This article is divided into two sections, for the reader’s convenience: “Part 1: ‘The Outbreak'” and “Part 2: ‘Commentary: An superbug outbreak waiting to happen?'”  (‘Part 2’ can be read separately, in a different “window.” Just click the link immediately below.)

  1. Part 1 – “The Outbreak”
  2. Part 2 – “Commentary: An superbug outbreak waiting to happen?”

PART 1 – “The Outbreak”:  The Chicago Tribune published an article on January 10, 2014, with the headline:  “Superbug found at suburban hospital. Lutheran General, health officials taking steps to prevent spread of CRE” (click here to read this article).

This newspaper article provides some new information about this hospital’s outbreak of the “superbug” CRE, or carbapenem-resistant Enterobacteriaceae, that had not been previously reported.

For example, this Chicago Tribune article leaves the door open for Advocate Lutheran General Hospital’s outbreak of this “nightmare bacteria” to have been indirectly responsible for at least one patient’s death. It states that:

“State health officials said that no one had died as a direct result of infection or exposure. Officials could not say whether the bacteria had contributed to any deaths or current hospitalizations.”

Quality and Safety Services for Hospitals, Manufacturers, Patients:  Click here to read about Dr. Muscarella’s quality and safety services committed to reducing the risk of healthcare-associated infections, including CRE outbreaks linked to contaminated endoscopes and other reusable medical equipment.

According to Advocate Lutheran General Hospital, a type of gastrointestinal (GI) endoscope, known as a side-viewing duodenoscope, or “ERCP endoscope,” became contaminated and transmitted infectious CRE from one patient to another over a period of 8 months, from January, 2013, to September, 2013, when the outbreak was finally controlled.

As their name suggests, ERCP endoscopes are used during “endoscopic retrograde cholangiopancreatography,” or during ERCP, which is a specific type of upper GI endoscopic procedure that is routinely performed, in conjunction with fluoroscopy, to diagnose and treat diseases and disorders of the biliary and pancreatic ductal systems.

This Chicago Tribune article further reports that: “Even people who are asymptomatic can pose a risk because they still can transmit the bacteria, health officials said” — a weighty statement both with far-reaching public health implications (could handshaking transmit this disease?) and that may explain why Advocate Lutheran General Hospital disclosed this superbug outbreak to the public (8 months after it identified its first case of CRE infection), namely:

-> to prevent additional instances of CRE transmission (from a colonized or infected person) possibly in the community, outside and independent of the healthcare setting — for example, during direct physical contact.

Finally, this article in the Chicago Tribune quotes Dr. Leo Kelly, Lutheran General’s vice president of medical management, as warning the public with the following injunction:

“This is going to be a problem in other places,” … “It’s going to spread.”

This is a portentous and spot-on instruction, if not also an indictment, that requires heed.  Indeed, this risk assessment by Dr. Kelly suggests that Advocate Lutheran General Hospital’s documented outbreak of CRE linked to ERCP (and, possibly, the risk of transmission of other superbugs during other types of GI endoscopic procedures), with associated morbidity and mortality, may reveal only the tip of a vast and “infectious” iceberg.

What are “superbugs”? Certain infectious organisms have been assigned the moniker “superbugs” or “nightmare bacteria” by the Centers for Disease Control and Prevention (CDC) primarily because of their resistance to most antibiotics and their association with patient morbidity and mortality.

But Dr. Kelly’s statement otherwise is one with which this blog’s author might not entirely agree. Respectfully, this hospital’s outbreak of CRE during ERCP may display otherwise inconspicuous weaknesses of a system that have been and that are currently inherent to the practice of GI endoscopy and of endoscope reprocessing (see: “Part 2,” next page; question #3) — not merely a public-health concern that only the future singularly faces.

Supplement:  This article by Dr. Muscarella is a supplement to the following three articles discussing Advocate General Hospital’s “superbug” outbreak; the reader is directed to each:

  • Muscarella LF. “Overlooked Outbreaks of CRE Following GI Endoscopy: A Superbug Epidemic in Our Midst?” (Click here);
  • Muscarella LF. “Largest Outbreak of Dangerous Bacteria in U.S. Tied to GI Endoscopy at a Hospital in Park Ridge, Illinois.” (Click here);
  • Muscarella LF. “Investigation and Prevention of Bacterial Outbreaks following Endoscopic Retrograde Cholangiopancreatography.” (Click here);
  • Medscape. “CDC Confirms Superbug Transmission via Endoscopy – Medscape.” Click here. (Registration is free.)

