{"href":"http://player.captivate.fm/services/oembed?url=http%3A%2F%2Fplayer.captivate.fm%2Fepisode%2F50fb3f7f-a57d-4d56-9a4e-1da32b707dd3","version":"1.0","provider_name":"Captivate.FM","provider_url":"https://www.captivate.fm","width":600,"height":200,"type":"rich","html":"<iframe style=\"width: 100%; height: 200px;\" title=\"FDA Proposes Allowing Medical Device Makers to Summarize Malfunctions: What does that Mean for You?\" frameborder=\"0\" scrolling=\"no\" allow=\"clipboard-write\" seamless src=\"http://player.captivate.fm/episode/50fb3f7f-a57d-4d56-9a4e-1da32b707dd3\"></iframe>","title":"FDA Proposes Allowing Medical Device Makers to Summarize Malfunctions: What does that Mean for You?","description":"The FDA announced a new proposal regarding the bundling of device malfunctions when Medical Device Reporting (MDR).\n\nOn today\u2019s episode, we have Mike Drues, president of Vascular Sciences, to help us dive into the impact of this proposal and the safety of medical devices.\n\nThe FDA proposal\u2019s benefits probably outweigh the risks and should be implemented on a small scale.\n\nSome highlights of the show include\n\n\u25cfDepending on the severity of the malfunction, you are given a specified amount of time to report it.\n\u25cfWhat companies should do to make patients and providers aware of issues.\n\u25cfShould you react immediately or investigate the root cause? A malfunction is a serious matter and time is critical.\n\u25cfThe importance of having decision trees and processes in place before an issue arises.\n\u25cfA company\u2019s obligations for severe, life-threatening events and reporting timeframes.\n\u25cfRather than reporting individual malfunctions, companies will report malfunction summaries every quarter.\n\u25cfCompanies should be proactive and keep an eye on competitors\u2019 similar products that have problems.","thumbnail_width":300,"thumbnail_height":300,"thumbnail_url":"https://artwork.captivate.fm/1cfe9674-d1af-4476-9b93-ce07d1db996f/e103a1ca-20be-421a-ba34-a9816efd138f.jpg"}