Japanese maker of medical scopes withheld warning of infection, reported emails show
Japanese device maker Olympus Corp. made a strategic decision not to warn American hospital systems, including UPMC, about tainted medical scopes in the midst of superbug outbreaks in two European countries, according to emails uncovered in a news report Monday.
The emails, first reported by Kaiser Health News , show that an Olympus executive in Pennsylvania asked higher-ups in 2013 whether the company should warn UPMC about its duodenoscopes at UPMC Presbyterian in Oakland. The scopes, which are placed down the throat to examine digestive problems, have been linked to infections and deaths at hospitals across the country.
“Should (we) also be communicating to our users the information that (Olympus Europe) is communicating to their European users?” Laura Storms, vice president of regulatory and clinical affairs in Center Valley, Lehigh County, asked in an email to Tokyo headquarters on Jan. 31, 2013.
Susumu Nishina, the company's chief manager for market quality administration in Tokyo, replied Feb. 6, 2013, that there was no need to volunteer information about the faulty scopes.
It is “not need(ed) to communicate to all the users actively,” Nishina wrote, because a company assessment of the risk to patients found it to be “acceptable.” He specified that Storms should respond to questions only from a customer.
The emails suggest the company blamed hospitals, including UPMC, for failing to properly clean scopes.
UPMC declined to comment on the emails.
“UPMC cannot get into details because this is an ongoing legal investigation,” spokeswoman Allison Hydzik wrote in a statement. “We were among the first health systems to detect an issue and immediately began investigating. We created a new process for cleaning our duodenoscopes, which includes gas sterilization, and have had no issues since implementation. This process was deployed systemwide and we have reported our results multiple times at significant academic meetings in an effort to share what we've learned with as many peer institutions as possible.”
At least 35 people at U.S. hospitals have died since 2013 after suffering infections from contaminated gastrointestinal scopes manufactured by Olympus, according to Kaiser Health News.
“A company's failure to acknowledge its errors and promptly correct them, choosing instead to blame others for infections, myopically results in poor health care quality, rising health care costs, and patient harm,” said Lawrence Muscarella, a Philadelphia-based biomedical engineer who specializes in infection control.
UPMC started investigating the infections in November 2012, when several patients tested positive for a superbug called CRE, or carbapenem-resistant enterobacteriaceae. Top health authorities call it “nightmare bacteria” because it can be deadly, and most antibiotics are ineffective against it. None of the patients at UPMC died as a direct result of the infection, officials said.
All UPMC hospitals halted use of the scopes during the investigation and adopted a new disinfection technique to replace a high-level disinfection. Hydzik said the new disinfection process has prevented further issues.
In additional emails, Storms questioned the manner in which Olympus handled the UPMC outbreak at Presby. Storms was leery of a conclusion by Olympus that UPMC failed to properly clean its scopes.
“Can you please explain how OMSC (Olympus Japan) reached the conclusion that insufficient reprocessing was the cause for this MDR (medical device injury report)? Since OMSC was not on-site at UPMC and did not investigate this facility, how is OMSC reaching this conclusion?” she asked.
“Specifically what evidence does OMSC have that supports inadequate reprocessing by UPMC? You do not cite any objective findings, testing, etc. for this endoscope model,” Storms wrote.
Ben Schmitt and Wes Venteicher are Tribune-Review staff writers.
