Olympus Recalls Medical Scope tied to Superbug Outbreak, Will Change the Design
Olympus Corp. announced Friday that it is voluntarily recalling a medical scope product that was tied to a superbug outbreak. Superbugs are bacterial infections that have become resistant to certain antibiotics, making them very hard to treat.
The company added that it would be redesigning the medical scopes to reduce the risk of infections. The Food and Drug Administration (FDA) has approved the new design for the product, which is called a duodenoscope. The FDA stated that for the time being, hospitals can continue to use the device but should strictly follow the cleaning directions.
Olympus will be changing an internal mechanism with the goal of making it easier to disinfect in between uses. Currently, it is almost impossible to properly disinfect the device after using it, which can increase a patient's risk of infection.
Olympus' announcement comes two days after a U.S. Senate report linked 25 outbreaks involving at least 250 patients to these scopes made by Olympus and two other companies, Pentax and Fujifilm. One of the most common illnesses was a superbug called carbapenem-resistant Enterobacteriaceae (CRE), which can kill up to 50 percent of infected people.
In the 301-page Senate report, the authors wrote that all three manufacturers "failed at every level to meet basic expectations of transparency and opened and to actively engage with FDA to address contamination issues."
The report continued, "This disregard for the spirit, and sometimes the letter, of the law resulted in potentially preventable serious and potentially fatal illnesses in hospitals around the world."
Prior to this report, there was a series of articles published by TIME that claimed that Olympus was aware of the flaws in their design as early as 2012. Olympus, however, had repeatedly blamed the rise of superbug infections on hospitals.
"The steps taken today are important," senator Patty Murray said, "but there is much more we need to do to make sure the FDA can respond quickly and appropriately when problems with medical devices occur."
Olympus makes 85 percent of all of the scopes that are used in the U.S. Pentax and Fujifilm did not say whether or not they have plans to recall and redesign their scopes.