Sharing information is vital to heading off public health threats
Emails made public for the first time two weeks ago revealed that Olympus Corp. decided in February 2013 not to warn UPMC and other U.S. hospitals about issues with its newly designed duodenoscope. In addition to having not received a legal clearance from the Food and Drug Administration (until three years later, in 2016), the scope was unreasonably prone to infecting patients with deadly “superbugs” during a gastrointestinal procedure called ERCP, or endoscopic retrograde cholangiopancreatography. Possibly displaying a concern that health regulators across the pond might balk at a “too big to fail” defense and instead impose stricter sanctions on the company than their counterparts, Olympus did, however, notify its European customers the previous month, in January 2013, of this endoscope's infection risk. Olympus makes 85 percent of the gastrointestinal endoscopes used to treat patients in the United States.
For the record, Kaiser Health News and other news sources, including this newspaper, have reported that since 2013, this Olympus suspect duodenoscope has been blamed for dozens of infections and the deaths of at least 35 U.S. patients (a conservative estimate), including those who underwent ERCP at UPMC, Allegheny General Hospital and Thomas Jefferson University Hospital in Philadelphia. It was not until two years later, in February 2015, that the FDA (and Olympus) finally notified U.S. hospitals that this duodenoscope had an unusual penchant for retaining harming bacteria, including CRE, in inaccessible crevices, infecting patients during ERCP.
One year later, in January 2016, Olympus recalled this duodenoscope amid complaints from members of Congress that this device was a safety hazard.
The emails released two weeks ago became public as a result of a lawsuit filed earlier this year in a Pennsylvania court by a patient who is suing Olympus for negligence after undergoing multiple ERCP procedures at a medical center in the South between 2013 and 2015. Almost four years ago in November 2012, UPMC began investigating its own CRE outbreak. Eighteen of the hospital's patients were infected with the superbug, half of whom had undergone ERCP. This newspaper quoted hospital officials saying in 2014, and again two weeks ago, that none of these infected patients died as a direct result of the infection, leaving open the possibility that one or more of them might have died albeit as an indirect result of the outbreak.
Some of the emails that became public two weeks ago also revealed that a hospital in North Carolina, between 2013 and 2014, had been performing an internal study to evaluate the risk of infection during endoscopy. According to one email labeled “confidential” that the hospital wrote to Olympus in March 2014, more than a third of the hospital's tested endoscopes remained contaminated with potentially harmful bacteria, even though the hospital had cleaned and disinfected, or “reprocessed,” these endoscopes according to manufacturer instructions. If resistant to carbapenems — the “last resort” antibiotics for treating certain bacterial infections — these bacteria likely would be carbapenem-resistant Enterobacteriaceae, a deadly type of superbug better known to the public as CRE.
This North Carolina hospital's email to Olympus does not specify the types or models of gastrointestinal endoscopes that its study tested and found to remain contaminated at such an unusually high rate, raising reasonable speculation about whether these endoscopes were duodenoscopes, or another type of endoscope such as a colonoscope. Whereas duodenoscopes are used to perform ERCP as many as 700,000 times a year in the United States, colonoscopes are used millions of times a year to screen patients for colon cancer, among other uses.
To be clear, a patient's exposure to a superbug does not ensure infection. And, no cases of a colonoscope infecting a patient with CRE have been published. In general, only patients who are ill or have a suppressed immune system are prone to such bacterial infections. But, if teaching us little else, this North Carolina hospital's internal study raises fair questions about whether gastrointestinal endoscopes, possibly even colonoscopes, could be inadvertently exposing patients to potentially harmful bacteria at a higher rate than previously recognized by health officials.
I wrote a peer-reviewed article in 2014 that helped publicize the risk of superbug infections during gastrointestinal endoscopy, pointing out (possibly for the first time) that the potential for duodenoscopes to transmit deadly diseases was not localized or limited to one hospital, but a global risk. Even more well-taken and timely is the recommendation published by some experts including myself that hospitals and clinicians not remain quiet, but publish and openly share instances of endoscopes remaining contaminated with superbugs despite being reprocessed in accordance with the manufacturer's instructions, and also the interventions that prevented the hospital's patients from being infected with these bacteria during the endoscopic procedure.
Transparency and the exchange of information and study data about effective interventions and strategies shown to improve the safety of patients undergoing gastrointestinal procedures in U.S. hospitals has been a basic tenet of public health. Whether the superbug outbreaks at UPMC and Allegheny General could have been averted if Olympus had warned U.S. hospitals when the company first learned that its scopes posed an unreasonably high risk of infecting patients with superbugs is unclear, but a fair — if necessary — hypothetical to raise.
Lessons about the documented contribution of openness and disclosures to improving the safety of patients and the quality of health care, and to a marked reduction in hospital-associated infections, superbug outbreaks and health care costs, are being taught. They just aren't being learned.
Lawrence F. Muscarella, Ph.D., is the owner of LFM Healthcare Solutions, a Pennsylvania-based quality improvement and consulting company that provides services for hospitals, manufacturers and the public. A more detailed version of his opinion on this topic can be read on his blog “Discussions in Infection Control” at LFM-HCS.com.