Niche markets
Especially in niche markets, such as the children's ward, hospitals face limitations. Erik illustrates this with an example: "For ECMO procedures in neonatology, we used double-lumen veno-venous catheters, which require only one venous blood vessel. But because of the MDR, the manufacturer had to provide additional clinical evidence and therefore decided to withdraw the product from the market. As a result, we were forced to use alternative single-lumen venoarterial catheters for a period of time, which require a vein and an artery. For those newborns, this is drastic: sacrificing a carotid means that they have to live their entire lives with only one blood vessel to the brain."
The consequences for the individual are enormous, but for manufacturers the small target group is often an obstacle. “In addition, it is difficult to collect clinical evidence for minors or incapacitated people because of strict regulations. And if the market is too small, companies prefer not to take risks,” says Erik.
Another sticking point is the lack of clarity about why products are being taken off the market. “Hospitals don’t get that information,” says Erik. “I understand that manufacturers can’t consult with all hospitals, but you would expect that when they remove products, they would look at what hospitals need and what competitors offer. That way, you prevent essential resources from disappearing.”
Responsibility and safety
In his role as a clinical physicist, Erik answers questions from colleagues on a daily basis about the safe use of medical devices. “A doctor or nurse may want to use a medical device slightly differently than stated in the user manual, or may have asked a technician to make a small adjustment. I then think along to see how we can do that in a responsible manner.”
According to Erik, the ultimate responsibility for the safe use of a device always lies with the healthcare institution or healthcare professional, not with the manufacturer. “The manufacturer is responsible for the product being safe, but how exactly is it used? That is ultimately up to the healthcare professional. Yet the MDR seems to place that responsibility with the manufacturer.”
He also emphasizes that clinical evidence should primarily focus on safety. “Too much emphasis is placed on proving effectiveness, while demonstrating it is only relevant for a portion of all medical devices. I am thinking in particular of innovative devices such as a new type of implant, surgical robot or an AI-based prediction model. The rest has already proven itself or is simply indispensable for performing a medical procedure. The question of effectiveness should then be answered by the field, for example based on guidelines from the professional groups.”
Working together towards solutions
The challenges that Erik outlines require a joint approach by healthcare professionals and manufacturers. The Medical Electronics Event on January 30 is an opportunity to strengthen this collaboration. In the Experience Center of the Radboudumc, manufacturers present the latest technological innovations, while they discuss practical applications and joint solutions with healthcare professionals. Chairman Erik Gelderblom looks forward to providing inspiration: “I hope that we can amaze the visitors with what is possible in healthcare.”
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