Why Duodenoscope Infections Could Affect Entire Medtech Industry

The medical device industry may face more regulatory burden if FDA follows the advice of a recent panel.

Brian Buntz

FDA's reaction to duodenoscope-related infections could impact virtually all medical device manufacturers, says Michael Drues, PhD, president of Vascular Sciences (Boston). Instead of being a matter only related to makers of endoscopes and related products, the subject of duodenoscope-related infections could ultimately go down in history as a regulatory touchstone relevant to makers of nearly all medical devices. "This could be right up there with the infusion pump malfunctions, which led to the FDA requiring usability testing for devices, and the breast implant fiasco in the 1990s, which led FDA to revamp its biocompatibility guidelines," Drues says. "The ramifications could touch devices used in cardiology, neurology, oncology--pretty much ever '-ology' you could think of."

The FDA has received 142 reports of possible duodenoscope-related infections, prompting the agency to organize an advisory panel to look into the safety of the devices. The panel, which met last week, unanimously found that the devices were not safe.

"There was very little actual evidence or data that was presented in terms of the number of infections or deaths that occurred compared to the number of devices used. It is a terrible tragedy when somebody becomes infected, it is even worse when somebody dies," Drues says. "But there was no comparison of infections or deaths as a function of how many times these devices have been used not over the years but over the decades."

While the panel's recommendations are not binding, FDA generally follows the advice of such panels.

The panel recommended that the scopes not only be cleaned but sterilized with ethylene oxide before reuse, which could increase hospitals' costs and could be toxic to workers.

The panel's conclusions also could lead to an increase in regulatory burden for many medical device makers, making them follow a regulatory process more in line with pharmaceutical companies, Drues says.

"One of the biggest differences between a medical device and a drug is that the regulation requires medical devices to have reasonable evidence of safety and effectiveness for medical devices whereas with drugs it is a matter of having substantial evidence. To most people, it probably sounds like a matter of semantics but in simple reality it is a huge difference," Drues says. "Essentially what this panel was doing, in my opinion, was treating the device has a drug. And if we applied that same standard for medical devices, I guarantee at least 80 or 90% of the medical devices that we have on the market today would not be on the market."

The members of the panel had primarily academic background, which may be one of the reasons for the consistency of their views. "It would have been nice to have someone on the panel who had experience developing devices and some with experience reprocessing them," Drues explains. While there was an industry representative on the panel, they had a pharmaceutical background rather than a medtech one. "Do you really want someone who has not designed a device or reprocessed one making these kinds of recommendations?"

In the end, it comes down to establishing a reasonable criteria for safety. Drues concludes: "It is impossible to guarantee that a product is 100% safe. While it is a noble thing to want to prevent infections, how do we measure how many people don't have access to a valuable product because we've raised the regulatory burden to the point that companies decide it's not worth it to bring that device to market?"

Brian Buntz is the editor-in-chief of MPMN and Qmed. Follow him on Twitter at @brian_buntz.

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