Rather, having received little (if any) attention, almost a dozen instances of  transmission of the same superbug (CRE) and during the same GI endoscopic procedure (ERCP) as Advocate Lutheran General Hospital’s have been reported during just the past few years, both in the U.S. and globally.

Further, that other U.S. hospitals may, too, have encountered a CRE outbreak, but have not publicly disclosed it to date, is certainly a possibility.

These several reports of CRE infections are discussed in Dr. Muscarella’s article “Investigation and Prevention of Bacterial Outbreaks following Endoscopic Retrograde Cholangiopancreatography, or ERCP” (click here) to which the reader is directed.

It is unclear why corrective actions to prevent CRE transmission during ERCP have not been previously published, employed, and underscored, based on these dozen documented reports, but are surfacing only now. These several instances of CRE transmission during ERCP raise the possibility that Advocate Luthern General Hospital’s recent outbreak is a case of deja vu?— LF Muscarella PhD

Is disinfection of GI endoscope inadequate?  Advocate Lutheran General Hospital’s CRE outbreak was also discussed during Fox News’s popular, round-table “Sunday Housecall” program (January 12, 2014) entitled: “Troubling outbreak of drug-resistant bacteria linked to hospital in Chicago area” — click here.

Like Fox News’s “Sunday Housecall” program, this article in the Chicago Tribune further reports that:

“Based on what happened at Lutheran General, which properly followed sanitizing protocols, federal and state agencies now are investigating whether there needs to be a change in how such scopes are sterilized between procedures,” quoting Dr. Alex Kallen, a medical officer with the CDC, as saying that: “It is concerning, and it is something that we are paying attention to.”

Again, respectfully, this blog’s author would not necessarily agree, having previously published in his recent article “Overlooked Outbreaks of ‘CRE’ Following GI Endoscopy: A ‘Superbug’ Epidemic in Our Midst?” (click here) that:

CRE and other types of vegetative bacteria are susceptible to, and readily and quickly destroyed by, high-level disinfection, provided, however, that the design of the GI endoscope or other type of processed instrument does not hinder contact of the detergent and high-level disinfectant with every one of its contaminated surfaces. — Lawrence F Muscarella PhD

A quality system:  Inadequate disinfection of Advocate Lutheran General Hospital’s ERCP endoscopes, possibly with one or more associated patient deaths, may be due more to flaws with the “dovetailing” of the instrument’s complex physical design with an effective reprocessing regimen than necessarily to a potential shortcoming in the disinfection process or in published national infection-control guidelines.

If this assessment is true — and this point is at the heart of the core principles of a quality assurance program — then the redesign of complex instruments, so that they may more readily and conveniently facilitate reprocessing, might be the more apt, if urgent, action to take to reduce the risk of further instances of CRE transmission than to revamp altogether the procedures used to reprocess ERCP endoscopes after each clinical exam.

The use of high-level disinfectants, in strict accordance with their FDA-cleared labeling, would presumably prevent any contaminated GI endoscope, even a ERCP endoscope, from transmitting CRE from one patient to another, provided, again, that the disinfectant — whether used manually or in conjunction with an automated endoscope reprocessor, or AER — contacts every one of the GI endoscope’s potentially contaminated surfaces and internal channels (including the ERCP endoscope’s elevator wire-channel and distal forceps).

Alert: Infection, colonization: Another Chicago newspaper, the Chicago Sun-Times (click here), recently reported that:

  • a total of 243 patients underwent ERCP at this hospital during the time of its outbreak (i.e., between January and September, 2013) and, therefore, are considered by health officials to be at risk of CRE infection;
  • of the patients contacted, 105 have returned for screening after the hospital notified them of their increased risk of a superbug infection (due to each having undergone ERCP at this hospital at the time of its outbreak, between January, 2013, and September, 2013); and
  • thirty-eight (38) of these 105 patients of Advocate Lutheran General Hospital were found to be infected or colonized with CRE — that’s a minimum of 16% of the total number of “at risk” patients.

Alert: A December 27, 2013, report in the Daily Herald newspaper (click here) discloses that, while 105 of its notified patients had returned to Advocate Lutheran General Hospital, so far, to be tested for CRE infection, a total of 243 patients underwent ERCP at this hospital during the time of its outbreak (i.e., between January and September, 2013) and, therefore, 138 additional patients, considered by health officials to be at risk of CRE infection, have not returned to the hospital for screening.

