At the beginning of the year, the FDA announced a recall of the Olympus TJF-Q180V duodenoscope. A series of superbug bacterial infections had been linked to the device, and the manufacturer promised updates and a new design to reduce the infection risk.
Indeed, according to a 2016 report by the U.S. Health, Education, Labor, and Pensions Committee, so-called “closed channel” duodenoscope-related infections have sickened at least 250 patients worldwide.
Significantly, the FDA had also ordered Custom Ultrasonics, manufacturers of scope-cleaning machines, to recall them due to violations that could result in an increased risk of infection transmission. At the time, an estimated 2,800 of these machines—called “automated endoscope reprocessors (AERs)”—were in use in hospitals and outpatient clinics across the country.
According to Kaiser Health News the FDA has now backed off and is permitting custom Ultrasonics to leave their signature product, the System 83 Plus machine, in the field while regulatory issues are being addressed.
FDA Orders Recall of Scope Cleaning Machines
In their initial safety alert, the FDA explained that AERs are designed to wash and provide high-level disinfection to endoscopes, including duodenoscopes, and scope accessories. The machines are designed to expose all surfaces and interior channels to chemical solutions that kill microorganisms and prevent the spread of infection from patient to patient as the scopes are reused.
When investigators inspected the Custom Ultrasonics’ facility in April 2015, however, they found that the company had no way to validate that the AERs could adequately wash and disinfect the scopes. The FDA allowed the manufacturer to correct the violations, but following a review, determined that the violations were not adequately addressed, which could result in an increased risk of infection in patients. It was after that the recall was ordered.
FDA Reiterates Recall and Recommends Alternative Cleaning Methods
In February 2016, the FDA provided an update on the recall, noting that it had sent a letter to Custom Ultrasonics in January, reinforcing the terms of the recall order. “Because Custom Ultrasonics has not demonstrated that its AERs can adequately wash and disinfect endoscopes to mitigate the risk of patient infection,” the letter stated, “the Agency continues to recommend that health care facilities using Custom Ultrasonics AERs transition to alternative methods to reprocess flexible endoscopes as soon as possible.”
As part of its recommendations, the FDA suggested alternative AERs, manual high-level disinfection, or other cleaning and sterilization methods.
Now, however, the FDA is backing off, but just a little. It is allowing Custom Ultrasonics to leave their signature machine on the market for the time being, stating, “Based on information provided by the company, the FDA has determined that the products may remain in the field.”
The FDA still insists, however, that these machines not be used to disinfect the duodenoscopes that were tied to 41 infection breaks worldwide and at least 24 deaths in the U.S. They can be used to wash other endoscopes, but not these.
Custom Ultrasonic Machines Linked to Superbug Infections
The Senate report released in January criticized Custom Ultrasonics, as it found that at least 9 of the 16 hospitals identified as suffering from scope-related antibiotic-resistant infections at the time were using the machines. The senate report did add, however, that the company’s equipment was not solely responsible for the infections.
Previous attention has been focused on the design of the duodenoscopes themselves, which is why Olympus updated their design, to help reduce risk of bacteria becoming trapped inside the scope. The cleaning machines represent another piece of the puzzle, however, and are believed to be part of the reason why so many people were infected.
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