Information continues to come to light about threatening bacteria found in medical scopes used for critical procedures, the LA Times reports. Cleaning requirements for the devices have become increasingly strenuous since 2015. That’s when Olympus, a major manufacturer, disclosed to US medical professionals that their hard-to-clean duodenoscope design retained bacteria – even after going through reprocessing.
The FDA has urged hospitals and other facilities that use duodenoscopes to strictly observe manufacturers’ protocols when cleaning the devices. They’ve also suggested four supplemental cleaning methods: microbiological culturing, ethylene oxide sterilization, use of a liquid chemical sterilant processing system, and repeated high-level disinfection. Furthermore, they have required manufacturers to report instances of a device contributing to a patient infection within 30 days of learning about it. However, mere months would go by before a United States Senate report found that manufacturers were not meeting these specifications.
Citing a seven month study in the American Journal of Infection Control lead by epidemiologist Cori Ofstead, the Times detailed how 17 of 20 tested scopes were returned to Olympus because of a defect. In addition, 12 were found to be contaminated with bacteria “even after being disinfected using the current guidelines or additional measures” and would potentially put patients in harm’s way if used.
A slimy layer of biofilm can build up inside a scope and shelter bacteria from being removed during the cleaning process. The result is the incubation of an antibiotic-resistant “superbug” that severely impacts patients who “have a right to assume that clean instruments are being used on them,” says Ofstead. Michelle Alfa, a professor of medical microbiology at the University of Manitoba and an advisor on scope testing, was more direct, saying the scopes shouldn’t even be used because key components were “covered in so much crud.”
Duodenoscopes are likely responsible for at least 35 deaths in the last four years. Major outbreaks that resulted from the use of compromised scopes have occurred in California and Oregon, but FDA records dating back to 2010 indicate that at least 350 infections have taken place across more than 40 locations throughout the US and other nations. This data, along with the findings of the study published in the American Journal of Infection Control, suggests that measures taken to prevent harm inflicted by the scopes have been gravely ineffective.
In 2013, Olympus disclosed the defective design of their scopes to the European medical community, almost two full years before informing those in the US. The company has since said it “welcomes additional research and perspectives as helpful.” Similarly, the FDA has acknowledged that “a broader approach to understanding how well duodenoscope devices work” is necessary.
Regulating organizations, such as the FDA, have shown themselves to be more reactive than proactive about the safety of medical scopes, however. Despite the presence of more vigorous guidelines, Americans who undergo procedures that use the devices continue to remain at risk.