In spring 2012 at a Dutch hospital, a technician for Olympus, maker of medical scopes, found a brown, grimy film inside parts of the flexible scope that were supposed to be sealed, and a rubber ring designed to keep bacteria out was cracked and worn.
The bacteria found on the scope were the same bacteria that had sickened patients treated at the hospital, the Los Angeles Times reports.
An investigator concluded that the scope’s design could allow blood and tissue to become trapped in the device, spreading bacteria from one patient to another when the scope was used in subsequent procedures. The investigator called for a worldwide investigation and recall of the Olympus scopes if similar problems were found elsewhere. But, according to the Times, over the next three years, 21 people died and at least two dozen more became ill from infections related to scopes in Pittsburgh, Seattle and Los Angeles. The Food and Drug Administration (FDA) has identified 10 infection outbreaks, seven of which involve Olympus scopes.
Despite the patient deaths and illnesses, Olympus continued to sell the scopes and failed to warn U.S. hospitals that the scopes were linked to dangerous infections, the Times reports. Olympus treated each instance as an isolated incident and did not inform U.S. hospitals of other outbreaks. The company blamed the hospitals for not cleaning the scopes properly.
The device—the duodenoscope—was developed for use in endoscopic retrograde cholangiopancreatography (ERCP). The flexible scope is inserted down the patient’s throat and into the digestive tract, where cancers, gallstones and other conditions can be diagnosed and treated, without the risks of more invasive surgery, the Times explains. Nearly 700,000 of these procedures are performed annually in the U.S. Many of the patients undergoing ERCP have serious illnesses, which can make them more vulnerable to infection. But the duodenoscopes have proven difficult to properly clean and disinfect, even when a hospital carefully follows the manufacturer’s instructions.
In 2012, equipment at the University of Pittsburgh Medical Center began testing positive for carbapenem-resistant Enterobacteriaceae (CRE), a superbug that is resistant to many antibiotics. Many patients infected with CRE had been treated with an Olympus scope. The hospital pulled the devices out of service, alerted Olympus and tested for the bacteria, the Times reports. Five of 31 scopes tested positive for bacteria, even after they had undergone hand and machine cleaning and disinfection. An Olympus representative told doctors the hospital was using the wrong type of automatic washer, but a scope tested positive for bacteria even after the hospital cleaned it in a new machine. The medical center began sterilizing scopes with a toxic gas, a more costly and time-consuming method.
In early 2015, UCLA tied its infections to the Olympus duodenoscopes and in February the FDA warned U.S. hospitals about the danger of the scopes spreading deadly bacteria. During the spring and summer, Justice Department and congressional investigations began, and in September the FDA expanded its warnings about medical scopes, adding a warning about bronchoscopes, scopes used to examine the throat, larynx, trachea, and lungs, the Times reports.
A number of lawsuits have been filed against Olympus, including one by the parents of an 11-year-old California boy who was treated with an Olympus scope at UCLA during the outbreak and developed an infection. The boy died a month later, the Times reports, and his parents blame the scope.