FDA signs off on 2 of 5 companies producing duodenoscope cleaners

Hospitals, duodenoscope makers, the U.S. Food and Drug Administration and even the Centers for Disease Control and Prevention have been scrambling for more than a year to discern how to eliminate bacterial contamination from duodenoscopes, devices that are reused repeatedly on patients to view the top of the small intestines. Transferring antibiotic-resistant bacteria in this way has resulted in hundreds of related outbreaks and even patient deaths.

As part of the effort, last fall the FDA rolled out updated standards for the machines that are used to clean, or reprocess, endoscopes prior to their reuse. The agency has also been cracking down on duodenoscope manufacturers including a requirement for postmarket studies of their devices.

Advantage Plus Endoscope Reprocessing System--Courtesy of Medivators

The FDA, in its latest move, has now signed off on two out of the 5 manufacturers making automated endoscope reprocessors that are labeled for use with duodenoscopes: Cantel's ($CMN) Medivators and its Advantage Plus and DSD Edge as well as Steris and its System 1E Liquid Chemical Sterilant Processing System. Earlier this year, the agency also signed off on a new version of a duodenoscope from maker Olympus.

Another endoscope reprocessor maker, Custom Ultrasonics, was subject to a massive recall that the FDA disclosed in November; it was due to inadequate disinfection. In January, a Senate committee came out with a report that was critical not only of the device makers but also of the FDA itself, since infections from duodenoscope use continued for years after the agency's initial warning in early 2013.

The FDA has committed to continuing updates as more endoscope reprocessor makers meet its updated requirements.

But the industry is already working to perhaps make duodenoscope reprocessing and the reuse of these jointed and difficult-to-clean device a thing of the past. Disposable duodenoscopes, as well as disposable covers for existing devices, could be among the solutions to put this superbug scare permanently in the past.

- here is the FDA updated information