July 28, 2016 — A manufacturer decided not to warn U.S. hospitals in February 2013 about a certain complex endoscope that reports indicated was unreasonably prone to infecting patients with potentially deadly bacterial ‘superbugs,’ emails released for the first time earlier this month show.
By that time, Olympus Corp. had received a number of reports from hospitals in three different countries, including the U.S., linking the company’s newly designed duodenoscope to a number of deadly bacterial outbreaks, including one at University of Pittsburgh Medical Center (or, “UPMC” in Pittsburgh, PA).
As if concerned that regulators across the pond might be less compromising and instead impose stricter sanctions against the company than the FDA, Olympus did, however, notify European hospitals the previous month, in January 2013, about this duodenoscope’s infection risk.
These emails became public this month as a result of a lawsuit filed earlier this year in a Pennsylvania court by a patient who is suing Olympus for negligence.
This suit claims the patient was exposed to a contaminated Olympus duodenoscope while undergoing multiple ERCP procedures beginning in January 2013 at the Carolinas Medical Center (Charlotte, NC).
The content of these emails — and the controversy surrounding them — were first reported last Sunday by The Los Angeles Times. Later in the week, other news sources, including the Pittsburgh Tribune Review (and its editorial board) and Allentown’s Morning Call, also published news articles about these emails.
As early as 2008, however, other documents and reports confirm that Olympus and the FDA were aware of the difficulty cleaning duodenoscopes, and the risk of their transmitting deadly superbug diseases.
UPMC began investigating its CRE outbreak in November 2012. Eighteen patients were infected with the superbug, half of whom had undergone ERCP. None of these infected patients died as a “direct” result of the infection, Pittsburgh’s Tribune-Review newspaper quoted hospital officials to say in 2014 and again last week. This clinical determination leaves open the possibility, however, that some of them might have died as an indirect result of the outbreak. (I contacted UPMC in 2014 and again this week to discuss this, but I received no response.)
UNC Health Care study
Last Sunday’s Los Angeles Times article also reported for the first time, as some of these emails revealed, that the University of North Carolina Health Care (UNC) in 2014 had been investigating the cause of “positive” cultures microbiologically sampled from endoscopes.
According to one of these emails, approximately 40% of the cultured endoscopes were contaminated with potentially harmful gastrointestinal bacteria after three weeks of testing, despite UNC having cleaned and disinfected — or “reprocessed” — these endoscopes according to manufacturer instructions.
The hospital reprocessed these tested endoscopes using either the Olympus OER-Pro Endoscope Reprocessor or an unnamed automated endoscope reprocessor (“AER”) sold by Medivators (Minneapolis, MN), according to this email, which added that UNC found no differences in the “contamination rate” of endoscopes reprocessed using either AER.
These findings are detailed in a March 31, 2014 email that UNC’s Dr. William Rutala wrote to both Olympus and Medivators alerting the companies about the UNC study’s concerning results. His email further confided that these potentially harmful enteric bacteria were cultured from the suction channel of 70% of the contaminated endoscopes.
But Dr. Rutala’s email also reported, even more alarmingly, that during the first week of UNC’s three-week study, more than two thirds — 69% — of the tested endoscopes remained contaminated with the bacteria after reprocessing.
In all, UNC’s study sampled 30 endoscopes, according to Dr. Rutala’s email, which also informed Olympus (and Medivators) that, “Despite substantial time and effort we have been unable to discover the exact cause of these positive cultures and implement a strategy to prevent contamination.”
Dr. Rutala’s email does not specify the types or models of endoscopes that UNC’s study tested and remained contaminated after automated reprocessing, raising reasonable speculation about whether these endoscopes were duodenoscopes or another type of gastrointestinal endoscope, such as a colonoscope.
Olympus manufactures 85% of gastrointestinal endoscopes used in the U.S.
UNC is a medical system owned by the State of North Carolina and based in Chapel Hill.
Whether Olympus notified the FDA about UNC’s findings that the hospital’s tested endoscopes posed an unreasonably high rate of contamination, as well as the possible exposure and infection of patients, with potentially pathogenic bacteria after reprocessing is unclear.
I searched the FDA’s medical device database, however, and found five reports that Olympus filed with the FDA, each dated January 31, 2014, documenting endoscope contamination at one hospital. But, these five regulatory reports cite the contamination of colonoscopes with Klebsiella, E. coli, and Pseudomonas, among other types of bacteria.
