"Superbugs. \n\nReprocessing.\n\nThe White House.\n\nAnd Design Controls.\n\nProbably not a combo of topics you see grouped together very often.\n\nBut we have them all for you on today\u2019s Global Medical Device Podcast.\n\nThis is the 2nd edition in our series focused on Design Controls and related topics within the Medical Device Industry. \n\nDuring this episode, we\u2019ll surface some interesting and potentially controversial views on the subject with our three industry thought leaders.\n\nIf you\u2019re like many, you may very well have already heard about the high profile superbug outbreak connected to reprocessing.\n\nYou may also have already seen some of the industry\u2019s reactions with lawsuits being filed, FDA alerts being issued...and even the White House getting involved. \n\nThat\u2019s where we kickoff today\u2019s conversation with our amazing guests Mike Drues, Jon Speer and Jason McKibbin along with moderator Bill Loss. \n\nAll three guests share some very insightful and through provoking responses to Bill\u2019s questions like:\n\n1. What\u2019s the background behind this reprocessing tragedy anyway?\n\n2. How do our experts see the responsibility panning out at the manufacture\u2019s level as well as those ultimately handling the reprocessing?\n\n3. Could better orchestrated design controls have potentially prevented this tragedy?\n\n4. Do existing design controls apply to problems like this, and if they don\u2019t, should they?\n\n5. Was this problem a design control failure or possibly different steps that should have been handled during the design review process? \n\n6. How do you feel the Design Verification and Design Validation process should fall into place?\n\nYou\u2019re going to want to listen closely because these guys really dive deep on some important and controversial topics.","thumbnail_width":300,"thumbnail_height":300,"thumbnail_url":"https://artwork.captivate.fm/997c286d-7dcd-4558-b0a0-d742306ab20d/88fff261-f3ae-4db1-afe0-de899aadd5a3.jpg"}