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FDA Urges Medical Centers to Avoid Custom Ultrasonics Scope Cleaning Devices


The FDA has released another warning about the infection risk linked with duodenoscopes.

On January 15, 2016, they announced that Olympus America, a medical and surgical products manufacturer, was recalling its controversial TJF-Q180V duodenoscope to update it with new design and labeling modifications. These changes were supposed to help reduce the risk of “superbug” bacterial infections linked to the duodenoscopes.

Even with these changes, however, medical centers have remained concerned about how these scopes are cleaned, and whether the cleanings are sufficient to kill all the bacteria potentially present in the scopes.

On August 17, 2016, the FDA alerted the healthcare community to the Custom Ultrasonics May 6 urgent medical device recall of their System 83 Plus AER, a popular cleaning device frequently used with duodenoscopes. According to the FDA, doctors should stop using these devices to clean duodenoscopes.

Though the FDA warned back in February that medical facilities should transition to other methods of cleaning duodenoscopes, now they are urging users to stop using the Custom Ultrasonics device completely on duodenoscopes. They are allowing doctors to retain the devices for reprocessing “endoscopes other than duodenoscopes.”

The Challenge of Cleaning Duodenoscopes

A duodenoscope is a unique type of endoscope used mainly in a procedure called an endoscopic retrograde cholangiopancreatography (ERCP), which is meant to diagnose and treat health problems in the liver, bile ducts and pancreas.

Because of the way these duodenoscopes are designed, they are harder to clean than other types of flexible endoscopes. When bacteria remains trapped inside, it can be carried from one patient to another, since these devices are designed to be reused.

Indeed, according to a 2016 report by the U.S. Health, Education, Labor, and Pensions Committee, so-called “closed channel” duodenoscope-related infections were linked with antibiotic-resistance infections that sickened at least 250 patients worldwide.

FDA Urges Healthcare Facilities Not to Use Custom Ultrasonics Reprocessors

Automated Endoscope Reprocessors (AERS) are devices used in health care settings to “reprocess” or clean endoscopes, like duodenoscopes and endoscope accessories, to make sure they’re decontaminated between uses. These AERs are supposed to kill microorganisms through chemical cleaning solutions.

There have been problems with Custom Ultrasonics AERs for awhile, however. Back in 2012, the company was ordered to stop manufacturing and distributing their devices because they failed to obtain proper approval for significant software changes they had made. Then after an FDA inspection in April 2015, a number of other violations were found. The company was also unable to show that their AERs could adequately disinfect scopes to the point of preventing infection.

In November 2015, the FDA ordered Custom Ultrasonics to recall all of its AERs. In January 2016, they sent a letter to the company reinforcing the terms of the recall. In February, they reiterated that health care facilities should use other devices to clean their scopes.

Custom Ultrasonics released a letter on May 6, 2016, indicating that they were recalling the System 83 Plus AER for use on duodenocopes, but that the devices could remain in use for reprocessing other endoscopes. They also sent out a label that is supposed to be attached to the devices, warning that they are not intended for reprocessing duodenoscopes.

In their recent August safety communication, the FDA reminded healthcare facilities of the need to stop using these devices for duodenoscopes, but they also officially revised previous recall orders to allow for the devices to be used on other types of scopes.











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