Medtech Matters

In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we dig into a story about an Italian firm that reportedly falsified information related to sterilization certificates going back as far as 2016. On June 2, 2021, the FDA published a letter to industry regarding the firm Steril Milano. In the letter, the agency stated it was working with a number of manufacturers and other partners to determine the scope of medical devices affected and contact any potentially impacted firms. Specifically, the following questions are addressed:How does this happen?Is there anything a device manufacturer can do to verify whether information from their sterilization provider has been falsified?If this happened to a device manufacturer whose products were used within healthcare facilities and a problem occurred, does this open them up to a liability lawsuit.This seems like a situation where the agency would be just as interested in working with the device manufacturer to res