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FDA Warns Against Using Recalled Scope-Cleaning Machine


August 17, 2016 — The FDA is asking hospitals to stop using a recalled endoscope-cleaning machine made by Custom Ultrasonics.

The problem is that the machine may not actually work. Custom Ultrasonics never proved that it could disinfect duodenoscopes sufficiently to kill bacteria that can cause infections.

In November 2015, the FDA ordered Custom Ultrasonics to recall the System 83 Automated Endoscope Reprocessors. The machines were not pulled off the market because they are used in life-saving procedures.

In February 2016, the FDA told hospitals to switch to another method of cleaning the scopes as soon as possible.

Now that hospitals have had plenty of time to transition, the FDA is warning them not to use the machines to clean duodenoscopes:

“Because inadequately reprocessed duodenoscopes have been associated with patient infections and death, health care facilities should not use Custom Ultrasonics’ System 83 Plus AERs for reprocessing duodenoscopes.”

Duodenoscopes are inserted down the throat to treat gallstones, blocked ducts, pancreatic cancer, and other diseases. They are very hard to clean because they have intricate mechanisms in the tip.

In recent years, dozens of people were infected and several died from antibiotic-resistant infections that were transmitted on dirty duodenoscopes. Inadequate cleaning instructions and ineffective scope-cleaning machines have been blamed on the outbreaks.


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