FDA Clears Pentax’s Easier-To-Disinfect Duodenoscope
The US FDA cleared Pentax Medical’s new duodenoscope as the first in the US with a disposable elevator part that reduces the number of parts needed to be disinfected compared to earlier designs.
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Inadequate validation testing paired with highly-publicized bacterial outbreaks in Illinois and California involving use of contaminated duodenoscopes has led to stricter reprocessing standards for those devices. And FDA is likely moving towards tougher reprocessing requirements more broadly for reusable devices in an upcoming guidance.
The US Senate on a 72-18 vote approved radiation oncologist Stephen Hahn as Commissioner of the FDA on 12 December. Voting “no” were a block of liberal Democrats, including the ranking member of a key Senate health committee. Industry advocates and most senators said Hahn is an excellent choice to lead the FDA, but some fear he will not move quickly enough to ban candy flavors in vaping products favored by teens.