These three are enteric bacteria (i.e., indigenous to the gastrointestinal tract), like the type described in Dr. Rutala’s email to Olympus, dated March 31, 2014. Some of the other details in Dr. Rutala’s email are also consistent with these five regulatory reports, none of which identifies the hospital by name, however.
Strains of Klebsiella and E. coli that are resistant to carbapenems — the “last resort” drugs for treating certain bacterial infections — would be CRE. (None of the five reports discloses whether the bacteria were multidrug-resistant, however.)
Since 2012, CRE have been directly linked to more than a dozen deadly outbreaks in the U.S. following ERCP. CRE is a deadly type of superbug better known clinically as carbapenem-resistant Enterobacteriaceae.
As with most types of flexible endoscopes, colonoscopes testing “positive” for bacteria after either manual or automated reprocessing, among other possible reprocessing errors (or instrument design flaws), can indicate that the devices were not properly dried. Endoscope drying is generally achieved by flushing its internal channels using 70% alcohol, followed by forced air.
Colonoscopes are used millions of times a year in the U.S. to screen patients for colon cancer, among other uses.
On April 19, 2014, three weeks after receiving Dr. Rutala’s email, an Oympus employee wrote another stating that “Dr. Rutala has requested to know the surface area of a colonoscope instrument/suction channel.” Whether this request was a direct result of the types of endoscopes that UNC’s 2014 study tested is unclear and could not be determined for this article.
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Olympus 160 Series Endoscopes – A Sample Report: “Deadly ‘Superbug’ Infections Linked to the Olympus TJF-160F and TJF-160VF Duodenoscopes: My Complete Review of the FDA’s Adverse Event Database.” (“Discussions in Infection Control“)
The Olympus OER-Pro Endoscope Reprocessor
Also on January 31, 2014, the same day that Olympus filed the five aforementioned regulatory reports with the FDA, the company filed two other regulatory reports documenting the contamination of endoscopes reprocessed by the OER-Pro Endoscope Reprocessor.
Both of these reports, which appear to describe the same hospital’s incident, also contain certain details that are consistent with Dr. Rutala’s March 31, 2014 email to Olympus. According to these two reports, endoscopes remained contaminated with Klebsiella after being reprocessed by the OER-Pro and another (unnamed) AER. Whether Medivators was the manufacturer of this other AER is not discussed in either report.
But, both reports implicate duodenoscopes, and they each acknowledge that the hospital’s AER may not have been properly rinsing the endoscopes with 70% alcohol after each completed cycle — a terminal reprocessing step that virtually every AER model performs to facilitate the endoscope’s drying.
The increased risk of inadequately dried endoscopes transmitting potentially deadly bacterial infections, including those caused by Klebsiella and Pseudomonas, is discussed in a peer-reviewed article I wrote in The American Journal of Gastroenterology.
Duodenoscopes are used to perform endoscopic retrograde cholangiopancreatography, or ERCP, as many as 700,000 times a year.
Bacterial exposure vs. infection
A patient’s exposure to a multidrug-resistant bacteria including CRE does not ensure infection. To be clear, no cases of a colonoscope infecting a patient with CRE or a related superbug have been published. In general, only patients who are ill or with suppressed immune systems are prone to such bacterial infections.
No matter the types of endoscopes UNC’s study tested in 2014, however — duodenoscopes, colonoscopes or another type of gastrointestinal endoscope — the five regulatory reports that Olympus filed in January 2014 apparently confirm, possibly for the first time, that inadequately reprocessed colonoscopes could pose a risk of exposing patients to Klebsiella and other potentially harmful enteric bacteria that could be multidrug-resistant or even CRE.
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Confidential Quality and Safety Healthcare Services, Risk Assessments, and Legal Reviews for Hospitals, Manufacturers and the Public: Click here to read about Dr. Muscarella’s quality and safety services committed to educating and helping hospitals (and manufacturers and patients) reduce the risk of healthcare-associated infections, including those linked to contaminated GI endoscopes and heater-cooler devices, among other types of reusable devices.
“URGENT, CONFIDENTIAL” emails
Showing the seriousness of UNC’s findings, yet the need for discretion, the subject heading of internal emails shared among Olympus employees discussing Dr. Rutala’s March 31, 2014 email is labeled “Re: URGENT. CONFIDENTIAL – UNC + cultures from OER-Pro.” (In this context, “+” refers to the endoscopes being “positive” for bacterial contamination.)
