Olympus to Recall Scope, Redesign Hard-to-Clean Part

(Los Angeles Times/TNS) -

Olympus Corp. said Friday that it would voluntarily recall and redesign a troubled medical scope that has been linked to potentially deadly patient infections around the world.

The company, which sells about 85 percent of the duodenoscopes used in the United States, said it would revamp an internal mechanism inside the reusable device that had been almost impossible to disinfect before being used on the next patient.

The recall and redesign announcement comes two days after a Senate report concluded that 25 outbreaks were linked to dirty scopes made by Olympus and two other manufacturers.

A series of Los Angeles 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.

The U.S. Food and Drug Administration said Friday that it had approved Olympus’ new design of the device, which is called a duodenoscope.

American doctors use the scope nearly 700,000 times a year in a procedure known as ERCP, or endoscopic retrograde cholangiopancreatography. Doctors thread the flexible scope down a patient’s throat and into the digestive tract to diagnose and treat cancers, gallstones and other conditions.

The voluntary recall marks a major turnaround for Olympus, which for years has blamed the growing number of infections on hospitals, saying they improperly cleaned the scopes.

In 2010, Olympus engineers had modified the $40,000 scope to seal a narrow internal channel to keep out blood and other infectious material. The change aimed to make the scope easier to clean and followed similar redesigns by its two rivals, Pentax and Fuji.

But three independent investigations — the first in early 2012 — found that the design could allow bacteria to remain inside the scope even after it was cleaned according to Olympus’ instructions.

The Senate report backed up those findings, noting it “is now evident” that such models can “trap and transmit bacteria” even after cleaning.