August 24, 2016 — (Updated: August 29, 2016) — Newspapers frequently print articles discussing my independent research, views and conclusions about hospital safety, public health, and the possible causes of — and the necessary steps to prevent — ‘superbug’ infections in a hospital’s endoscopy department, operating room or neonatal intensive care unit, among other settings.

Examples of some recent newspaper articles that present my insight about a particular deadly outbreaks or the factors that might have contributed to it include:  The Washington Post, Bloomberg Business, and The Los Angeles Times, as well as the Denver Post, the New York Post, the Allentown Morning Call, and The York Dispatch.

Television news shows, too, have interviewed me about superbug outbreaks, including CNN, The Wall Street Journal (video), NBC’s The Today Show,  NBC Nightly NewsThe CBS Evening NewsABC World News Tonight and Huffington Post (video).

To be certain, these news articles and television reports have significantly contributed to public awareness, if not also to directly increasing hospital safety.

CRE, or carbapenem-resistant Enterobacteriaceaewhich have been linked to multiple outbreaks and patient deaths following ERCP, is the particularly insidious bacteria that was the focus of these news articles and television reports.

These “nightmarish” bacteria are resistant to virtually every antibiotic (including carbapenems), and they have even received significant attention from members of the U.S. Congress.

ERCP, or endoscopic retrograde cholangiopancreatography, is an endoscopic procedure commonly used to diagnose and treat certain disorders and diseases of the biliary and pancreatic ductal systems in the upper gastrointestinal tract.

Quotes v. misquotes

The majority of the dozens of newspapers that have interviewed me for my independent opinions and conclusions about the risk of duodenoscopes and other type of gastrointestinal endoscopes infecting patients — or, too, the designs of heater-cooler devices, which have infected patients with deadly nontuberculous mycobacteria during certain open-heart procedures, or overlooked factors that might have contributed to harmful bacterial infections during arthroscopy — among other devices and procedures, have accurately quoted me (or, paraphrased my spoken words to accurately reflect my professional conclusions).

A few published newspaper articles, however, have inadvertently mischaracterized my conclusions about the risk and causes of hospital infections.

The Chicago Tribune, for example, published an article in February 2015 about a teenager who underwent ERCP and became infected with CRE. Authored by the Associated Press, this same article was also published by Yahoo! News and The Charlotte Observer, among several other newspapers including The Kuwait Times (see: “Blame game, to follow ‘superbug’ scare” — February 22, 2106).

In response to being asked by the AP whether a duodenoscope can be implicated as the cause of an infection, I replied that, yes, proving causation is certainly possible and often common, and that hospitals have previously acknowledged when a patient became infected with a superbug during ERCP.

However, these newspapers incorrectly (and inadvertently) quoted me to have said, “Proving causation is impossible.

Consistent with my finding that investigations routinely identify the endoscope as the outbreak’s source, this same AP article (correctly) quoted me to have said that, “Doctors rarely list the infection as the cause of death, and some hospitals have said patients entered their facility with the antibiotic-resistant bacteria, a notion (Dr. Muscarella) dismisses.”

Update (August 26, 2016): Responsible reporting

On August 26, 2016, The Associated Press issued a correction of its original February 20 2015 story.

The AP wrote in its now on-line corrected article, “Correction: Hospital Superbug Outbreak story,” that, “In a Feb. 20, 2015 story about an antibiotic-resistant ‘superbug’ outbreak at Ronald Reagan UCLA Medical Center, The Associated Press mischaracterized a statement an expert made about proving the cause of an infection.”

This corrected article added that, “Lawrence Muscarella, a health care and sterilization expert, said he was suggesting an argument hospitals might use when he said, “‘Proving causation is impossible.’ Muscarella said an infection can be proven to come from a hospital instrument.”

The Chicago Tribune, as well as the  Yahoo! News, The Charlotte Observer, and several other newspapers, promptly updated their articles to depict my conclusions accurately.

Confidential Quality, Safety and Legal Reviews for Hospitals, Manufacturers and the Public:  Click here to read about Dr. Muscarella’s quality and safety services committed to assisting manufacturers, hospitals and patients reduce the risk of healthcare-associated infections, including ‘superbug’ outbreaks linked to contaminated duodenoscopes.

More about causation

A year earlier in January 2014, Medscape interviewed me about evaluating an endoscope as the cause of an infection. It (correctly) quoted me to say that, “If an outbreak is detected, consider dismantling the (duodenoscope) and microbiologically sampling all of its internal surfaces, including the sealed elevator wire channel and distal hood, to rule either out as, or to confirm either to be, a source of the outbreak’s strain of bacteria.”

I also told Medscape during this same interview that it may be that the (new duodenoscope model’s) ‘sealed’ elevator wire channel, or the ‘sealed’ distal hood or case at the (duodenoscope’s) distal tip, is retaining debris and infectious CRE .. that are being transmitted to patients during ERCP.”