Ten of these 38 patients were confirmed to be infected with CRE, while the majority, 28 of these 38 patients, were colonized with CRE, meaning simply that these 28 patients harbored this superbug in their bodies — and therefore could unwittingly transmit it to others during, for example, physical contact — but did not display clinical signs and symptoms of CRE infection, presumably being entirely unaware that each was carrying infectious CRE (linked to the largest superbug outbreak in U.S. history).

The CDC reports that 44 people, in total, were infected or colonized with CRE in northeastern Illinois (38 of whom were patients of Advocate Lutheran General Hospital and underwent ERCP between January and September, 2013).

Whether any of these other remaining 6 people infected with CRE — none of whom were patients of, or underwent ERCP at, Advocate Lutheran General Hospital — had been in direct or indirect physical contact with one or more of this hospital’s 38 infected or colonized patients, demonstrating, possibly, community-transmission of CRE, is unclear, but is important to determine. These 6 other patients infected with CRE had been treated in other health care facilities in northeastern Illinois.

CRE’s mortality rate:  The aforementioned Chicago Tribune article (dated: 01/10/2014) states that: “… 10 of (the hospital’s patients infected with CRE) were ill — some of them critically, with infections in the blood, urine or in wounds.”

This is a particularly concerning finding, because CRE infections of the blood are associated with a mortality rate of as high as 50%.

The importance of GI endoscopes being properly designed by manufacturers and attended to by staff to ensure their thorough reprocessing after each clinical use is emphasized. — Lawrence F Muscarella PhD

Until definitively stated to the contrary, it may be reasonable to conclude that Advocate Lutheran General Hospital’s recent outbreak of CRE following ERCP resulted, either directly or indirectly, in at least one of these 10 patients’ death.

Examples of CRE: Two examples of CRE are: (i) NDM-producing Escherichia coli and (ii) KPC-producing Klebsiella pneumoniae.     Click here to read Dr. Muscarella’s article that discusses in more detail the family, genus, and species classifications of CRE.

Flexible endoscopes, HAIs: Flexible endoscopes are reportedly associated with more documented instances of healthcare-associated infections (“HAIs”) than any other type of reusable medical equipment, in part because of the complexity of their physical design, which is a consequence of their clinical uses and applications.

Part 2: Commentary: An “superbug” outbreak waiting to happen?

Advocate Lutheran General Hospital’s outbreak of CRE following GI endoscopy, if nothing else, raises the question whether the current program, or healthcare system, of treating patients with GI endoscopes is enduring too much stress and may be placing unreasonable demands on healthcare staffers, manufacturers, and regulatory agencies, posing an increased risk of patient harm and superbug transmissions.

In short, among other failings, Advocate Lutheran General Hospital’s outbreak of CRE may indicate that GI endoscopy has pushed itself beyond its reprocessing limits and original design specifications, causing the formation of a “perfect storm,” due to the conflation of:

  • a large number of patients — many of whom are ill, immuno-suppressed and otherwise vulnerable to infections, particular those caused by superbugs — seeking medical treatment for diseases and disorders of the GI tract;
  • healthcare facilities and providers, facing growing financial constraints and pressures, being asked to see more patients and to perform more GI procedures using GI endoscopes, but with fewer resources;
  • reprocessing staffers and technicians being expected, possibly, to reprocess — that is, to clean and disinfect — GI endoscopes too quickly, too cursorily, so that these coveted instruments may be quickly returned to the GI endoscopy department for immediate use on the next patient in line, the reasons for which may include healthcare facilities having a limited number of expensive GI endoscopes in their inventory, despite the high number of patients requiring GI endoscopy;
  • federal regulators being overwhelmed and with limited resources; and
  • medical-device manufacturers being responsible for designing complex surgical instruments and flexible endoscopes, not necessarily or only to facilitate their cleaning and disinfection, but also, due to customer requests, to accommodate the growing therapeutic and diagnostic demands of the medical procedure.

The possibility that the reprocessing of GI endoscopes has become stressed to the point of, and beyond, tensile breakage appears to be supported by the facts and therefore is important to consider. — Lawrence F Muscarella PhD

As mentioned in this article’s “Part 1” (above), Advocate Lutheran General Hospital’s outbreak of CRE is not the first instance of recent transmission of a superbug during ERCP.  As many as a dozen reports linking CRE transmission to ERCP have been previously reported during the past few years, both in the U.S. and Europe – click here to read about these reports.

