At RSNA, HCB News sat down with Dennis Durmis, head of commercial operations, Radiology Americas at Bayer to discuss a wide range of topics that were being discussed at the annual meeting and could have big implications for the future of health care.
HCB News: Let's talk about gadolinium. We're seeing a lot of concern about retention but no evidence of side effects. As a manufacturer of the contrast agent, how has this impacted Bayer?
Dennis Durmis: We've been actively working with the PRAC in Europe to understand what's transpiring there, working with them to provide whatever evidence we have with regards to retention. In the U.S. it's been a little different with the FDA looking and saying, 'we're monitoring and will continue to monitor but we don't see any evidence that there's a cause for clinical concern.'
So it depends on geography but overall we take the position that the benefit-risk profile on gadolinium is positive — whether it be a macrocyclic agent or a linear agent — and it's up to the physician to make the best choice for their patient. That's how we've been approaching it and we work locally so whatever guidelines the local regulatory bodies have, we will continue to follow that.
HCB News: When we think about the third-party debate taking place with the FDA's investigation of equipment safety and who can safely service medical equipment, what is Bayer's stake in that conversation?
DD: We have tens of thousands of vascular injectors in the U.S. These are electromechanical devices that are connected to patients and are pushing some form of pharmaceutical product, so we actually think this is a pretty important issue. We participate in angiograph,y so you're looking at the arterial side of the body and the importance of pressure and flow rates. We're not a scanner company so we're not as big as some of those but we do have some pretty complex and intricate electromechanical devices that need to be calibrated, need to be tested...
HCB News: So it's a lot of very delicate equipment requiring precise management and handling.
DD: Exactly. Also, you have to remember that it doesn't matter what part of the suite goes down. For example, CT contrast enhancement is almost always power injected so if your CT injector is down then you're going to miss out on a lot of your procedures,... so this subject is important with regard to throughput and up time and those types of things.
Until recently, Bayer had a multi-vendor service (MVS) business where we manufactured MR coils and serviced coils for a lot of the big scanner companies and hospitals directly and we also did ultrasound transducers. In fact, I was employee #14 back in 2003 with that group so I'm pretty passionate about the third party space and I know there are some really good third party companies out there that have quality systems and trained personnel who reverse engineer equipment to understand technically how it operates — and how replacing a particular resistor with the exact same wattage is critical — versus someone who doesn't.
