by
Gus Iversen, Editor in Chief | August 10, 2018
From the August 2018 issue of HealthCare Business News magazine
As a medical device leader, Bayer supports collaboration across the servicing industry to drive quality standards. Bayer believes the sharing of information would be productive if it’s done in a comprehensive and regulated manner. Proper training, experience operating within a quality system, and knowledge of FDA regulatory requirements are essential to the safe and effective operation of medical devices.
HCB News: What does this whole conversation boil down to? Is there a bottom line that gets lost in the discussion?
DD: Yes, the bottom line is patient safety. There are incentives for good service behaviors by OEM’s that maximize patient safety as a result of FDA QSR guidelines. There is no dispute amongst OEM’s that these guidelines yield positive outcomes. The lack of any guidelines for third party servicers allows for significant interpretation of what is right and what is wrong. The system actually incents third party service companies to test the boundaries of putting profits ahead of patient safety. Many choose the right path, and others, unfortunately, do not.
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