No matter, once the CDC wrote in the January 3, 2014, issue of the MMWR (click here to read this CDC report) that:

— “the design of the ERCP endoscopes might pose a particular challenge for cleaning and disinfection”;

— despite manual cleaning and high-level disinfection using an automated endoscope reprocessor, NDM-producing E. coli and KPC-producing K. pneumoniae were recovered from the terminal section (the elevator channel) of the ERCP endoscope; and

— no new infections of CRE were identified once Lutheran General Hospital began reprocessing its ERCP endoscopes, no longer with the automated endoscope reprocessor, but instead using ethylene oxide gas sterilization,

it then becomes self-evident that immediate attention and redress are necessary, to ensure the safety of GI endoscopy and to prevent additional patient harms.

Corrective actions: Medical errors and deviations cannot be corrected, prevented or otherwise remediated unless every one of their significant contributing factors or root causes is identified, investigated, and correspondingly mapped to one or more effective corrective and/or preventive actions, known as “CAPAs.” Such are the requirements of a quality system.

Now that at least some of the deviations that contributed to Advocate Lutheran General Hospital’s CRE outbreak appear to have been identified, several “prescribed” corrective actions that would reasonably reduce the stress placed on GI endoscopy, and would prevent further instances of CRE transmission during a GI endoscopic procedure, would include (but not be limited to):

  • improved management of patient scheduling;
  • more frequent internal (and external) audits of the infection-control practices of reprocessing staffers to ensure proper techniques are being employed;
  • more funding for GI endoscopy department, especially those performing ERCP, ensuring that a sufficient number of GI endoscopes are in inventory to treat the number of daily scheduled patients;
  • reprocessing staffers and technicians being provided sufficient time and training, if not also being certified, to ensure GI endoscopes are thoroughly cleaned and disinfected (or, possibly, sterilized) after each use, in accordance with the manufacturer’s published instructions;
  • enhanced quality-control and safety procedures within medical device companies to ensure unrivaled quality; the prompt issuance and completion of CAPAs, as warranted; the implementation and control of safe device designs that facilitate reprocessing; and the development of thorough root cause analyses (RCAs) and failure-mode-and-effects-analyses (FMEAs), as required;
  • improved federal oversight, including more funding for the federal regulation of medical devices; and, to be sure,
  • more frequent and detailed interactions, collaborations, and discussions between stakeholders, namely, between the FDA and other regulatory and accrediting agencies; gastrointestinal nursing and physician organizations; medical device companies; hospital associations; and patient advocacy groups.

Notably, these corrective actions may contribute as much to the reduction of disease transmission during ERCP, if not more so, than a singular change to the ERCP endoscope’s disinfection regimen.

Additionally, a number of recommendations to prevent disease transmission during GI endoscopy, in general, are provided here, and during ERCP, in particular are provided here.

Responsibility for correcting this apparently broken system rests not merely at Advocate Lutheran General Hospital, but nationally, and with all of us. — Lawrence F Muscarella PhD

Closing questions – Question #1:  A question that remains unanswered is whether — based on Advocate General Hospital’s comments and the CDC’s findings recently published in MMWR (see above, Part 1) — all ERCP endoscopes now require, after each clinical use, exposure to a complete ethylene oxide (EtO) gas sterilization cycle.

Contact Precautions: Patients identified with CRE infection or colonization would likely require being placed onclick here — Contact Precautions to prevent the superbug’s spread via direct or indirect contact.

This is an important question to ask, understanding that EtO gas sterilization is time-consuming; of questionable effectiveness when used to reprocess ERCP endoscopes; and a stark deviation from current (and past) reprocessing guidelines for GI endoscopes.

The standard of care for the past several decades has always required the high-level disinfection of all type of GI endoscopes, including ERCP endoscopes — click here to read an article by Dr. Muscarella that discusses this question in more detail.

Update: In August, 2015, the FDA published four supplemental measures — including that hospitals consider EtO gas sterilization of duodenoscopes following their cleaning and high-level disinfection — to further reduce the risk of superbug transmissions.

Question #2: A second fair question to ask — based on the finding, reported in the aforementioned Chicago Tribune article (01/10/2014), that a significant number of the patients who were called back to Advocate Lutheran General Hospital to be screened for CRE infection were either infected or colonized with the superbug — is whether there are sufficient data to notify and screen, too, for CRE infection or colonization, all patients who have undergone ERCP within the past year or two (or longer) at any U.S. hospital using the same or a comparable model of ERCP endoscope as the one Advocate Lutheran General Hospital linked to its CRE outbreak.

This question has not, to date, been addressed by health officials.

