|Rep. Ted Lieu (D-CA)|
Superbug outbreaks tied to duodenoscope devices have caused regulators to step up their oversight of the products. But one lawmaker wants the agency to go even further and is asking Congress to back his efforts.
Rep. Ted Lieu (D-CA) is trying to change a law so medical device manufacturers would have to notify the FDA when they make design changes. As it stands, manufacturers can decide whether a change to a device is significant enough to tell a regulator.
"There are loopholes in the law that need to be closed," Lieu told Bloomberg. "I don't think it's appropriate for device manufacturers to make the decision."
Lieu's move comes after a public fallout over duodenoscope devices last year. Companies such as Olympus, Fujifilm and Pentax changed the design of the scopes, and, as a result, they became more difficult to clean. None of the companies told the FDA about the design changes to the scopes, which were linked to superbug outbreaks in the U.S. and abroad.
Over time, it came out that the FDA knew about Olympus' new device design and privately told the company in 2014 to seek new clearance for the device. But the agency did not recall the scope or alert the public that it wasn't cleared for use until almost a year later, a move that has garnered public criticism.
Lieu's bill could face a rough road ahead. The medical device lobby works closely with regulators and lawmakers to get favorable oversight rules, Bloomberg points out, and the sheer number of infections related to duodenoscope devices could change the dynamic.
Medical device industry group AdvaMed said it's reviewing the legislation and shares Lieu's "commitment to ensuring the continued safety and effectiveness of medical devices marketed in the U.S.," the group told Bloomberg.
But for Lieu, the time is ripe for updated laws. "I think the situation is different now, because we can point to a concrete example where a company did not notify the FDA of a design change," Lieu said, as quoted by Bloomberg. And that change "resulted in hundreds of infections," he added, which should be enough to spur Congress to act.
- read the Bloomberg story