One of these emails shared among Olympus employees is dated the next day, April 1, 2014.
The email Dr. Rutala wrote to the company was similarly labeled “CONFIDENTIAL.” It is unclear whether UNC’s tested endoscopes included colonoscopes, because his email does not specify the types and models of the cultured endoscopes.
Nor do any of the released emails shed light on whether, in response to its findings, UNC had adopted a safety measure to minimize the risk of exposing patients to these potentially harmful enteric bacteria during endoscopy.
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. — Lawrence F Muscarella, PhD (Pittsburgh Tribune Review, July 26, 2016)
It appears that last Sunday’s Times article was the first time the public learned of UNC’s study. (I could not identify UNC’s findings in the literature after performing a thorough search, but my not finding these data does not confirm they weren’t previously published.)
When Dr. Rutala spoke to the FDA during a 2-day panel meeting focusing on how to reduce the risk of endoscopes infecting patients with superbugs, in May 2015 — a year after the completion of UNC’s study — he reported that UNC is “going from high-level disinfection (alone) to high-level disinfection with ethylene oxide (gas) sterilization.” It is reasonable to conclude that this adopted practice was a result, at least in part, of the findings of UNC’s 2014 study.
Also during this 2-day meeting, Dr. Rutala presented an educational presentation about recent bacterial outbreaks linked to contaminated duodenoscopes that had been cleaned and disinfected according to manufacturer instructions (or professional guidelines).
A few months after this 2-day panel meeting, the FDA published four supplemental measures in September 2015 that U.S. hospitals should consider adopting to reduce the risk of duodenoscopes infecting patients with superbugs. One of these recommended measures is to use ethylene oxide gas to sterilize the endoscopes.
Dr. Rutala’s March 31, 2014 email states that the reason for performing the study was to improve quality, and was not in response to patient infection or a bacterial outbreak. Each of the aforementioned regulatory reports I found that might describe the findings of UNC’s 2014 study state that no patients were infected.
If teaching nothing else, UNC’s study raises concerns that gastrointestinal endoscopes, possibly even colonoscopes, could be exposing patients to potentially harmful bacterial diseases at a much higher rate than previously recognized by health officials.
Contaminated suction channels
According to Dr. Rutala’s March 31, 2014 email, most of the cultured bacteria were sampled (not from a duodenoscope’s distal tip, forceps elevator mechanism or recess area, but) from an endoscope’s suction channel.
This finding raises questions about other types of inadequately reprocessed flexible endoscopes with a suction channel.
A regulatory report filed by a manufacturer (Karl Storz, El Segundo CA) with the FDA on December 19, 2013 (this report was brought to my attention by a colleague*) suggests that several patients were infected with Klebsiella pneumoniae — possibly, CRE — using a contaminated intubation endoscope. Three of the infected patients expired, according to this report.
Intubation endoscopes are simple in design, generally only one internal channel, not four like some colonoscopes, and intubation endoscopes do not feature a complex forceps elevator mechanism.
On September 18, 2015, the FDA issued an alert warning the public of the potential for contaminated bronchoscopes, which also feature a suction channel, to infect patients with superbugs. Two months earlier, I had published an article that brought this risk to the public’s attention for the first time.
Hospital care is about integrity, compassion and honesty — not silence. — Lawrence F. Muscarella, PhD (The Pasadena Star-News, May 5, 2016)
According to the Los Angeles Times, Dr. Rutala declined to comment when the newspaper asked him about the results of UNC’s 2014 study and Olympus’ response to his email.
Several deadly bacterial outbreaks have been linked to contaminated gastrointestinal endoscopes during that past year, raising questions about whether current measures adopted by hospitals are sufficient.
On February 25, 2015, CNN reported that 18 patients at Carolinas Medical Center, also in North Carolina, were infected with CRE. According to a January 2016 senate report spearheaded by Senator Patty Murray (D-WA), some of these infections were linked to contaminated duodenoscopes.
A few months later, in the summer of 2015, Pasadena’s Huntington Memorial Hospital linked an outbreak of antibiotic-resistant Pseudomonas to contaminated Olympus duodenoscopes. In all, sixteen patients were infected, 11 of whom died. But it was not until nine months later, in May of this year, that the public learned of these 11 patient deaths for the first time.