Question #3:  And a third question to ask, based on Advocate Lutheran General Hospital’s CRE outbreak and one that follows from the second question, above, is whether GI endoscopes might more often than reported, though certainly inadvertently, transmit (from one patient to another) otherwise inconspicuous bacteria during GI endoscopy, including colonoscopy, that would be realized only if they are of a readily detectable “superbug” type, such as CRE, that cause observable infection, as opposed to asymptomatic (if silent) colonization.

This possibility raises some questions about the Veterans Health Administration’s (VHA) decision in 2009 to notify more than 10,000 patients affected by one or more instrument-reprocessing breaches only of their risk of infection with a blood-borne virus — not, too, of the potential for them to have been infected or colonized with a superbug, such as CRE.

The report by the VA’s Office of the Inspector General (VA-OIG) that discusses the VHA’s notification of these 10,000 veterans is entitled “Use and Reprocessing of Flexible Fiberoptic Endoscopes at VA Medical Facilities” — clicking here to read it.

As Dr. Muscarella discusses in detail in his article “Overlooked Outbreaks of ‘CRE’ Following GI Endoscopy: A ‘Superbug’ Epidemic in Our Midst?” (click here), the VHA wrote in this report that it considered the 10,000 affected patients to be at risk only for viral illnesses specifically caused by the hepatitis B and C viruses and HIV.

The VHA did not inform these affected patients of the risk of infection from a superbug such as CRE for the sole reason that, according to the VHA, bacterial infection “would result in illness within days of the endoscopy.”

But, the investigation of Advocate Lutheran General Hospital’s outbreak appears to belie these actions by the VHA in 2009.

This Chicago hospital’s post-endoscopic surveillance data suggest that, possibly, some of the VHA’s 10,000 affected patients might have harbored CRE (or another type of superbug) as a result of cross-contamination caused by one of the several confirmed instrument-reprocessing breaches discussed in the VA-OIG’s report.

Breaches within the VA: These breaches within the VHA — namely, at the VA medical facilities in Murfreesboro (TN), Augusta (GA) and Miami (FL) — are discussed, not only in this report by the VA-OIG, but also in Dr. Muscarella’s related article “Improper Use and Reprocessing of a Gastrointestinal Endoscope’s Auxiliary Water System” — click here.

Most striking, if colonized (not infected) with a superbug, these veterans would not display symptoms of disease and therefore might not know that their bodies were harboring a superbug. These patients would be carrying a “microbial time bomb” that, possibly waiting to explode, would warrant prompt attention and antibiotic therapy.

It would be interesting to learn, if some of these 10,000 affected veterans were called back and screened for CRE, whether their incidence of colonization (or even infection) with a superbug is significantly higher than that of randomly selected members of the general public (i.e., a control group).

Question #4: As previously noted, the CDC reports that a total of 44 people were infected or colonized with CRE in northeastern Illinois, 38 of whom were patients of Advocate Lutheran General Hospital (located near Chicago, Illinois) and underwent ERCP at this hospital at the time of its outbreak, between January and September, 2013.

These findings raise an important question:  Were any of these other 6 people who were infected with CRE, but whom reportedly did not undergo ERCP at Advocate Lutheran General Hospital, in physical contact with one or more of this hospital’s 38 infected or colonized patients, demonstrating, possibly, community-transmission of CRE?

This is a good question, but its answer is unknown at this time.

Additional recommended reading:

  • Muscarella LF. “Overlooked Outbreaks of CRE Following GI Endoscopy: A Superbug Epidemic in Our Midst?” (Click here);
  • Muscarella LF. “Largest Outbreak of Dangerous Bacteria in U.S. Tied to GI Endoscopy at a Hospital in Park Ridge, Illinois.” (Click here);
  • Muscarella LF. “Investigation and Prevention of Bacterial Outbreaks following Endoscopic Retrograde Cholangiopancreatography, or ERCP.” (Click here);
  • Medscape. CDC Confirms Superbug Transmission via Endoscopy – Medscape. Click here. (Registration is free.)
  • Muscarella LF. Muscarella LF. Investigation and prevention of infectious outbreaks during endoscopic retrograde cholangiopancreatography. Endoscopy [Editorial] 2010;42:957–9.
  • Centers for Disease Control and Prevention. Notes from the Field: New Delhi Metallo-β-Lactamase–Producing Escherichia coli Associated with Endoscopic Retrograde Cholangiopancreatography — Illinois, 2013. MMWR January 3, 2014;62(51);1051-1051.

Article by Lawrence F Muscarella, PhD, president and owner of LFM Healthcare Solutions, LLCclick here for a list of its services. Article posted 1/24/2014; updated 9/10/2015, Rev A.

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