Six months ago, the FDA ruled that a machine tied to a dangerous superbug outbreak needed to be taken off the market to protect public health. However, the machine remains in use after FDA officials backed down, according to Bloomberg.
Irving, Pa.-based company Custom Ultrasonics created the System 83 Plus machines,
which use water, disinfectant and sound waves to clean certain surgical instruments. The 2,800 automated washing machines are most commonly used throughout hospitals in the United States to clean endoscopes.
Duodenoscopes, used to look in the tiny crevices of the small intestine, have been linked to antibiotic-resistant infections in hospitals over the last few years. Use of the System 83 Plus machines is cited as a contributing factor in the spread of these dangerous infections due to improperly cleaned duodenoscopes, although outbreaks were not limited to hospitals using System 83 Plus devices. Nine of 16 U.S. hospitals that experienced superbug cases linked to duodenoscopes were identified as using Custom Ultrasonics machines to clean the device.
In 2007, Custom Ultrasonics entered a consent decree with the FDA. In 2012, the FDA ordered a recall of the machine citing violations of the consent decree. However, after the company made significant changes to its software operating system, the machines were allowed back on the market.
The FDA then pushed for a second recall in November 2015, raising concerns about the machine's compatibility with disinfectants, whether it properly cleans duodenoscopes, and whether it successfully eliminates microorganisms from water. Again, the regulator dropped the recall request, saying the machines can stay in the field while it proves the devices work as advertised.
Presently, the machines are used to clean a variety of medical instruments, including scopes. Custom Ultrasonics has sent warning labels to hospitals to place on the washers, advising users not clean duodenoscopes with the machines.
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