The time lag is raising more questions about what the device maker knew of the health risk its hard-to-clean scopes posed to patients and why U.S. hospitals weren’t notified immediately.
LOS ANGELES — Nearly two years before recent superbug outbreaks in Seattle and Los Angeles, the maker of the medical scopes involved was already warning hospitals in Europe about the risk of such patient infections.
But no alerts were sounded in the U.S. by Olympus, the leading manufacturer of gastrointestinal scopes worldwide, until this year.
The time lag is raising more questions concerning what the device maker knew about the health risk its hard-to-clean scopes posed to patients and why U.S. hospitals weren’t notified immediately.
The Japanese company and federal regulators have been faulted for not acting sooner in response to previous outbreaks.
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In Seattle, at least 32 patients treated at Virginia Mason Medical Center between 2012 and 2014 were part of an outbreak of multidrug-resistant E. coli infections tied to contaminated Olympus scopes. Eleven of those patients died, though hospital officials said it’s not clear what role, if any, the infections played in their deaths.
Once Virginia Mason officials confirmed the infections appeared to be spread by the scopes — and that recommended cleaning procedures weren’t adequate to stop it — they instituted a protocol to culture and quarantine the devices to make sure they were free of potentially harmful bacteria.
That procedure has since been recommended by the Centers for Disease Control and Prevention and adopted by other hospitals across the country.
The first of two warnings to European hospitals came in January 2013.
Olympus issued “important safety advice” to European hospitals and recommended a specific cleaning brush to help prevent contamination on its TJF-Q180V duodenoscope. That’s the same model at the center of the outbreaks in Los Angeles, Seattle and other cities.
In August 2014, Olympus sent a second safety alert in Europe after receiving complaints of debris on scopes even after they were disinfected.
In that letter, the company said it “is always very concerned about patient safety issues, including the prevention of cross infection among patients through endoscopy.”
Olympus considered the letter so important that it asked the European hospitals to fill out and return a form, acknowledging they had shared it with relevant staff.
Both notices in Europe were posted on the websites of regulatory agencies in Germany, Ireland and other countries.
Olympus didn’t respond to repeated requests for comment about the notices in Europe and the later alert in the U.S.
The company didn’t issue a similar warning in the U.S. until Feb. 19.
Last month, Olympus published new cleaning procedures for U.S. hospitals and advised them to use the same brush highlighted in Europe, labeled as MAJ-1888.
The U.S. Food and Drug Administration (FDA) said it learned of the European letters last summer but took no action then to alert hospitals.
A spokeswoman said the agency didn’t immediately take those steps because officials were already working with Olympus and two other scope manufacturers to ensure their cleaning protocols worked.
About 500,000 patients nationally undergo ERCP (endoscopic retrograde cholangiopancreatography) procedures each year. Olympus is the largest supplier of duodenoscopes, with an estimated market share of 70 percent.
In ERCP, doctors thread the long, thin scopes down a patient’s throat to diagnose and treat cancers, gallstones and other digestive conditions.
Both letters sent by Olympus in Europe focused on trouble with cleaning the forceps elevator at the tip of the duodenoscope. That area allows for attachments such as catheters or guide wires that doctors can use.
The FDA has warned that dangerous bacteria can build up in tiny crevices in that elevator area.