Skip to content
Health

FDA OKs change to endoscopes blamed for superbugs

    by Tom Avril
    Published 

The U.S. Food and Drug Administration approved a modification to a controversial type of endoscope made by Olympus Corp., which has U.S. headquarters in Center Valley, Pa.

The company modified the design of its duodenoscope to create a tighter seal around an intricate mechanism that was difficult to clean and had been blamed for transmission of dangerous infections.

The move comes on the heels of a Senate committee report that accused both manufacturers and the FDA of being too slow to act. That report, issued Wednesday by the minority staff of the Senate Health Committee, linked the scopes to 25 different incidents

of antibiotic-resistant infections that sickened at least 250 patients worldwide.

The FDA said Olympus had voluntarily agreed to recall a version of its duodenoscope called the TJF-Q180V, and that the company would make the fixes "as quickly as possible."

Duodenoscopes, also made by Fujifilm and Pentax, are used in more than 500,000 procedures a year, enabling doctors to examine and treat the bile and pancreatic ducts without resorting to traditional surgery.

Read more from the Check Up blog »