August 17, 2016 — The FDA is warning health care facilities not to use an endoscope-cleaning machine that was recalled last year by Custom Ultrasonics.
The company never proved the machine can actually wash and disinfect duodenoscopes to prevent infections.
In November 2015, the FDA ordered a recall for the System 83 Automated Endoscope Reprocessors, but left them on the market.
In February 2016, the FDA asked hospitals to switch to another scope-cleaning method as soon as possible.
Now that hospitals have had time to transition, the FDA is asking everyone to stop using the machine 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 diseases of the upper gastrointestinal system, such as gallstones, blocked ducts, and pancreatic cancer.
The problem is that the scopes have complex instruments in the tip that are very hard to clean. In recent years, there have been several outbreaks of antibiotic-resistant infections on scopes that were not sterilized between uses.
At first, these outbreaks were blamed on hospitals not cleaning the scopes properly. However, the FDA has concluded that manufacturers and scope-cleaning machines may share some of the blame. These manufacturers are facing a growing number of lawsuits from victims.