Another outbreak of the “superbug” attributed to non-sterile duodenoscopes has been reported, this time infecting at least five patients. The outbreaks are the result of a slimy layer of biofilm that can build up inside a scope and shelter bacteria from being removed during the cleaning process; also known as reprocessing.
This most recent outbreak comes despite a product redesign by Olympus, one of the largest manufacturers of the devices in the world. It happened in December, just two months after a small but defective mechanism was replaced. The Los Angeles Times details how the company voluntarily recalled all TJF-Q180V models in January of 2016 so it could replace the defective parts that had been identified. Olympus recommended new cleaning procedures for their scopes at that time, as well. Roughly 4,400 are still in use at hospitals throughout the U.S.
It is unclear if the hospital using the scopes that led to the outbreak followed the new cleaning guidelines properly or if it can be traced to the device itself, according to Lawrence Muscarella, a medical safety expert in Montgomeryville, Pennsylvania. Olympus already had to make changes to the design of their scopes in 2010 to “seal a narrow internal channel to keep out blood and other infectious material.” FDA records dating back to that year indicate that at least 350 infections have taken place across more than 40 locations throughout the US and other nations.
The FDA did not publicize the newest outbreak. It was found by Muscarella in the agency’s database of medical device injuries. Deborah Kotz, a spokesperson for the FDA, said that “the agency ‘was aware of these reports and continues to investigate adverse events associated with duodenoscopes as appropriate.’” However, the FDA seems to be in a more reactive posture than proactive, and their actions thus far have been gravely ineffective in this matter. A California outbreak in 2015 resulted in 15 deaths and defective scopes are responsible for at least 35 total deaths in the last four years.
Duodenoscopes are used in roughly 700,000 procedures each year. The “superbug” is a strain of bacteria called klebsiella pneumoniae, which has become resistant to all but the most extreme antibiotics.
Epidemiologist Cori Ofstead has said that “patients have a right to assume clean instruments are being used on them.” That largely depends on manufacturers following FDA guidelines to report instances of infection within 30 days, but a U.S. Senate report found that does not reliably happen. As a result, every fumble made by the FDA and the companies trusted to manufacture these devices properly puts hundreds of thousands in danger during what should otherwise be standard procedures.