Medtech Matters

In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we’re discussing MAUDE safety reports and taking a look at what the issues are with them. More specifically, we’re digging in to find out why almost a third of the reports are delayed or incomplete. We’ll get insight on what these reports are, if they are important, and what should be done to improve that 30% figure. During this conversation, the following questions are addressed:First, Mike, if you would, please explain what the Manufacturer and User Facility Device Experience (MAUDE) Database is.What are the MAUDE reporting requirements?How well does the MAUDE reporting system work?Are there consequences for a delayed or incomplete report?Given the statistics, is the MAUDE database a reliable source of information for medical device manufactures? for clinicians? for patients? for anyone?What should manufacturers do?What should the FDA do?What else is important?What are today’s takeaways?Listen to this