Three Companies to Hold Studies for Duodenoscopes
Three Japanese producers of duodenoscopes have been called upon by the United States Food and Drug Administration (FDA) to conduct studies on how the medical instruments are being cleaned in response to a recent disease outbreak.
What are Duodenoscopes?
According to Reuters, duodenoscopes are used to drain fluids from blocked pancreatic and biliary ducts. They are made up of long, flexible, lighted tubes that are inserted down the patients’ throat.
Just recently the duodenoscopes were the center of a “superbug” outbreak. Superbugs are bacteria that have become resistant to antibiotic drugs.
In August, the FDA asked the health care facilities that use duodenoscopes and other similar reusable medical devices to follow the included cleaning instructions for the instruments to a T.
Details of the Duodenoscope Studies
On Monday, October 5th, the FDA called on three companies to individually hold 30 day studies on the effectiveness of the instructions they asked health care facilities to follow so meticulously.
These three companies are Olympus Corp, Fujifilm Holdings Corp, and Pentax Medical (which belongs to Hoya Corp). All three are Japanese countries who produce duodenoscopes, Olympus being the largest producer, and sell them in the United States. All three were given warning letters from the FDA after multiple violations were found during facilities inspections both abroad and in the U.S.
The FDA says the information obtained from the studies will go towards creating new labels and instructions for cleaning the medical instruments so to further prevent any spread of infections.