Newly released internal e-mails show that Olympus executives told U.S. employees not to warn their customers about potentially deadly infections linked to its duodenoscopes.
The e-mails suggest that Olympus officials based in its Japanese headquarters attempted to hide news of a potential outbreak from U.S. customers, even though it allegedly knew that its duodenoscope design made it difficult to clean the scopes and prevent cross-contamination, according to reports from The Los Angeles Times and Kaiser Health News.
After Olympus issued a safety alert about its duodenoscopes to its European customers following infection outbreaks at French and Dutch hospitals in January 2013, U.S. executives e-mailed their superiors, asking whether they should also communicate the information about the risks of the scopes with their U.S. users. In response, the officials told the U.S. executives that issuing a global alert was "not needed" and instead said the problems were due to poor reprocessing by the U.S. hospitals.
These exchanges continued for several months, the report says, with U.S. officials becoming more and more concerned about the growing number of carbapenem-resistant Enterobacteria (CRE) infections at U.S. hospitals. Still, Olympus continued to say that these were isolated incidents and that the hospitals' reprocessing protocols, not the scope's design, were at fault.
According to the report, at least 35 people were killed due to tainted duodenoscopes during U.S. outbreaks. Between January 2010 and October 2015, as many as 350 patients in 41 medical facilities worldwide were infected or exposed to contaminated scopes from Olympus and 2 other manufacturers.
Since the outbreaks, several patients and their families have sued Olympus, saying that the manufacturer was negligent in its response to the contaminated duodenoscopes. The internal e-mails were filed in court as part of one patient's lawsuit against the company. Federal authorities are also investigating Olympus's handling of the infections.
Despite allegedly knowing since 2012 that design issues made the scopes nearly impossible to clean, the report says that Olympus continued blaming hospitals for the infections, even as the FDA began investigating the scopes in 2013. In February 2015, 2 years after Olympus warned its European customers, the FDA finally issued a safety alert saying that the scope's design was at fault for the infections.
It was only in January 2016, 2 days after Congress released a report criticizing Olympus' handling of the infections, that the company issued a U.S. recall of the scopes. The devices remain on the market while the company repairs them, the report states, which it expects to complete by the end of the summer.
Olympus representatives did not return calls from Outpatient Surgery seeking comment. The company declined to comment for the report due to the pending litigation, but did release a statement saying: "Patient safety is our top priority. The duodenoscope issue continues to receive the highest level of attention at Olympus, and we remain committed to working with the proper authorities and our stakeholders to understand and address the potential root causes."