Since the FDA has approved the redesigned Olympus TJF-Q180V duodenoscope that has modifications to the device’s design and labeling, which are intended to help reduce the risk of bacterial infections., Olympus will voluntarily recall its original model which is approximately 4,4000 currently being used in health care facilities and make the needed repair as quickly as possible. The faulty internal mechanism inside the reusable device had made it almost impossible to disinfect the device before using it in the next patient. The company sells about 85 % of the duodenoscopes used in the United States.
As you will recall from some of my previous blogs, Olympus Corp was one of the three medical scope makers to receive a warning letter from the FDA this past spring detailing several alleged violations related to complaint handling, sterilization procedures that lead to so-called antibiotic-resistant “superbugs” in many individuals. The recall and redesign announcement comes two days after a U.S. Senate report concluded that 25 outbreaks — including two in Los Angeles in which three people died — were linked to dirty scopes made by Olympus and two other manufacturers. A series of LA Times stories last year reported that Olympus knew of the potential flaws in the scope as early as the spring of 2012 but failed to alert American hospitals or regulators. Since then, at least 141 patients in nine U.S. cities were infected, investigators found. Many of the illnesses were from a superbug known as CRE, or carbapenem-resistant Enterobacteriaceae, which can kill as many as half its victims.
Duodenoscopes are used in more than 500,000 procedures each year as a less invasive way than traditional surgery to drain fluids from pancreatic and biliary ducts blocked by cancerous tumors, gallstones or other gastrointestinal conditions. While these devices play an important role in the treatment of patients, there is evidence that some have been associated with the transmission of infectious agents, including antibiotic-resistant infections.
Olympus modified its design of 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. Leakage into this channel could pose an infection risk to subsequent patients exposed to the contaminated device because the sealed area cannot be cleaned and disinfected between uses. The company also plans to conduct annual inspections of each scope in use by facilities to identify any wear and tear on the elevator channel sealing mechanism or the presence of attached debris at the scope’s tip, which would require replacement of the potentially contaminated parts.