Olympus is undergoing a big recall of its duodenoscopes after dozens of gotten sick and some have died due to superbug infections.
Olympus Corp. is recalling and redesigning a medical scope that has been linked to a huge amount of superbug infections and possible deaths.
The company will voluntarily recall its medical scopes, which have been linked to many potentially deadly infections worldwide, according to a Los Angeles Times report.
Olympus sells about 85 percent of duodenoscopes, and it will redesign a part of the scope that is difficult to disinfect, likely leading to the infections. The U.S. Food and Drug Administration signed off on the proposed redesign effort.
Olympus is accused of knowing that such scopes could house potentially deadly bacteria but chose not toi warn hospitals for three years.
The scope has been tied to dozens of people who fell ill at Seattle’s Virginia Mason Medical Center.
A Senate committee report claims that 141 patients in nine cities had gotten an infection in 25 separate incidents involving the duodenoscopes. There have been an estimated 250 people worldwide who have gotten sick. The Virginia Mason outbreak involved 39 people getting sick and 18 dying between 2012 and 2014.
In a statement, Sen. Patty Murray (D-Wash.) said that the “devices exposed far too many patients and their families to unacceptable risks, and I am pleased to see that the FDA and manufacturers have taken additional actions to protect patients in the future.”
While she said the steps the company is taking now are good, “there is much more we need to do to make sure the FDA can respond quickly and appropriately when problems with medical devices occur,” she added.