To be sure, confirming that a surgical instrument was a source or reservoir of bacteria that might have exposed a patient to a deadly outbreak’s bacteria is a common practice and can require little more than testing the instrument to verify that it’s contaminated with the outbreak’s bacterial strain.

By way of an example, Medscape also reported in this same 2014 article that the U.S. Centers for Disease Control and Prevention (CDC) had published a report in MMWR discussing its investigation of a deadly CRE outbreak at Advocate Lutheran General Hospital (Park Ridge, IL) that officials the year earlier, in 2013, had linked directly to ERCP.

The CDC wrote in this MMWR article (also published in January 2014) that “cultures were obtained from the ERCP endoscope used on five of the case-patients. NDM-producing E. coli and KPC-producing K. pneumoniae were recovered from the terminal section (the elevator channel) of the device. The E. coli isolate was highly related (>95%) to the outbreak strain by PFGE.”

The CDC concluded in this same article that its investigation of the cause of this hospital’s outbreak “highlights the potential for CRE transmission following ERCP,” confirming that the hospital’s duodenoscopes exposed the infected patients to the outbreak’s bacteria.

And, referencing an editorial I wrote four years earlier in the journal Endoscopy, the CDC also wrote in this MMWR article that the complex design of duodenoscopes is a concern and might “pose a particular challenge for cleaning and disinfection.”

Confirmatory testing data

In summary, if investigators sample a duodenoscope and determine it to be contaminated with an outbreak’s bacteria (a “positive” result), then it is reasonable to conclude causation and that the duodenoscope exposed the infected patients to these bacteria during ERCP.

However, if the duodenoscope yields no bacteria (a “negative” result) during such microbiological testing, investigators should not exonerate the endoscope and (possibly incorrectly) conclude, based on no other supporting data, that the instrument did not cause the outbreak.

Sampled duodenoscopes (and other types of flexible endoscopes) contaminated with deadly bacteria can, and have been documented, to yield “no growth” results, falsely suggesting a contaminated instrument is sterile.

In short, the technique of endoscope sampling is often used correctly to evaluate causation and confirm a duodenoscope is contaminated with an outbreak’s bacterial strain, but because of the technique’s inherent limitations, its use to evaluate an duodenoscope’s sterility is ill-advised, because sampling can yield “false-negative” results.

Closing remark: A list of other published newspaper articles discussing causation

The following is a list of six other published newspaper articles that accurately quote me (directly or indirectly, and exactly or in effect) about causation and the confirmed contribution of the duodenoscope’s complex design to deadly superbug outbreaks:

[1] The Seattle Times on January 21, 2015 wrote: “(Dr. Muscarella is) worried that growing numbers of patients undergoing a special procedure known as endoscopic retrograde cholangiopancreatography, or ERCP, which examines and treats disease of the bile or pancreatic ducts, may be contracting the dangerous, hard-to-treat CRE infections spread by the medical devices. Worse, Muscarella said, he’s convinced that the design of the scopes is to blame. The distal ends of the long, flexible scopes … may also harbor bacteria that can’t be cleaned, even with recommended disinfection techniques, Muscarella said.”

[2] The Advisory Board on January 27, 2015 reported my conclusion that “The design of the duodenoscope is to blame for the spreading bacteria, because the device contains small flaps that hold stents and other accessories. As a result, bacteria can become trapped in the flaps, making it difficult to purge even when following manufacturer or FDA guidelines.”

[3] The Seattle Times on July 2, 2016 provided my counsel that “Any infections that you contract shortly after the procedure could therefore be due to the endoscopic procedure, which would be important for you to know.”

[4] The Los Angeles Times on February 18, 2015 reported my assessment that: “These outbreaks at UCLA and other hospitals could collectively be the most significant instance of disease transmission ever linked to a contaminated reusable medical instrument.”

[5] The Los Angeles Times on March 25, 2016 wrote: “Muscarella said the secrecy surrounding the outbreaks means that the public probably will never know how many patients died from infections tied to the scopes. … ‘The number of patients infected and killed (as a result of a contaminated duodenoscope) … could be orders of magnitude higher,’ (Dr. Muscarella) said.”

[6] USA TODAY on March 19, 2015 reported my opinion that: “It’s fair to ask whether the FDA could have been doing more to regulate these devices and significantly reduce the risk of patient harm … Patients have died, and the agency seems to be moving slowly.”

Article by: Lawrence F Muscarella PhD. Posted August 24, 2016, Rev A.

Lawrence F Muscarella PhD founded LFM Healthcare Solutions, LLC, a Pennsylvania-based quality improvement and consulting company that provides safety services for hospitals, manufacturer and the publicEmail Dr. Muscarella for more details.

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