The Food and Drug Administration (FDA) is issuing an update to a March 26, 2015, Safety Communication regarding one of Olympus Corporation’s duodenoscopes. The specialized endoscopes have come under scrutiny in recent months when they were linked to the spread of drug-resistant superbugs at more than a dozen hospitals across the country.
Duodenoscopes are surgical tools that are fed down patients’ throats in order to diagnose or treat conditions affecting the pancreas and bile duct. Researchers found that small crevasses in the scope could harbor bacteria even after the devices have been cleaned and disinfected. The bacteria can then be spread from patient to patient when the device is reused.
In March, the FDA issued updated information about the cleaning and disinfecting – or reprocessing – of duodenoscopes. At the time, Olympus, the country’s largest manufacturer of specialized duodenoscopes, approval of Olympus’ TJF-Q180V duodenoscope was pending with the FDA, however the company continued to market the device while the application was under review.
On Jan. 15, 2016, the FDA cleared the TJF-Q180V design modifications to the elevator channel sealing mechanism to create a tighter seal and reduce the potential for leakage of patient fluids and tissue into the closed elevator channel. Also on Jan. 15, 2016, Olympus issued a Customer Notification Letter informing of the design and labeling changes ordered by the FDA, and detailing the company’s strategy to repair all TJF-Q180V elevator mechanism in accordance with the new design.
“The FDA is closely monitoring the possible association between reprocessed duodenoscopes and the transmission of infectious agents, including multidrug-resistant bacterial infections caused by Carbapenem-Resistant Enterobacteriaceae (CRE) such as Klebsiella species and Escherichia coli. If not properly reprocessed, residual body fluids and organic debris may remain in microscopic crevices of the device following an attempted cleaning and high level disinfection. If these residual fluids contain microbial contamination, subsequent patients may be exposed to serious infections,” the FDA’s Safety Communication states.
Any adverse events related to duodenoscopes should be reported to the FDA MedWatch Adverse Event Reporting Program at www.FDA.gov/MedWatch/Report.htm.