And, this past May, the University of Colorado Hospital acknowledged that nine of its patients had been infected with a resistant E. coli strain earlier in the year during ERCP. Three of these infected patients died.
According to a (low) estimate by the Kaiser Health News, at least 35 infected patients have died in the U.S. since 2013 — the year Olympus decided not to inform U.S. hospitals about its endoscope’s infection risk — following ERCP performed using the company’s duodenoscope contaminated with superbugs.
I spoke with and emailed the Carolinas Medical Center asking about its 2015 superbug outbreak, and to comment on the findings of UNC’s study, but it did not respond.
Update (August 2, 2016) — When I also asked the State of North Carolina’s Department of Health and Human Services by email to discuss UNC’s 2014 study, it responded saying: “we did not have any involvement in that study.”
Editorial: Closing remarks
The publication and sharing of information about effective interventions and strategies demonstrated to prevent “reprocessed” endoscopes from transmitting deadly superbugs is critical to patient safety.
Months after the completion of UNC’s endoscope study, Dr. Rutala editorialized in the October 8, 2014 issue of a medical journal that it is necessary “to examine (in part whether current U.S. endoscope reprocessing guidelines are adequate to ensure a patient-safe gastrointestinal endoscope, one devoid of potential pathogens) and offer recommendations, understanding current knowledge on endoscope reprocessing.”
Well said, and I agree.
Whether any of the aforementioned superbug outbreaks linked to contaminated endoscopes in 2015 could have been averted if Olympus, in 2013, had warned U.S. hospitals when it first learned that its newly designed duodenoscope model was unreasonably prone to infecting patients with potentially deadly bacteria is unclear, but a fair hypothetical to raise.
It was not until February 2015 that the FDA (and Olympus) first notified U.S. hospitals about the risk of duodenoscopes remaining contaminated after reprocessing and infecting patients with potentially deadly bacteria.
This culture of secrecy is not in patients’ best interest. Hospitals don’t realize the more transparent they are, the more infection risks would decrease. — Lawrence F Muscarella, PhD (Philadelphia Inquirer, February 22, 2016)
I wrote a peer-reviewed article in 2014 that helped publicize the risk of superbug transmissions during ERCP, pointing out (possibly for the first time) that the potential for duodenoscopes to transmit deadly diseases was not localized or limited to one hospital (i.e., Advocate Lutheran General Hospital in Park Ridge, IL), but a global risk.
Even more well-taken and timely is Dr. Rutala’s instruction in this same October 8, 2014 medical journal advising clinicians to “report and publish cases of infectious diseases related to endoscopy, especially if current reprocessing methods were adhered to.”
This advice echos that of a Philadelphia gastroenterologist, who a year later, in the September 22, 2015 issue of different medical journal, urged openness about superbug infections linked to endoscopes, writing that: “Health care facilities and providers should strive to establish an environment of open information exchange with patients about what is being done to maximize their safety.”
Well said, too, and I could not agree more with the recommendations of these two clinicians.
But, displaying healthcare’s lack of disclosure, Sen. Murray’s January 2016 report stated that: “Although at least 16 separate U.S. hospitals traced antibiotic-resistant infections directly to duodenoscopes, the hospitals generally did not raise alarms about these infections with federal regulators.” Her report added that: “It appears that not a single hospital that experienced infection outbreaks tied to the duodenoscopes sent the required adverse event form to the device manufacturers.”
When asked to comment and clarify whether any of the endoscopes that UNC tested during its 2014 study were colonoscopes — and whether any of UNC’s patients could have been inadvertently exposed to potentially harmful bacteria — a representative of the medical system wrote me by email saying: “UNC Hospitals have experienced no infections due to contaminated scopes, and UNC Hospitals followed all mandated guidelines. We cannot comment further at this time.”
Article by: Lawrence F Muscarella, PhD. Posted July 28, 2016. © Copyright 2016. All Rights reserved. Lawrence F Muscarella PhD is the owner of LFM Healthcare Solutions, LLC, a Pennsylvania-based quality improvement and consulting company that provides safety services for hospitals, manufacturer and the public. LFM Healthcare Solutions, LLC, owns, publishes, and is solely responsible for the content of this and every article posted in “Discussions in Infection Control.”
E: Larry@LFM-HCS.com. Twitter: @MuskiePhD
*Acknowledgements: Information provided by Device Events.